The Gates Foundation is part of the Grand Challenges partnership network. Visit <a href="https://www.grandchallenges.org" target="_blank">www.grandchallenges.org</a> to view the map of awarded grants across this network and grant opportunities from partners.

Grand Challenges supports exceptional scientists with the expertise to do breakthrough R&amp;D as well as the experience, networks, and skills to excel as scientific leaders. These champions co-create projects with global partners, mobilize key institutions in their countries, and improve public health in their communities and around the world.

Grand Challenges funds innovations to tackle the biggest problems in global health and development. Since 2004, through the Grand Challenges program, we have supported more than 2500 innovation projects in more than 90 countries.

For more than 20 years, Grand Challenges has built trusted relationships with global health funders and researchers. We tap into this powerful network to create unique scientific collaborations with a transformative impact on people's lives.

Innovation happens all along the journey from idea, to experiment, to product or policy, and finally to delivery at scale in communities. We fund innovation projects while supporting an environment of champions, systems, and partnerships to maximize the impact these projects make in people's lives.

The 4 Pillars of the Grand Challenges Ecosystem

Doing groundbreaking science requires the right mix of institutions, policies, and tools. Grand Challenges works with partners in low- and middle-income countries to build or strengthen the capacities they need to succeed in R&amp;D.

Professor Abdoulaye Djimdé Named to UN Secretary General's Scientific Advisory Board

<a href="https://gcgh.grandchallenges.org/champion/abdoulaye-djimde" target="_blank">Professor Abdoulaye Djimdé</a> has been appointed to the <a href="https://www.un.org/scientific-advisory-board/en/board-members" target="_blank">United Nations Secretary-General's Scientific Advisory Board</a>, marking an important step in elevating African leaders' voices in global research and science policy conversations.A leading expert in malaria genomics and drug resistance, Prof. Djimdé is focused on building research capacity and scientific collaboration across the continent. He embodies the <a href="https://gcgh.grandchallenges.org/champions" target="_blank">Calestous Juma Science Leadership Fellowship's</a> vision to cultivate scientists who not only drive innovation but also guide decision-making and international cooperation.At a time when the world faces increasingly complex health and development challenges, Prof. Djimdé will bring an important and unique perspective to the board's work on science, technology, and innovation for sustainable development. "Scientific knowledge is strongest when it reflects diverse perspectives," Prof. Djimdé said in response to the appointment, "and I look forward to contributing African experience and expertise to conversations shaping the future of global health and development."

We challenge innovators around the world to work on urgent priorities in global health and development. We issue new challenges regularly and award the most promising proposals with grant funding.&nbsp;

Past Challenges

Grand Challenges

Addressing Physiological Barriers to Micronutrient Absorption from Fortified Foods

Before applying to this Grand Challenges request for proposals (RFP), applicants should familiarize themselves with the supporting documents, including the <a href="https://docs.gatesfoundation.org/documents/sample-terms-and-conditions.pdf" target="_blank" rel="noopener noreferrer">terms and conditions of the Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/strategies_to_improve_fortification_programs_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/strategies_to_improve_fortification_programs_application_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/addressing-physiological-barriers-micronutrient-absorption-fortified-foods-frequently-asked" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated <a href="https://events.teams.microsoft.com/event/56546af0-f206-4898-9303-a5ebfac6e9a7@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" rel="noopener noreferrer">webinar</a> on April 2, from 8:30-9:30 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the <a href="https://events.teams.microsoft.com/event/56546af0-f206-4898-9303-a5ebfac6e9a7@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" rel="noopener noreferrer">webinar</a>, please register and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dMKiReMZsCJFmCa42S92Da1UNkJHR1BPNkhSMVNDVDUwNEdKRlBQUExRVS4u" target="_blank" rel="noopener noreferrer">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
Despite the proven potential of large-scale food fortification to address micronutrient deficiencies, biological constraints may limit its impact in high-burden settings. Chronic inflammation - driven by recurrent infections, environmental enteric dysfunction (EED), poor sanitation, metabolic disorders, or other systemic stressors - can impair intestinal absorption and alter nutrient metabolism. For example, inflammation-induced upregulation of hepcidin reduces iron absorption and mobilization, diminishing the effectiveness of iron fortification even when dietary intake is sufficient. Inflammation and gut barrier dysfunction can also compromise the absorption of other micronutrients, including zinc and fat-soluble vitamins. In parallel, alterations in the gut microbiome may influence micronutrient bioavailability through competitive uptake, reduced endogenous vitamin synthesis, and amplification of mucosal inflammation. These physiological barriers are particularly salient in low-resource contexts where infection and undernutrition co-occur.
<h2>The Challenge</h2>
We are soliciting, through this Grand Challenges RFP, applications that advance innovative approaches to better understand, measure, and mitigate infection, inflammation- and microbiome-mediated constraints that limit the impact of fortification interventions. The goal is to overcome key biological barriers and unlock the full potential of fortification programs to accelerate equitable gains in nutrition and health. Solutions could include novel biomarkers to identify populations with impaired nutrient utilization, fortificant formulations optimized for inflammatory states, adjunctive strategies to restore gut function, or integrated interventions that address infection, gut health, and micronutrient delivery simultaneously. Addressing these biological barriers is essential to unlocking the full potential of fortification programs and accelerating equitable gains in nutrition and health.
The challenge aims to:
<ul>
<li>Identify the physiological parameters that can be modulated to improve micronutrient absorption.</li>
<li>Offer a solution for delivery and effective absorption of micronutrients such as iron in a target population where nutritional interventions have not been effective.</li>
<li>All stages of development would be accepted provided the potential impact is clearly defined. We will particularly consider new innovative product ideas, proof of concept and discovery of new approaches to achieve more effective fortification. The solution is not limited to a product; it can also be a strategic approach and is open to discovery R&amp;D program proposals to address unanswered scientific questions.&nbsp;</li>
</ul>
Funding Level
We will consider proposals for awards of up to $250,000 USD for each project, with a grant term of 18 months. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered and should be included in the budget for the up to $250,000 USD award (subject to the&nbsp;<a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank" title="https://docs.gatesfoundation.org/documents/indirect_cost_policy.pdf" rel="noopener noreferrer">Gates Foundation's indirect cost policy</a>).
Eligibility Criteria
This initiative is open globally to nonprofit organizations, for-profit companies, international organizations, government agencies and academic institutions. Multi stakeholder collaborations are encouraged. Individuals and organizations classified as individuals for U.S. tax purposes are not eligible to receive an award from the foundation as part of this initiative.&nbsp;
We are looking for proposals that consider:&nbsp;
<ul>
<li>Clear framing of the problem:
<ul>
<li>Explicit articulation of how inflammation, infection, EED, metabolic conditions, or gut dysbiosis limit micronutrient absorption and utilization.</li>
<li>Defined target population and context where fortification effectiveness is currently constrained.</li>
</ul>
</li>
<li>Strong biological rationale
<ul>
<li>Mechanistic understanding (e.g., hepcidin-mediated iron blockade, impaired fat absorption, microbiome–nutrient interactions).</li>
<li>Clear linkage between proposed solution and the underlying physiological barrier.</li>
</ul>
</li>
<li>Innovative and testable solution
<ul>
<li>Novel fortificant formulations, delivery approaches, or adjunctive therapies.</li>
<li>Microbiome-modulating, anti-inflammatory, or gut-repair strategies integrated with fortification.</li>
<li>Development or validation of practical biomarkers to identify or stratify affected populations.</li>
</ul>
</li>
<li>Feasibility and scalability
<ul>
<li>Practical pathway for integration into existing fortification platforms or delivery systems.</li>
<li>Cost-effective design appropriate for low-resource settings.</li>
<li>Consideration of regulatory, manufacturing, and supply chain implications.</li>
</ul>
</li>
<li>Measurement and evaluation plan
<ul>
<li>Clearly articulated theory of change with appropriate outcomes related to micronutrient absorption, status, and functional impact.</li>
<li>Inclusion of inflammation and/or gut function biomarkers where appropriate.</li>
<li>Rigorous study design with defined milestones and go/no-go criteria.</li>
</ul>
</li>
<li>Equity and context relevance
<ul>
<li>Focus on populations with high burdens of infection, undernutrition, or systemic inflammation.</li>
<li>Engagement with local partners and alignment with national nutrition strategies.</li>
</ul>
</li>
<li>Risk assessment and mitigation
<ul>
<li>Consideration of potential unintended consequences (e.g., microbiome disruption, pathogen proliferation, adverse nutrient interactions).</li>
<li>Defined strategy for mitigating and managing scientific and implementation risks.</li>
</ul>
</li>
<li>Team capability
<ul>
<li>Multidisciplinary expertise as required for the topic (nutrition, immunology, microbiome science, implementation science, product development).</li>
<li>Demonstrated ability to translate discovery into scalable impact.</li>
</ul>
</li>
</ul>
We will not fund proposals that focus on:
<ul>
<li>Agricultural and plant biology related topics of research.</li>
<li>Live biotherapeutics which will encounter regulatory challenges for use in food.</li>
<li>Public health data collection and population status assessment.</li>
<li>Policy making and advocacy.</li>
<li>Commercialization and marketing solely.</li>
</ul>

We are soliciting applications that advance innovative approaches to better understand, measure, and mitigate infection, inflammation- and microbiome-mediated constraints that limit the impact of fortification interventions. The goal is to overcome key biological barriers and unlock the full potential of fortification programs to accelerate equitable gains in nutrition and health.

Artificial Intelligence (AI) to Accelerate Charitable Giving

Before applying to this Grand Challenges request for proposals (RFP), applicants should familiarize themselves with the supporting documents, including the <a href="https://docs.gatesfoundation.org/documents/sample-terms-and-conditions.pdf" target="_blank" rel="noopener noreferrer">terms and conditions of the Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/ai_accelerate_charitable_giving_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/ai_accelerate_charitable_giving_applications_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/artificial-intelligence-ai-accelerate-charitable-giving-frequently-asked-questions-faqs" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated <a href="https://events.teams.microsoft.com/event/f5a7bf0d-a822-4102-a6d3-5e1c5bbeb22f@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" rel="noopener noreferrer">webinar</a> on March 23, from 7:00-8:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the <a href="https://events.teams.microsoft.com/event/f5a7bf0d-a822-4102-a6d3-5e1c5bbeb22f@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" rel="noopener noreferrer">webinar</a>, please register and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dMKiReMZsCJFmCa42S92Da1UNEFaUTNVMjNSUVYzVklVTk0zQkFJQzZWSC4u" target="_blank" rel="noopener noreferrer">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
The Gates Foundation's Philanthropic Partnerships Team (PPT) mobilizes resources and cultivates champions for global health and development (GH&amp;D), ensuring that philanthropy helps the world's most vulnerable children survive and thrive.
Many people want to make a difference but aren't always sure how to turn that intention into action. Our work helps donors move from interest to impact, working alongside individuals, foundations, advisors, and other sector partners while strengthening the broader systems that support effective giving.
Artificial intelligence (AI) is advancing rapidly, reshaping how people access information, make decisions, and engage with the world. For philanthropy, this creates an opportunity to rethink how AI can help donors discover causes and move from interest to action at moments when it matters most.
To explore this opportunity, PPT is launching the AI to Accelerate Charitable Giving Grand Challenges RFP to explore how AI can strengthen philanthropic practice and unlock new possibilities for generosity. The Challenge aims to enhance human decision-making with AI-powered tools, data, and insights that help donors give more and give sooner.
<h2>The Challenge</h2>
We are seeking applications and use cases of AI that address the core question: How might AI support donors to give more and give sooner?
This RFP is focused on supporting donor-facing applications and underlying systems of giving that test and demonstrate bold, innovative applications of AI that strengthen and expand philanthropic giving. Desired outputs include generating practical evidence and examples to inform broader practice across the philanthropic sector. We are particularly interested in solutions that increase support for GH&amp;D.
For this RFP, GH&amp;D refers broadly to efforts that improve health, economic opportunity, and human well-being in low- and middle-income countries. Within this field, we are especially interested in efforts that reduce preventable mortality, combat infectious diseases, and expand pathways out of extreme poverty, consistent with the <a href="https://www.gatesfoundation.org/ideas/articles/core-mission-child-health-success" target="_blank" rel="noopener noreferrer">Gates Foundation's long-term goals</a>.
Projects do not need to focus exclusively on GH&amp;D to be competitive. However, proposals that clearly demonstrate applicability to GH&amp;D challenges, or that generate insights relevant to these priorities, will receive additional consideration. We welcome proposals that address the needs of various donor types including everyday donors, high-net-worth individuals, foundations, or other entities relevant to the challenge areas below.
We invite proposals that address at least one of the following challenge areas:
1. Help donors connect with causes and understand where to give to achieve their giving goals
How can AI help people discover causes they care about, understand why they matter, and see where their giving can make a meaningful difference?
Many donors want to give but struggle to navigate a crowded and complex landscape of causes, organizations, and appeals. Geographic distance, limited context, and uncertainty about effectiveness can make it difficult to decide where to focus funds or where to begin.
We seek solutions that help donors make sense of their options, connect their values to specific opportunities, and build confidence that their contributions can make a meaningful difference across a range of issue areas, including GH&amp;D. Examples include:
<ul>
<li>AI-powered recommendation engines that match donors to issues they care about</li>
<li>Personalized learning tools that adapt content, depth, or recommendations as a donor's understanding, interests, and confidence evolve over time</li>
<li>Immersive or narrative tools that make global issues feel human and relatable</li>
<li>Applications that help donors visualize the impact their dollars can create</li>
</ul>
2. Turn interest and intent into donations
How can AI create pathways to help people move from motivation to meaningful contribution?
Many people are motivated to contribute yet fail to follow through because the giving process feels complex, overwhelming, or uncertain.
We seek solutions that reduce friction, enable follow-through on the intention to give, and foster sustained engagement beyond a single transaction. Examples include:
<ul>
<li>Tools that simplify logistical barriers to giving such as cross-border vetting, due diligence, or compliance challenges</li>
<li>Systems that build community or shared motivation among donors</li>
<li>Designs that make giving feel clear, safe, and meaningful</li>
</ul>
3. Develop the foundational systems and infrastructure that enable AI-powered giving
How can we ensure that AI systems reflect accurate philanthropic data and values so that giving and social impact are part of the information people access every day?
As AI increasingly shapes how people learn and make decisions, philanthropy must be represented in the underlying data and tools that drive these systems.
We seek focused, practical projects that ensure philanthropic data is visible, credible, and usable by AI systems in ways that support donor understanding, confidence, and giving. Examples include:
<ul>
<li>Data pipelines or open standards that expose charitable data to algorithms</li>
<li>Training models to better recognize and contextualize social impact</li>
<li>Applications that make nonprofit websites and payment platforms more interoperable with AI agents (i.e., enabling agents to donate to nonprofit organizations)</li>
<li>Solutions that detect and prevent fraud or misuse in donation processes supported by AI</li>
</ul>
AI Ethics and Responsibility
The Gates Foundation is committed to harnessing AI for social good while mitigating risks such as bias, inequity, and potential harm, particularly to vulnerable populations. As AI-enabled tools increasingly shape how people access information and make decisions, ethical and responsible use of AI is a foundational consideration that should inform how solutions are designed, tested, and deployed.
Applicants are not required to submit a separate response on ethical and responsible AI considerations. However, proposals should demonstrate thoughtful awareness of ethical issues as part of the project's learning and experimentation process, including how potential risks may evolve as systems are tested with real users. The Foundation may request clarification during the application review process as needed.
In evaluating proposals, reviewers will consider alignment with the Foundation's AI principles, which are summarized below:
<ol>
<li>AI efforts should align with the Foundation's mission to improve health, reduce poverty, and expand opportunities for those facing the greatest challenges.</li>
<li>AI solutions should be informed by the needs and perspectives of the community they are intended to serve.</li>
<li>Potential risks and unintended harms should be identified and addressed throughout the AI lifecycle, including monitoring for unintended consequences.</li>
<li>Personal and sensitive data must be handled responsibly and protected from misuse.</li>
<li>AI solutions should be designed for broad benefit and be accessible and usable in their intended contexts.</li>
<li>Be transparent about how AI is used, including its purpose, limitations, and governance.</li>
</ol>
Funding Level
We will consider applications requesting awards up to $150,000 USD per project, with a grant duration of up to 1 year. Budgets should align with the scale and complexity of the proposed work. Indirect costs are allowable and should be included within the total requested funding (subject to the Gates Foundation's <a href="https://docs.gatesfoundation.org/documents/indirect_cost_policy.pdf" target="_blank" rel="noopener noreferrer">indirect cost policy</a>).
Travel expenses for in-person convenings with peer grantees hosted by the Gates Foundation will be covered separately by the Foundation. Please only include additional travel costs within your proposed budget.
Eligibility Criteria
Applicants must be able to conduct all project activities and reporting in English and be willing and able to participate in up to three virtual and/or in-person learning convenings with peer grantees over the one-year grant period. Eligible entities for this initiative include:
<ul>
<li>Nonprofit and Civil Society Organizations, including registered nonprofits and charities, non-governmental organizations (NGOs), and community-based organizations.</li>
<li>Mission-Driven For-Profit Organizations. For-profit entities that have a clear public-benefit mission aligned with the goals of the RFP are eligible. Funding cannot be used for core commercial product development or general business operations. Proposed activities must advance equitable, responsible, or safe uses of AI in ways that benefit society.</li>
<li>Consortia, Partnerships, &amp; Collaborative Proposals. Proposals may be submitted through partnerships and other collaborative arrangements. In such cases, one lead organization must serve as the primary applicant and submit the proposal, with partner organizations included as sub-grantees.</li>
</ul>
For this initiative, the following entities are not eligible:
<ul>
<li>Individuals and organizations classified as individuals for U.S. tax purposes.</li>
<li>Government agencies or departments.</li>
<li>Academic institutions applying independently (unless part of a consortium led by an eligible organization).</li>
</ul>
Proposal Requirements
Recognizing that AI-enabled philanthropic tools are part of an evolving field, we value both measurable donor outcomes and the production of practical learning about what works, what does not, and why. Proposals are encouraged to contribute insights that can inform broader philanthropic practice, even where initial approaches require iteration.
We are looking for proposals that:
<ul>
<li>Have relevance to the challenge areas
<ul>
<li>Apply AI in clear, compelling ways to motivate donors to give more and give sooner, directly advancing one or more of the challenge areas. &nbsp;</li>
</ul>
</li>
<li>Illustrate expected impact
<ul>
<li>Articulate the meaningful change the project is expected to produce that can inform broader philanthropic practice. &nbsp;</li>
</ul>
</li>
<li>Plan for feasibility
<ul>
<li>Describe the methodology for pressure-testing and validating the proposed concept, including how AI tools, models, or data pipelines will be tested and evaluated in real-world conditions to assess feasibility. &nbsp;</li>
</ul>
</li>
<li>Have plans for measuring success
<ul>
<li>Describe how success will be assessed during the grant period including the indicators or methods used to evaluate both pilot outcomes (i.e., changes in donor behavior or confidence) and learning outcomes.</li>
<li>Explain how these insights will inform broader philanthropic practice. &nbsp;</li>
</ul>
</li>
<li>Describe potential scale
<ul>
<li>Articulate how the project could be sustained, scaled, or shared beyond the grant period.</li>
<li>Demonstrate the potential for adaptation or extension across geographies, donor types, philanthropic issues, or giving platforms.</li>
<li>Go beyond narrowly tailored, organization-specific use cases to create insights, tools, or approaches that improve donor experience or decision-making and have broader applicability across the philanthropic ecosystem. &nbsp;</li>
</ul>
</li>
<li>Use responsible AI practices and safeguards
<ul>
<li>Identify risks related to responsible AI use and describe plans to mitigate them, including fairness, transparency, privacy, and data governance.</li>
</ul>
</li>
</ul>
We will not consider funding for proposals that:
<ul>
<li>Do not address the core question: How might AI support donors to give more and give sooner?</li>
<li>Do not identify at least one challenge area and demonstrate how the proposed solution meaningfully aligns with it.</li>
<li>Do not apply AI as a central component of the proposed solution.</li>
<li>Lack clear relevance to donor decision-making and charitable giving, including meaningful applicability to GH&amp;D.</li>
<li>Do not include a practical plan to test, measure, and generate actionable learning within the grant period that informs broader philanthropic practice.</li>
<li>Primarily support commercial product development, general business operations, or private profit.</li>
<li>Fail to demonstrate responsible AI practices, including attention to bias, privacy, transparency, and data governance.</li>
<li>Request more than $150,000 USD, exceed a one-year grant term, or are submitted by ineligible entities.</li>
</ul>

Artificial intelligence (AI) is advancing rapidly, reshaping how people access information, make decisions, and engage with the world. For philanthropy, this creates an opportunity to rethink how AI can help donors discover causes and move from interest to action at moments when it matters most. To explore this opportunity, PPT is launching the AI to Accelerate Charitable Giving Fund to explore how AI can strengthen philanthropic practice and unlock new possibilities for generosity. The fund aims to enhance human decision-making with AI-powered tools, data, and insights that help donors give more and give sooner.

Breakthrough Innovations to Significantly Reduce the Cost of Severe Acute Malnutrition Treatment

Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including <a href="https://docs.gatesfoundation.org/documents/sample-terms-and-conditions.pdf" target="_blank" rel="noopener noreferrer">the terms and conditions of the Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/reduce_cost_severe_acute_malnutrition_treatment_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/reduce_cost_severe_acute_malnutrition_treatment_application_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/breakthrough-innovations-significantly-reduce-cost-severe-acute-malnutrition-treatment-grand" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>
If you are planning to apply to this RFP, we will be hosting a dedicated <a href="https://events.teams.microsoft.com/event/d0518693-9f25-46b1-a48a-de12e5113440@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" rel="noopener noreferrer">webinar</a> on April 2, from 7:00-8:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the <a href="https://events.teams.microsoft.com/event/d0518693-9f25-46b1-a48a-de12e5113440@296b3838-4bd5-496c-bd4b-f456ea743b74">webinar</a>, please register and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dMKiReMZsCJFmCa42S92Da1UNEFaUTNVMjNSUVYzVklVTk0zQkFJQzZWSC4u" target="_blank" rel="noopener noreferrer">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
Please note that <a href="https://ciff.org/" target="_blank" title="https://ciff.org/" rel="noopener noreferrer">Children's Investment Fund Foundation (CIFF)</a> and&nbsp;<a href="https://www.givewell.org/" target="_blank" title="https://www.givewell.org/" rel="noopener noreferrer">GiveWell</a> have expressed interest in potentially funding projects submitted through this RFP. Representatives from these organizations will participate in the review process. Applicants will be notified if their proposal is selected for further consideration by either organization.
<h2>Background</h2>
Severe Acute Malnutrition (SAM) remains a leading contributor to child mortality globally. At the same time, global resources available for SAM treatment are flat or declining, while the burden of wasting remains high. Under these constraints, improving outcomes will require not only expanding budgets but fundamentally improving the cost-effectiveness of SAM treatment.
While Ready-to-Use Therapeutic Food (RUTF) is central to SAM treatment, it represents only one component of total treatment cost. In many contexts, logistics, staffing, supervision, visit frequency, and system overhead account for a substantial share of the total cost per child treated.
This Grand Challenge seeks innovations that can substantially increase the number of children treated per dollar spent by reducing the total cost per child treated, without changing the ex-factory price of RUTF or substituting RUTF with an alternative product.
This initiative is designed as an idea-sourcing and proof-of-concept mechanism to identify transformative, system-level innovations.
<h2>The Challenge</h2>
We seek innovative approaches capable of achieving a 20 - 30% or greater reduction in the total cost per child successfully treated for SAM in Sub-Saharan Africa and South Asia.
We recognize that reductions may result from a single breakthrough innovation or from a combination of product, logistics, protocol, and delivery efficiencies that collectively achieve meaningful cost reduction.
Solutions must:
<ul>
<li>Provide a validated pathway to a 20% - 30% or greater reduction in total cost per child treated.</li>
<li>Include a transparent cost model with clear assumptions, key drivers, and sensitivity analyses.</li>
<li>Demonstrate proof-of-concept feasibility (e.g., modeling, simulation, pilot data).</li>
<li>Present a credible pathway to normative and/or regulatory acceptance, where relevant.</li>
<li>Show a clear scalability pathway and explain why cost reductions are durable at scale.</li>
</ul>
Proposals must articulate a clear theory of change linking the innovation to specific reductions in cost components and demonstrate how these reductions are achieved and sustained.
Focus Areas
This call targets system-level levers that reduce the total cost of treating a child for SAM by 20% - 30% or greater, independent of reducing the RUTF unit price.
Applicants may propose innovations under one or more of the following focus areas:
<div class="responsive-table"><table>
<tbody>
<tr>
<td>Focus Area</td>
<td>Potential Approaches</td>
<td>Required Deliverables</td>
</tr>
<tr>
<td>
Logistics and Distribution Optimization
Logistics and distribution (transport, storage, losses, inefficiencies) often represent a significant share of total SAM treatment cost.
&nbsp;
</td>
<td>
<ul>
<li>Redesigned distribution networks reducing transport frequency or distance</li>
<li>Community- or facility-linked delivery models reducing parallel systems</li>
<li>Consolidated deliveries across other programs (e.g., immunization, MDAs, REACH)</li>
<li>Inventory optimization tools to reduce stockouts</li>
<li>Warehousing solutions</li>
<li>Storage optimization for shelf life and efficiency</li>
<li>Loss-reduction strategies (spoilage, leakage, diversion)</li>
<li>Digital demand forecasting tools</li>
<li>Route optimization or fleet management systems</li>
</ul>
</td>
<td>
<ul>
<li>Identification of targeted logistics / warehousing cost components</li>
<li>Clear causal pathway to a 20% - 30% or greater reduction in total cost per child treated</li>
<li>Analytical or pilot feasibility evidence</li>
<li>Contextual assumptions (e.g., emergency vs. non-emergency settings)</li>
</ul>
&nbsp;
</td>
</tr>
<tr>
<td>
Treatment Protocols and Regimen Design
Treatment protocols influence cost through product consumption, visit frequency, duration of care, and monitoring intensity.
This call seeks novel protocol concepts that go beyond existing simplified treatment approaches
</td>
<td>
<ul>
<li>Adaptive dosage or duration based on child response</li>
<li>Regimens reducing total RUTF consumption without compromising outcomes</li>
<li>Dynamic or phased treatment models</li>
<li>New admission, discharge, or monitoring criteria</li>
<li>Simplified or adaptive monitoring approaches</li>
<li>Point-of-care diagnostics guiding intensity</li>
<li>Digital or analytical decision-support tools</li>
<li>Regimen-level cost-effectiveness modeling and scenario analysis</li>
</ul>
Proposals relying solely on already widely adopted simplified protocols will be considered nonresponsive.
</td>
<td>
<ul>
<li>Clear differentiation from existing simplified protocols</li>
<li>Identification of affected cost drivers (e.g., RUTF use, visits, duration)</li>
<li>Analytical rationale demonstrating plausible 20% - 30% or greater cost reduction</li>
<li>Proof-of-concept evidence (modeling, retrospective analysis, simulations)</li>
<li>Discussion of safety assumptions</li>
</ul>
</td>
</tr>
<tr>
<td>
Program Delivery Models
Delivery models significantly affect total treatment cost, especially through staffing, visit schedules, supervision, and system overhead.
</td>
<td>
<ul>
<li>Community-based or decentralized care models</li>
<li>Task-shifting to community health workers or volunteers</li>
<li>Reduced-touchpoint or simplified monitoring strategies</li>
<li>Integrated service delivery models</li>
<li>Alignment with routine health systems to reduce parallel structures</li>
</ul>
</td>
<td>
<ul>
<li>Description of how the delivery model differs from current practice</li>
<li>Identification of affected delivery cost drivers</li>
<li>Modeling or evidence supporting plausible 20% - 30% or greater cost reduction</li>
<li>Discussion of quality and safety safeguards</li>
</ul>
</td>
</tr>
<tr>
<td>
Complicated (In-patient) SAM Care Optimization
Concepts that reduce the cost of inpatient/complicated SAM care while maintaining or improving clinical outcomes.
(In many settings, 10–20% of children with SAM require inpatient management due to medical complications, yet inpatient care can represent a disproportionately large share of total treatment costs.)
</td>
<td>
<ul>
<li>Innovations reducing length of stay without compromising safety</li>
<li>Clinical pathway optimization</li>
<li>Resource-efficient stabilization models</li>
<li>Integrated inpatient–outpatient transition strategies</li>
<li>Cost-efficient therapeutic, monitoring, or staffing models</li>
</ul>
</td>
<td>
<ul>
<li>Clear identification of inpatient cost drivers affected</li>
<li>Cost model demonstrating plausible 20 - 30% or greater reduction in total cost per child successfully treated</li>
<li>Evidence supporting clinical safety assumptions</li>
<li>Consideration of scalability and normative alignment</li>
</ul>
</td>
</tr>
</tbody>
</table></div>
Cross-Cutting Requirements
Successful proposals must provide:
<ul>
<li>
Cost Reduction Analysis and Proof of Concept
<ul>
<li>Clear articulation of the cost components affected (e.g., logistics, staff time, visits, supervision)</li>
<li>A baseline cost decomposition and explanation of how the proposed innovation changes the cost structure</li>
<li>A transparent and credible cost model quantifying a 20% - 30% or greater reduction in total cost per child treated</li>
<li>Proof-of-concept evidence supporting feasibility (e.g., modeling, pilot data, simulations) &nbsp;</li>
</ul>
All proposals must include a cost model clearly aligned with the proposed operational or technical innovation.
</li>
<li>For the purposes of this call, "cost per child treated" refers at minimum to the cost per child successfully discharged according to standard SAM program exit criteria.
<ul>
<li>Proposals must clearly describe safeguards to ensure that cost reductions do not compromise clinical outcomes, quality of care, or safety standards.</li>
</ul>
</li>
<li>Data Sharing and Transparency
<ul>
<li>Commitment to share relevant data (with appropriate safeguards) to support replication and policy processes</li>
<li>Contribution to cross-project learning where possible</li>
</ul>
</li>
<li>Environmental Considerations
<ul>
<li>Brief discussion of environmental implications (e.g., energy use, waste, system efficiencies) and how these are managed</li>
</ul>
</li>
<li>Responsible Use of AI and Digital Technologies (if applicable)
<ul>
<li>Clear articulation of data privacy and security safeguards</li>
<li>Consideration of explainability and usability for nonexpert users in LMIC contexts</li>
</ul>
</li>
</ul>
Funding Structure
For any of the Focus Areas we will consider proposals under two funding options. Please consider which is most relevant to your proposal.
<ul>
<li>Option A: We will consider several proposals for awards of up to $500,000 USD for each project, with a grant term of up to 18 months. Application budgets should be commensurate with the scope of work proposed.</li>
<li>Option B: We will consider several proposals for awards of up to $1,500,000 USD for each project, with a grant term of up to 36 months. Application budgets should be commensurate with the scope of work proposed.</li>
</ul>
Indirect costs should be included in the budget and should not exceed 10-15% of the total award (subject to the&nbsp;<a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank" rel="noopener noreferrer">Gates Foundation's indirect cost policy</a>).
Eligibility
We welcome applications from universities and research institutes, nongovernmental organizations with strong technical capacity, for-profit entities / private sector companies (subject to <a href="https://globalaccess.gatesfoundation.org/" target="_blank" rel="noopener noreferrer">global access requirements</a>), and consortia combining scientific, manufacturing, and implementation expertise. Consortia led by or including LMIC-based organizations are strongly encouraged.
Individuals and organizations classified as individuals for U.S. tax purposes are not eligible to receive an award from the foundation as part of this initiative.
What we are looking for
Successful proposals will:
<ul>
<li>Demonstrate a 20% - 30% or greater reduction in total cost per child treated.</li>
<li>Include a transparent and credible cost model.</li>
<li>Show proof-of-concept feasibility.</li>
<li>Clearly articulate affected cost components and durable savings.</li>
<li>Present a credible pathway to scalability.</li>
<li>Address real-world adoption constraints and data availability.</li>
</ul>
We will not fund proposals that:
<ul>
<li>Fund clinical trials or definitive efficacy studies.</li>
<li>Scale or geographically expand existing simplified protocols.</li>
<li>Support routine implementation or business-as-usual operations.</li>
<li>Replicate existing approaches without step-change potential.</li>
<li>Lack a plausible pathway to a 20% - 30% or greater cost reduction.</li>
</ul>

This Grand Challenge seeks innovations that can substantially increase the number of children treated per dollar spent by reducing the total cost per child treated, without changing the ex-factory price of RUTF or substituting RUTF with an alternative product. This initiative is designed as an idea-sourcing and proof-of-concept mechanism to identify transformative, system-level innovations.

Cost-Disrupting Innovations to Reduce the Cost of Ready-to-Use Therapeutic Food

Before applying,&nbsp;applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the <a href="https://docs.gatesfoundation.org/documents/sample-terms-and-conditions.pdf" target="_blank" rel="noopener noreferrer">terms and conditions of the&nbsp;Gates Foundation</a>, the&nbsp;<a href="https://gcgh.grandchallenges.org/sites/default/files/files/reduce_cost_of_ready-to-use_therapeutic_food_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>,&nbsp;<a href="https://gcgh.grandchallenges.org/sites/default/files/files/reduce_cost_of_ready-to-use_therapeutic_food_application_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and&nbsp;<a href="https://gcgh.grandchallenges.org/cost-disrupting-innovations-reduce-cost-ready-use-therapeutic-food-frequently-asked-questions-faqs" target="_blank" rel="noopener noreferrer">Frequently Asked Questions (FAQs)</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated <a href="https://events.teams.microsoft.com/event/d22d7b22-99e6-49c5-93fd-d31d2cd66660@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" rel="noopener noreferrer">webinar</a> on March 30, from 7:00-8:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the <a href="https://events.teams.microsoft.com/event/d22d7b22-99e6-49c5-93fd-d31d2cd66660@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" rel="noopener noreferrer">webinar</a>, please register and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dMKiReMZsCJFmCa42S92Da1UNVBJQ0JERFZQNUhWTE5ZNDFDNE9HR1k1Si4u" target="_blank" rel="noopener noreferrer">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
Please note that&nbsp;<a href="https://ciff.org/" target="_blank" rel="noopener noreferrer">Children's Investment Fund Foundation (CIFF)</a> and&nbsp;<a href="https://www.givewell.org/" target="_blank" rel="noopener noreferrer">GiveWell</a> have expressed interest in potentially funding projects submitted through this RFP. Representatives from these organizations will participate in the review process. Applicants will be notified if their proposal is selected for further consideration by either organization.
<h2>Background</h2>
Global resources available for the treatment of Severe Acute Malnutrition (SAM) are flat or declining, while the burden of wasting remains high. Under these constraints, improving outcomes will depend on seeking to expand budgets but also more on fundamentally improving the cost-effectiveness of SAM treatment.
This Grand Challenge seeks innovations that can substantially increase the number of children treated for SAM per dollar of spend. We are interested in solutions that achieve step-change improvements in economics by reducing the cost of Ready-to-Use Therapeutic Food (RUTF). Another Grand Challenges RFP looks at reducing the total cost of treating a child without changing the unit cost of RUTF or using a RUTF alternative.
The Grand Challenge is explicitly designed as an idea-sourcing and proof-of-concept mechanism.
<h2>The Challenge</h2>
We seek innovative approaches capable of achieving at least a 30% reduction in the ex-factory unit cost of RUTF in Sub-Saharan Africa and South Asia.
Cost reductions should be calculated relative to the applicant's own current ex-factory production baseline or a clearly justified comparator. Applicants should explicitly state baseline assumptions. Reductions are not required to be measured against a single global benchmark price.
This call focuses specifically on physical composition, ingredients, manufacturing, packaging, and factory-level production economics. Clinical trials and delivery-only approaches are out of scope.
All formulations must present a plausible pathway to meet the&nbsp;<a href="https://openknowledge.fao.org/server/api/core/bitstreams/aa5ce8b6-9a27-4a91-ac02-35523f4b3b04/content" target="_blank" rel="noopener noreferrer">Codex Guidelines for Ready-to-Use Therapeutic Foods (CXG 95 2022)</a>.
Solutions must:
<ul>
<li>Provide a validated pathway to ≥30% cost reduction.</li>
<li>Include a transparent cost model with clear assumptions and sensitivity analysis.</li>
<li>Demonstrate proof-of-concept feasibility (e.g., pilot manufacturing, engineering models, simulations).</li>
<li>Present a credible pathway to normative/regulatory acceptance and adoption.</li>
<li>Show a clear scalability pathway with durable cost reductions at scale.</li>
</ul>
Focus Areas
Applicants may propose innovations under one or more of the following focus areas:
<div class="responsive-table"><table>
<thead>
<tr>
<th>Focus Area</th>
<th>Potential Approaches</th>
<th>Required Deliverables</th>
</tr>
</thead>
<tbody>
<tr>
<td>
Protein Diversification and Dairy Replacement (Highest Priority)
Milk powder is the largest cost driver in standard RUTF. We seek high-quality protein solutions (PDCAAS ≥0.9, preference toward 1.0) that reduce cost while maintaining a credible pathway to Codex compliance.
</td>
<td>
<ul>
<li>Optimized dairy-based protein systems (≥50% dairy protein retained)</li>
<li>Partial dairy reduction (25–75%) using complementary proteins</li>
<li>Dairy-free high-quality protein blends (excluding fava/field beans)</li>
<li>Protein quality optimization technologies (fermentation, extrusion, fortification, enzymatic treatment)</li>
<li>Novel protein matrices enhancing absorption, efficiency, or stability &nbsp;</li>
</ul>
</td>
<td>
<ul>
<li>Prototype formulations meeting Codex/WHO specifications</li>
<li>PDCAAS ≥0.9 with documented amino acid profiles and digestibility</li>
<li>Stability testing (Climatic Zone IVb)</li>
<li>Sensory and acceptability data</li>
<li>Cost comparison model (USD/MT)</li>
<li>Roadmap for regulatory and normative uptake</li>
</ul>
</td>
</tr>
<tr>
<td>
Lipid Optimization and Stabilization
Oils are significant cost and volatility drivers. We seek lipid systems that enable use of lower-cost or local oils while maintaining shelf life and nutritional adequacy.
</td>
<td>
<ul>
<li>Stable regional oils or blends (e.g., sunflower, sesame, cottonseed, palm olein)</li>
<li>Processing or antioxidant systems enabling use of less refined oils</li>
<li>Encapsulation or matrix innovations to reduce oxidation</li>
<li>Approaches reducing reliance on high-barrier packaging&nbsp;</li>
</ul>
</td>
<td>
<ul>
<li>Fatty acid profile characterization</li>
<li>Oxidation stability data (target 24-month shelf life in Zone IVb)</li>
<li>Sensory assessment</li>
<li>Local supply and volatility assessment</li>
<li>Quantified cost impact (USD/MT)&nbsp;</li>
</ul>
</td>
</tr>
<tr>
<td>
Packaging Materials Science
Foil-based sachets are a major cost driver and difficult to recycle.
</td>
<td>
<ul>
<li>Low-cost multilayer laminates</li>
<li>Recyclable alternatives to foil</li>
<li>Downgauged materials</li>
<li>Packaging designs improving efficiency or reducing waste&nbsp;</li>
</ul>
</td>
<td>
<ul>
<li>Packaging prototypes and performance testing</li>
<li>Demonstrated 24-month shelf life in Zone IVb</li>
<li>Unit cost comparison vs. standard sachets</li>
<li>Environmental impact narrative&nbsp;</li>
</ul>
</td>
</tr>
<tr>
<td>
Production and Supply Innovations
Manufacturing and supply inefficiencies materially affect ex-factory cost.
</td>
<td>
<ul>
<li>Continuous/semi-continuous processing</li>
<li>Process intensification</li>
<li>Automation/digitization</li>
<li>Modular or scalable LMIC-appropriate equipment</li>
<li>Input sourcing and procurement innovations</li>
<li>Factory-integration strategies reducing logistics and working capital&nbsp;</li>
</ul>
</td>
<td>
<ul>
<li>Description of innovation vs. current practice</li>
<li>Proof-of-concept feasibility evidence</li>
<li>Cost comparison (current vs. proposed USD/MT)</li>
<li>Scalability and capital/payback assessment&nbsp;</li>
</ul>
</td>
</tr>
</tbody>
</table></div>
Cross-Cutting Requirements
All funded projects must address:
<ul>
<li>Clinical Safety and Nutritional Adequacy.
<ul>
<li>Compliance with Codex RUTF Guidelines (CXG 95-2022).</li>
<li>Energy density: 520–550 kcal/100g.</li>
<li>Protein: 10–12% energy.</li>
<li>Lipids: 45–60% energy.</li>
<li>PDCAAS ≥0.9 (preference toward 1.0).</li>
<li>Micronutrient and food safety compliance.</li>
</ul>
</li>
</ul>
Projects materially altering formulation must present a path to clinical noninferiority and normative acceptance.
<ul>
<li>LMIC Applicability &amp; Equity
<ul>
<li>Feasible manufacturing in LMICs</li>
<li>Strengthened regional production capacity</li>
<li>Encouragement of LMIC-led consortia</li>
</ul>
</li>
<li>Intellectual Property &amp; Global Access
<ul>
<li>Nonexclusive or affordable licensing in low-income and humanitarian markets</li>
<li>Evidence sharing with normative agencies</li>
</ul>
</li>
<li>Data Sharing &amp; Transparency</li>
<li>Environmental Considerations</li>
<li>Responsible Use of AI &amp; Digital Technologies&nbsp;</li>
</ul>
Funding Structure
For any of the Focus Areas we will consider proposals under two funding options. Please consider which is most relevant to your proposal.
<ul>
<li>Option A:&nbsp;We will consider proposals for awards of up to $500,000 USD across any of the categories within this call, with a grant term of up to 18 months. Application budgets should be commensurate with the scope of work proposed.</li>
<li>Option B:&nbsp;We will consider several proposals for awards of up to $1,500,000 USD for each project, with a grant term of up to 36 months. Application budgets should be commensurate with the scope of work proposed.</li>
</ul>
Indirect costs should be included in the budget and should not exceed 10-15% of the total award (subject to the&nbsp;<a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf">Gates Foundation's indirect cost policy</a>).
Eligibility
We welcome applications from universities and research institutes, RUTF manufacturers and food processors, ingredient and packaging suppliers, engineering and technology firms, NGOs with strong technical capacity, and for-profit entities (subject to&nbsp;<a href="https://globalaccess.gatesfoundation.org/">global access requirements</a>). Consortia led by or including LMIC-based organizations are strongly encouraged. Individuals and organizations classified as individuals for U.S. tax purposes are not eligible to receive an award from the foundation as part of this initiative.&nbsp;
What we are looking for
Successful proposals will:
<ul>
<li>Demonstrate ≥30% ex-factory cost reduction.</li>
<li>Include a credible, transparent cost model.</li>
<li>Provide proof-of-concept feasibility evidence.</li>
<li>Present a regulatory and normative adoption pathway.</li>
<li>Show durable scalability.</li>
<li>Address LMIC manufacturability and equity considerations. &nbsp;</li>
</ul>
We will not fund proposals that:
<ul>
<li>Focus solely on policy advocacy or tariff reform.</li>
<li>Are standalone training or general capacity-building efforts.</li>
<li>Subsidize routine operations or infrastructure.</li>
<li>Are purely market studies.</li>
<li>Rely on price negotiation or procurement tactics without technological innovation.</li>
<li>Focus solely on clinical trials.</li>
<li>Focus solely on delivery models without product innovation.</li>
</ul>

This Grand Challenge seeks innovations that can substantially increase the number of children treated for Severe Acute Malnutrition (SAM) per dollar of spend. We are interested in solutions that achieve step-change improvements in economics by reducing the cost of Ready-to-Use Therapeutic Food (RUTF). Another Grand Challenges RFP looks at reducing the total cost of treating a child without changing the unit cost of RUTF or using a RUTF alternative.

Innovations in Cost-Disruptive Tools for Diagnosis and Screening

We define cost-disruptive tools for diagnosis and screening as approaches that target less than US$1 or devices with negligible incremental cost per use. For screening applications, cost targets should be interpreted per person screened; for diagnostic or monitoring applications, per test performed. Accordingly, this initiative aims to translate these cost-disruptive concepts into scalable solutions across high-priority disease areas.
This Grand Challenge seeks both devices that amortize capital to near-zero incremental cost and consumable $1-class tests that materially reset the cost curve in LMICs while meeting real-world point-of-care constraints.

Novel Interventions Targeting Placental and Gut Inflammation to Improve Fetal Growth

We seek solutions that can accelerate identification and early validation of interventions (novel or repurposed), including drug-based, biologic, dietary, and microbiome-informed approaches, that modulate inflammatory and or oxidative stress processes in the placenta-maternal gut axis, with the potential to improve fetal growth outcomes. We encourage applicants to pair ambitious ideas with a feasible plan to generate decision-grade evidence within the award duration.

This RFP is jointly launched by several Grand Challenges funding partners, including Grand Challenges Africa (Science for Africa Foundation), Grand Challenges Brazil (Brazilian Ministry of Health and the National Council on Research), Grand Challenges India (Biotechnology Industry Research Assistance Council), Grand Challenges South Africa (South African Medical Research Council), and the Gates Foundation. Each RFP may differ in its geographic focus, topic areas, and funding levels. Please review the eligibility criteria and specific requirements for each RFP carefully. The individual RFPs are listed separately <a href="https://gcgh.grandchallenges.org/challenges/JTdCJTIyc29ydCUyMiUzQSUyMmRlc2NlbmRpbmclMjIlMkMlMjJzb3J0RmllbGQlMjIlM0ElMjJkYXRlJTIyJTJDJTIybnVtYmVyUGVyUGFnZSUyMiUzQTEwJTJDJTIycGFnZU51bWJlciUyMiUzQTAlN0Q=/JTdCJTIyeWVhcnMlMjIlM0ElNUIlNUQlMkMlMjJjaGFsbGVuZ2VzJTIyJTNBJTVCJTIyMzk0JTIyJTVEJTJDJTIydGVybXMlMjIlM0ElNUIlNUQlMkMlMjJpbml0aWF0aXZlcyUyMiUzQSU1QiU1RCUyQyUyMmxvY2F0aW9ucyUyMiUzQSU1QiU1RCU3RA==" target="_blank">here</a>. If you qualify for more than one, we encourage you to apply to the RFP that best aligns with your proposed project and geographical location.Please note: Grand Challenges Brazil will review proposals submitted by Brazilian organizations through the link on this webpage. Proposals selected to receive financial support from the Brazilian Ministry of Health / GC Brazil must be led by researchers linked to non-profit Science, Technology and Innovation Institutions (Instituição Científica, Tecnológica e de Inovação – ICT), registered in Brazil.Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the Rules and Guidelines, Application Instructions, and Frequently Asked Questions.If you are planning to apply to this RFP, we will be hosting a dedicated webinar on November 20, from 6:00 to 7:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP technical details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/2957503f-d95d-47b0-8bfa-b7d28f55266c@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank">register</a> and <a href="https://forms.office.com/pages/responsepage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dMKiReMZsCJFmCa42S92Da1UMFBSMVlMQUNLSlRDOVNOMFdNR0dSUUFXNC4u&amp;origin=lprLink&amp;route=shorturl" target="_blank">submit your questions</a> in advance. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.<h2>Background</h2>Local delivery of drugs into the vagina for prevention and treatment of female-specific conditions remains understudied and under-utilized despite clear potential advantages such as discreetness, potent local efficacy, large surface area for drug absorption, high potential for API dosage sparing, potential for fewer systemic side effects, as well as providing autonomy and empowerment of women. Several key drivers may be responsible for this lag, including paucity of mechanistic biological data, particularly from high-burden settings such as low- and middle-income countries (LMICs), to support the development of specific formulations for vaginal use as well as a persistent misconception that vaginally delivered products may not be embraced by women and their sexual partners. Several of our priorities for impactful products for sexual and reproductive health will require vaginal delivery for immediate, on-demand use. We seek to catalyze the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. We expect these approaches to have user appeal, including promotion of self-care capability and other beneficial features that women seek, hence the need to couple discovery research with high-quality end-user input.<h2>The Challenge</h2>We are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure. We anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health. We welcome innovations at any stage of development that meet the scope of this call.Applicants may apply to address one or more of the following objectives of this challenge:<ol><li>Leverage biology for vaginally administered products: In this objective, we seek: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefit to the vaginal mucosal epithelium. Specifically, we seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).</li><li>Define characteristics of an ideal vaginal product: In this objective, we seek to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). We are particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. We acknowledge that there may be regional, cultural, demographic or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, we aim to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable'.</li></ol>Funding LevelProjects with a duration of up to two years and a maximum requested budget of $250,000USD are eligible for funding. Exploratory projects with shorter durations/lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority. Budgets should be commensurate with the scope of work proposed and in line with allowable costs of the targeted funding organization for which the applicant is eligible. Indirect costs should be included in the budget and should not exceed 10-15% of the total award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank">Gates Foundation's indirect cost policy</a>).Eligibility CriteriaThis initiative is open to research institutes, nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. Please note that all applicants will be expected to comply with the Foundation's global access clause. We encourage groups to build upon existing and/or complimentary projects/studies/trials and to collaborate with other institutions. We particularly encourage applications from projects led by women and/or researchers at institutions based in LMICs and/or involving collaboration with women-led or LMIC-based organizations. Only individuals who are applying through a legally recognized corporate entity are eligible.We are looking for proposals that:<ul><li>Focus on vaginal delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.</li><li>Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.</li><li>Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection and privacy.</li><li>Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.</li><li>Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists, then the proposal should be limited in scope.</li><li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li><li>Promote a diverse, inclusive, and supportive research environment, with priority for collaborations involving LMIC-based experts in reproductive health.</li></ul>We will not fund proposals that:<ul><li>Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g. menstrual products, contraceptive devices, over-the-counter probiotics, etc.).</li><li>Focus on approaches that would not be feasible or affordable in low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.</li><li>Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.</li><li>Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.</li><li>Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.</li><li>Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.</li><li>Primarily depend on traditional acceptability questionnaires or surveys (e.g., “if x hypothetical product existed, how interested would you be in using it?”).</li><li>Do not directly address one of the core objectives as outlined above.</li><li>Cannot be accomplished within a two-year maximum project duration or within the stipulated budget maximum.</li><li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li></ul>

Accelerating Innovation in Vaginal Formulations in Support of Women's Health

This RFP is jointly launched by several Grand Challenges funding partners, including Grand Challenges Africa (Science for Africa Foundation), Grand Challenges Brazil (Brazilian Ministry of Health and the National Council on Research), Grand Challenges India (Biotechnology Industry Research Assistance Council), Grand Challenges South Africa (South African Medical Research Council), and the Gates Foundation. Each RFP may differ in its geographic focus, topic areas, and funding levels. Please review the eligibility criteria and specific requirements for each RFP carefully. The individual RFPs are listed separately <a href="https://gcgh.grandchallenges.org/challenges/JTdCJTIyc29ydCUyMiUzQSUyMmRlc2NlbmRpbmclMjIlMkMlMjJzb3J0RmllbGQlMjIlM0ElMjJkYXRlJTIyJTJDJTIybnVtYmVyUGVyUGFnZSUyMiUzQTEwJTJDJTIycGFnZU51bWJlciUyMiUzQTAlN0Q=/JTdCJTIyeWVhcnMlMjIlM0ElNUIlNUQlMkMlMjJjaGFsbGVuZ2VzJTIyJTNBJTVCJTIyMzk0JTIyJTVEJTJDJTIydGVybXMlMjIlM0ElNUIlNUQlMkMlMjJpbml0aWF0aXZlcyUyMiUzQSU1QiU1RCUyQyUyMmxvY2F0aW9ucyUyMiUzQSU1QiU1RCU3RA==" target="_blank" rel="noopener noreferrer">here</a>. If you qualify for more than one, we encourage you to apply to the RFP that best aligns with your proposed project and geographical location.
Please note: Grand Challenges Brazil will review proposals submitted by Brazilian organizations through the link on this webpage. Proposals selected to receive financial support from the Brazilian Ministry of Health / GC Brazil must be led by researchers linked to non-profit Science, Technology and Innovation Institutions (Instituição Científica, Tecnológica e de Inovação – ICT), registered in Brazil.
Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the Rules and Guidelines, Application Instructions, and Frequently Asked Questions.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on November 20, from 6:00 to 7:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP technical details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/2957503f-d95d-47b0-8bfa-b7d28f55266c@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" rel="noopener noreferrer">register</a> and <a href="https://forms.office.com/pages/responsepage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dMKiReMZsCJFmCa42S92Da1UMFBSMVlMQUNLSlRDOVNOMFdNR0dSUUFXNC4u&amp;origin=lprLink&amp;route=shorturl" target="_blank" rel="noopener noreferrer">submit your questions</a> in advance. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
Local delivery of drugs into the vagina for prevention and treatment of female-specific conditions remains understudied and under-utilized despite clear potential advantages such as discreetness, potent local efficacy, large surface area for drug absorption, high potential for API dosage sparing, potential for fewer systemic side effects, as well as providing autonomy and empowerment of women. Several key drivers may be responsible for this lag, including paucity of mechanistic biological data, particularly from high-burden settings such as low- and middle-income countries (LMICs), to support the development of specific formulations for vaginal use as well as a persistent misconception that vaginally delivered products may not be embraced by women and their sexual partners. Several of our priorities for impactful products for sexual and reproductive health will require vaginal delivery for immediate, on-demand use. We seek to catalyze the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. We expect these approaches to have user appeal, including promotion of self-care capability and other beneficial features that women seek, hence the need to couple discovery research with high-quality end-user input.
<h2>The Challenge</h2>
We are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure. We anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health. We welcome innovations at any stage of development that meet the scope of this call.
Applicants may apply to address one or more of the following objectives of this challenge:
<ol>
<li>Leverage biology for vaginally administered products: In this objective, we seek: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefit to the vaginal mucosal epithelium. Specifically, we seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).</li>
<li>Define characteristics of an ideal vaginal product: In this objective, we seek to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). We are particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. We acknowledge that there may be regional, cultural, demographic or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, we aim to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable'.</li>
</ol>
Funding Level
Projects with a duration of up to two years and a maximum requested budget of $250,000USD are eligible for funding. Exploratory projects with shorter durations/lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority. Budgets should be commensurate with the scope of work proposed and in line with allowable costs of the targeted funding organization for which the applicant is eligible. Indirect costs should be included in the budget and should not exceed 10-15% of the total award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank" rel="noopener noreferrer">Gates Foundation's indirect cost policy</a>).
Eligibility Criteria
This initiative is open to research institutes, nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. Please note that all applicants will be expected to comply with the Foundation's global access clause. We encourage groups to build upon existing and/or complimentary projects/studies/trials and to collaborate with other institutions. We particularly encourage applications from projects led by women and/or researchers at institutions based in LMICs and/or involving collaboration with women-led or LMIC-based organizations. Only individuals who are applying through a legally recognized corporate entity are eligible.
We are looking for proposals that:
<ul>
<li>Focus on vaginal delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.</li>
<li>Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.</li>
<li>Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection and privacy.</li>
<li>Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.</li>
<li>Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists, then the proposal should be limited in scope.</li>
<li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li>
<li>Promote a diverse, inclusive, and supportive research environment, with priority for collaborations involving LMIC-based experts in reproductive health.</li>
</ul>
We will not fund proposals that:
<ul>
<li>Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g. menstrual products, contraceptive devices, over-the-counter probiotics, etc.).</li>
<li>Focus on approaches that would not be feasible or affordable in low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.</li>
<li>Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.</li>
<li>Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.</li>
<li>Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.</li>
<li>Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.</li>
<li>Primarily depend on traditional acceptability questionnaires or surveys (e.g., “if x hypothetical product existed, how interested would you be in using it?”).</li>
<li>Do not directly address one of the core objectives as outlined above.</li>
<li>Cannot be accomplished within a two-year maximum project duration or within the stipulated budget maximum.</li>
<li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li>
</ul>

We are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure.

Accelerating Innovation in Vaginal Formulations in Support of Womens Health

Note that this Request for Proposals is being launched by multiple partners, across variable geographies, topic areas, and funding levels. Please review the requirements for each RFP to determine your eligibility. African researchers located in South Africa should apply through the corresponding country-specific Grand Challenges portal; African researchers located in all other African countries should apply <a href="https://agaseke.scienceforafrica.foundation/Login.aspx" target="_blank">through the Grand Challenges Africa portal</a>; Brazilian researchers located in Brazilian organizations should apply through the Grand Challenges Brazil portal; and Indian researchers located in Indian organizations should apply through the Grand Challenges India portal. Researchers outside of these geographies should apply through the Gates Foundation Grand Challenges portal. Please consult the information provided in the subsection on geography of interest to ensure that your application fits the requirements of the RFP you are applying to.Before applying, applicants should familiarise themselves with the supporting documents for this Grand Challenge, including the <a href="https://scienceforafrica.foundation/funding/womens-health-innovation-accelerating-innovation-vaginal-formulations-support-womens-health/rules-and-guidelines" target="_blank">Rules and Guidelines</a>, <a href="https://scienceforafrica.foundation/funding/womens-health-innovation-accelerating-innovation-vaginal-formulations-support-womens-health/application-instructions" target="_blank">Application Instructions,</a> and <a href="https://scienceforafrica.foundation/funding/womens-health-innovation-accelerating-innovation-vaginal-formulations-support-womens-health/faqs" target="_blank">Frequently Asked Questions.</a>Application DeadlineTuesday, 16 December 1700HRS, East African Time (EAT)<h2>Background</h2>Local delivery of drugs into the vagina for prevention and treatment of female-specific conditions remains understudied and under-utilized despite clear potential advantages such as discreetness, potent local efficacy, large surface area for drug absorption, high potential for API dosage sparing, and potential for fewer systemic side effects. Several key drivers may be responsible for this lag, including paucity of mechanistic biological data, particularly from high-burden settings such as low- and middle-income countries (LMICs), to support the development of specific formulations for vaginal use as well as a persistent misconception that vaginally delivered products may not be embraced by women and their sexual partners. Several of our priorities for impactful products for sexual and reproductive health will require vaginal delivery for immediate, on-demand use. We seek to catalyse the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. We expect these approaches to have user appeal, including promotion of self-care capability and other beneficial features that women seek, hence the need to couple discovery research with high-quality end-user input.<h2>The Challenge</h2>We are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure. We anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health. We welcome innovations at any stage of development that meet the scope of this call.Applicants may apply to address one or more of the following objectives of this challenge:<ul><li>Leverage biology for vaginally administered products: In this objective, we seek: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefit to the vaginal mucosal epithelium. Specifically, we seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).</li><li>Define characteristics of an ideal vaginal product: In this objective, we seek to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). We are particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. We acknowledge that there may be regional, cultural, demographic or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, we aim to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable'.</li></ul>Funding LevelIt is expected that successful awardees will be awarded grants in the range of $100,000–200,000. With a funding duration of up to 24 months. Exploratory projects with shorter durations/lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority. Budgets should be commensurate with the scope of work proposed. Indirect costs should be included in the budget and should not exceed 10-15% of the total awardEligibility CriteriaThis initiative is open to research institutes, nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. Please note that all applicants will be expected to comply with the Foundation's global access clause. We encourage groups to build upon existing and/or complimentary projects/studies/trials and to collaborate with other institutions. We particularly encourage applications from projects led by women and/or researchers at institutions based in LMICs and/or involving collaboration with women-led or LMIC-based organizations. Only individuals who are applying through a legally recognized corporate entity are eligible.We are looking for proposals that:<ul><li>Focus on vaginal delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.</li><li>Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.</li><li>Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection and privacy.</li><li>Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.</li><li>Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists then the proposal should be limited in scope.</li><li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li><li>Promote a diverse, inclusive, and supportive research environment, with priority for collaborations involving LMIC-based experts in reproductive health.</li></ul>We will not fund proposals that:<ul><li>Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g. menstrual products, contraceptive devices, over-the-counter probiotics, etc.).</li><li>Focus on approaches that would not be feasible or affordable in low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.</li><li>Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.</li><li>Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.</li><li>Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.</li><li>Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.</li><li>Primarily depend on traditional acceptability questionnaires or surveys (e.g., "if x hypothetical product existed, how interested would you be in using it?").</li><li>Do not directly address one of the core objectives as outlined above.</li><li>Cannot be accomplished within a two-year maximum project duration or within the stipulated budget maximum.</li><li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li></ul>

Grand Challenges Africa

Note that this Request for Proposals is being launched by multiple partners, across variable geographies, topic areas, and funding levels. Please review the requirements for each RFP to determine your eligibility. African researchers located in South Africa should apply through the corresponding country-specific Grand Challenges portal; African researchers located in all other African countries should apply <a href="https://agaseke.scienceforafrica.foundation/Login.aspx" target="_blank" rel="noopener noreferrer">through the Grand Challenges Africa portal</a>; Brazilian researchers located in Brazilian organizations should apply through the Grand Challenges Brazil portal; and Indian researchers located in Indian organizations should apply through the Grand Challenges India portal. Researchers outside of these geographies should apply through the Gates Foundation Grand Challenges portal. Please consult the information provided in the subsection on geography of interest to ensure that your application fits the requirements of the RFP you are applying to.
Before applying, applicants should familiarise themselves with the supporting documents for this Grand Challenge, including the <a href="https://scienceforafrica.foundation/funding/womens-health-innovation-accelerating-innovation-vaginal-formulations-support-womens-health/rules-and-guidelines" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://scienceforafrica.foundation/funding/womens-health-innovation-accelerating-innovation-vaginal-formulations-support-womens-health/application-instructions" target="_blank" rel="noopener noreferrer">Application Instructions,</a> and <a href="https://scienceforafrica.foundation/funding/womens-health-innovation-accelerating-innovation-vaginal-formulations-support-womens-health/faqs" target="_blank" rel="noopener noreferrer">Frequently Asked Questions.</a>
Application Deadline
Tuesday, 16 December 1700HRS, East African Time (EAT)
<h2>Background</h2>
Local delivery of drugs into the vagina for prevention and treatment of female-specific conditions remains understudied and under-utilized despite clear potential advantages such as discreetness, potent local efficacy, large surface area for drug absorption, high potential for API dosage sparing, and potential for fewer systemic side effects. Several key drivers may be responsible for this lag, including paucity of mechanistic biological data, particularly from high-burden settings such as low- and middle-income countries (LMICs), to support the development of specific formulations for vaginal use as well as a persistent misconception that vaginally delivered products may not be embraced by women and their sexual partners. Several of our priorities for impactful products for sexual and reproductive health will require vaginal delivery for immediate, on-demand use. We seek to catalyse the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. We expect these approaches to have user appeal, including promotion of self-care capability and other beneficial features that women seek, hence the need to couple discovery research with high-quality end-user input.
<h2>The Challenge</h2>
We are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure. We anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health. We welcome innovations at any stage of development that meet the scope of this call.
Applicants may apply to address one or more of the following objectives of this challenge:
<ul>
<li>Leverage biology for vaginally administered products: In this objective, we seek: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefit to the vaginal mucosal epithelium. Specifically, we seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).</li>
<li>Define characteristics of an ideal vaginal product: In this objective, we seek to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). We are particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. We acknowledge that there may be regional, cultural, demographic or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, we aim to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable'.</li>
</ul>
Funding Level
It is expected that successful awardees will be awarded grants in the range of $100,000–200,000. With a funding duration of up to 24 months. Exploratory projects with shorter durations/lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority. Budgets should be commensurate with the scope of work proposed. Indirect costs should be included in the budget and should not exceed 10-15% of the total award
Eligibility Criteria
This initiative is open to research institutes, nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. Please note that all applicants will be expected to comply with the Foundation's global access clause. We encourage groups to build upon existing and/or complimentary projects/studies/trials and to collaborate with other institutions. We particularly encourage applications from projects led by women and/or researchers at institutions based in LMICs and/or involving collaboration with women-led or LMIC-based organizations. Only individuals who are applying through a legally recognized corporate entity are eligible.
We are looking for proposals that:
<ul>
<li>Focus on vaginal delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.</li>
<li>Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.</li>
<li>Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection and privacy.</li>
<li>Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.</li>
<li>Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists then the proposal should be limited in scope.</li>
<li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li>
<li>Promote a diverse, inclusive, and supportive research environment, with priority for collaborations involving LMIC-based experts in reproductive health.</li>
</ul>
We will not fund proposals that:
<ul>
<li>Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g. menstrual products, contraceptive devices, over-the-counter probiotics, etc.).</li>
<li>Focus on approaches that would not be feasible or affordable in low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.</li>
<li>Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.</li>
<li>Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.</li>
<li>Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.</li>
<li>Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.</li>
<li>Primarily depend on traditional acceptability questionnaires or surveys (e.g., "if x hypothetical product existed, how interested would you be in using it?").</li>
<li>Do not directly address one of the core objectives as outlined above.</li>
<li>Cannot be accomplished within a two-year maximum project duration or within the stipulated budget maximum.</li>
<li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li>
</ul>

This RFP is jointly launched by several Grand Challenges funding partners, including Grand Challenges Africa (Science for Africa Foundation), Grand Challenges Brazil (Brazilian Ministry of Health and the National Council on Research), Grand Challenges India (Biotechnology Industry Research Assistance Council), Grand Challenges South Africa (South African Medical Research Council), and the Gates Foundation. Each RFP may differ in its geographic focus, topic areas, and funding levels. Please review the eligibility criteria and specific requirements for each RFP carefully. The individual RFPs are listed separately <a href="https://gcgh.grandchallenges.org/challenges/JTdCJTIyc29ydCUyMiUzQSUyMmRlc2NlbmRpbmclMjIlMkMlMjJzb3J0RmllbGQlMjIlM0ElMjJkYXRlJTIyJTJDJTIybnVtYmVyUGVyUGFnZSUyMiUzQTEwJTJDJTIycGFnZU51bWJlciUyMiUzQTAlN0Q=/JTdCJTIyeWVhcnMlMjIlM0ElNUIlNUQlMkMlMjJjaGFsbGVuZ2VzJTIyJTNBJTVCJTIyMzk0JTIyJTVEJTJDJTIydGVybXMlMjIlM0ElNUIlNUQlMkMlMjJpbml0aWF0aXZlcyUyMiUzQSU1QiU1RCUyQyUyMmxvY2F0aW9ucyUyMiUzQSU1QiU1RCU3RA==" target="_blank">here</a>. If you qualify for more than one, we encourage you to apply to the RFP that best aligns with your proposed project and geographical location.Please note: Grand Challenges Brazil will review proposals submitted by Brazilian organizations through the link on this webpage. Proposals selected to receive financial support from the Brazilian Ministry of Health / GC Brazil must be led by researchers linked to non-profit Science, Technology and Innovation Institutions (Instituição Científica, Tecnológica e de Inovação – ICT), registered in Brazil.Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the Rules and Guidelines, Application Instructions, and Frequently Asked Questions.If you are planning to apply to this RFP, we will be hosting a dedicated webinar on November 20, from 6:00 to 7:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP technical details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/2957503f-d95d-47b0-8bfa-b7d28f55266c@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank">register</a> and <a href="https://forms.office.com/pages/responsepage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dMKiReMZsCJFmCa42S92Da1UMFBSMVlMQUNLSlRDOVNOMFdNR0dSUUFXNC4u&amp;origin=lprLink&amp;route=shorturl" target="_blank">submit your questions</a> in advance. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.<h2>Background</h2>Local delivery of drugs into the vagina for prevention and treatment of female-specific conditions remains understudied and under-utilized despite clear potential advantages such as discreetness, potent local efficacy, large surface area for drug absorption, high potential for API dosage sparing, potential for fewer systemic side effects, as well as providing autonomy and empowerment of women. Several key drivers may be responsible for this lag, including paucity of mechanistic biological data, particularly from high-burden settings such as low- and middle-income countries (LMICs), to support the development of specific formulations for vaginal use as well as a persistent misconception that vaginally delivered products may not be embraced by women and their sexual partners. Several of our priorities for impactful products for sexual and reproductive health will require vaginal delivery for immediate, on-demand use. We seek to catalyze the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. We expect these approaches to have user appeal, including promotion of self-care capability and other beneficial features that women seek, hence the need to couple discovery research with high-quality end-user input.<h2>The Challenge</h2>We are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure. We anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health. We welcome innovations at any stage of development that meet the scope of this call.Applicants may apply to address one or more of the following objectives of this challenge:<ol><li>Leverage biology for vaginally administered products: In this objective, we seek: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefit to the vaginal mucosal epithelium. Specifically, we seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).</li><li>Define characteristics of an ideal vaginal product: In this objective, we seek to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). We are particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. We acknowledge that there may be regional, cultural, demographic or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, we aim to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable'.</li></ol>Funding LevelProjects with a duration of up to two years and a maximum requested budget of $250,000USD are eligible for funding. Exploratory projects with shorter durations/lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority. Budgets should be commensurate with the scope of work proposed and in line with allowable costs of the targeted funding organization for which the applicant is eligible. Indirect costs should be included in the budget and should not exceed 10-15% of the total award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank">Gates Foundation's indirect cost policy</a>).Eligibility CriteriaThis initiative is open to research institutes, nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. Please note that all applicants will be expected to comply with the Foundation's global access clause. We encourage groups to build upon existing and/or complimentary projects/studies/trials and to collaborate with other institutions. We particularly encourage applications from projects led by women and/or researchers at institutions based in LMICs and/or involving collaboration with women-led or LMIC-based organizations. Only individuals who are applying through a legally recognized corporate entity are eligible.We are looking for proposals that:<ul><li>Focus on vaginal delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.</li><li>Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.</li><li>Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection and privacy.</li><li>Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.</li><li>Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists, then the proposal should be limited in scope.</li><li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li><li>Promote a diverse, inclusive, and supportive research environment, with priority for collaborations involving LMIC-based experts in reproductive health.</li></ul>We will not fund proposals that:<ul><li>Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g. menstrual products, contraceptive devices, over-the-counter probiotics, etc.).</li><li>Focus on approaches that would not be feasible or affordable in low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.</li><li>Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.</li><li>Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.</li><li>Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.</li><li>Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.</li><li>Primarily depend on traditional acceptability questionnaires or surveys (e.g., “if x hypothetical product existed, how interested would you be in using it?”).</li><li>Do not directly address one of the core objectives as outlined above.</li><li>Cannot be accomplished within a two-year maximum project duration or within the stipulated budget maximum.</li><li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li></ul>&nbsp;

Grand Challenges Brazil

This RFP is jointly launched by several Grand Challenges funding partners, including Grand Challenges Africa (Science for Africa Foundation), Grand Challenges Brazil (Brazilian Ministry of Health and the National Council on Research), Grand Challenges India (Biotechnology Industry Research Assistance Council), Grand Challenges South Africa (South African Medical Research Council), and the Gates Foundation. Each RFP may differ in its geographic focus, topic areas, and funding levels. Please review the eligibility criteria and specific requirements for each RFP carefully. The individual RFPs are listed separately <a href="https://gcgh.grandchallenges.org/challenges/JTdCJTIyc29ydCUyMiUzQSUyMmRlc2NlbmRpbmclMjIlMkMlMjJzb3J0RmllbGQlMjIlM0ElMjJkYXRlJTIyJTJDJTIybnVtYmVyUGVyUGFnZSUyMiUzQTEwJTJDJTIycGFnZU51bWJlciUyMiUzQTAlN0Q=/JTdCJTIyeWVhcnMlMjIlM0ElNUIlNUQlMkMlMjJjaGFsbGVuZ2VzJTIyJTNBJTVCJTIyMzk0JTIyJTVEJTJDJTIydGVybXMlMjIlM0ElNUIlNUQlMkMlMjJpbml0aWF0aXZlcyUyMiUzQSU1QiU1RCUyQyUyMmxvY2F0aW9ucyUyMiUzQSU1QiU1RCU3RA==" target="_blank" rel="noopener noreferrer">here</a>. If you qualify for more than one, we encourage you to apply to the RFP that best aligns with your proposed project and geographical location.
Please note: Grand Challenges Brazil will review proposals submitted by Brazilian organizations through the link on this webpage. Proposals selected to receive financial support from the Brazilian Ministry of Health / GC Brazil must be led by researchers linked to non-profit Science, Technology and Innovation Institutions (Instituição Científica, Tecnológica e de Inovação – ICT), registered in Brazil.
Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the Rules and Guidelines, Application Instructions, and Frequently Asked Questions.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on November 20, from 6:00 to 7:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP technical details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/2957503f-d95d-47b0-8bfa-b7d28f55266c@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" rel="noopener noreferrer">register</a> and <a href="https://forms.office.com/pages/responsepage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dMKiReMZsCJFmCa42S92Da1UMFBSMVlMQUNLSlRDOVNOMFdNR0dSUUFXNC4u&amp;origin=lprLink&amp;route=shorturl" target="_blank" rel="noopener noreferrer">submit your questions</a> in advance. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
Local delivery of drugs into the vagina for prevention and treatment of female-specific conditions remains understudied and under-utilized despite clear potential advantages such as discreetness, potent local efficacy, large surface area for drug absorption, high potential for API dosage sparing, potential for fewer systemic side effects, as well as providing autonomy and empowerment of women. Several key drivers may be responsible for this lag, including paucity of mechanistic biological data, particularly from high-burden settings such as low- and middle-income countries (LMICs), to support the development of specific formulations for vaginal use as well as a persistent misconception that vaginally delivered products may not be embraced by women and their sexual partners. Several of our priorities for impactful products for sexual and reproductive health will require vaginal delivery for immediate, on-demand use. We seek to catalyze the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. We expect these approaches to have user appeal, including promotion of self-care capability and other beneficial features that women seek, hence the need to couple discovery research with high-quality end-user input.
<h2>The Challenge</h2>
We are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure. We anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health. We welcome innovations at any stage of development that meet the scope of this call.
Applicants may apply to address one or more of the following objectives of this challenge:
<ol>
<li>Leverage biology for vaginally administered products: In this objective, we seek: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefit to the vaginal mucosal epithelium. Specifically, we seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).</li>
<li>Define characteristics of an ideal vaginal product: In this objective, we seek to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). We are particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. We acknowledge that there may be regional, cultural, demographic or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, we aim to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable'.</li>
</ol>
Funding Level
Projects with a duration of up to two years and a maximum requested budget of $250,000USD are eligible for funding. Exploratory projects with shorter durations/lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority. Budgets should be commensurate with the scope of work proposed and in line with allowable costs of the targeted funding organization for which the applicant is eligible. Indirect costs should be included in the budget and should not exceed 10-15% of the total award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank" rel="noopener noreferrer">Gates Foundation's indirect cost policy</a>).
Eligibility Criteria
This initiative is open to research institutes, nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. Please note that all applicants will be expected to comply with the Foundation's global access clause. We encourage groups to build upon existing and/or complimentary projects/studies/trials and to collaborate with other institutions. We particularly encourage applications from projects led by women and/or researchers at institutions based in LMICs and/or involving collaboration with women-led or LMIC-based organizations. Only individuals who are applying through a legally recognized corporate entity are eligible.
We are looking for proposals that:
<ul>
<li>Focus on vaginal delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.</li>
<li>Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.</li>
<li>Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection and privacy.</li>
<li>Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.</li>
<li>Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists, then the proposal should be limited in scope.</li>
<li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li>
<li>Promote a diverse, inclusive, and supportive research environment, with priority for collaborations involving LMIC-based experts in reproductive health.</li>
</ul>
We will not fund proposals that:
<ul>
<li>Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g. menstrual products, contraceptive devices, over-the-counter probiotics, etc.).</li>
<li>Focus on approaches that would not be feasible or affordable in low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.</li>
<li>Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.</li>
<li>Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.</li>
<li>Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.</li>
<li>Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.</li>
<li>Primarily depend on traditional acceptability questionnaires or surveys (e.g., “if x hypothetical product existed, how interested would you be in using it?”).</li>
<li>Do not directly address one of the core objectives as outlined above.</li>
<li>Cannot be accomplished within a two-year maximum project duration or within the stipulated budget maximum.</li>
<li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li>
</ul>
&nbsp;

Grand Challenges India - Biotechnology Industry Research Assistance Council (GCI-BIRAC) announce an open call on 'Accelerating Innovation in Vaginal Formulations in Support of Women's Health,' a program directed at addressing challenges that limit effective local drug delivery for women's health, particularly in managing reproductive tract infections (RTIs) and sexually transmitted infections (STIs) in low- and middle-income countries (LMICs).This initiative seeks to catalyze the development of context-driven innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. By promoting discovery research informed by high-quality end-user input, the call emphasizes the importance of coupling scientific innovation with women's preferences, cultural contexts, and lived experiences.<h2>Background</h2>Local vaginal drug delivery remains an underexplored and underutilized approach for the prevention and treatment of female-specific conditions, despite its clear potential advantages, including discreetness, potent local efficacy, large surface area for drug absorption, potential for lower API doses, and fewer systemic side effects as well as providing autonomy and empowerment of women. Progress in this area has been limited by a lack of mechanistic understanding of the vaginal milieu, especially in high-burden, low- and middle-income countries (LMICs), and by persistent misconceptions regarding the acceptability of vaginally administered products among women and their partners.Vaginal formulations hold significant promise for the management of reproductive tract infections (RTIs), sexually transmitted infections (STIs), contraceptive innovation, and maintenance of a healthy vaginal microbiome. Emerging scientific and translational opportunities make this an opportune time to reposition vaginal products as both public health tools and user-preferred interventions, for immediate, on-demand use. Evidence suggests that women's interests often extend beyond primary therapeutic or preventive functions to include secondary benefits such as odor control, sexual enhancement, and privacy of use.While there has been meaningful progress in delivery systems such as gels, films, and intravaginal rings, major gaps remain in acceptability, scalability, affordability, and integration into routine care in LMICs (Das Neves et al., 2021; Hussain et al., 2022). Addressing these gaps will require the development of innovative, scientifically rigorous formulations that integrate end-user perspectives and are adaptable to diverse settings.Therefore, this initiative seeks to catalyze the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products with strong user appeal, promoting self-care and other beneficial features that women value, while coupling discovery research with high-quality end-user insights.<h2>The Challenge</h2>GCI-BIRAC are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure. GCI-BIRAC anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health.GCI-BIRAC welcome innovations at any stage of development that meet the scope of this call.Applicants may apply to address one or more of the following objectives of this challenge:<ol><li>Leverage biology for vaginally administered products: In this objective, GCI-BIRAC seeks: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefit to the vaginal mucosal epithelium. Specifically, GCI-BIRAC seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).</li><li>Define characteristics of an ideal vaginal product: In this objective, GCI-BIRAC seeks to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). GCI-BIRAC is particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. GCI-BIRAC acknowledges that there may be regional, cultural, demographic or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, it is aimed to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable'.</li></ol>Call to ActionIndia has the opportunity to lead the world in transformative women's health innovation, being home to over 400 million women of reproductive age. The unique biological, cultural, and healthcare realities of Indian women, spanning diverse geographies from urban metros to rural communities, demand locally relevant, affordable, and acceptable vaginal health solutions.The initiative aims to bridge the critical gap between cutting-edge vaginal formulation science and ground-level implementation in India. The initiative is calling on innovators, researchers, and product developers to push the boundaries of women's health by creating context-driven, bold, transformative solutions for vaginal formulations. GCI-BIRAC encourages applications that combine scientific rigor with creativity, integrating both biological insights and the real-world preferences of women.This is an opportunity to design products that are not only therapeutically effective but also genuinely desirable, products that women will choose to use because they address their needs, enhance their well-being, and fit seamlessly into their lives.GCI-BIRAC welcome proposals at any stage of development, from early-stage discovery to near-market innovations. Your work could redefine what is possible in vaginal health, uncover new ways to leverage the vaginal microenvironment, and identify product features that resonate across diverse populations. By coupling cutting-edge science with user-centered design, you have the chance to deliver products that are safe, effective, and widely embraced.Through this initiative, India can demonstrate global leadership in women's health, catalyze low-cost, high-impact technologies, and inspire the next generation of innovators to think boldly and inclusively.DeliverablesBy the end of this program, the initiative aims to generate actionable knowledge and prototype innovations that are regulation-ready, market-viable, and designed for widespread adoption across India's diverse contexts. The initiative will deliver outcomes across two strategic objectives:Objective 1: Biology-Driven Formulation Innovation (Leveraging the Vaginal Microenvironment for Indian Women)<ul><li>Novel Formulations or Components: Proof-of-concept mechanisms adapted to Indian environmental and storage conditions, low-cost, locally sourced, with potential for extended or on-demand delivery</li><li>Biological Characterization: Impact on vaginal microbiome, epithelial health, pH, mucosal immunity; compatibility with common vaginal conditions; preliminary safety/tolerability</li><li>Scalability Roadmap: Cost analysis, manufacturing pathways, stability testing under Indian conditions, regulatory alignment with CDSCO.</li></ul>Objective 2: User-Centered Design Research (Defining characteristics of an ideal vaginal products)<ul><li>Comprehensive User Insights: Preferences, barriers, ancillary benefits (odor control, sexual wellness, menstrual support), across ≥3 demographic segments.</li><li>Actionable Design Principles: Prioritized features, regional/cultural mapping, discreet vs. conspicuous formats, preferred delivery formats.</li><li>Implementation Framework: Messaging, distribution channels, pricing/willingness-to-pay, community engagement strategies.</li></ul>GCI-BIRAC is looking for proposals that:<ul><li>Focus on vaginally delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.</li><li>Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.</li><li>Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection and privacy.</li><li>Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.</li><li>Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists then the proposal should be limited in scope.</li><li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li></ul>GCI-BIRAC will not fund proposals that:<ul><li>Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g. menstrual products, contraceptive devices, over-the-counter probiotics, etc.).</li><li>Focus on approaches that would not be feasible or affordable in India and low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.</li><li>Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.</li><li>Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.</li><li>Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.</li><li>Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in India and low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.</li><li>Primarily depend on traditional acceptability questionnaires or surveys (e.g., “if x hypothetical product existed, how interested would you be in using it?”).</li><li>Do not directly address one of the core objectives as outlined above.</li><li>Cannot be accomplished within a two-year maximum project duration or within the stipulated budget maximum.</li><li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li></ul>

Grand Challenges India

Grand Challenges India - Biotechnology Industry Research Assistance Council (GCI-BIRAC) announce an open call on 'Accelerating Innovation in Vaginal Formulations in Support of Women's Health,' a program directed at addressing challenges that limit effective local drug delivery for women's health, particularly in managing reproductive tract infections (RTIs) and sexually transmitted infections (STIs) in low- and middle-income countries (LMICs).
This initiative seeks to catalyze the development of context-driven innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. By promoting discovery research informed by high-quality end-user input, the call emphasizes the importance of coupling scientific innovation with women's preferences, cultural contexts, and lived experiences.
<h2>Background</h2>
Local vaginal drug delivery remains an underexplored and underutilized approach for the prevention and treatment of female-specific conditions, despite its clear potential advantages, including discreetness, potent local efficacy, large surface area for drug absorption, potential for lower API doses, and fewer systemic side effects as well as providing autonomy and empowerment of women. Progress in this area has been limited by a lack of mechanistic understanding of the vaginal milieu, especially in high-burden, low- and middle-income countries (LMICs), and by persistent misconceptions regarding the acceptability of vaginally administered products among women and their partners.
Vaginal formulations hold significant promise for the management of reproductive tract infections (RTIs), sexually transmitted infections (STIs), contraceptive innovation, and maintenance of a healthy vaginal microbiome. Emerging scientific and translational opportunities make this an opportune time to reposition vaginal products as both public health tools and user-preferred interventions, for immediate, on-demand use. Evidence suggests that women's interests often extend beyond primary therapeutic or preventive functions to include secondary benefits such as odor control, sexual enhancement, and privacy of use.
While there has been meaningful progress in delivery systems such as gels, films, and intravaginal rings, major gaps remain in acceptability, scalability, affordability, and integration into routine care in LMICs (Das Neves et al., 2021; Hussain et al., 2022). Addressing these gaps will require the development of innovative, scientifically rigorous formulations that integrate end-user perspectives and are adaptable to diverse settings.
Therefore, this initiative seeks to catalyze the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products with strong user appeal, promoting self-care and other beneficial features that women value, while coupling discovery research with high-quality end-user insights.
<h2>The Challenge</h2>
GCI-BIRAC are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure. GCI-BIRAC anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health.
GCI-BIRAC welcome innovations at any stage of development that meet the scope of this call.
Applicants may apply to address one or more of the following objectives of this challenge:
<ol>
<li>Leverage biology for vaginally administered products: In this objective, GCI-BIRAC seeks: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefit to the vaginal mucosal epithelium. Specifically, GCI-BIRAC seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).</li>
<li>Define characteristics of an ideal vaginal product: In this objective, GCI-BIRAC seeks to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). GCI-BIRAC is particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. GCI-BIRAC acknowledges that there may be regional, cultural, demographic or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, it is aimed to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable'.</li>
</ol>
Call to Action
India has the opportunity to lead the world in transformative women's health innovation, being home to over 400 million women of reproductive age. The unique biological, cultural, and healthcare realities of Indian women, spanning diverse geographies from urban metros to rural communities, demand locally relevant, affordable, and acceptable vaginal health solutions.
The initiative aims to bridge the critical gap between cutting-edge vaginal formulation science and ground-level implementation in India. The initiative is calling on innovators, researchers, and product developers to push the boundaries of women's health by creating context-driven, bold, transformative solutions for vaginal formulations. GCI-BIRAC encourages applications that combine scientific rigor with creativity, integrating both biological insights and the real-world preferences of women.
This is an opportunity to design products that are not only therapeutically effective but also genuinely desirable, products that women will choose to use because they address their needs, enhance their well-being, and fit seamlessly into their lives.
GCI-BIRAC welcome proposals at any stage of development, from early-stage discovery to near-market innovations. Your work could redefine what is possible in vaginal health, uncover new ways to leverage the vaginal microenvironment, and identify product features that resonate across diverse populations. By coupling cutting-edge science with user-centered design, you have the chance to deliver products that are safe, effective, and widely embraced.
Through this initiative, India can demonstrate global leadership in women's health, catalyze low-cost, high-impact technologies, and inspire the next generation of innovators to think boldly and inclusively.
Deliverables
By the end of this program, the initiative aims to generate actionable knowledge and prototype innovations that are regulation-ready, market-viable, and designed for widespread adoption across India's diverse contexts. The initiative will deliver outcomes across two strategic objectives:
Objective 1: Biology-Driven Formulation Innovation (Leveraging the Vaginal Microenvironment for Indian Women)
<ul>
<li>Novel Formulations or Components: Proof-of-concept mechanisms adapted to Indian environmental and storage conditions, low-cost, locally sourced, with potential for extended or on-demand delivery</li>
<li>Biological Characterization: Impact on vaginal microbiome, epithelial health, pH, mucosal immunity; compatibility with common vaginal conditions; preliminary safety/tolerability</li>
<li>Scalability Roadmap: Cost analysis, manufacturing pathways, stability testing under Indian conditions, regulatory alignment with CDSCO.</li>
</ul>
Objective 2: User-Centered Design Research (Defining characteristics of an ideal vaginal products)
<ul>
<li>Comprehensive User Insights: Preferences, barriers, ancillary benefits (odor control, sexual wellness, menstrual support), across ≥3 demographic segments.</li>
<li>Actionable Design Principles: Prioritized features, regional/cultural mapping, discreet vs. conspicuous formats, preferred delivery formats.</li>
<li>Implementation Framework: Messaging, distribution channels, pricing/willingness-to-pay, community engagement strategies.</li>
</ul>
GCI-BIRAC is looking for proposals that:
<ul>
<li>Focus on vaginally delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.</li>
<li>Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.</li>
<li>Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection and privacy.</li>
<li>Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.</li>
<li>Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists then the proposal should be limited in scope.</li>
<li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li>
</ul>
GCI-BIRAC will not fund proposals that:
<ul>
<li>Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g. menstrual products, contraceptive devices, over-the-counter probiotics, etc.).</li>
<li>Focus on approaches that would not be feasible or affordable in India and low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.</li>
<li>Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.</li>
<li>Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.</li>
<li>Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.</li>
<li>Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in India and low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.</li>
<li>Primarily depend on traditional acceptability questionnaires or surveys (e.g., “if x hypothetical product existed, how interested would you be in using it?”).</li>
<li>Do not directly address one of the core objectives as outlined above.</li>
<li>Cannot be accomplished within a two-year maximum project duration or within the stipulated budget maximum.</li>
<li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li>
</ul>

Grand Challenges India - Biotechnology Industry Research Assistance Council (GCI-BIRAC) announce an open call on 'Accelerating Innovation in Vaginal Formulations in Support of Women's Health,' a program directed at addressing challenges that limit effective local drug delivery for women's health, particularly in managing reproductive tract infections (RTIs) and sexually transmitted infections (STIs) in low- and middle-income countries (LMICs).

This RFP is jointly launched by several Grand Challenges funding partners, including Grand Challenges Africa (Science for Africa Foundation), Grand Challenges Brazil (Brazilian Ministry of Health and the National Council on Research), Grand Challenges India (Biotechnology Industry Research Assistance Council), and Grand Challenges South Africa (South African Medical Research Council). Each RFP may differ in its geographic focus, topic areas, and funding levels. Please review the eligibility criteria and specific requirements for each RFP carefully. The individual RFPs are listed separately <a href="https://gcgh.grandchallenges.org/challenges/JTdCJTIyc29ydCUyMiUzQSUyMmRlc2NlbmRpbmclMjIlMkMlMjJzb3J0RmllbGQlMjIlM0ElMjJkYXRlJTIyJTJDJTIybnVtYmVyUGVyUGFnZSUyMiUzQTEwJTJDJTIycGFnZU51bWJlciUyMiUzQTAlN0Q=/JTdCJTIyeWVhcnMlMjIlM0ElNUIlNUQlMkMlMjJjaGFsbGVuZ2VzJTIyJTNBJTVCJTIyMzk0JTIyJTVEJTJDJTIydGVybXMlMjIlM0ElNUIlNUQlMkMlMjJpbml0aWF0aXZlcyUyMiUzQSU1QiU1RCUyQyUyMmxvY2F0aW9ucyUyMiUzQSU1QiU1RCU3RA==" target="_blank">here</a>. If you qualify for more than one, we encourage you to apply to the RFP that best aligns with your proposed project.Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the Rules and Guidelines, Application Instructions, and Frequently Asked Questions.If you are planning to apply to this RFP, we will be hosting a dedicated webinar on November 20, from 6:00 to 7:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please register and submit your questions in advance. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.<h2>Background</h2>Local delivery of drugs into the vagina for prevention and treatment of female-specific conditions remains understudied and under-utilized despite clear potential advantages such as discreetness, potent local efficacy, large surface area for drug absorption, high potential for API dosage sparing, potential for fewer systemic side effects, as well as providing autonomy and empowerment of women. Several key drivers may be responsible for this lag, including paucity of mechanistic biological data, particularly from high-burden settings such as low- and middle-income countries (LMICs), to support the development of specific formulations for vaginal use as well as a persistent misconception that vaginally delivered products may not be embraced by women and their sexual partners. Several of our priorities for impactful products for sexual and reproductive health will require vaginal delivery for immediate, on-demand use. We seek to catalyze the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. We expect these approaches to have user appeal, including promotion of self-care capability and other beneficial features that women seek, hence the need to couple discovery research with high-quality end-user input.<h2>The Challenge</h2>We are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure.We anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health. We welcome innovations at any stage of development that meet the scope of this call.Applicants may apply to address one or more of the following objectives of this challenge:<ol><li>Leverage biology for vaginally administered products: In this objective, we seek: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefits to the vaginal mucosal epithelium. Specifically, we seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).</li><li>Define characteristics of an ideal vaginal product: In this objective, we seek to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). We are particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. We acknowledge that there may be regional, cultural, demographic, or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, we aim to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable.'</li></ol>Funding LevelProjects with a duration of up to two years and a maximum requested budget of Up to $250,000 USD (~R4.5 million) per project are eligible for funding. Exploratory projects with shorter durations/lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority. Budgets should be commensurate with the scope of work proposed and in line with allowable costs of the targeted funding organization for which the applicant is eligible. Indirect costs should be included in the budget and should not exceed 5% of the total award (subject to the <a href="https://www.samrc.ac.za/sites/default/files/attachments/2024-09/SAMRC%20Terms%20and%20Conditions%20of%20Funding.pdf" target="_blank">SAMRC Terms and Conditions of funding</a>).Eligibility CriteriaThis initiative is open to research institutes, NGOs, academic institutions, government agencies, and for-profit companies, with priority given to women-led projects and collaborations based in low- and middle-income countries (LMICs). Projects must be based in South Africa and led by South African principal investigators, who are citizens or permanent residents. All applicants are expected to comply with the Foundation's global access clause. Applicants are encouraged to build upon existing or complementary projects, studies, or trials, and to engage in collaborations with other institutions. Applications from teams led by women and/or researchers at LMIC-based institutions or involving collaboration with women-led or LMIC-based organizations, are strongly encouraged. Only individuals applying through a legally recognized corporate entity are eligible.We are looking for proposals that:&nbsp;<ul><li>Focus on vaginally delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.</li><li>Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.</li><li>Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection, and privacy.</li><li>Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.</li><li>Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists then the proposal should be limited in scope.</li><li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li><li>Promote a diverse, inclusive, and supportive research environment, with priority for collaborations involving LMIC-based experts in reproductive health.</li></ul>We will not fund proposals that:&nbsp;<ul><li>Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g., menstrual products, contraceptive devices, over-the-counter probiotics, etc.).</li><li>Focus on approaches that would not be feasible or affordable in low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.</li><li>Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.</li><li>Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.</li><li>Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.</li><li>Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.</li><li>Primarily depend on traditional acceptability questionnaires or surveys (e.g., "if x hypothetical product existed, how interested would you be in using it?").</li><li>Do not directly address one of the core objectives as outlined above.</li><li>Can not be accomplished within a two-year maximum project duration or within the stipulated budget maximum.</li><li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li></ul>Application SubmissionAll applications must be submitted directly through the Grand Challenges South Africa online portal (RedCap): <a href="https://eur02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsamrc-redcap.mrc.ac.za%2Fsurveys%2F%3Fs%3DK9EL9FLPFXJEHJHL&amp;data=05%7C02%7CKarabo.Kgomo%40mrc.ac.za%7C1866ef4376b6441f44d208de1525c6d5%7Cf1930bff9b514d0cb2bdc26a9e0f4600%7C0%7C0%7C638971449165598983%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=b3jIENZek4Ggub2jN7RmCexuWNYTnOmhRVwXXzZc8AU%3D&amp;reserved=0" target="_blank">GCSA Women's Health Innovation Call</a>. (Submissions via email or any other method will not be accepted).Applicants are required to complete the following within the portal:<ol><li>Project Proposal – Complete all registration fields, including the Applicant Profile.</li><li>Uploads – Applicants must provide the following documents:<ul><li>Full Proposal –<a href="https://www.samrc.ac.za/sites/default/files/attachments/2025-10/GCSA%20Vaginal%20Formulations%20Proposal%20Template%202025.docx" target="_blank">Proposal Template</a> (Signed by the institution)</li><li>Budget – Upload as a Microsoft Excel or PDF file using the <a href="https://www.samrc.ac.za/sites/default/files/attachments/2025-10/SAMRC%20Project%20Budget%20Template.xlsx" target="_blank">official budget template</a>. provided in the RFP.</li><li>Curriculum Vitae (CVs) – Upload CVs for the Principal Investigator and all Co-investigators.</li></ul></li></ol>Submission Requirements:<ul><li>Proposals must comply with all formatting and file size limits specified in the RFA.</li><li>Applications must be complete, responsive, and submitted by the deadline.</li><li>Applicants must meet all SAMRC eligibility criteria (e.g., South African PIs, citizens, or permanent residents).</li></ul>For questions regarding the RFP, selection criteria, or application instructions, applicants can contact Karabo Kgomo | SAMRC <a href="mailto:Karabo.Kgomo@mrc.ac.za">Karabo.Kgomo@mrc.ac.za</a> ) for South Africa–specific guidance.Budget Guidelines<ul><li>Budgets submitted must include all applicable taxes.</li><li>South African applicants must prepare budgets in South African Rands (ZAR).</li><li>Applicants from other eligible countries may prepare their budgets in South African Rand or USD, noting that the exchange rate for awards will be based on the USD/ZAR rate at which the SAMRC received the funds.</li><li>All direct line items must be auditable.</li></ul>Allowable costs:<ul><li>Personnel: Soft-funded posts for individuals working on the project (e.g., post-docs, students, technicians, project managers) will be funded, provided an accurate estimation of time allocation is provided, and they are not already funded by other means.</li><li>Consultants: Local and/or foreign consultants providing a service or capability not available among project partners but essential for the completion of project deliverables.</li><li>Equipment: Partial or full support for the cost of equipment directly required for the project. Budget limitations may apply.</li><li>Supplies, consumables, and other direct laboratory or research costs.</li><li>Sub-contracts: Any local or international organization providing essential services or capabilities not available among project partners.</li><li>Travel and accommodation directly related to the project's execution.</li><li>Institutional overhead: An indirect cost rate of 5% is allowed.</li></ul>Non-Allowable Costs:<ul><li>Salaries of permanent or fixed-term staff, e.g., tenured staff, professors, etc. That is fully covered by the host institutions.</li><li>Purchase or construction of buildings.</li><li>Rental costs for space owned by the institutions participating in the project.</li><li>Recruitment or retrenchment costs for staff.</li><li>Purchase of office furniture.</li></ul>Review and Evaluation of ProposalsEligibility Screening:<ul><li>All applications will be screened by the SAMRC and Grand Challenges funding partners for completeness and responsiveness to the call and its administrative requirements/provisions.</li><li>Incomplete or non-responsive applications, or those submitted after the deadline, will not be processed further.</li></ul>Evaluation: All eligible applications will be reviewed by local and international experts, considering at least the following criteria:<ul><li>Significance / Relevance / Impact: Potential impact on public health outcomes.</li><li>Approach: Innovation, rationale, work plan, and cost-effectiveness.</li><li>Team: Size, reach, experience, and complementarity of project partners.</li><li>Environment: Availability of infrastructure, equipment, and resources; unique features of the project environment, subject populations, or collaborative arrangements.</li></ul>Timeline<table class="table"><thead><tr><th>Milestone</th><th>Date</th></tr></thead><tbody><tr><td>RFP Launch</td><td>Tuesday, 28 October 2025</td></tr><tr><td>Application Close</td><td>Tuesday, 16 December 2025, 8:30 p.m. SAST</td></tr><tr><td>Review &amp; Approvals</td><td>Jan – March 2026</td></tr><tr><td>Notification of Awards</td><td>April 2026</td></tr><tr><td>Anticipated Project Start</td><td>April/May 2026</td></tr></tbody></table>Additional Information<ul><li>Ethics and regulatory approvals must be obtained before disbursement.</li><li>Funders may verify information provided by applicants.</li><li>No responsibility for costs incurred in preparing applications.</li><li>Funders may amend or withdraw the RFP at any time.</li><li>Successful applicants may be asked to address reviewer comments or negotiate budgets.</li></ul>Contact for queries: Karabo Kgomo | SAMRC <a href="mailto:Karabo.Kgomo@mrc.ac.za">Karabo.Kgomo@mrc.ac.za</a>

Grand Challenges South Africa

This RFP is jointly launched by several Grand Challenges funding partners, including Grand Challenges Africa (Science for Africa Foundation), Grand Challenges Brazil (Brazilian Ministry of Health and the National Council on Research), Grand Challenges India (Biotechnology Industry Research Assistance Council), and Grand Challenges South Africa (South African Medical Research Council). Each RFP may differ in its geographic focus, topic areas, and funding levels. Please review the eligibility criteria and specific requirements for each RFP carefully. The individual RFPs are listed separately <a href="https://gcgh.grandchallenges.org/challenges/JTdCJTIyc29ydCUyMiUzQSUyMmRlc2NlbmRpbmclMjIlMkMlMjJzb3J0RmllbGQlMjIlM0ElMjJkYXRlJTIyJTJDJTIybnVtYmVyUGVyUGFnZSUyMiUzQTEwJTJDJTIycGFnZU51bWJlciUyMiUzQTAlN0Q=/JTdCJTIyeWVhcnMlMjIlM0ElNUIlNUQlMkMlMjJjaGFsbGVuZ2VzJTIyJTNBJTVCJTIyMzk0JTIyJTVEJTJDJTIydGVybXMlMjIlM0ElNUIlNUQlMkMlMjJpbml0aWF0aXZlcyUyMiUzQSU1QiU1RCUyQyUyMmxvY2F0aW9ucyUyMiUzQSU1QiU1RCU3RA==" target="_blank" rel="noopener noreferrer">here</a>. If you qualify for more than one, we encourage you to apply to the RFP that best aligns with your proposed project.
Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the Rules and Guidelines, Application Instructions, and Frequently Asked Questions.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on November 20, from 6:00 to 7:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please register and submit your questions in advance. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
Local delivery of drugs into the vagina for prevention and treatment of female-specific conditions remains understudied and under-utilized despite clear potential advantages such as discreetness, potent local efficacy, large surface area for drug absorption, high potential for API dosage sparing, potential for fewer systemic side effects, as well as providing autonomy and empowerment of women. Several key drivers may be responsible for this lag, including paucity of mechanistic biological data, particularly from high-burden settings such as low- and middle-income countries (LMICs), to support the development of specific formulations for vaginal use as well as a persistent misconception that vaginally delivered products may not be embraced by women and their sexual partners. Several of our priorities for impactful products for sexual and reproductive health will require vaginal delivery for immediate, on-demand use. We seek to catalyze the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. We expect these approaches to have user appeal, including promotion of self-care capability and other beneficial features that women seek, hence the need to couple discovery research with high-quality end-user input.
<h2>The Challenge</h2>
We are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure.We anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health. We welcome innovations at any stage of development that meet the scope of this call.
Applicants may apply to address one or more of the following objectives of this challenge:
<ol>
<li>Leverage biology for vaginally administered products: In this objective, we seek: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefits to the vaginal mucosal epithelium. Specifically, we seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).</li>
<li>Define characteristics of an ideal vaginal product: In this objective, we seek to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). We are particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. We acknowledge that there may be regional, cultural, demographic, or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, we aim to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable.'</li>
</ol>
Funding Level
Projects with a duration of up to two years and a maximum requested budget of Up to $250,000 USD (~R4.5 million) per project are eligible for funding. Exploratory projects with shorter durations/lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority. Budgets should be commensurate with the scope of work proposed and in line with allowable costs of the targeted funding organization for which the applicant is eligible. Indirect costs should be included in the budget and should not exceed 5% of the total award (subject to the <a href="https://www.samrc.ac.za/sites/default/files/attachments/2024-09/SAMRC%20Terms%20and%20Conditions%20of%20Funding.pdf" target="_blank" rel="noopener noreferrer">SAMRC Terms and Conditions of funding</a>).
Eligibility Criteria
This initiative is open to research institutes, NGOs, academic institutions, government agencies, and for-profit companies, with priority given to women-led projects and collaborations based in low- and middle-income countries (LMICs). Projects must be based in South Africa and led by South African principal investigators, who are citizens or permanent residents. All applicants are expected to comply with the Foundation's global access clause. Applicants are encouraged to build upon existing or complementary projects, studies, or trials, and to engage in collaborations with other institutions. Applications from teams led by women and/or researchers at LMIC-based institutions or involving collaboration with women-led or LMIC-based organizations, are strongly encouraged. Only individuals applying through a legally recognized corporate entity are eligible.
We are looking for proposals that:&nbsp;
<ul>
<li>Focus on vaginally delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.</li>
<li>Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.</li>
<li>Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection, and privacy.</li>
<li>Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.</li>
<li>Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists then the proposal should be limited in scope.</li>
<li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li>
<li>Promote a diverse, inclusive, and supportive research environment, with priority for collaborations involving LMIC-based experts in reproductive health.</li>
</ul>
We will not fund proposals that:&nbsp;
<ul>
<li>Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g., menstrual products, contraceptive devices, over-the-counter probiotics, etc.).</li>
<li>Focus on approaches that would not be feasible or affordable in low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.</li>
<li>Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.</li>
<li>Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.</li>
<li>Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.</li>
<li>Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.</li>
<li>Primarily depend on traditional acceptability questionnaires or surveys (e.g., "if x hypothetical product existed, how interested would you be in using it?").</li>
<li>Do not directly address one of the core objectives as outlined above.</li>
<li>Can not be accomplished within a two-year maximum project duration or within the stipulated budget maximum.</li>
<li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li>
</ul>
Application Submission
All applications must be submitted directly through the Grand Challenges South Africa online portal (RedCap): <a href="https://eur02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsamrc-redcap.mrc.ac.za%2Fsurveys%2F%3Fs%3DK9EL9FLPFXJEHJHL&amp;data=05%7C02%7CKarabo.Kgomo%40mrc.ac.za%7C1866ef4376b6441f44d208de1525c6d5%7Cf1930bff9b514d0cb2bdc26a9e0f4600%7C0%7C0%7C638971449165598983%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=b3jIENZek4Ggub2jN7RmCexuWNYTnOmhRVwXXzZc8AU%3D&amp;reserved=0" target="_blank" rel="noopener noreferrer">GCSA Women's Health Innovation Call</a>. (Submissions via email or any other method will not be accepted).
Applicants are required to complete the following within the portal:
<ol>
<li>Project Proposal – Complete all registration fields, including the Applicant Profile.</li>
<li>Uploads – Applicants must provide the following documents:
<ul>
<li>Full Proposal –<a href="https://www.samrc.ac.za/sites/default/files/attachments/2025-10/GCSA%20Vaginal%20Formulations%20Proposal%20Template%202025.docx" target="_blank" rel="noopener noreferrer">Proposal Template</a> (Signed by the institution)</li>
<li>Budget – Upload as a Microsoft Excel or PDF file using the <a href="https://www.samrc.ac.za/sites/default/files/attachments/2025-10/SAMRC%20Project%20Budget%20Template.xlsx" target="_blank" rel="noopener noreferrer">official budget template</a>. provided in the RFP.</li>
<li>Curriculum Vitae (CVs) – Upload CVs for the Principal Investigator and all Co-investigators.</li>
</ul>
</li>
</ol>
Submission Requirements:
<ul>
<li>Proposals must comply with all formatting and file size limits specified in the RFA.</li>
<li>Applications must be complete, responsive, and submitted by the deadline.</li>
<li>Applicants must meet all SAMRC eligibility criteria (e.g., South African PIs, citizens, or permanent residents).</li>
</ul>
For questions regarding the RFP, selection criteria, or application instructions, applicants can contact Karabo Kgomo | SAMRC <a href="mailto:Karabo.Kgomo@mrc.ac.za">Karabo.Kgomo@mrc.ac.za</a> ) for South Africa–specific guidance.
Budget Guidelines
<ul>
<li>Budgets submitted must include all applicable taxes.</li>
<li>South African applicants must prepare budgets in South African Rands (ZAR).</li>
<li>Applicants from other eligible countries may prepare their budgets in South African Rand or USD, noting that the exchange rate for awards will be based on the USD/ZAR rate at which the SAMRC received the funds.</li>
<li>All direct line items must be auditable.</li>
</ul>
Allowable costs:
<ul>
<li>Personnel: Soft-funded posts for individuals working on the project (e.g., post-docs, students, technicians, project managers) will be funded, provided an accurate estimation of time allocation is provided, and they are not already funded by other means.</li>
<li>Consultants: Local and/or foreign consultants providing a service or capability not available among project partners but essential for the completion of project deliverables.</li>
<li>Equipment: Partial or full support for the cost of equipment directly required for the project. Budget limitations may apply.</li>
<li>Supplies, consumables, and other direct laboratory or research costs.</li>
<li>Sub-contracts: Any local or international organization providing essential services or capabilities not available among project partners.</li>
<li>Travel and accommodation directly related to the project's execution.</li>
<li>Institutional overhead: An indirect cost rate of 5% is allowed.</li>
</ul>
Non-Allowable Costs:
<ul>
<li>Salaries of permanent or fixed-term staff, e.g., tenured staff, professors, etc. That is fully covered by the host institutions.</li>
<li>Purchase or construction of buildings.</li>
<li>Rental costs for space owned by the institutions participating in the project.</li>
<li>Recruitment or retrenchment costs for staff.</li>
<li>Purchase of office furniture.</li>
</ul>
Review and Evaluation of Proposals
Eligibility Screening:
<ul>
<li>All applications will be screened by the SAMRC and Grand Challenges funding partners for completeness and responsiveness to the call and its administrative requirements/provisions.</li>
<li>Incomplete or non-responsive applications, or those submitted after the deadline, will not be processed further.</li>
</ul>
Evaluation: All eligible applications will be reviewed by local and international experts, considering at least the following criteria:
<ul>
<li>Significance / Relevance / Impact: Potential impact on public health outcomes.</li>
<li>Approach: Innovation, rationale, work plan, and cost-effectiveness.</li>
<li>Team: Size, reach, experience, and complementarity of project partners.</li>
<li>Environment: Availability of infrastructure, equipment, and resources; unique features of the project environment, subject populations, or collaborative arrangements.</li>
</ul>
Timeline
<div class="responsive-table"><table>
<thead>
<tr>
<th>Milestone</th>
<th>Date</th>
</tr>
</thead>
<tbody>
<tr>
<td>RFP Launch</td>
<td>Tuesday, 28 October 2025</td>
</tr>
<tr>
<td>Application Close</td>
<td>Tuesday, 16 December 2025, 8:30 p.m. SAST</td>
</tr>
<tr>
<td>Review &amp; Approvals</td>
<td>Jan – March 2026</td>
</tr>
<tr>
<td>Notification of Awards</td>
<td>April 2026</td>
</tr>
<tr>
<td>Anticipated Project Start</td>
<td>April/May 2026</td>
</tr>
</tbody>
</table></div>
Additional Information
<ul>
<li>Ethics and regulatory approvals must be obtained before disbursement.</li>
<li>Funders may verify information provided by applicants.</li>
<li>No responsibility for costs incurred in preparing applications.</li>
<li>Funders may amend or withdraw the RFP at any time.</li>
<li>Successful applicants may be asked to address reviewer comments or negotiate budgets.</li>
</ul>
Contact for queries: Karabo Kgomo | SAMRC <a href="mailto:Karabo.Kgomo@mrc.ac.za">Karabo.Kgomo@mrc.ac.za</a>

Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low-cost_nutritients_cost_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low_cost_nutrients_application_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/accelerating-development-innovative-exceptionally-low-cost-maternal-and-child-nutrient-ingredients" target="_blank">Frequently Asked Questions</a>.If you are planning to apply to this RFP, we will be hosting a dedicated webinar on November 12, from 7:00 to 8:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/e41294d9-be6c-4906-a5db-bd5aedaa5e75@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74">register</a> and <a href="https://forms.office.com/r/sUWxxATXyT?origin=lprLink" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.<blockquote>This is a call for transformative innovation. We seek solutions that ensure every mother and child – regardless of where they live – can access the essential nutrients to survive and thrive.</blockquote><h2>Background</h2>Malnutrition remains one of the most urgent and pervasive threats to maternal, newborn, and child health in low- and middle-income countries (LMICs). It contributes to nearly half of all under-five child deaths and is a significant driver of maternal and child morbidity and mortality. During the first 1,000 days of a child's life (from conception to a child's second birthday), nutritional deficiencies can cause irreversible physical and cognitive impairments, limiting educational attainment, economic productivity, and lifelong health. In LMICs, where poverty, limited health services, and food insecurity intersect, the burden of malnutrition disproportionately affects the most vulnerable populations, exacerbating inequities and hindering progress toward global development goals.Targeted interventions that improve maternal nutrition before and during pregnancy are essential for breaking this cycle.Despite decades of evidence demonstrating the importance of adequate intakes and effectiveness of nutrition interventions, many solutions are inaccessible in LMICs due to high costs of nutrients and final products.The nutrients we are particularly interested in are calcium, choline, and omega-3 long chain polyunsaturated fatty acids (specifically docosahexaenoic acid – DHA).Calcium supplementation has been recommended by the World Health Organization (WHO) (1.5–2.0 g elemental calcium daily in populations with low dietary intake) since 2011 as a strategy to reduce the risk of preeclampsia in pregnant women. In two recent randomized trials in India and Tanzania, a low-dose regimen (500 mg elemental calcium daily) was found to be noninferior to the high-dose regimen (1,500 mg) in reducing preeclampsia incidence, supporting the possibility of a simpler, lower-dose strategy.Choline is an essential nutrient that supports fetal brain development, memory function, and placental health, with increasing evidence linking adequate maternal intake to improved child neurocognitive outcomes. The U.S. National Academies of Medicine, the American Academy of Pediatrics, and the European Food Safety Authority (EFSA) all recommend adequate intakes (450–480 mg/day), yet studies consistently show that most pregnant women consume less than recommended, making insufficiency highly prevalent.DHA supports fetal brain, eye, and nervous system development. A Cochrane meta-analysis found that omega-3 supplementation including DHA in pregnancy reduces the risk of preterm birth (before 37 weeks and before 34 weeks). The WHO and the Food and Agriculture Organization (FAO) recommend ≥200 mg/day of DHA for pregnant and lactating women, while the EFSA advises 100–200 mg/day DHA in addition to regular omega-3 intake. This is consistent with recommendations from professional societies such as the American College of Obstetricians and Gynecologists and the International Society for the Study of Fatty Acids and Lipids. Despite this alignment across authorities, dietary surveys show that most pregnant women worldwide do not meet these targets, particularly in regions with low fish consumption.The United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) is a standard formulation that provides a base reference for antenatal multiple micronutrient supplementation and is used in this call for proposals.<h2>The Challenge</h2>High input costs, complex production processes, and limited manufacturing capacity in LMICs keep the price of essential nutrient ingredients and products prohibitively high. As a result, millions of women and children cannot access proven, lifesaving interventions.At the same time, there is a clear opportunity: innovations across the entire product lifecycle - raw material sourcing, ingredient formulation, manufacturing methods, and packaging - can dramatically lower costs while maintaining quality. Advances in biotechnology, materials science, food technology, and other industries provide models that could be adapted to nutrition.We are not seeking incremental improvements. This call is for transformative, bold solutions that can reduce costs by at least 50% compared to current baselines, while maintaining or improving safety, efficacy, and user acceptability. We want to support the development and validation of scalable, sustainable strategies that make high-quality nutrient ingredients and products affordable for LMIC health systems and ensure equitable access for every mother and child.Based on Latham BioPharm Group research, the commonly available pharmaceutical quality ingredients for the nutrients of interest are calcium carbonate, choline bitartrate, choline chloride, and algal DHA powder. The lowest prices reported are 2.1 USD/kg, 5.8 USD/kg, 1.2 USD/kg, and 52 USD/kg (30% purity) respectively. The target cost for exceptionally low-cost nutrient ingredients should be at least 50% below the lowest price identified.Focus AreasApplicants may propose projects under one of the following options:<table class="table"><thead><tr><th>Option</th><th>Scope</th><th>Key Requirements</th></tr></thead><tbody><tr><td>A</td><td>Development of exceptionally low-cost nutrient ingredients (calcium, choline, DHA)</td><td><ul><li>≥50% cost reduction compared to current lowest prices (CaCO₃ $2.1/kg, choline chloride $1.2/kg, algal DHA powder $52/kg, etc.)</li><li>Must meet pharmacopeial standards and International Council for Harmonisation (ICH) Q7 Good Manufacturing Practice (GMP) requirements</li><li>Expected to be stable, allergen-free, culturally inclusive (vegetarian, halal, kosher), and taste neutral</li></ul></td></tr><tr><td>B</td><td>Development of a low-cost prenatal supplement (UNIMMAP MMS + 500 mg/day calcium)</td><td><ul><li>Target cost &lt; US$2 per 180-day regimen</li><li>Informed by consumer research (acceptability, usability, palatability)</li><li>Demonstrated 3 month real-time and 6-month accelerated stability at ICH Q1 (Zone IVb)</li><li>Ideally meet WHO GMP requirements</li></ul></td></tr><tr><td>C</td><td>Development of an advanced prenatal supplement (MMSplus: UNIMMAP MMS + 500 mg/day calcium + 100 mg/day nicotinamide + 450 mg/day choline + 200 mg/day DHA)</td><td><ul><li>Multiple dosage forms or units acceptable (not limited to a single tablet)</li><li>Informed by consumer research - Demonstrated 3 month real-time and 6-month accelerated stability at ICH Q1 (Zone IVb)</li><li>Ideally meet WHO GMP requirements</li></ul></td></tr></tbody></table>Funding Level<table class="table"><thead><tr><th>Option</th><th>Scope</th><th>Target (summary)</th><th>Funding</th><th>Duration</th></tr></thead><tbody><tr><td>A</td><td>Exceptionally low-cost nutrient ingredients (Calcium, Choline, DHA)</td><td>≥50% cost reduction vs current lowest prices; pharmaceutical quality; stable, allergen-free, culturally inclusive</td><td>Up to US$500,000 per ingredient</td><td>Up to 18 months</td></tr><tr><td>B</td><td>Low-cost prenatal supplement (MMS + 500 mg Calcium)</td><td>Less than US$2 per 180-day regimen; consumer informed; 6-month accelerated stability in Zone IVb</td><td>Up to US$200,000</td><td>Up to 12 months</td></tr><tr><td>C</td><td>Advanced prenatal supplement (MMSplus)</td><td>Consumer informed; 6-month accelerated stability in Zone IVb</td><td>Up to US$400,000</td><td>Up to 12 months</td></tr></tbody></table> Application budgets should be commensurate with the scope of work proposed. Indirect costs should be included in the budget and should not exceed 10-15% of the total award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank">Gates Foundation's indirect cost policy</a>).EligibilityThis initiative is open globally to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. We invite innovators from nutrition, biotechnology, food technology, pharmaceuticals, and beyond to apply. Only individuals who are applying through a legally recognized corporate entity are eligible.What We Are Looking ForSuccessful proposals will demonstrate bold thinking, technical rigor, and a pathway to scale. Specifically, we are seeking proposals that:<ul><li>Present transformative cost-reduction strategies, not incremental improvements, with a clear pathway to achieve ≥50% cost reduction.</li><li>Provide specific steps and/or end-to-end solutions, including credible cost modeling at scale (e.g., 3 million regimens per year).</li><li>Demonstrate technical feasibility with the ability to generate meaningful data within 12–18 months.</li><li>Clearly outline team capabilities and expertise, with strong preference for collaborations involving LMIC partners.</li><li>Include a justified budget, which will be reviewed for alignment with scope and deliverables.</li><li>Consider and enable manufacturing in LMICs, ensuring cultural and dietary inclusivity (vegetarian, halal, kosher).</li><li>Are informed by consumer research, addressing acceptability, usability, and adherence.</li></ul>We encourage applicants to identify and build collaborations with organizations that bring complementary expertise. Where appropriate, the Foundation may facilitate connections among applicants working on related challenges.We will not fund proposals that:<ul><li>Rely solely on price negotiation or procurement tactics (e.g., bulk purchasing).</li><li>Offer only stepwise, incremental improvements with minimal cost impact.</li><li>Focus on delivery models (e.g., distribution, supply chain tools, or market shaping) without product innovation.</li><li>Address nutrients or products outside the defined scope.</li></ul>

Accelerating Development of Innovative, Exceptionally Low-Cost Maternal and Child Nutrient Ingredients and Products

Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank" rel="noopener noreferrer">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low-cost_nutritients_cost_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low_cost_nutrients_application_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/accelerating-development-innovative-exceptionally-low-cost-maternal-and-child-nutrient-ingredients" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on November 12, from 7:00 to 8:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/e41294d9-be6c-4906-a5db-bd5aedaa5e75@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" rel="noopener noreferrer">register</a> and <a href="https://forms.office.com/r/sUWxxATXyT?origin=lprLink" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u" rel="noopener noreferrer">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<blockquote>This is a call for transformative innovation. We seek solutions that ensure every mother and child – regardless of where they live – can access the essential nutrients to survive and thrive.
</blockquote>
<h2>Background</h2>
Malnutrition remains one of the most urgent and pervasive threats to maternal, newborn, and child health in low- and middle-income countries (LMICs). It contributes to nearly half of all under-five child deaths and is a significant driver of maternal and child morbidity and mortality. During the first 1,000 days of a child's life (from conception to a child's second birthday), nutritional deficiencies can cause irreversible physical and cognitive impairments, limiting educational attainment, economic productivity, and lifelong health. In LMICs, where poverty, limited health services, and food insecurity intersect, the burden of malnutrition disproportionately affects the most vulnerable populations, exacerbating inequities and hindering progress toward global development goals.
Targeted interventions that improve maternal nutrition before and during pregnancy are essential for breaking this cycle.
Despite decades of evidence demonstrating the importance of adequate intakes and effectiveness of nutrition interventions, many solutions are inaccessible in LMICs due to high costs of nutrients and final products.
The nutrients we are particularly interested in are calcium, choline, and omega-3 long chain polyunsaturated fatty acids (specifically docosahexaenoic acid – DHA).
Calcium supplementation has been recommended by the World Health Organization (WHO) (1.5–2.0 g elemental calcium daily in populations with low dietary intake) since 2011 as a strategy to reduce the risk of preeclampsia in pregnant women. In two recent randomized trials in India and Tanzania, a low-dose regimen (500 mg elemental calcium daily) was found to be noninferior to the high-dose regimen (1,500 mg) in reducing preeclampsia incidence, supporting the possibility of a simpler, lower-dose strategy.
Choline is an essential nutrient that supports fetal brain development, memory function, and placental health, with increasing evidence linking adequate maternal intake to improved child neurocognitive outcomes. The U.S. National Academies of Medicine, the American Academy of Pediatrics, and the European Food Safety Authority (EFSA) all recommend adequate intakes (450–480 mg/day), yet studies consistently show that most pregnant women consume less than recommended, making insufficiency highly prevalent.
DHA supports fetal brain, eye, and nervous system development. A Cochrane meta-analysis found that omega-3 supplementation including DHA in pregnancy reduces the risk of preterm birth (before 37 weeks and before 34 weeks). The WHO and the Food and Agriculture Organization (FAO) recommend ≥200 mg/day of DHA for pregnant and lactating women, while the EFSA advises 100–200 mg/day DHA in addition to regular omega-3 intake. This is consistent with recommendations from professional societies such as the American College of Obstetricians and Gynecologists and the International Society for the Study of Fatty Acids and Lipids. Despite this alignment across authorities, dietary surveys show that most pregnant women worldwide do not meet these targets, particularly in regions with low fish consumption.
The United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) is a standard formulation that provides a base reference for antenatal multiple micronutrient supplementation and is used in this call for proposals.
<h2>The Challenge</h2>
High input costs, complex production processes, and limited manufacturing capacity in LMICs keep the price of essential nutrient ingredients and products prohibitively high. As a result, millions of women and children cannot access proven, lifesaving interventions.
At the same time, there is a clear opportunity: innovations across the entire product lifecycle - raw material sourcing, ingredient formulation, manufacturing methods, and packaging - can dramatically lower costs while maintaining quality. Advances in biotechnology, materials science, food technology, and other industries provide models that could be adapted to nutrition.
We are not seeking incremental improvements. This call is for transformative, bold solutions that can reduce costs by at least 50% compared to current baselines, while maintaining or improving safety, efficacy, and user acceptability. We want to support the development and validation of scalable, sustainable strategies that make high-quality nutrient ingredients and products affordable for LMIC health systems and ensure equitable access for every mother and child.
Based on Latham BioPharm Group research, the commonly available pharmaceutical quality ingredients for the nutrients of interest are calcium carbonate, choline bitartrate, choline chloride, and algal DHA powder. The lowest prices reported are 2.1 USD/kg, 5.8 USD/kg, 1.2 USD/kg, and 52 USD/kg (30% purity) respectively. The target cost for exceptionally low-cost nutrient ingredients should be at least 50% below the lowest price identified.
Focus Areas
Applicants may propose projects under one of the following options:
<div class="responsive-table"><table>
<thead>
<tr>
<th>Option</th>
<th>Scope</th>
<th>Key Requirements</th>
</tr>
</thead>
<tbody>
<tr>
<td>A</td>
<td>Development of exceptionally low-cost nutrient ingredients (calcium, choline, DHA)</td>
<td>
<ul>
<li>≥50% cost reduction compared to current lowest prices (CaCO₃ $2.1/kg, choline chloride $1.2/kg, algal DHA powder $52/kg, etc.)</li>
<li>Must meet pharmacopeial standards and International Council for Harmonisation (ICH) Q7 Good Manufacturing Practice (GMP) requirements</li>
<li>Expected to be stable, allergen-free, culturally inclusive (vegetarian, halal, kosher), and taste neutral</li>
</ul>
</td>
</tr>
<tr>
<td>B</td>
<td>Development of a low-cost prenatal supplement (UNIMMAP MMS + 500 mg/day calcium)</td>
<td>
<ul>
<li>Target cost &lt; US$2 per 180-day regimen</li>
<li>Informed by consumer research (acceptability, usability, palatability)</li>
<li>Demonstrated 3 month real-time and 6-month accelerated stability at ICH Q1 (Zone IVb)</li>
<li>Ideally meet WHO GMP requirements</li>
</ul>
</td>
</tr>
<tr>
<td>C</td>
<td>Development of an advanced prenatal supplement (MMSplus: UNIMMAP MMS + 500 mg/day calcium + 100 mg/day nicotinamide + 450 mg/day choline + 200 mg/day DHA)</td>
<td>
<ul>
<li>Multiple dosage forms or units acceptable (not limited to a single tablet)</li>
<li>Informed by consumer research - Demonstrated 3 month real-time and 6-month accelerated stability at ICH Q1 (Zone IVb)</li>
<li>Ideally meet WHO GMP requirements</li>
</ul>
</td>
</tr>
</tbody>
</table></div>
Funding Level
<div class="responsive-table"><table>
<thead>
<tr>
<th>Option</th>
<th>Scope</th>
<th>Target (summary)</th>
<th>Funding</th>
<th>Duration</th>
</tr>
</thead>
<tbody>
<tr>
<td>A</td>
<td>Exceptionally low-cost nutrient ingredients (Calcium, Choline, DHA)</td>
<td>≥50% cost reduction vs current lowest prices; pharmaceutical quality; stable, allergen-free, culturally inclusive</td>
<td>Up to US$500,000 per ingredient</td>
<td>Up to 18 months</td>
</tr>
<tr>
<td>B</td>
<td>Low-cost prenatal supplement (MMS + 500 mg Calcium)</td>
<td>Less than US$2 per 180-day regimen; consumer informed; 6-month accelerated stability in Zone IVb</td>
<td>Up to US$200,000</td>
<td>Up to 12 months</td>
</tr>
<tr>
<td>C</td>
<td>Advanced prenatal supplement (MMSplus)</td>
<td>Consumer informed; 6-month accelerated stability in Zone IVb</td>
<td>Up to US$400,000</td>
<td>Up to 12 months</td>
</tr>
</tbody>
</table></div>
 Application budgets should be commensurate with the scope of work proposed. Indirect costs should be included in the budget and should not exceed 10-15% of the total award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank" rel="noopener noreferrer">Gates Foundation's indirect cost policy</a>).
Eligibility
This initiative is open globally to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. We invite innovators from nutrition, biotechnology, food technology, pharmaceuticals, and beyond to apply. Only individuals who are applying through a legally recognized corporate entity are eligible.
What We Are Looking For
Successful proposals will demonstrate bold thinking, technical rigor, and a pathway to scale. Specifically, we are seeking proposals that:
<ul>
<li>Present transformative cost-reduction strategies, not incremental improvements, with a clear pathway to achieve ≥50% cost reduction.</li>
<li>Provide specific steps and/or end-to-end solutions, including credible cost modeling at scale (e.g., 3 million regimens per year).</li>
<li>Demonstrate technical feasibility with the ability to generate meaningful data within 12–18 months.</li>
<li>Clearly outline team capabilities and expertise, with strong preference for collaborations involving LMIC partners.</li>
<li>Include a justified budget, which will be reviewed for alignment with scope and deliverables.</li>
<li>Consider and enable manufacturing in LMICs, ensuring cultural and dietary inclusivity (vegetarian, halal, kosher).</li>
<li>Are informed by consumer research, addressing acceptability, usability, and adherence.</li>
</ul>
We encourage applicants to identify and build collaborations with organizations that bring complementary expertise. Where appropriate, the Foundation may facilitate connections among applicants working on related challenges.
We will not fund proposals that:
<ul>
<li>Rely solely on price negotiation or procurement tactics (e.g., bulk purchasing).</li>
<li>Offer only stepwise, incremental improvements with minimal cost impact.</li>
<li>Focus on delivery models (e.g., distribution, supply chain tools, or market shaping) without product innovation.</li>
<li>Address nutrients or products outside the defined scope.</li>
</ul>

High input costs, complex production processes, and limited manufacturing capacity in LMICs keep the price of essential nutrient ingredients and products prohibitively high. As a result, millions of women and children cannot access proven, lifesaving interventions.
This call is for transformative, bold solutions that can reduce costs by at least 50% compared to current baselines, while maintaining or improving safety, efficacy, and user acceptability. We want to support the development and validation of scalable, sustainable strategies that make high-quality nutrient ingredients and products affordable for LMIC health systems and ensure equitable access for every mother and child.

Accelerating Development of Innovative Exceptionally Low-Cost Maternal and Child Nutrient Ingredients and Products

**NOTE: This opportunity was open only to institutions who had been invited directly by email.Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/enteric_and_diarrheal_diseases_data_analysis_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/enteric_and_diarrheal_diseases_data_analysis_application_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/strengthening-analytic-capacity-enteric-and-diarrheal-diseases-low-and-middle-income-settings" target="_blank">Frequently Asked Questions</a>.<h2>Background</h2>Enteric and diarrheal diseases remain a leading cause of morbidity and mortality in low- and middle-income countries (LMICs), particularly among children under five. Over the past two decades, substantial investments have been made in large-scale epidemiological studies generating rich datasets on enteric pathogens, risk factors, and outcomes across diverse LMIC settings. Despite the volume and potential of this data, much of it remains underutilized, with limited secondary analysis conducted by in-country researchers. Empowering LMIC-based investigators to lead secondary analyses not only enhances the contextual relevance of findings but also strengthens local research capacity and ownership of health solutions. Therefore, there is a significant opportunity to catalyze novel insights into enteric and diarrheal disease etiology, sequelae, interventions, and policy, while promoting equitable research partnerships and advancing global health equity.<h2>The Challenge</h2>This RFP seeks to develop the capacity for leading data analysis related to enteric and diarrheal diseases in low-and-middle income settings.Specifically, the objectives of the challenge will be:<ul><li>Develop novel insights from existing data</li><li>Promote LMIC leadership and independence in global health research</li><li>Strengthen analytical capacity in LMICs</li><li>Inform policy and program decision-making</li><li>Advance open science and data stewardship</li></ul>Funding LevelWe will consider proposals for awards of up to $100,000 USD in direct costs for each project, with a grant term of up to 1 year. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered, and should be included in the budget for up to $15,000 USD award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank">Gates Foundation's indirect cost policy</a>).Eligibility CriteriaThis initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies and academic institutions that 1) are based in a LMIC country<a href="#_ftn1" title="" id="_ftnref1" name="_ftnref1">1</a>; and 2) have received funding from the Gates Foundation as a direct awardee or sub-grantee on enteric and diarrheal disease-related investments. We particularly encourage applications involving projects led by women or from women-led organizations. Applicants should align within their institutions before submitting a proposal as no more than one award will be given to a single institution.We are looking for proposals that:<ul><li>Are led by junior or mid-level researchers that: 1) have experience in the field of enterics and want to lead more analytics work, 2) have analytical skills who want to gain experience in applications in enterics or 3) have experience in both enterics and data analysis and would like to expand their analytic skillset in specific ways.</li><li>Focus on enteric and diarrheal diseases (including but not limited to diarrhea and diarrheal etiologies, typhoid/enteric fever and invasive nontyphoidal Salmonella, Hepatitis E and A)&nbsp;including but not limited to disease epidemiology, genomics, vaccine performance, disease dynamics, treatment effects, diagnostic performance, cost-effectiveness, and/or mathematical models.</li><li>Prioritize policy-relevant analytic questions.</li><li>Demonstrate institutional support and partnerships necessary for growth in analytic skills and successful completion of the objectives.</li><li>Conduct analyses beyond what was funded by the parent study and/or published.</li><li>Result in at least one pre-print manuscript and one policy brief.</li><li>Include support for investigators through a mentor, mentoring team, and/or training plan (e.g., coursework) to develop the analytic skills needed to successfully complete the proposed research. These resources may be provided by the applicant's home institution or a partner institution (located anywhere in the world) supported by a subgrant.</li><li>Contribute to sustainable capacity building for data analysis to be conducted at the home institution in future research projects.</li></ul>We will not fund proposals that:<ul><li>Aim to collect or generate new data through this funding.</li><li>Propose descriptive analyses alone.</li><li>Propose analyses that overlap with results already funded and/or published.</li><li>Are not led by an LMIC investigator.</li><li>Do not demonstrate how this award would strengthen local capacity to conduct and lead analysis of future datasets.</li><li>Do not have timely access to necessary data.</li><li>Do not focus on enteric and diarrheal diseases.</li><li>Do not demonstrate a clear commitment to open science and making their findings, processes and/or tools developed accessible and reusable.</li></ul><a href="#_ftnref1" title="" id="_ftn1" name="_ftn1">1</a> See <a href="https://data.worldbank.org/country/XO" target="_blank">World Bank - Low Income Countries for definitions</a>). Subject to the eligibility requirements in the Rules &amp; Guidelines, investigators in low- and middle-income countries are invited (in connection with the organization with which they are affiliated) to apply through the Gates Foundation’s application portal. We reserve the right to determine eligibility for this call based on these characteristics. Grants will go to investigators in low- and middle-income countries, but we encourage partnerships with investigators in other countries regardless of location, especially where the opportunity exists to build on existing collaborations.

Strengthening Analytic Capacity for Enteric and Diarrheal Diseases in Low-and-Middle Income Settings

**NOTE: This opportunity is open only to institutions who have been invited directly by email.
Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/enteric_and_diarrheal_diseases_data_analysis_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/enteric_and_diarrheal_diseases_data_analysis_application_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/strengthening-analytic-capacity-enteric-and-diarrheal-diseases-low-and-middle-income-settings" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>.
<h2>Background</h2>
Enteric and diarrheal diseases remain a leading cause of morbidity and mortality in low- and middle-income countries (LMICs), particularly among children under five. Over the past two decades, substantial investments have been made in large-scale epidemiological studies generating rich datasets on enteric pathogens, risk factors, and outcomes across diverse LMIC settings. Despite the volume and potential of this data, much of it remains underutilized, with limited secondary analysis conducted by in-country researchers. Empowering LMIC-based investigators to lead secondary analyses not only enhances the contextual relevance of findings but also strengthens local research capacity and ownership of health solutions. Therefore, there is a significant opportunity to catalyze novel insights into enteric and diarrheal disease etiology, sequelae, interventions, and policy, while promoting equitable research partnerships and advancing global health equity.
<h2>The Challenge</h2>
This RFP seeks to develop the capacity for leading data analysis related to enteric and diarrheal diseases in low-and-middle income settings.
Specifically, the objectives of the challenge will be:
<ul>
<li>Develop novel insights from existing data</li>
<li>Promote LMIC leadership and independence in global health research</li>
<li>Strengthen analytical capacity in LMICs</li>
<li>Inform policy and program decision-making</li>
<li>Advance open science and data stewardship</li>
</ul>
Funding Level
We will consider proposals for awards of up to $100,000 USD in direct costs for each project, with a grant term of up to 1 year. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered, and should be included in the budget for up to $15,000 USD award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank" rel="noopener noreferrer">Gates Foundation's indirect cost policy</a>).
Eligibility Criteria
This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies and academic institutions that 1) are based in a LMIC country<a href="#_ftn1" title id="_ftnref1" name="_ftnref1">1</a>; and 2) have received funding from the Gates Foundation as a direct awardee or sub-grantee on enteric and diarrheal disease-related investments. We particularly encourage applications involving projects led by women or from women-led organizations. Applicants should align within their institutions before submitting a proposal as no more than one award will be given to a single institution.
We are looking for proposals that:
<ul>
<li>Are led by junior or mid-level researchers that: 1) have experience in the field of enterics and want to lead more analytics work, 2) have analytical skills who want to gain experience in applications in enterics or 3) have experience in both enterics and data analysis and would like to expand their analytic skillset in specific ways.</li>
<li>Focus on enteric and diarrheal diseases (including but not limited to diarrhea and diarrheal etiologies, typhoid/enteric fever and invasive nontyphoidal Salmonella, Hepatitis E and A)&nbsp;including but not limited to disease epidemiology, genomics, vaccine performance, disease dynamics, treatment effects, diagnostic performance, cost-effectiveness, and/or mathematical models.</li>
<li>Prioritize policy-relevant analytic questions.</li>
<li>Demonstrate institutional support and partnerships necessary for growth in analytic skills and successful completion of the objectives.</li>
<li>Conduct analyses beyond what was funded by the parent study and/or published.</li>
<li>Result in at least one pre-print manuscript and one policy brief.</li>
<li>Include support for investigators through a mentor, mentoring team, and/or training plan (e.g., coursework) to develop the analytic skills needed to successfully complete the proposed research. These resources may be provided by the applicant's home institution or a partner institution (located anywhere in the world) supported by a subgrant.</li>
<li>Contribute to sustainable capacity building for data analysis to be conducted at the home institution in future research projects.</li>
</ul>
We will not fund proposals that:
<ul>
<li>Aim to collect or generate new data through this funding.</li>
<li>Propose descriptive analyses alone.</li>
<li>Propose analyses that overlap with results already funded and/or published.</li>
<li>Are not led by an LMIC investigator.</li>
<li>Do not demonstrate how this award would strengthen local capacity to conduct and lead analysis of future datasets.</li>
<li>Do not have timely access to necessary data.</li>
<li>Do not focus on enteric and diarrheal diseases.</li>
<li>Do not demonstrate a clear commitment to open science and making their findings, processes and/or tools developed accessible and reusable.</li>
</ul>
<a href="#_ftnref1" title id="_ftn1" name="_ftn1">1</a> See <a href="https://data.worldbank.org/country/XO" target="_blank" rel="noopener noreferrer">World Bank - Low Income Countries for definitions</a>). Subject to the eligibility requirements in the Rules &amp; Guidelines, investigators in low- and middle-income countries are invited (in connection with the organization with which they are affiliated) to apply through the Gates Foundation’s application portal. We reserve the right to determine eligibility for this call based on these characteristics. Grants will go to investigators in low- and middle-income countries, but we encourage partnerships with investigators in other countries regardless of location, especially where the opportunity exists to build on existing collaborations.

**NOTE: This opportunity is open only to institutions who have been invited directly by email.

The information regarding this Grand Challenges Request for Proposals was last updated on June 6, 2025.Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/controlled_trials_on_stis_and_rtis_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/controlled_trials_on_stis_and_rtis_application_instructions.pdf" target="_blank">Application Instructions</a>, and&nbsp;<a href="https://gcgh.grandchallenges.org/randomized-controlled-trial-sexually-transmitted-infections-stis-and-reproductive-tract-sequelae" target="_blank">Frequently Asked Questions</a>.We are planning a webinar to provide more information and answer your questions on June 17 from 7:00-8:00 AM Pacific Time. To participate, <a href="https://events.teams.microsoft.com/event/96243f4f-c909-4175-9cc6-aa5fa3699391@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank">please register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUMzJGQUZFNEZDWExXTTZVM0xYTDQzV0pKUy4u" target="_blank">submit your questions</a> ahead of time.<h2>Background</h2>Sexually active young women in low- and middle-income countries (LMICs) experience a high incidence of sexually transmitted infections (STIs), limited access to screening and treatment, and poorly characterized but significant reproductive tract morbidity from untreated infection. Global estimates put the prevalence of gonorrhea and chlamydia among women at 0.8% and 4.0%, respectively, with incidence rates of 1.9 and 3.6 cases per 100 person-years.<a href="#_ftn1" title="" id="_ftnref1" name="_ftnref1">[1]</a> However, these estimates are limited by sparse data, with few sources providing representative measures of disease frequency, including asymptomatic infections. Studies among young women in LMICs interested in HIV pre-exposure prophylaxis have measured incidence rates per 100 person-years of 12-53 for chlamydia, 6-20 for gonorrhea, and 6-7 for trichomoniasis.<a href="#_ftn2" title="" id="_ftnref2" name="_ftnref2">[2]</a> Due to the asymptomatic nature of most infections and reliance on syndromic management, most STIs in women go undetected. Untreated STIs have been linked to a range of poor health outcomes, including pelvic inflammatory disease (PID), chronic pelvic pain, infertility, and ectopic pregnancy. However, these estimates of association are imprecise and draw primarily from cross-sectional, case-control, and retrospective cohort studies, mostly conducted in high-income countries. Gaps in available data limit our ability to draw robust inferences on the risk of sequelae following an infection, the timing of pathogenesis, or how factors such as the presence of symptoms or repeat infection may modify these risks.Better data on the risk of PID and related sequelae are critical to inform prevention and treatment guidelines, motivate funding for product development and provision of services, and shift care-seeking and care-provision behaviors. Research on the prevalence and risk of PID in LMICs has been challenging due to a lack of accurate and scalable diagnostic methods for PID along with funding gaps that limit consistent and comprehensive diagnosis.&nbsp; Although diagnosing subclinical PID remains challenging, targeted research is critical to better understand the risk of developing clinical PID and to evaluate the effectiveness of STI screening and treatment in preventing reproductive tract complications. Strengthening the evidence base in this area will not only advance our understanding of STI-related morbidity but may also stimulate the development and application of improved diagnostic tools to reduce the burden of PID and related outcomes.<h2>The Challenge</h2>This Grand Challenge on Randomized Controlled Trial on Sexually Transmitted Infections (STIs) and Reproductive Tract Sequelae in Non-Pregnant Women aims to fill critical gaps in understanding of the risk of PID and related sequelae attributable to STIs and to evaluate the impact of etiologic STI screening and treatment on morbidity. With this Grand Challenge we welcome letters of intent (LOIs) from organizations to conduct a randomized controlled trial (RCT) in sub-Saharan Africa comparing STI screening and standard of care syndromic management. The primary outcome of this study should be PID, with secondary outcomes possibly including chronic pelvic pain, ectopic pregnancy, and infertility. The study should provide insight into the risk of outcomes following infection with gonorrhea, chlamydia, and/or trichomoniasis and the impact and cost-effectiveness of etiologic screening to prevent morbidity.Funding LevelWe will consider applications requesting awards ranging from $8 million to $10 million USD per project, with a grant duration of up to 48 months. Budgets should align with the scale and complexity of the proposed work. Indirect costs are allowable and should be included within the total requested funding. (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank">Gates Foundation's indirect cost policy</a>).Eligibility Criteria<ul><li>This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions.</li><li>Study design must be randomized controlled trial or comparable, robust prospective in Sub-Saharan African settings.</li><li>We encourage groups to build upon existing and/or complimentary projects/studies/trials and to collaborate with other institutions.</li><li>We particularly encourage applications involving projects led by African Primary Investigators (PIs), women, early-career researchers, and practitioners seeking to innovate in women's health measurement, or from women-led organizations and applications from institutions based in LMICs.</li></ul>We are looking for proposals that:<ul><li>Are designed to provide insight into the timing of pathogenesis. This insight could come from comparison of outcomes across arms with varying screening intervals and/or from more frequent collection and storage of samples for subsequent batch testing.</li><li>Consider symptom tracking tools (such as symptom diaries) that could be used to track the onset, type, and severity of symptoms. Ideally, based on validated instruments.</li><li>Ideally enable stratification of risk by the presence of symptoms, co-infection, and repeat infection.</li><li>Ideally provide data to estimate STI incidence and the duration of untreated infection.</li><li>Collect detailed sexual behavior data, including the number of current and recent partners, partner type, partnership duration, concurrency, frequency of sex, type of sex, use of condoms, and characteristics and behaviors of partners.</li><li>Captures costs of screening, treatment, and management of sequelae.</li><li>Engage stakeholders and utilize community advisory boards.</li></ul>We will not fund proposals that:<ul><li>Have trial sites that are not based in sub-Saharan Africa.</li><li>Do not include PID as a primary outcome.</li><li>Include women who are pregnant at baseline.</li><li>Include women with a known diagnosis of infertility at baseline as part of the outcome analysis population.</li><li>Restrict the study population based on HIV status without justification.</li><li>Propose purely observational, retrospective, or modeling-only design.</li><li>Do not address the timing of pathogenesis or provide a strategy for identifying or analyzing the onset of sequelae following STI.</li><li>Do not plan for ethical, community, and gender-informed engagement.</li><li>Lack consideration of downstream policy relevance, such as linking findings to potential influence on screening, syndromic management, or STI prevention guidelines.</li></ul><a href="#_ftnref1" title="" id="_ftn1" name="_ftn1">[1]</a> World Health Organization. (2025). Global and regional STI estimates. The Global Health Observatory. https://www.who.int/data/gho/data/themes/topics/global-and-regional-sti-estimates<a href="#_ftnref2" title="" id="_ftn2" name="_ftn2">[2]</a> Kiweewa, et al. (2019). JAIDS, 22(2), e25257. <a href="https://doi.org/10.1002/jia2.25257" target="_blank">https://doi.org/10.1002/jia2.25257</a>; Stewart et al. (2020). AIDS, 34(5), 651–658. <a href="https://doi.org/10.1097/QAD.0000000000002472">https://doi.org/10.1097/QAD.0000000000002472</a>; Delany-Moretlwe (2023). Sex Transm Infect, 99(7), 433–439. <a href="https://doi.org/10.1136/sextrans-2022-055696" target="_blank">https://doi.org/10.1136/sextrans-2022-055696</a>.

Randomized Controlled Trial on Sexually Transmitted Infections (STIs) and Reproductive Tract Sequelae in Non-Pregnant Women

The information regarding this Grand Challenges Request for Proposals was last updated on June 6, 2025.
Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/controlled_trials_on_stis_and_rtis_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/controlled_trials_on_stis_and_rtis_application_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and&nbsp;<a href="https://gcgh.grandchallenges.org/randomized-controlled-trial-sexually-transmitted-infections-stis-and-reproductive-tract-sequelae" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>.
We are planning a webinar to provide more information and answer your questions on June 17 from 7:00-8:00 AM Pacific Time. To participate, <a href="https://events.teams.microsoft.com/event/96243f4f-c909-4175-9cc6-aa5fa3699391@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" rel="noopener noreferrer">please register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUMzJGQUZFNEZDWExXTTZVM0xYTDQzV0pKUy4u" target="_blank" rel="noopener noreferrer">submit your questions</a> ahead of time.
<h2>Background</h2>
Sexually active young women in low- and middle-income countries (LMICs) experience a high incidence of sexually transmitted infections (STIs), limited access to screening and treatment, and poorly characterized but significant reproductive tract morbidity from untreated infection. Global estimates put the prevalence of gonorrhea and chlamydia among women at 0.8% and 4.0%, respectively, with incidence rates of 1.9 and 3.6 cases per 100 person-years.<a href="#_ftn1" title id="_ftnref1" name="_ftnref1">[1]</a> However, these estimates are limited by sparse data, with few sources providing representative measures of disease frequency, including asymptomatic infections. Studies among young women in LMICs interested in HIV pre-exposure prophylaxis have measured incidence rates per 100 person-years of 12-53 for chlamydia, 6-20 for gonorrhea, and 6-7 for trichomoniasis.<a href="#_ftn2" title id="_ftnref2" name="_ftnref2">[2]</a> Due to the asymptomatic nature of most infections and reliance on syndromic management, most STIs in women go undetected. Untreated STIs have been linked to a range of poor health outcomes, including pelvic inflammatory disease (PID), chronic pelvic pain, infertility, and ectopic pregnancy. However, these estimates of association are imprecise and draw primarily from cross-sectional, case-control, and retrospective cohort studies, mostly conducted in high-income countries. Gaps in available data limit our ability to draw robust inferences on the risk of sequelae following an infection, the timing of pathogenesis, or how factors such as the presence of symptoms or repeat infection may modify these risks.
Better data on the risk of PID and related sequelae are critical to inform prevention and treatment guidelines, motivate funding for product development and provision of services, and shift care-seeking and care-provision behaviors. Research on the prevalence and risk of PID in LMICs has been challenging due to a lack of accurate and scalable diagnostic methods for PID along with funding gaps that limit consistent and comprehensive diagnosis.&nbsp; Although diagnosing subclinical PID remains challenging, targeted research is critical to better understand the risk of developing clinical PID and to evaluate the effectiveness of STI screening and treatment in preventing reproductive tract complications. Strengthening the evidence base in this area will not only advance our understanding of STI-related morbidity but may also stimulate the development and application of improved diagnostic tools to reduce the burden of PID and related outcomes.
<h2>The Challenge</h2>
This Grand Challenge on Randomized Controlled Trial on Sexually Transmitted Infections (STIs) and Reproductive Tract Sequelae in Non-Pregnant Women aims to fill critical gaps in understanding of the risk of PID and related sequelae attributable to STIs and to evaluate the impact of etiologic STI screening and treatment on morbidity. With this Grand Challenge we welcome letters of intent (LOIs) from organizations to conduct a randomized controlled trial (RCT) in sub-Saharan Africa comparing STI screening and standard of care syndromic management. The primary outcome of this study should be PID, with secondary outcomes possibly including chronic pelvic pain, ectopic pregnancy, and infertility. The study should provide insight into the risk of outcomes following infection with gonorrhea, chlamydia, and/or trichomoniasis and the impact and cost-effectiveness of etiologic screening to prevent morbidity.
Funding Level
We will consider applications requesting awards ranging from $8 million to $10 million USD per project, with a grant duration of up to 48 months. Budgets should align with the scale and complexity of the proposed work. Indirect costs are allowable and should be included within the total requested funding. (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank" rel="noopener noreferrer">Gates Foundation's indirect cost policy</a>).
Eligibility Criteria
<ul>
<li>This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions.</li>
<li>Study design must be randomized controlled trial or comparable, robust prospective in Sub-Saharan African settings.</li>
<li>We encourage groups to build upon existing and/or complimentary projects/studies/trials and to collaborate with other institutions.</li>
<li>We particularly encourage applications involving projects led by African Primary Investigators (PIs), women, early-career researchers, and practitioners seeking to innovate in women's health measurement, or from women-led organizations and applications from institutions based in LMICs.</li>
</ul>
We are looking for proposals that:
<ul>
<li>Are designed to provide insight into the timing of pathogenesis. This insight could come from comparison of outcomes across arms with varying screening intervals and/or from more frequent collection and storage of samples for subsequent batch testing.</li>
<li>Consider symptom tracking tools (such as symptom diaries) that could be used to track the onset, type, and severity of symptoms. Ideally, based on validated instruments.</li>
<li>Ideally enable stratification of risk by the presence of symptoms, co-infection, and repeat infection.</li>
<li>Ideally provide data to estimate STI incidence and the duration of untreated infection.</li>
<li>Collect detailed sexual behavior data, including the number of current and recent partners, partner type, partnership duration, concurrency, frequency of sex, type of sex, use of condoms, and characteristics and behaviors of partners.</li>
<li>Captures costs of screening, treatment, and management of sequelae.</li>
<li>Engage stakeholders and utilize community advisory boards.</li>
</ul>
We will not fund proposals that:
<ul>
<li>Have trial sites that are not based in sub-Saharan Africa.</li>
<li>Do not include PID as a primary outcome.</li>
<li>Include women who are pregnant at baseline.</li>
<li>Include women with a known diagnosis of infertility at baseline as part of the outcome analysis population.</li>
<li>Restrict the study population based on HIV status without justification.</li>
<li>Propose purely observational, retrospective, or modeling-only design.</li>
<li>Do not address the timing of pathogenesis or provide a strategy for identifying or analyzing the onset of sequelae following STI.</li>
<li>Do not plan for ethical, community, and gender-informed engagement.</li>
<li>Lack consideration of downstream policy relevance, such as linking findings to potential influence on screening, syndromic management, or STI prevention guidelines.</li>
</ul>
<a href="#_ftnref1" title id="_ftn1" name="_ftn1">[1]</a> World Health Organization. (2025). Global and regional STI estimates. The Global Health Observatory. <a href="https://www.who.int/data/gho/data/themes/topics/global-and-regional-sti-estimates">https://www.who.int/data/gho/data/themes/topics/global-and-regional-sti…</a>
<a href="#_ftnref2" title id="_ftn2" name="_ftn2">[2]</a> Kiweewa, et al. (2019). JAIDS, 22(2), e25257. <a href="https://doi.org/10.1002/jia2.25257" target="_blank" rel="noopener noreferrer">https://doi.org/10.1002/jia2.25257</a>; Stewart et al. (2020). AIDS, 34(5), 651–658. <a href="https://doi.org/10.1097/QAD.0000000000002472">https://doi.org/10.1097/QAD.0000000000002472</a>; Delany-Moretlwe (2023). Sex Transm Infect, 99(7), 433–439. <a href="https://doi.org/10.1136/sextrans-2022-055696" target="_blank" rel="noopener noreferrer">https://doi.org/10.1136/sextrans-2022-055696</a>.

This Grand Challenge on Randomized Controlled Trial on Sexually Transmitted Infections (STIs) and Reproductive Tract Sequelae in Non-Pregnant Women aims to fill critical gaps in understanding of the risk of PID and related sequelae attributable to STIs and to evaluate the impact of etiologic STI screening and treatment on morbidity.

**NOTE: This opportunity was open only to participants who registered for the 2025 Grand Challenges Annual Meeting.Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gcam_2025_cta_rules_and_guidelines.pdf" target="_blank" title="GCAM 2025 CtA - Rules and Guidelines">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gcam_2025_cta_application_instructions.pdf" target="_blank" title="GCAM 2025 CtA - Application Instructions">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/2025-grand-challenges-annual-meeting-call-action-frequently-asked-questions-faqs" target="_blank" title="GCAM 2025 CtA - Frequently Asked Questions (FAQs)">Frequently Asked Questions</a>.<h2>The Opportunity</h2>The Grand Challenges Annual Meeting fosters innovation and international collaboration to address the biggest challenges in global health and development. It has been held in&nbsp;<a href="https://grandchallenges.org/annual-meeting" target="_blank">13 countries</a> over the past 20 years and in a virtual format for three years, including this year's. The 2025 meeting continues the Annual Meeting's goal to support a global community of problem solvers who work together to set an innovation agenda and do the breakthrough science to deliver on it – to go further and faster together.<h2>The Challenge</h2>This Call-to-Action provides an opportunity for those registered for the 2025 Grand Challenges Annual Meeting to take action based on ideas they develop and people they engage with during the virtual meeting. For individuals who will not be able to attend the sessions in real time, recordings will be available post-meeting and we encourage all registered participants to watch them and engage with other participants before applying. As noted by past applicants in their submitted proposals, the meeting provides diverse ways to combine expertise and perspectives to speed up the impact of what would otherwise be separate work by individual investigators. The&nbsp;<a href="https://gcgh.grandchallenges.org/grants/JTdCJTIyc29ydCUyMiUzQSUyMmRlc2NlbmRpbmclMjIlMkMlMjJzb3J0RmllbGQlMjIlM0ElMjJkYXRlJTIyJTJDJTIybnVtYmVyUGVyUGFnZSUyMiUzQTEwMCUyQyUyMnBhZ2VOdW1iZXIlMjIlM0EwJTdE/JTdCJTIyeWVhcnMlMjIlM0ElNUIlNUQlMkMlMjJjaGFsbGVuZ2VzJTIyJTNBJTVCJTIyMTI5JTIyJTVEJTJDJTIydGVybXMlMjIlM0ElNUIlNUQlMkMlMjJpbml0aWF0aXZlcyUyMiUzQSU1QiU1RCUyQyUyMmxvY2F0aW9ucyUyMiUzQSU1QiU1RCU3RA==" target="_blank">grants awarded</a> for past Call-to-Action opportunities show this, and we hope that this year's meeting will also provide ways to catalyze collaborative projects that yield a tangible solution to a key problem by the end of the grant.FundingEach meeting participant will have one opportunity to apply as the primary applicant, on behalf of their institution, for a USD $100,000 grant or a collaborative USD $200,000 grant, both with an 18-month grant duration. Collaborative awards require the participation of one meeting participant and one or more collaborators from different institutions. While restricted to one application as the primary applicant, meeting participants may participate as collaborators in multiple collaborative applications. Priority will be given to new or newly expanded collaborations, rather than to existing collaborations seeking new funding.Eligibility Criteria<ul><li>Participants who registered for the 2025 Grand Challenges Annual Meeting are eligible to apply as a Primary Applicant on behalf of an organization with which they are affiliated and will receive further information via email.</li><li>Applications are permitted from both non-US and US organizations, including non-profit organizations, for-profit companies, international organizations, government agencies, and academic institutions.</li><li>Individuals and organizations classified as individuals for U.S. tax purposes are not eligible to receive an award from the foundation as part of this initiative.</li><li>Employees, officers, and directors of the Gates Foundation are not eligible to apply as Primary Applicants nor as collaborators for either type of proposal.</li><li>We encourage proposals led by scientists based in low- and middle-income countries and women or women-led institutions.</li></ul>We will give highest priority to proposed projects that:<ul><li>Contribute to a partnership network that empowers those with the local perspective required to direct the right approaches to the right parts of the problems to ensure success. This includes projects led by investigators from low- and middle-income countries and a balanced representation of women principal investigators. Their collective action and directed energy will help solve today's key problems in global health, while building research networks ready to solve tomorrow's.</li><li>Are explicitly aligned with the content within the meeting's scientific track sessions. Please note that proposals will be reviewed based on their alignment with one primary track and the specific content presented there (see <a href="https://web.cvent.com/hub/events/def88072-c4c4-4667-ab1a-df1c7d34912d/sessions" target="_blank">meeting agenda</a>), since we seek to provide an opportunity for participants to take action based on an idea that they developed and people they engaged during their virtual participation in a scientific track. Eligible scientific tracks for this Call-to-Action are listed below.</li></ul>Scientific tracks eligible for the Grand Challenges Annual Meeting Call-to-Action<ul><li>Vaccines &amp; Biologics - Innovation &amp; Platforms</li><li>Advancing Drug Discovery for Global Health</li><li>Strengthening Innovation Ecosystems to Solve Global Health Challenges</li><li>Advancing Women's Health Data, Science &amp; Technology</li><li>Strengthening the Women's Health R&amp;D Ecosystem</li></ul>We will not consider funding approaches that:<ul><li>Are not explicitly aligned with the specific content within the meeting scientific tracks listed above that are eligible for this request for proposals.</li><li>Address the meeting scientific track that is not part of this request for proposals: Strengthening Data Modelling for Global Health &amp; Development in Africa</li></ul>

2025 Grand Challenges Annual Meeting Call-to-Action

**NOTE: This opportunity was open only to participants who registered for the 2025 Grand Challenges Annual Meeting.
Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gcam_2025_cta_rules_and_guidelines.pdf" target="_blank" title="GCAM 2025 CtA - Rules and Guidelines" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gcam_2025_cta_application_instructions.pdf" target="_blank" title="GCAM 2025 CtA - Application Instructions" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/2025-grand-challenges-annual-meeting-call-action-frequently-asked-questions-faqs" target="_blank" title="GCAM 2025 CtA - Frequently Asked Questions (FAQs)" rel="noopener noreferrer">Frequently Asked Questions</a>.
<h2>The Opportunity</h2>
The Grand Challenges Annual Meeting fosters innovation and international collaboration to address the biggest challenges in global health and development. It has been held in&nbsp;<a href="https://grandchallenges.org/annual-meeting" target="_blank" rel="noopener noreferrer">13 countries</a> over the past 20 years and in a virtual format for three years, including this year's. The 2025 meeting continues the Annual Meeting's goal to support a global community of problem solvers who work together to set an innovation agenda and do the breakthrough science to deliver on it – to go further and faster together.
<h2>The Challenge</h2>
This Call-to-Action provides an opportunity for those registered for the 2025 Grand Challenges Annual Meeting to take action based on ideas they develop and people they engage with during the virtual meeting. For individuals who will not be able to attend the sessions in real time, recordings will be available post-meeting and we encourage all registered participants to watch them and engage with other participants before applying. As noted by past applicants in their submitted proposals, the meeting provides diverse ways to combine expertise and perspectives to speed up the impact of what would otherwise be separate work by individual investigators. The&nbsp;<a href="https://gcgh.grandchallenges.org/grants/JTdCJTIyc29ydCUyMiUzQSUyMmRlc2NlbmRpbmclMjIlMkMlMjJzb3J0RmllbGQlMjIlM0ElMjJkYXRlJTIyJTJDJTIybnVtYmVyUGVyUGFnZSUyMiUzQTEwMCUyQyUyMnBhZ2VOdW1iZXIlMjIlM0EwJTdE/JTdCJTIyeWVhcnMlMjIlM0ElNUIlNUQlMkMlMjJjaGFsbGVuZ2VzJTIyJTNBJTVCJTIyMTI5JTIyJTVEJTJDJTIydGVybXMlMjIlM0ElNUIlNUQlMkMlMjJpbml0aWF0aXZlcyUyMiUzQSU1QiU1RCUyQyUyMmxvY2F0aW9ucyUyMiUzQSU1QiU1RCU3RA==" target="_blank" rel="noopener noreferrer">grants awarded</a> for past Call-to-Action opportunities show this, and we hope that this year's meeting will also provide ways to catalyze collaborative projects that yield a tangible solution to a key problem by the end of the grant.
Funding
Each meeting participant will have one opportunity to apply as the primary applicant, on behalf of their institution, for a USD $100,000 grant or a collaborative USD $200,000 grant, both with an 18-month grant duration. Collaborative awards require the participation of one meeting participant and one or more collaborators from different institutions. While restricted to one application as the primary applicant, meeting participants may participate as collaborators in multiple collaborative applications. Priority will be given to new or newly expanded collaborations, rather than to existing collaborations seeking new funding.
Eligibility Criteria
<ul>
<li>Participants who registered for the 2025 Grand Challenges Annual Meeting are eligible to apply as a Primary Applicant on behalf of an organization with which they are affiliated and will receive further information via email.</li>
<li>Applications are permitted from both non-US and US organizations, including non-profit organizations, for-profit companies, international organizations, government agencies, and academic institutions.</li>
<li>Individuals and organizations classified as individuals for U.S. tax purposes are not eligible to receive an award from the foundation as part of this initiative.</li>
<li>Employees, officers, and directors of the Gates Foundation are not eligible to apply as Primary Applicants nor as collaborators for either type of proposal.</li>
<li>We encourage proposals led by scientists based in low- and middle-income countries and women or women-led institutions.</li>
</ul>
We will give highest priority to proposed projects that:
<ul>
<li>Contribute to a partnership network that empowers those with the local perspective required to direct the right approaches to the right parts of the problems to ensure success. This includes projects led by investigators from low- and middle-income countries and a balanced representation of women principal investigators. Their collective action and directed energy will help solve today's key problems in global health, while building research networks ready to solve tomorrow's.</li>
<li>Are explicitly aligned with the content within the meeting's scientific track sessions. Please note that proposals will be reviewed based on their alignment with one primary track and the specific content presented there (see <a href="https://web.cvent.com/hub/events/def88072-c4c4-4667-ab1a-df1c7d34912d/sessions" target="_blank" rel="noopener noreferrer">meeting agenda</a>), since we seek to provide an opportunity for participants to take action based on an idea that they developed and people they engaged during their virtual participation in a scientific track. Eligible scientific tracks for this Call-to-Action are listed below.</li>
</ul>
Scientific tracks eligible for the Grand Challenges Annual Meeting Call-to-Action
<ul>
<li>Vaccines &amp; Biologics - Innovation &amp; Platforms</li>
<li>Advancing Drug Discovery for Global Health</li>
<li>Strengthening Innovation Ecosystems to Solve Global Health Challenges</li>
<li>Advancing Women's Health Data, Science &amp; Technology</li>
<li>Strengthening the Women's Health R&amp;D Ecosystem</li>
</ul>
We will not consider funding approaches that:
<ul>
<li>Are not explicitly aligned with the specific content within the meeting scientific tracks listed above that are eligible for this request for proposals.</li>
<li>Address the meeting scientific track that is not part of this request for proposals: Strengthening Data Modelling for Global Health &amp; Development in Africa</li>
</ul>

**NOTE: This opportunity was open only to participants who registered for the 2025 Grand Challenges Annual Meeting.

Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of <a href="https://wellcome.org/grant-funding/guidance/policies-grant-conditions/grant-conditions" target="_blank">Wellcome</a>, the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank">Gates Foundation</a>, and the <a href="https://novonordiskfonden.dk/en/how-we-work/what-are-grants/conditions-for-grants/" target="_blank">Novo Nordisk Foundation</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gram-negative_antibiotic_discovery_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gram-negative_antibiotic_discovery_application_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/innovations-gram-negative-antibiotic-discovery-frequently-asked-questions-faqs" target="_blank">Frequently Asked Questions</a>.If you are planning to apply to this RFP, we will be hosting a dedicated webinar on February 27, from 6:00 to 7:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/3d705bb0-2252-4827-92bd-6f8669f144a0@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" id="menur1bd">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUOTFHU1BERVlUSTNBSU9FSk1LRDFRNlNHOS4u" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u" id="menur1bf">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.<h2>Overview</h2>In 2021, antimicrobial resistance (AMR) was associated with 4.7 million deaths, predominantly impacting low- and middle-income countries (LMICs), but the 2024 GRAM report projections indicate that development of novel antibiotics targeting Gram-negative bacteria would lead to a reduction in AMR burden. In response to this global health priority, the Novo Nordisk Foundation (NNF), Wellcome, and the Gates Foundation (GF) are jointly launching a new initiative, Gram-Negative Antibiotic Discovery Innovator (Gr-ADI), to drive innovation in early drug discovery for Gram-negative pathogens. Gr-ADI will function as a consortium, working collectively across multiple funders, research institutions, and industry partners. The consortium will be formed through this Grand Challenges request for proposals (RFP), with a focus on the discovery of direct-acting small molecule antibiotics with broad-spectrum activity against Enterobacteriaceae, using Klebsiella spp. as the pathogen to initiate a discovery program.<h2>Background</h2>Bacterial AMR is now the 3rd-leading cause of death globally, behind ischemic heart disease and stroke. The WHO has classified life-threatening community- and hospital-acquired infections due to Gram-negative bacteria, highlighting carbapenem-resistant Enterobacteriaceae (CRE) (including K. pneumoniae and E. coli) and Acinetobacter baumannii (CRAB) as the most critical AMR global health threats.Recent progress in new antibiotic development has been dominated by incremental improvements in well-established drug classes, such as β-lactam antibiotics, already impacted by resistance. There are few drugs in development that target a new mode of action, which is essential for combatting the ongoing emergence of bacteria resistant to existing classes of antibiotics. While there are multiple factors that have impeded the progression of a diverse antibiotic pipeline, a key factor has been a lack of coordinated investment and collaborative effort.This Grand Challenges RFP will be a first step to build a collaborative portfolio of Gr-ADI projects across multiple sectors, all working towards a common goal and unifying efforts of early antibiotic discovery by fostering cooperation and synergy among researchers. Successful applicants will demonstrate a spirit of collaboration and embrace the consortium approach, with all grantees functioning within the consortium under a single data sharing agreement [See <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gr-adi_cooperation_and_data_sharing_principles.pdf" target="_blank">Cooperation and Data-Sharing Principles</a>].Acknowledging that Gr-ADI operates within a wider antibiotic R&amp;D ecosystem, encompassing several initiatives further downstream in the development pipeline, it is anticipated that the most promising projects graduating from Gr-ADI could be supported by one of these initiatives.<h2>The Challenge</h2>The ultimate objective of Gr-ADI will be to enable discovery of safe and simple first-line broad-spectrum drugs for syndromic management, through:<ul><li>Development of novel and emerging biological, chemical, and AI tools that could be applied broadly for antibiotic discovery to identify new antibiotic targets.</li><li>Application of these innovative approaches to generate chemical starting points for project-based drug discovery.</li><li>Fostering a collective mindset to address gaps in knowledge, solve problems, and manage a portfolio of targets and hits.</li></ul>This Grand Challenges RFP will identify and select the first projects within the consortium. The focus of this RFP will be on the discovery of antibiotics with broad spectrum activity against Enterobacteriaceae, using Klebsiella spp. as the pathogen to initiate a discovery program. This provides a common focus point on Klebsiella spp. for all projects in the consortium and facilitates sharing of knowledge and data for mutual benefit. As such, proposals must have a primary focus on Klebsiella spp. but can also include investigation of other Enterobacteriaceae.Proposals must address at least one of the following themes:<ol><li>Development of genome-scale tools or other innovative technologies to identify new chemical starting points linked to targets as well as assessment of potential drug target vulnerability, singly or in combination.</li><li>Development of innovative technologies to select targets and chemical leads with a very high bar to resistance.</li><li>Gaining a better understanding of the chemistry underlying penetration of compounds to different compartments of the bacterial cell to build a platform to rapidly test whether compounds reach and accumulate at their target.</li><li>Development of novel and coordinated approaches to identifying new chemical leads for clinically or in vivo validated drug targets, for which there is currently no agent in Phase 3.</li></ol>Funding Level and ProcessProjects with a duration of up to three years and a maximum requested budget of $5,000,000 USD are eligible for funding. Exploratory projects with shorter durations or lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority.Budgets should be commensurate with the proposed scope of work. Indirect costs will be considered by some funders and should be included within the total budget of up to $5,000,000 USD. Indirect/overheard cost policies vary by funder, please refer to the application instructions document for specific details. Projects with secured co-funding are eligible to apply, provided they fully comply with the Gr-ADI collaborative ways of working and funding conditions, as if entirely funded by Gr-ADI.Wellcome, NNF, and GF will collaborate to achieve the overall objectives of the Gr-ADI. Successful projects will receive awards either through Wellcome, NNF, or GF and will be bound by the specific terms and conditions of the individual funder (see terms for each funder linked below).The application process will be conducted in two stages:<ol><li>A letter of inquiry, with a scientific proposal not to exceed five pages, should be submitted through this Grand Challenges RFP.</li><li>Applicants selected to provide a full proposal will be informed by the end of June 2025 and will receive further details on the submission, review, and decision timeline at that time.</li></ol>Cooperation and Data SharingThe funded projects will collectively form a consortium to catalyze and accelerate early antibiotic drug discovery. The funded organizations (including collaborators receiving Gr-ADI funding) will be required to enter into a consortium-wide data sharing agreement (before they receive their funding) to facilitate their interactions and to maximize cross-learnings and integration. Applicants should review and consider the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gr-adi_cooperation_and_data_sharing_principles.pdf" target="_blank">Gr-ADI Cooperation and Data Sharing Principles</a>, which will be reflected in the formal data sharing agreement. The full data sharing agreement will be shared with applicants invited to submit a full application. These describe how the collaboration will share data (with the exception of detailed chemical structures of proprietary compounds) during the course of funded projects to support Gr-ADI’s research efforts and how outputs will be shared more broadly upon completion of each project to benefit the wider research community.Eligibility Criteria<ul><li>This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions.</li><li>Only individuals who are applying through a legally recognized corporate entity are eligible.</li><li>We particularly encourage applications from institutions based in LMICs and projects led by women and other groups that are historically under-represented in the drug discovery field. All applications received will then be reviewed on their merits.</li><li>Lead applicants must be able to demonstrate the experience needed to drive and lead a project and to deliver on the objectives.</li><li>Applications can be from multi- and inter-disciplinary teams, and we encourage lead applicants to put together diverse teams, promoting a diverse, inclusive, and supportive research environment.</li><li>Researchers may participate as co-applicants or collaborators on multiple proposals but may submit only one application as a lead applicant to this RFP. If researchers are co-applicants or collaborators on multiple proposals, they must be able to demonstrate that they can dedicate enough time and resources to all projects if all the projects they are involved in are funded.</li><li>Applicants must be able to sign up to the terms and conditions of at least one of the funders to be eligible to apply.</li></ul>We are looking for proposals that:<ul><li>Address one or more of the thematic areas described above.</li><li>Focus on (direct acting) small molecule drug discovery for Klebsiella spp.</li><li>Focus on the earliest phases of drug discovery up to lead optimization through a concentrated and coordinated effort addressing the specific, well-defined problems articulated above</li><li>Provide preliminary data in support of the proposed approach; if no preliminary data exists then the proposal should be limited in scope with specific Go/No Go milestones</li><li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li><li>Promote a diverse, inclusive, and supportive research environment.</li></ul>We will not consider funding proposals that:<ul><li>Do not directly address the core objectives as outlined above.</li><li>Are not focused on direct-acting small molecules (for example, proposals focused on vaccines, phages, peptides, and microbiome are not in scope).</li><li>Do not include Klebsiella spp.</li><li>Use surrogate organisms to develop tools or identify leads that will then need to be validated in pathogens of interest.</li><li>Are focused solely on basic exploratory scientific research without a direct connection to or impact on advancing antibiotic discovery. There must be a component of development of novel tools and technologies or methodologies.</li><li>Focus on development of technologies that do not have a direct link to development of small molecules.</li><li>Describe a distributed, broad approach to fixing the portfolio and/or pipeline.</li><li>Are submitted by teams not committed to collaborating with other projects funded through this RFP.</li><li>Are not willing to agree to sign up to the data sharing agreement between the cohort of successful projects.</li><li>Aim to conduct clinical trials or randomized control trials.</li><li>Cannot be accomplished within a three-year project duration or have a requested budget exceeding $5,000,000 USD.</li><li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li></ul>This Grand Challenge is a collaboration between the GF, NNF and Wellcome, but each funder will make independent funding decisions. Applicants successful at the preliminary stage will be invited to submit a full application via GF, NNF, or Wellcome as applicable. Note: success at the preliminary stage does not guarantee that the full application will be successful in receiving funding.Applicants should familiarize themselves with the relevant terms and conditions for each funder at the following links:Wellcome funding to universities and not for profit research institutions will be made via grants (i.e. under our <a href="https://wellcome.org/grant-funding/guidance/policies-grant-conditions/grant-conditions" target="_blank">grant conditions</a> and subject to our <a href="https://wellcome.org/grant-funding/guidance/policies-grant-conditions/grant-conditions" target="_blank">grant funding policies</a>).Wellcome funding to companies will be made via grants in instances where all of the research outputs will be made freely available to the wider research community.Wellcome funding to companies will be made via programme related investments (convertible loans or revenue sharing agreements) if subsequent commercialisation of identified lead compounds is a possibility.Gates Foundation: <a href="https://docs.gatesfoundation.org/documents/sample-terms-and-conditions.pdf" target="_blank">sample terms &amp; conditions</a> and <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank">RFP terms and conditions</a>NNF:<a href="https://novonordiskfonden.dk/en/how-we-work/what-are-grants/conditions-for-grants/" target="_blank"> example terms and conditions</a>.Please note that the final terms and conditions for awards made under this RFP will have additional conditions specific to Gr-ADI and to align with the wider trilateral partnership (NNF, Wellcome, and Gates Foundation) under which the Gr-ADI initiative is being run. Further information will be provided to applicants invited to submit full applications.

Innovations for Gram-Negative Antibiotic Discovery

Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of <a href="https://wellcome.org/grant-funding/guidance/policies-grant-conditions/grant-conditions" target="_blank" rel="noopener noreferrer">Wellcome</a>, the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank" rel="noopener noreferrer">Gates Foundation</a>, and the <a href="https://novonordiskfonden.dk/en/how-we-work/what-are-grants/conditions-for-grants/" target="_blank" rel="noopener noreferrer">Novo Nordisk Foundation</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gram-negative_antibiotic_discovery_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gram-negative_antibiotic_discovery_application_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/innovations-gram-negative-antibiotic-discovery-frequently-asked-questions-faqs" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on February 27, from 6:00 to 7:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/3d705bb0-2252-4827-92bd-6f8669f144a0@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" id="menur1bd" rel="noopener noreferrer">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUOTFHU1BERVlUSTNBSU9FSk1LRDFRNlNHOS4u" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u" id="menur1bf" rel="noopener noreferrer">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Overview</h2>
In 2021, antimicrobial resistance (AMR) was associated with 4.7 million deaths, predominantly impacting low- and middle-income countries (LMICs), but the 2024 GRAM report projections indicate that development of novel antibiotics targeting Gram-negative bacteria would lead to a reduction in AMR burden. In response to this global health priority, the Novo Nordisk Foundation (NNF), Wellcome, and the Gates Foundation (GF) are jointly launching a new initiative, Gram-Negative Antibiotic Discovery Innovator (Gr-ADI), to drive innovation in early drug discovery for Gram-negative pathogens. Gr-ADI will function as a consortium, working collectively across multiple funders, research institutions, and industry partners. The consortium will be formed through this Grand Challenges request for proposals (RFP), with a focus on the discovery of direct-acting small molecule antibiotics with broad-spectrum activity against Enterobacteriaceae, using Klebsiella spp. as the pathogen to initiate a discovery program.
<h2>Background</h2>
Bacterial AMR is now the 3rd-leading cause of death globally, behind ischemic heart disease and stroke. The WHO has classified life-threatening community- and hospital-acquired infections due to Gram-negative bacteria, highlighting carbapenem-resistant Enterobacteriaceae (CRE) (including K. pneumoniae and E. coli) and Acinetobacter baumannii (CRAB) as the most critical AMR global health threats.
Recent progress in new antibiotic development has been dominated by incremental improvements in well-established drug classes, such as β-lactam antibiotics, already impacted by resistance. There are few drugs in development that target a new mode of action, which is essential for combatting the ongoing emergence of bacteria resistant to existing classes of antibiotics. While there are multiple factors that have impeded the progression of a diverse antibiotic pipeline, a key factor has been a lack of coordinated investment and collaborative effort.
This Grand Challenges RFP will be a first step to build a collaborative portfolio of Gr-ADI projects across multiple sectors, all working towards a common goal and unifying efforts of early antibiotic discovery by fostering cooperation and synergy among researchers. Successful applicants will demonstrate a spirit of collaboration and embrace the consortium approach, with all grantees functioning within the consortium under a single data sharing agreement [See <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gr-adi_cooperation_and_data_sharing_principles.pdf" target="_blank" rel="noopener noreferrer">Cooperation and Data-Sharing Principles</a>].
Acknowledging that Gr-ADI operates within a wider antibiotic R&amp;D ecosystem, encompassing several initiatives further downstream in the development pipeline, it is anticipated that the most promising projects graduating from Gr-ADI could be supported by one of these initiatives.
<h2>The Challenge</h2>
The ultimate objective of Gr-ADI will be to enable discovery of safe and simple first-line broad-spectrum drugs for syndromic management, through:
<ul>
<li>Development of novel and emerging biological, chemical, and AI tools that could be applied broadly for antibiotic discovery to identify new antibiotic targets.</li>
<li>Application of these innovative approaches to generate chemical starting points for project-based drug discovery.</li>
<li>Fostering a collective mindset to address gaps in knowledge, solve problems, and manage a portfolio of targets and hits.</li>
</ul>
This Grand Challenges RFP will identify and select the first projects within the consortium. The focus of this RFP will be on the discovery of antibiotics with broad spectrum activity against Enterobacteriaceae, using Klebsiella spp. as the pathogen to initiate a discovery program. This provides a common focus point on Klebsiella spp. for all projects in the consortium and facilitates sharing of knowledge and data for mutual benefit. As such, proposals must have a primary focus on Klebsiella spp. but can also include investigation of other Enterobacteriaceae.
Proposals must address at least one of the following themes:
<ol>
<li>Development of genome-scale tools or other innovative technologies to identify new chemical starting points linked to targets as well as assessment of potential drug target vulnerability, singly or in combination.</li>
<li>Development of innovative technologies to select targets and chemical leads with a very high bar to resistance.</li>
<li>Gaining a better understanding of the chemistry underlying penetration of compounds to different compartments of the bacterial cell to build a platform to rapidly test whether compounds reach and accumulate at their target.</li>
<li>Development of novel and coordinated approaches to identifying new chemical leads for clinically or in vivo validated drug targets, for which there is currently no agent in Phase 3.</li>
</ol>
Funding Level and Process
Projects with a duration of up to three years and a maximum requested budget of $5,000,000 USD are eligible for funding. Exploratory projects with shorter durations or lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority.
Budgets should be commensurate with the proposed scope of work. Indirect costs will be considered by some funders and should be included within the total budget of up to $5,000,000 USD. Indirect/overheard cost policies vary by funder, please refer to the application instructions document for specific details. Projects with secured co-funding are eligible to apply, provided they fully comply with the Gr-ADI collaborative ways of working and funding conditions, as if entirely funded by Gr-ADI.
Wellcome, NNF, and GF will collaborate to achieve the overall objectives of the Gr-ADI. Successful projects will receive awards either through Wellcome, NNF, or GF and will be bound by the specific terms and conditions of the individual funder (see terms for each funder linked below).
The application process will be conducted in two stages:
<ol>
<li>A letter of inquiry, with a scientific proposal not to exceed five pages, should be submitted through this Grand Challenges RFP.</li>
<li>Applicants selected to provide a full proposal will be informed by the end of June 2025 and will receive further details on the submission, review, and decision timeline at that time.</li>
</ol>
Cooperation and Data Sharing
The funded projects will collectively form a consortium to catalyze and accelerate early antibiotic drug discovery. The funded organizations (including collaborators receiving Gr-ADI funding) will be required to enter into a consortium-wide data sharing agreement (before they receive their funding) to facilitate their interactions and to maximize cross-learnings and integration. Applicants should review and consider the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/gr-adi_cooperation_and_data_sharing_principles.pdf" target="_blank" rel="noopener noreferrer">Gr-ADI Cooperation and Data Sharing Principles</a>, which will be reflected in the formal data sharing agreement. The full data sharing agreement will be shared with applicants invited to submit a full application. These describe how the collaboration will share data (with the exception of detailed chemical structures of proprietary compounds) during the course of funded projects to support Gr-ADI’s research efforts and how outputs will be shared more broadly upon completion of each project to benefit the wider research community.
Eligibility Criteria
<ul>
<li>This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions.</li>
<li>Only individuals who are applying through a legally recognized corporate entity are eligible.</li>
<li>We particularly encourage applications from institutions based in LMICs and projects led by women and other groups that are historically under-represented in the drug discovery field. All applications received will then be reviewed on their merits.</li>
<li>Lead applicants must be able to demonstrate the experience needed to drive and lead a project and to deliver on the objectives.</li>
<li>Applications can be from multi- and inter-disciplinary teams, and we encourage lead applicants to put together diverse teams, promoting a diverse, inclusive, and supportive research environment.</li>
<li>Researchers may participate as co-applicants or collaborators on multiple proposals but may submit only one application as a lead applicant to this RFP. If researchers are co-applicants or collaborators on multiple proposals, they must be able to demonstrate that they can dedicate enough time and resources to all projects if all the projects they are involved in are funded.</li>
<li>Applicants must be able to sign up to the terms and conditions of at least one of the funders to be eligible to apply.</li>
</ul>
We are looking for proposals that:
<ul>
<li>Address one or more of the thematic areas described above.</li>
<li>Focus on (direct acting) small molecule drug discovery for Klebsiella spp.</li>
<li>Focus on the earliest phases of drug discovery up to lead optimization through a concentrated and coordinated effort addressing the specific, well-defined problems articulated above</li>
<li>Provide preliminary data in support of the proposed approach; if no preliminary data exists then the proposal should be limited in scope with specific Go/No Go milestones</li>
<li>Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.</li>
<li>Promote a diverse, inclusive, and supportive research environment.</li>
</ul>
We will not consider funding proposals that:
<ul>
<li>Do not directly address the core objectives as outlined above.</li>
<li>Are not focused on direct-acting small molecules (for example, proposals focused on vaccines, phages, peptides, and microbiome are not in scope).</li>
<li>Do not include Klebsiella spp.</li>
<li>Use surrogate organisms to develop tools or identify leads that will then need to be validated in pathogens of interest.</li>
<li>Are focused solely on basic exploratory scientific research without a direct connection to or impact on advancing antibiotic discovery. There must be a component of development of novel tools and technologies or methodologies.</li>
<li>Focus on development of technologies that do not have a direct link to development of small molecules.</li>
<li>Describe a distributed, broad approach to fixing the portfolio and/or pipeline.</li>
<li>Are submitted by teams not committed to collaborating with other projects funded through this RFP.</li>
<li>Are not willing to agree to sign up to the data sharing agreement between the cohort of successful projects.</li>
<li>Aim to conduct clinical trials or randomized control trials.</li>
<li>Cannot be accomplished within a three-year project duration or have a requested budget exceeding $5,000,000 USD.</li>
<li>Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.</li>
</ul>
This Grand Challenge is a collaboration between the GF, NNF and Wellcome, but each funder will make independent funding decisions. Applicants successful at the preliminary stage will be invited to submit a full application via GF, NNF, or Wellcome as applicable. Note: success at the preliminary stage does not guarantee that the full application will be successful in receiving funding.
Applicants should familiarize themselves with the relevant terms and conditions for each funder at the following links:
Wellcome funding to universities and not for profit research institutions will be made via grants (i.e. under our <a href="https://wellcome.org/grant-funding/guidance/policies-grant-conditions/grant-conditions" target="_blank" rel="noopener noreferrer">grant conditions</a> and subject to our <a href="https://wellcome.org/grant-funding/guidance/policies-grant-conditions/grant-conditions" target="_blank" rel="noopener noreferrer">grant funding policies</a>).
Wellcome funding to companies will be made via grants in instances where all of the research outputs will be made freely available to the wider research community.
Wellcome funding to companies will be made via programme related investments (convertible loans or revenue sharing agreements) if subsequent commercialisation of identified lead compounds is a possibility.
Gates Foundation: <a href="https://docs.gatesfoundation.org/documents/sample-terms-and-conditions.pdf" target="_blank" rel="noopener noreferrer">sample terms &amp; conditions</a> and <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank" rel="noopener noreferrer">RFP terms and conditions</a>
NNF:<a href="https://novonordiskfonden.dk/en/how-we-work/what-are-grants/conditions-for-grants/" target="_blank" rel="noopener noreferrer"> example terms and conditions</a>.
Please note that the final terms and conditions for awards made under this RFP will have additional conditions specific to Gr-ADI and to align with the wider trilateral partnership (NNF, Wellcome, and Gates Foundation) under which the Gr-ADI initiative is being run. Further information will be provided to applicants invited to submit full applications.

The focus of this RFP will be on the discovery of antibiotics with broad spectrum activity against Enterobacteriaceae, using Klebsiella spp. as the pathogen to initiate a discovery program. This provides a common focus point on Klebsiella spp. for all projects in the consortium and facilitates sharing of knowledge and data for mutual benefit. As such, proposals must have a primary focus on Klebsiella spp. but can also include investigation of other Enterobacteriaceae.

Please note: We anticipate notifying applicants of decisions related to this RFP by the end of June 2025. This timeline is later than originally stated in the Rules and Guidelines document.Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/heavy_menstrual_bleeding_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/heavy_menstrual_bleeding_application_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/accelerating-innovations-address-heavy-menstrual-bleeding-women-low-resource-settings-frequently" target="_blank">Frequently Asked Questions</a>.If you are planning to apply to this RFP, we will be hosting a dedicated webinar on February 25, from 7:00 to 8:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" id="menur1bd">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUQk5DTlk1TVJQWldKTDBPREdUNTRLQzJRTC4u" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u" id="menur1bf">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.<h2>Background</h2>Heavy menstrual bleeding (HMB) affects millions of women globally. Clinically, HMB is defined as excessive menstrual blood loss that negatively affects a woman's physical, emotional, and social well-being. In research settings, HMB is defined as directly measured blood loss exceeding 80 milliliters per menstrual cycle. Many women seek medical attention based on their perceptions of heavy bleeding and its impact on daily life. Abnormal uterine bleeding, of which HMB is a subset, is caused by various factors. Structural abnormalities include polyps, adenomyosis, fibroids, and malignancy, while non-structural factors include bleeding disorders, ovulatory and endometrial dysfunction, and other factors.Managing HMB presents significant clinical challenges when diagnostic tools are unavailable or inaccessible to distinguish between the diverse possible etiologies. The underlying biological mechanisms, particularly related to endometrial dysfunction-related HMB also remain poorly understood. For an individual woman, the preferred medical and surgical treatment options depend on the specific cause, symptoms, preferences (including factors such as pregnancy intention), and the availability of treatment, including minimally invasive therapies. Currently available medical treatments include hormonal therapies, including contraceptives, such as the hormonal intrauterine device, and non-hormonal options, such as tranexamic acid and non-steroidal anti-inflammatory drugs (NSAIDs). The efficacy of treatment could be improved with an increased understanding of the underlying biological mechanisms and the development of specifically targeted therapies.&nbsp;Research priorities in HMB include understanding the underlying biological mechanisms, particularly related to endometrial dysfunction-related HMB, developing and introducing cost-effective and easy to scale-up diagnostics to identify causes of HMB and guide treatment, and identifying ways to increase acceptability and access to treatments such as the hormonal intrauterine device for women in low-resource settings.<h2>The Challenge</h2>We invite research proposals on HMB based on the clinical definition that focus on:<ol><li>Biological Mechanisms – Advancing understanding of the fundamental biology of HMB to identify targets for innovative diagnostics and treatments.</li><li>Epidemiology and Impact – Assessing disease burden, patterns, and impact on gynecological health and quality of life in women in low-resource settings.</li><li>Measurement and Standardization – Developing and validating improved methods for measuring HMB and establishing standardized research protocols to enable consistent and comparable studies across diverse populations and healthcare systems.</li><li>Innovative Diagnostics – Proposing new technology or piloting the use of existing technology to identify causes of HMB in low resource settings, including the use of artificial intelligence. Technology should be easy to use and affordable.</li><li>Treatment and Access – Evaluating the effectiveness, acceptability, and ways to increase access to treatment including hormonal contraceptives, to inform patient-centered care in low-resource settings.</li></ol>Funding LevelWe will consider proposals for awards of up to&nbsp;150,000 USD for each project, with a grant term of up to 2 years. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered and should be included in the budget for a maximum of 15% of the total award (subject to the&nbsp;<a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf">Gates Foundation's indirect cost policy</a>).Eligibility CriteriaThis initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies and academic institutions.&nbsp;We particularly encourage applications involving projects led by women or from women-led organizations and applications from institutions based in low- and middle-income countries.We seek proposals that:<ol><li>Focus on original research and development.</li><li>Focus on the needs of women in Sub-Saharan Africa, India, and Pakistan. While researchers may be based globally, study populations (for original data collection) or intended beneficiaries (for new diagnostics and treatments) must be from these regions.</li><li>Address one or more of the outlined objectives within a single proposal.</li></ol>We will not fund proposals that:<ol><li>Do not focus on HMB – Even if related to gynecological conditions that are associated with HMB, such as infertility or pelvic pain.</li><li>Are not research. Proposals to fund the expansion of routine services, or train clinical service providers, for example, will not be funded.</li></ol>

Accelerating Innovations to Address Heavy Menstrual Bleeding in Women in Low-Resource Settings

Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank" rel="noopener noreferrer">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/heavy_menstrual_bleeding_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/heavy_menstrual_bleeding_application_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/accelerating-innovations-address-heavy-menstrual-bleeding-women-low-resource-settings-frequently" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on February 25, from 7:00 to 8:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" id="menur1bd" rel="noopener noreferrer">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUQk5DTlk1TVJQWldKTDBPREdUNTRLQzJRTC4u" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u" id="menur1bf" rel="noopener noreferrer">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
Heavy menstrual bleeding (HMB) affects millions of women globally. Clinically, HMB is defined as excessive menstrual blood loss that negatively affects a woman's physical, emotional, and social well-being. In research settings, HMB is defined as directly measured blood loss exceeding 80 milliliters per menstrual cycle. Many women seek medical attention based on their perceptions of heavy bleeding and its impact on daily life. Abnormal uterine bleeding, of which HMB is a subset, is caused by various factors. Structural abnormalities include polyps, adenomyosis, fibroids, and malignancy, while non-structural factors include bleeding disorders, ovulatory and endometrial dysfunction, and other factors.
Managing HMB presents significant clinical challenges when diagnostic tools are unavailable or inaccessible to distinguish between the diverse possible etiologies. The underlying biological mechanisms, particularly related to endometrial dysfunction-related HMB also remain poorly understood. For an individual woman, the preferred medical and surgical treatment options depend on the specific cause, symptoms, preferences (including factors such as pregnancy intention), and the availability of treatment, including minimally invasive therapies. Currently available medical treatments include hormonal therapies, including contraceptives, such as the hormonal intrauterine device, and non-hormonal options, such as tranexamic acid and non-steroidal anti-inflammatory drugs (NSAIDs). The efficacy of treatment could be improved with an increased understanding of the underlying biological mechanisms and the development of specifically targeted therapies.&nbsp;
Research priorities in HMB include understanding the underlying biological mechanisms, particularly related to endometrial dysfunction-related HMB, developing and introducing cost-effective and easy to scale-up diagnostics to identify causes of HMB and guide treatment, and identifying ways to increase acceptability and access to treatments such as the hormonal intrauterine device for women in low-resource settings.
<h2>The Challenge</h2>
We invite research proposals on HMB based on the clinical definition that focus on:
<ol>
<li>Biological Mechanisms – Advancing understanding of the fundamental biology of HMB to identify targets for innovative diagnostics and treatments.</li>
<li>Epidemiology and Impact – Assessing disease burden, patterns, and impact on gynecological health and quality of life in women in low-resource settings.</li>
<li>Measurement and Standardization – Developing and validating improved methods for measuring HMB and establishing standardized research protocols to enable consistent and comparable studies across diverse populations and healthcare systems.</li>
<li>Innovative Diagnostics – Proposing new technology or piloting the use of existing technology to identify causes of HMB in low resource settings, including the use of artificial intelligence. Technology should be easy to use and affordable.</li>
<li>Treatment and Access – Evaluating the effectiveness, acceptability, and ways to increase access to treatment including hormonal contraceptives, to inform patient-centered care in low-resource settings.</li>
</ol>
Funding Level
We will consider proposals for awards of up to&nbsp;150,000 USD for each project, with a grant term of up to 2 years. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered and should be included in the budget for a maximum of 15% of the total award (subject to the&nbsp;<a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf">Gates Foundation's indirect cost policy</a>).
Eligibility Criteria
This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies and academic institutions.&nbsp;We particularly encourage applications involving projects led by women or from women-led organizations and applications from institutions based in low- and middle-income countries.
We seek proposals that:
<ol>
<li>Focus on original research and development.</li>
<li>Focus on the needs of women in Sub-Saharan Africa, India, and Pakistan. While researchers may be based globally, study populations (for original data collection) or intended beneficiaries (for new diagnostics and treatments) must be from these regions.</li>
<li>Address one or more of the outlined objectives within a single proposal.</li>
</ol>
We will not fund proposals that:
<ol>
<li>Do not focus on HMB – Even if related to gynecological conditions that are associated with HMB, such as infertility or pelvic pain.</li>
<li>Are not research. Proposals to fund the expansion of routine services, or train clinical service providers, for example, will not be funded.</li>
</ol>

Heavy menstrual bleeding (HMB) affects millions of women globally. Clinically, HMB is defined as excessive menstrual blood loss that negatively affects a woman's physical, emotional, and social well-being. In research settings, HMB is defined as directly measured blood loss exceeding 80 milliliters per menstrual cycle. Many women seek medical attention based on their perceptions of heavy bleeding and its impact on daily life. Abnormal uterine bleeding, of which HMB is a subset, is caused by various factors. Structural abnormalities include polyps, adenomyosis, fibroids, and malignancy, while non-structural factors include bleeding disorders, ovulatory and endometrial dysfunction, and other factors.

Please note: We anticipate notifying applicants of decisions related to this RFP by the end of June 2025. This timeline is later than originally stated in the Rules and Guidelines document.Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/enhancing_hiv_and_tb_diagnosis_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/enhancing_hiv_and_tb_diagnosis_application_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/enhancing-hiv-and-tb-diagnosis-adjunct-technologies-sample-collection-and-processing-frequently" target="_blank">Frequently Asked Questions</a>.If you are planning to apply to this RFP, we will be hosting a dedicated webinar on February 26, from 6:00 to 7:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/8f02e3fa-a701-4f35-b67e-67a5e0902a4f@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" id="menur1bd">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUNUZUNFZLMlVLVE1SRldEU1g3VVpISFZHUi4u" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u" id="menur1bf">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.<h2>Background</h2>Effective diagnostics are the cornerstone of disease management for tuberculosis (TB) and human immunodeficiency virus (HIV), two of the world’s most significant infectious diseases. Early and accurate detection is critical for timely treatment initiation, reducing transmission, and improving patient outcomes. However, despite advancements in molecular and lateral flow assay (LFA) diagnostics, major gaps remain in accessibility, affordability, and implementation, particularly in resource-limited settings. Addressing these barriers requires innovative approaches to point-of-care (PoC) diagnostics and supporting technologies that streamline sample collection and sample processing in low-resource environments.PoC HIV viral load (HIV VL) testing with same-day turnaround times has demonstrated improved clinical outcomes (<a href="https://www.who.int/publications/i/item/9789240031593" target="_blank">"Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach"</a>), yet adoption remains low due to limited market options and technological constraints, as most currently approved tests are either near-PoC or require centralized laboratory processing. (<a href="https://www.theglobalfund.org/media/5ifod1fa/psm_productshiv-who_list_en.pdf" target="_blank">"List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy"</a>). A major challenge is the lack of affordable, user-friendly blood collection and sample processing devices that enable robust performance in true PoC settings. Overcoming these challenges is essential for broader adoption of and improved access to life-saving diagnostics for HIV management.Similarly, TB diagnosis faces significant gaps. Each year, an estimated 10 million people contract TB, yet over 25% go undiagnosed, and fewer than 50% of diagnosed cases utilize a WHO-recommended rapid diagnostic (WRD) (WHO World TB Report 2023). Due to its distinctive cell wall structure and resistance to traditional chemical lysis methods, Mycobacterium tuberculosis&nbsp;(MTB) typically requires instrumented mechanical lysis to achieve high sensitivity in molecular diagnostic assays (<a href="https://academic.oup.com/cid/article/78/5/1313/7596605" target="_blank">"New Manual Quantitative Polymerase Chain Reaction Assay Validated on Tongue Swabs Collected and Processed in Uganda Shows Sensitivity That Rivals Sputum-based Molecular Tuberculosis Diagnostics"</a>). Unlike diseases such as HIV and malaria, there are currently no instrument-free, true PoC molecular diagnostic tools that have adequate performance for detection of TB. While simple tuberculosis lipoarabinomannan (TB LAM) tests represent another unique solution for MTB detection using noninvasive sampling with urine, diagnostic accuracy is modest for PLHIV and otherwise poor. Expanding access to highly accurate testing, particularly in closer proximity to patients, is critical to ending the TB epidemic.To bridge these diagnostic gaps, developing adjunct technologies for sample collection, lysis, and preparation is essential. Pre-analytical solutions, such as simplified sample collection and stabilization and instrument free sample lysis specifically for TB could enable more reliable and consistent results while reducing reliance on complex laboratory infrastructure. By investing in these supporting technologies, diagnostic platforms can become more accessible, scalable, and effective in reaching underserved populations.<h2>The Challenge</h2>Recent improvements in diagnostic testing have enabled molecular and lateral flow testing to be performed closer to the patient than ever and in some cases at home with a fully consumable test format. The challenge lies in developing solutions upstream to testing that enable easier, more affordable, and self-administered sample collection, sample preparation, and lysis when needed to support innovative PoC tests with faster turnaround times.Specifically, the objectives of this challenge will be to address one, or all, of the following:<ol><li>Self-Sample Blood Collection Devices (Phlebotomist-free blood collection)<ol type="a"><li>Solutions must enable phlebotomist-free collection of at least 1 mL of whole blood with performance comparable to phlebotomist-collected samples. Key parameters include sample quality, volume collected, failure rate, and ease of use.</li><li>Solutions must ensure that the sample is stable for at least 24 hours at temperatures up to 40°C and humidity up to 70% without the need for cold chain.</li><li>Ideally, the solution should be compatible with serum or plasma generation but must, at minimum, enable robust whole blood collection.</li><li>If a design includes a sample collection or container component (e.g., a tube or cup), the storage device must prevent leakage and/or aerosolization of contents during storage and transportation.</li><li>If a design includes a buffer, it must be compatible with downstream immunoassay or nucleic acid amplification and detection without need for extraction or purification.</li><li>Solutions developed must be simple enough for use at home by a layperson or by a low-level healthcare worker.</li></ol></li><li>Sample Collection for MTB<ol type="a"><li>Solutions must enable collection of reproducibly consistent specimen biomass that does not require pipetting.</li><li>If a design includes a sample collection or container component (e.g., a tube or cup), the storage device must prevent leakage and/or aerosolization of contents during storage and transportation.</li><li>If a design includes a buffer, it must be compatible with downstream lysis and nucleic acid amplification and detection without need for extraction or purification.</li><li>Samples must be stable for up to 72 hours at temperatures up to 40°C and humidity up to 70% without the need for cold chain.</li><li>Solutions must be safe for administration and simple enough for home use by a layperson or low-level healthcare worker.</li></ol></li><li>Sample Preparation Devices (Instrument-free sample processing) for HIV detection<ol type="a"><li>Sample preparation solutions could include single or multiple sample processing aspects such as sample clean up, filtration, plasma/serum generation, analyte concentration, etc.</li><li>If sample preparation is integrated with sample collection, the processing step (e.g., plasma/serum separation) should be seamless and included in the collection workflow.</li><li>If sample preparation includes stabilization, specifically for RNA targets, solutions should enable sample stabilization for at least 24 hours or more at temperatures up to 40°C and humidity up to 70% without the need for cold chain. The samples must also meet performance equivalence to fresh samples (<a href="https://apps.who.int/iris/bitstream/handle/10665/251857/9789241511742-eng.pdf?sequence=1" target="_blank">TSS 1&nbsp;- Human immunodeficiency virus (HIV) rapid diagnostic tests for professional and/or self-testing</a>).</li><li>Ideally, no additional instruments should be required to complete the steps. However, if any are necessary, they must be compact, easily transportable, battery-powered, and cost-effective (under $50 USD).</li><li>The solution must be simple and safe enough to be performed at home by a lay user or by a low-level health care worker.</li></ol></li><li>Sample Lysis Devices (Instrument-free lysis) for TB lysis<ol type="a"><li>Novel devices must demonstrate feasibility of MTB cell inactivation (by standard biosafety analysis protocols) and lysis (as compared to mechanical lysis via bead beating or sonication) without the need for a reusable instrument. (<a href="https://academic.oup.com/cid/article/78/5/1313/7596605" target="_blank">New Manual Quantitative Polymerase Chain Reaction Assay Validated on Tongue Swabs Collected and Processed in Uganda Shows Sensitivity That Rivals Sputum-based Molecular Tuberculosis Diagnostics</a>).</li><li>The solution must break open the MTB cells (&gt;50% lysis efficiency compared to mechanical lysis via bead beating or sonication) without damaging target DNA.</li><li>The resulting lysate must be stable for up to 72 hours at temperatures up to 40°C and humidity up to 70% without the need for cold chain.</li><li>Ideally, no additional instruments should be required to complete the steps. However, if any are necessary, they must be compact, easily transportable, battery-powered, and cost-effective (under $50 USD).</li><li>The solution must be simple and safe enough to be performed at home by a lay user or by a low-level health care worker.</li></ol></li><li>Sample Clean up and Analyte Concentration<ol><li>Pre analytical solutions to improve analyte quality for improved assay performance including but not limited to sample clean up, analyte concentration, and interference removal.</li><li>The solution must demonstrate equivalence with laboratory sample clean up methods and analyte concentration kits.</li></ol></li></ol>Evaluation Criteria:<ul><li>Feasibility and innovation in meeting collection, processing, and/or lysis requirements.</li><li>Cost-effectiveness and scalability.</li><li>Analytical performance and validation data as per published guidelines.</li><li>Alignment with decentralized or PoC needs as per published guidelines.</li><li>Product shelf life at ambient temperature, and transportation stability in target LMIC countries as suggested by Global Fund Priority Country List.</li></ul>Eligibility CriteriaThis initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. We particularly encourage applications involving projects led by women or from women-led organizations and applications from institutions based in low- and middle-income countries.Funding LevelWe will consider proposals for awards of $100,000 to $250,000 USD for each project, with a grant term of up to 2 years. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered and should be included in the budget for the up to the grant amount awarded (subject to the&nbsp;<a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank">Gates Foundation's indirect cost policy</a>).

Enhancing HIV and TB Diagnosis: Adjunct Technologies for Sample Collection and Processing

Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank" rel="noopener noreferrer">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/enhancing_hiv_and_tb_diagnosis_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/enhancing_hiv_and_tb_diagnosis_application_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/enhancing-hiv-and-tb-diagnosis-adjunct-technologies-sample-collection-and-processing-frequently" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on February 26, from 6:00 to 7:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/8f02e3fa-a701-4f35-b67e-67a5e0902a4f@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" id="menur1bd" rel="noopener noreferrer">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUNUZUNFZLMlVLVE1SRldEU1g3VVpISFZHUi4u" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u" id="menur1bf" rel="noopener noreferrer">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
Effective diagnostics are the cornerstone of disease management for tuberculosis (TB) and human immunodeficiency virus (HIV), two of the world’s most significant infectious diseases. Early and accurate detection is critical for timely treatment initiation, reducing transmission, and improving patient outcomes. However, despite advancements in molecular and lateral flow assay (LFA) diagnostics, major gaps remain in accessibility, affordability, and implementation, particularly in resource-limited settings. Addressing these barriers requires innovative approaches to point-of-care (PoC) diagnostics and supporting technologies that streamline sample collection and sample processing in low-resource environments.
PoC HIV viral load (HIV VL) testing with same-day turnaround times has demonstrated improved clinical outcomes (<a href="https://www.who.int/publications/i/item/9789240031593" target="_blank" rel="noopener noreferrer">"Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach"</a>), yet adoption remains low due to limited market options and technological constraints, as most currently approved tests are either near-PoC or require centralized laboratory processing. (<a href="https://www.theglobalfund.org/media/5878/psm_productshiv-who_list_en.pdf" target="_blank" rel="noopener noreferrer">"List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy"</a>). A major challenge is the lack of affordable, user-friendly blood collection and sample processing devices that enable robust performance in true PoC settings. Overcoming these challenges is essential for broader adoption of and improved access to life-saving diagnostics for HIV management.
Similarly, TB diagnosis faces significant gaps. Each year, an estimated 10 million people contract TB, yet over 25% go undiagnosed, and fewer than 50% of diagnosed cases utilize a WHO-recommended rapid diagnostic (WRD) (WHO World TB Report 2023). Due to its distinctive cell wall structure and resistance to traditional chemical lysis methods, Mycobacterium tuberculosis&nbsp;(MTB) typically requires instrumented mechanical lysis to achieve high sensitivity in molecular diagnostic assays (<a href="https://academic.oup.com/cid/article/78/5/1313/7596605" target="_blank" rel="noopener noreferrer">"New Manual Quantitative Polymerase Chain Reaction Assay Validated on Tongue Swabs Collected and Processed in Uganda Shows Sensitivity That Rivals Sputum-based Molecular Tuberculosis Diagnostics"</a>). Unlike diseases such as HIV and malaria, there are currently no instrument-free, true PoC molecular diagnostic tools that have adequate performance for detection of TB. While simple tuberculosis lipoarabinomannan (TB LAM) tests represent another unique solution for MTB detection using noninvasive sampling with urine, diagnostic accuracy is modest for PLHIV and otherwise poor. Expanding access to highly accurate testing, particularly in closer proximity to patients, is critical to ending the TB epidemic.
To bridge these diagnostic gaps, developing adjunct technologies for sample collection, lysis, and preparation is essential. Pre-analytical solutions, such as simplified sample collection and stabilization and instrument free sample lysis specifically for TB could enable more reliable and consistent results while reducing reliance on complex laboratory infrastructure. By investing in these supporting technologies, diagnostic platforms can become more accessible, scalable, and effective in reaching underserved populations.
<h2>The Challenge</h2>
Recent improvements in diagnostic testing have enabled molecular and lateral flow testing to be performed closer to the patient than ever and in some cases at home with a fully consumable test format. The challenge lies in developing solutions upstream to testing that enable easier, more affordable, and self-administered sample collection, sample preparation, and lysis when needed to support innovative PoC tests with faster turnaround times.
Specifically, the objectives of this challenge will be to address one, or all, of the following:
<ol>
<li>Self-Sample Blood Collection Devices (Phlebotomist-free blood collection) 
<ol type="a">
<li>Solutions must enable phlebotomist-free collection of at least 1 mL of whole blood with performance comparable to phlebotomist-collected samples. Key parameters include sample quality, volume collected, failure rate, and ease of use.</li>
<li>Solutions must ensure that the sample is stable for at least 24 hours at temperatures up to 40°C and humidity up to 70% without the need for cold chain.</li>
<li>Ideally, the solution should be compatible with serum or plasma generation but must, at minimum, enable robust whole blood collection.</li>
<li>If a design includes a sample collection or container component (e.g., a tube or cup), the storage device must prevent leakage and/or aerosolization of contents during storage and transportation.</li>
<li>If a design includes a buffer, it must be compatible with downstream immunoassay or nucleic acid amplification and detection without need for extraction or purification.</li>
<li>Solutions developed must be simple enough for use at home by a layperson or by a low-level healthcare worker.</li>
</ol>
</li>
<li>Sample Collection for MTB 
<ol type="a">
<li>Solutions must enable collection of reproducibly consistent specimen biomass that does not require pipetting.</li>
<li>If a design includes a sample collection or container component (e.g., a tube or cup), the storage device must prevent leakage and/or aerosolization of contents during storage and transportation.</li>
<li>If a design includes a buffer, it must be compatible with downstream lysis and nucleic acid amplification and detection without need for extraction or purification.</li>
<li>Samples must be stable for up to 72 hours at temperatures up to 40°C and humidity up to 70% without the need for cold chain.</li>
<li>Solutions must be safe for administration and simple enough for home use by a layperson or low-level healthcare worker.</li>
</ol>
</li>
<li>Sample Preparation Devices (Instrument-free sample processing) for HIV detection 
<ol type="a">
<li>Sample preparation solutions could include single or multiple sample processing aspects such as sample clean up, filtration, plasma/serum generation, analyte concentration, etc.</li>
<li>If sample preparation is integrated with sample collection, the processing step (e.g., plasma/serum separation) should be seamless and included in the collection workflow.</li>
<li>If sample preparation includes stabilization, specifically for RNA targets, solutions should enable sample stabilization for at least 24 hours or more at temperatures up to 40°C and humidity up to 70% without the need for cold chain. The samples must also meet performance equivalence to fresh samples (<a href="https://apps.who.int/iris/bitstream/handle/10665/251857/9789241511742-eng.pdf?sequence=1" target="_blank" rel="noopener noreferrer">TSS 1&nbsp;- Human immunodeficiency virus (HIV) rapid diagnostic tests for professional and/or self-testing</a>).</li>
<li>Ideally, no additional instruments should be required to complete the steps. However, if any are necessary, they must be compact, easily transportable, battery-powered, and cost-effective (under $50 USD).</li>
<li>The solution must be simple and safe enough to be performed at home by a lay user or by a low-level health care worker.</li>
</ol>
</li>
<li>Sample Lysis Devices (Instrument-free lysis) for TB lysis 
<ol type="a">
<li>Novel devices must demonstrate feasibility of MTB cell inactivation (by standard biosafety analysis protocols) and lysis (as compared to mechanical lysis via bead beating or sonication) without the need for a reusable instrument. (<a href="https://academic.oup.com/cid/article/78/5/1313/7596605" target="_blank" rel="noopener noreferrer">New Manual Quantitative Polymerase Chain Reaction Assay Validated on Tongue Swabs Collected and Processed in Uganda Shows Sensitivity That Rivals Sputum-based Molecular Tuberculosis Diagnostics</a>).</li>
<li>The solution must break open the MTB cells (&gt;50% lysis efficiency compared to mechanical lysis via bead beating or sonication) without damaging target DNA.</li>
<li>The resulting lysate must be stable for up to 72 hours at temperatures up to 40°C and humidity up to 70% without the need for cold chain.</li>
<li>Ideally, no additional instruments should be required to complete the steps. However, if any are necessary, they must be compact, easily transportable, battery-powered, and cost-effective (under $50 USD).</li>
<li>The solution must be simple and safe enough to be performed at home by a lay user or by a low-level health care worker.</li>
</ol>
</li>
<li>Sample Clean up and Analyte Concentration
<ol>
<li>Pre analytical solutions to improve analyte quality for improved assay performance including but not limited to sample clean up, analyte concentration, and interference removal.</li>
<li>The solution must demonstrate equivalence with laboratory sample clean up methods and analyte concentration kits.</li>
</ol>
</li>
</ol>
Evaluation Criteria:
<ul>
<li>Feasibility and innovation in meeting collection, processing, and/or lysis requirements.</li>
<li>Cost-effectiveness and scalability.</li>
<li>Analytical performance and validation data as per published guidelines.</li>
<li>Alignment with decentralized or PoC needs as per published guidelines.</li>
<li>Product shelf life at ambient temperature, and transportation stability in target LMIC countries as suggested by Global Fund Priority Country List.</li>
</ul>
Eligibility Criteria
This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. We particularly encourage applications involving projects led by women or from women-led organizations and applications from institutions based in low- and middle-income countries.
Funding Level
We will consider proposals for awards of $100,000 to $250,000 USD for each project, with a grant term of up to 2 years. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered and should be included in the budget for the up to the grant amount awarded (subject to the&nbsp;<a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank" rel="noopener noreferrer">Gates Foundation's indirect cost policy</a>).

Recent improvements in diagnostic testing have enabled molecular and lateral flow testing to be performed closer to the patient than ever and in some cases at home with a fully consumable test format. The challenge lies in developing solutions upstream to testing that enable easier, more affordable, and self-administered sample collection, sample preparation, and lysis when needed to support innovative PoC tests with faster turnaround times.

Enhancing HIV and TB Diagnosis Adjunct Technologies for Sample Collection and Processing

Please note: We anticipate notifying applicants of decisions related to this RFP by the end of June 2025. This timeline is later than originally stated in the Rules and Guidelines document.Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/data_and_modeling_for_womens_health_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/data_and_modeling_for_womens_health_applications_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/innovative-data-and-modeling-approaches-measure-womens-health-frequently-asked-questions-faqs" target="_blank">Frequently Asked Questions</a>.If you are planning to apply to this RFP, we will be hosting a dedicated webinar on March 4, from 7:00 to 8:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/4a0d45a6-1ef5-45ff-aeaa-216f6047b6ad@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="Register for this webinar" id="menur1bd">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddURFg2UDgyVlRLSE1JVVhKS0NVMklBODAzUC4u" target="_blank" title="Submit your questions" id="menur1bf">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.<h2>Background</h2>Women's health continues to be under-represented and poorly measured in global health frameworks.Now is the time to address this challenge. Current measurement frameworks, such as the Disability-Adjusted Life Year (DALY), fail to capture the full complexity of women's health outcomes, as they do not account for the multidimensional factors that shape health burdens and progress. These dominant metrics often overlook gendered conditions and social determinants of health, limiting the ability to generate actionable insights. Harmful norms and gender-related discrimination often contribute to poorer health outcomes in women, yet they remain inadequately reflected in existing indicators. Without alternative approaches that incorporate gender-sensitive and multidimensional factors, policies and interventions risk being misaligned with the real needs of women globally. This gap leaves critical gender-related conditions and non-health interventions unmeasured, further hindering progress in advancing women's health.This Grand Challenge aims to bridge this gap by fostering innovative modeling approaches that rethink how women's health is measured, using available data, or easily obtainable, in new ways to provide a more holistic and actionable understanding of health outcomes. Advances in data science, modeling techniques, technological development, and gender-sensitive approaches present a unique opportunity to innovate; especially when global systems are facing unprecedented shifts that could further increase gaps in equity. This Grand Challenge builds on the <a href="https://cambercollective.com/wp-content/uploads/2025/01/Womens-Health-RD-Opportunity-Map-2023.pdf" target="_blank">Women's Health Innovation Opportunity Map 2023</a>, developed collaboratively by over 250 global stakeholders across 50 countries through the Innovation Equity Forum (IEF). The Opportunity Map identified key gaps and priorities in women's health, emphasizing the need for innovation across multiple areas, including data and modeling, health and economic impact, supply and access to services, and skills, knowledge, and networks. The Opportunity Map serves as a roadmap for transformative solutions that address systemic barriers and advance gender-equitable health outcomes for women.This Grand Challenge on Innovative Data and Modeling Approaches to Measure Women's Health seeks to advance innovative ways to measure women's health by either developing new measurement models or adapting existing ones to better capture the full scope of women's health burdens and progress. This Grand Challenge prioritizes solutions that leverage data sources that are existing or under development rather than relying on new, large-scale data collection efforts, ensuring sustainability and feasibility.Applicants are encouraged to build upon existing work, whether by enhancing ongoing projects with a stronger gender-sensitive approach, refining existing models, or expanding available datasets in ways that align with the Challenge's objectives. While this Grand Challenge does not fund broad new data collection efforts, proposals that require small-scale dataset expansion - where such an extension would significantly improve gendered analysis that generate policy-relevant measurement approaches that improve how women's health is understood and addressed globally - may be considered.<h2>The Challenge</h2>We invite applicants to explore bold, innovative approaches. Specifically, the objectives of the Challenge will be to:<ul><li>Reimagine new ways to understand and measure women's health that extend beyond the limitations of existing composite indicators such as DALY.</li><li>Use existing data sets or easily collectible datasets to quantify women's health outcomes across countries. While this Grand Challenge does not fund large-scale data collection, proposals may include small-scale data expansion where it is feasible, policy-relevant, and significantly enhances gendered analysis.</li><li>Design innovative methodologies that incorporate gendered, socio-cultural, economic, and structural determinants of health, ensuring a comprehensive gender-sensitive approach (A gender-sensitive approach takes into consideration how one's gender impacts access to services, risk and protective factors and barriers that are uniquely experienced because of one's gender in a society).</li><li>Create tools or frameworks that enable cross-cultural or subnational comparative analysis, identifying context-specific gaps and progress.</li><li>Reflect the interconnected dimensions of women's health across the life course</li><li>Incorporate gaps in the measurement of:<ul><li>Skills, knowledge, and networks: addressing how gender disparities in education, training, and professional networks impact health access, decision-making, and service delivery.</li><li>Supply and access to services: examining how health systems, financing mechanisms, and gender-based barriers affect the availability, affordability, and accessibility of essential services for women</li><li>Health and economic impacts: capturing the intersection of health outcomes with economic participation, caregiving burdens, workforce inclusion, and financial independence.</li></ul></li><li>Produce outputs that are:<ul><li>Methodologically rigorous: applying sound data science, statistical modeling, or analytical techniques that enhance the validity and reliability of women's health measurements.</li><li>Interpretable and actionable: ensuring results can be understood and applied by policymakers and implementers.</li><li>Comparative and scalable: enabling cross-cultural or subnational analysis to identify patterns, disparities, and opportunities for intervention.</li><li>Gender-sensitive and intersectional: incorporating the social, economic, and structural determinants that affect women's health outcomes.</li><li>Policy-relevant and decision-oriented: providing insights that have the potential to directly inform policies, resource allocation, or program design to improve women's health measurement and action.</li></ul></li></ul>Funding LevelWe will consider proposals for awards of up to $150,000 USD for each project, with a grant term of 18-24 months. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered and should be included in the budget for the up to $150,000 USD award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank">Gates Foundation's indirect cost policy</a>).Eligibility CriteriaThis initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies and academic institutions. We particularly encourage applications involving projects led by women, early-career researchers and practitioners seeking to innovate in women's health measurement, or from women-led organizations and applications from institutions based in low- and middle-income countries. We also encourage collaborative submissions across disciplines such as economics, public health, and gender studies.We are looking for proposals that:<ul><li>Demonstrate innovative thinking in modeling women's health, providing creative methodologies or tools to address gaps in measurement.</li><li>Leverage existing data sources and/or explore datasets that are feasible to collect within current capacities.</li><li>Incorporate intersectional approaches, addressing disparities (social, economic, and structural determinants of health) that disproportionately impact women.</li><li>Align with the Opportunity Map dimensions, focusing on multidimensional indicators beyond traditional composite measures.</li><li>Show potential to generate actionable insights for policy and programmatic interventions at a national and/or global scale.</li><li>Enable cross-country or subnational comparisons, offering solutions that reveal context-specific gaps and opportunities for progress.</li><li>Present a clear pathway for real-world impact, outlining how the outputs can inform resource allocation, policy, or program design.</li><li>Highlight the potential for scalability and adaptability of the proposed approach across diverse country contexts.</li><li>Promote interdisciplinary collaboration, combining perspectives from multiple sectors such as public health, data science, economics, and gender studies.</li></ul>We will not fund proposals that:<ul><li>Propose data collection-only efforts without a clear link to the development or testing of novel measurement approaches or without an analytical component that adds value to existing evidence.</li><li>Focus on implementing health interventions without a measurement or modeling component.</li><li>Focus solely on expanding or refining existing composite indicators (e.g., DALY) without demonstrating innovation.</li><li>Rely on proprietary or inaccessible datasets without clear justification or ability to share insights publicly.</li><li>Lack a gender-sensitive lens or fail to consider the intersectional factors affecting women's health outcomes.</li><li>Do not align with the Opportunity Map dimensions or fail to address measurable health and economic impacts.</li><li>Propose interventions without a clear focus on modeling and measurement.</li></ul>

Innovative Data and Modeling Approaches to Measure Women's Health

Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank" rel="noopener noreferrer">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/data_and_modeling_for_womens_health_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/data_and_modeling_for_womens_health_applications_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/innovative-data-and-modeling-approaches-measure-womens-health-frequently-asked-questions-faqs" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on March 4, from 7:00 to 8:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/4a0d45a6-1ef5-45ff-aeaa-216f6047b6ad@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="Register for this webinar" id="menur1bd" rel="noopener noreferrer">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddURFg2UDgyVlRLSE1JVVhKS0NVMklBODAzUC4u" target="_blank" title="Submit your questions" id="menur1bf" rel="noopener noreferrer">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
Women's health continues to be under-represented and poorly measured in global health frameworks.
Now is the time to address this challenge. Current measurement frameworks, such as the Disability-Adjusted Life Year (DALY), fail to capture the full complexity of women's health outcomes, as they do not account for the multidimensional factors that shape health burdens and progress. These dominant metrics often overlook gendered conditions and social determinants of health, limiting the ability to generate actionable insights. Harmful norms and gender-related discrimination often contribute to poorer health outcomes in women, yet they remain inadequately reflected in existing indicators. Without alternative approaches that incorporate gender-sensitive and multidimensional factors, policies and interventions risk being misaligned with the real needs of women globally. This gap leaves critical gender-related conditions and non-health interventions unmeasured, further hindering progress in advancing women's health.
This Grand Challenge aims to bridge this gap by fostering innovative modeling approaches that rethink how women's health is measured, using available data, or easily obtainable, in new ways to provide a more holistic and actionable understanding of health outcomes. Advances in data science, modeling techniques, technological development, and gender-sensitive approaches present a unique opportunity to innovate; especially when global systems are facing unprecedented shifts that could further increase gaps in equity. This Grand Challenge builds on the <a href="https://cambercollective.com/wp-content/uploads/2025/01/Womens-Health-RD-Opportunity-Map-2023.pdf" target="_blank" rel="noopener noreferrer">Women's Health Innovation Opportunity Map 2023</a>, developed collaboratively by over 250 global stakeholders across 50 countries through the Innovation Equity Forum (IEF). The Opportunity Map identified key gaps and priorities in women's health, emphasizing the need for innovation across multiple areas, including data and modeling, health and economic impact, supply and access to services, and skills, knowledge, and networks. The Opportunity Map serves as a roadmap for transformative solutions that address systemic barriers and advance gender-equitable health outcomes for women.
This Grand Challenge on Innovative Data and Modeling Approaches to Measure Women's Health seeks to advance innovative ways to measure women's health by either developing new measurement models or adapting existing ones to better capture the full scope of women's health burdens and progress. This Grand Challenge prioritizes solutions that leverage data sources that are existing or under development rather than relying on new, large-scale data collection efforts, ensuring sustainability and feasibility.
Applicants are encouraged to build upon existing work, whether by enhancing ongoing projects with a stronger gender-sensitive approach, refining existing models, or expanding available datasets in ways that align with the Challenge's objectives. While this Grand Challenge does not fund broad new data collection efforts, proposals that require small-scale dataset expansion - where such an extension would significantly improve gendered analysis that generate policy-relevant measurement approaches that improve how women's health is understood and addressed globally - may be considered.
<h2>The Challenge</h2>
We invite applicants to explore bold, innovative approaches. Specifically, the objectives of the Challenge will be to:
<ul>
<li>Reimagine new ways to understand and measure women's health that extend beyond the limitations of existing composite indicators such as DALY.</li>
<li>Use existing data sets or easily collectible datasets to quantify women's health outcomes across countries. While this Grand Challenge does not fund large-scale data collection, proposals may include small-scale data expansion where it is feasible, policy-relevant, and significantly enhances gendered analysis.</li>
<li>Design innovative methodologies that incorporate gendered, socio-cultural, economic, and structural determinants of health, ensuring a comprehensive gender-sensitive approach (A gender-sensitive approach takes into consideration how one's gender impacts access to services, risk and protective factors and barriers that are uniquely experienced because of one's gender in a society).</li>
<li>Create tools or frameworks that enable cross-cultural or subnational comparative analysis, identifying context-specific gaps and progress.</li>
<li>Reflect the interconnected dimensions of women's health across the life course</li>
<li>Incorporate gaps in the measurement of:
<ul>
<li>Skills, knowledge, and networks: addressing how gender disparities in education, training, and professional networks impact health access, decision-making, and service delivery.</li>
<li>Supply and access to services: examining how health systems, financing mechanisms, and gender-based barriers affect the availability, affordability, and accessibility of essential services for women</li>
<li>Health and economic impacts: capturing the intersection of health outcomes with economic participation, caregiving burdens, workforce inclusion, and financial independence.</li>
</ul>
</li>
<li>Produce outputs that are:
<ul>
<li>Methodologically rigorous: applying sound data science, statistical modeling, or analytical techniques that enhance the validity and reliability of women's health measurements.</li>
<li>Interpretable and actionable: ensuring results can be understood and applied by policymakers and implementers.</li>
<li>Comparative and scalable: enabling cross-cultural or subnational analysis to identify patterns, disparities, and opportunities for intervention.</li>
<li>Gender-sensitive and intersectional: incorporating the social, economic, and structural determinants that affect women's health outcomes.</li>
<li>Policy-relevant and decision-oriented: providing insights that have the potential to directly inform policies, resource allocation, or program design to improve women's health measurement and action.</li>
</ul>
</li>
</ul>
Funding Level
We will consider proposals for awards of up to $150,000 USD for each project, with a grant term of 18-24 months. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered and should be included in the budget for the up to $150,000 USD award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank" rel="noopener noreferrer">Gates Foundation's indirect cost policy</a>).
Eligibility Criteria
This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies and academic institutions. We particularly encourage applications involving projects led by women, early-career researchers and practitioners seeking to innovate in women's health measurement, or from women-led organizations and applications from institutions based in low- and middle-income countries. We also encourage collaborative submissions across disciplines such as economics, public health, and gender studies.
We are looking for proposals that:
<ul>
<li>Demonstrate innovative thinking in modeling women's health, providing creative methodologies or tools to address gaps in measurement.</li>
<li>Leverage existing data sources and/or explore datasets that are feasible to collect within current capacities.</li>
<li>Incorporate intersectional approaches, addressing disparities (social, economic, and structural determinants of health) that disproportionately impact women.</li>
<li>Align with the Opportunity Map dimensions, focusing on multidimensional indicators beyond traditional composite measures.</li>
<li>Show potential to generate actionable insights for policy and programmatic interventions at a national and/or global scale.</li>
<li>Enable cross-country or subnational comparisons, offering solutions that reveal context-specific gaps and opportunities for progress.</li>
<li>Present a clear pathway for real-world impact, outlining how the outputs can inform resource allocation, policy, or program design.</li>
<li>Highlight the potential for scalability and adaptability of the proposed approach across diverse country contexts.</li>
<li>Promote interdisciplinary collaboration, combining perspectives from multiple sectors such as public health, data science, economics, and gender studies.</li>
</ul>
We will not fund proposals that:
<ul>
<li>Propose data collection-only efforts without a clear link to the development or testing of novel measurement approaches or without an analytical component that adds value to existing evidence.</li>
<li>Focus on implementing health interventions without a measurement or modeling component.</li>
<li>Focus solely on expanding or refining existing composite indicators (e.g., DALY) without demonstrating innovation.</li>
<li>Rely on proprietary or inaccessible datasets without clear justification or ability to share insights publicly.</li>
<li>Lack a gender-sensitive lens or fail to consider the intersectional factors affecting women's health outcomes.</li>
<li>Do not align with the Opportunity Map dimensions or fail to address measurable health and economic impacts.</li>
<li>Propose interventions without a clear focus on modeling and measurement.</li>
</ul>

Women's health continues to be under-represented and poorly measured in global health frameworks.


 Now is the time to address this challenge. Current measurement frameworks, such as the Disability-Adjusted Life Year (DALY), fail to capture the full complexity of women's health outcomes, as they do not account for the multidimensional factors that shape health burdens and progress. These dominant metrics often overlook gendered conditions and social determinants of health, limiting the ability to generate actionable insights. Harmful norms and gender-related discrimination often contribute to poorer health outcomes in women, yet they remain inadequately reflected in existing indicators. Without alternative approaches that incorporate gender-sensitive and multidimensional factors, policies and interventions risk being misaligned with the real needs of women globally. This gap leaves critical gender-related conditions and non-health interventions unmeasured, further hindering progress in advancing women's health.

Innovative Data and Modeling Approaches to Measure Womens Health

Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/reducing_the_burden_of_preeclampsia_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/reducing_the_burden_of_preeclampsia_application_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/reducing-burden-preeclampsia-frequently-asked-questions-faqs" target="_blank">Frequently Asked Questions</a>.If you are planning to apply to this RFP, we will be hosting a dedicated webinar on February 27, from 7:30 to 8:30 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/84005cbd-aeaa-4c95-814b-99e4441d6551@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" id="menur1bd">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUQjJKQVJVWlc5VE01TlZVMjBYS1hHNE4yUi4u" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u" id="menur1bf">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.<h2>Background</h2>Preeclampsia is a leading cause worldwide of maternal morbidity and mortality, premature birth, stillbirth, and neonatal death. Preeclampsia is a placental disease caused by two different pathologies during pregnancy. Early-onset disease, caused by reduced uteroplacental blood supply, is a major driver of fetal mortality. Late-onset disease, caused by increased fetoplacental demands, is a major driver of maternal morbidity and mortality. These two pathologies converge on elevated levels of the protein sFlt1 and concomitant decreases in PlGF.This mechanistic understanding is being translated into new strategies to reduce the burden of preeclampsia. Therapeutic candidates are being developed that target sFlt1 activity, and levels of this protein can be used in screening for preeclampsia risk. Effective screening and low-dose aspirin therapy early in pregnancy has been shown to prevent early-onset preeclampsia and to ameliorate the disease's consequences for the fetus.Despite the growing understanding of preeclampsia biology, questions remain about heterogeneity of the disease across patients and the degree to which there are distinct subtypes and etiologies. New approaches are also needed to more quickly and comprehensively reduce the burden of preeclampsia, especially those suitable for the health care infrastructure in the countries with the highest burden.<h2>The Challenge</h2>We seek proposals for innovative solutions for the early detection, prevention, and treatment of preeclampsia, particularly in low- and middle-income countries where maternal mortality rates are high. To support this focus, we are looking for collaborations, including those with research institutions, health care providers, and global health organizations, that enable cross-sector insights and ensure that solutions are adaptable and practical.The objectives of the challenge are:<ol><li>Early prediction and detection of preeclampsia. We seek novel biomarkers as well as novel approaches to measurement of sFlt1 and PlGF, diagnostic tests, and point-of-care technologies to predict early in pregnancy the risk of preeclampsia and to diagnose it before symptoms become severe.</li><li>Understanding the pathophysiology of preeclampsia and its heterogeneity. We seek to understand the biological mechanisms driving the disease and its subtypes so that new interventions can be effectively tailored to the underlying etiology.</li><li>Preventive and therapeutic interventions. We seek new approaches to known targets or new targets to reduce the incidence and severity of preeclampsia, mitigate disease progression, and prevent the cardiovascular and metabolic complications that often follow it.</li></ol>Funding LevelWe will consider proposals for awards of up to $500,000 USD for each project, with a grant term of up to 2 years. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered, and should be included in the budget for the up to $500,000 USD award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank">Gates Foundation's indirect cost policy</a>).Eligibility CriteriaThis initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. We particularly encourage applications involving projects led by women or from women-led organizations and applications from institutions based in low- and middle-income countries.We are looking for proposals that:<ul><li>Identify biomarkers that easily, reliably, and affordably predict preeclampsia risk early in pregnancy</li><li>Identify biochemical, genetic, epigenetic, or metabolomic signatures that can be translated into point-of-care tests</li><li>Leverage innovations in mobile health, wearable sensors, or simple clinical algorithms to identify women at risk before symptoms become severe</li><li>Identify the underlying biological mechanisms driving preeclampsia and its subtypes, including the roles of the placenta, endothelial function, immune response, and gut microbiota</li><li>Identify preventive interventions synergistic with or additive to low-dose aspirin, such as nutritional, pharmacological, or lifestyle-related approaches to reduce the incidence or severity of preeclampsia</li><li>Identify new drug candidates, therapeutics, or repurposed medications that safely mitigate preeclampsia progression without harming the fetus</li></ul>We will not fund proposals that:<ul><li>Focus on implementation science, health systems integration, or social determinants (although these are all important elements, they are not in the scope of this request for proposals)</li><li>Do not have the potential to become affordable and scalable in resource-limited settings</li><li>Represent basic research without clear relevance to the objectives of this challenge</li><li>Lack a clearly articulated and testable hypothesis</li><li>Present unacceptable safety risks or detract from or interfere with beneficial practices</li><li>Approaches that leverage previously failed biomarker exploration</li></ul>

Reducing the Burden of Preeclampsia

Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the terms and conditions of the <a href="https://submit.gatesfoundation.org/res/p/RFPTermsConditions/" target="_blank" rel="noopener noreferrer">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/reducing_the_burden_of_preeclampsia_rules_and_guidelines.pdf" target="_blank" rel="noopener noreferrer">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/reducing_the_burden_of_preeclampsia_application_instructions.pdf" target="_blank" rel="noopener noreferrer">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/reducing-burden-preeclampsia-frequently-asked-questions-faqs" target="_blank" rel="noopener noreferrer">Frequently Asked Questions</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on February 27, from 7:30 to 8:30 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/84005cbd-aeaa-4c95-814b-99e4441d6551@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" id="menur1bd" rel="noopener noreferrer">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUQjJKQVJVWlc5VE01TlZVMjBYS1hHNE4yUi4u" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u" id="menur1bf" rel="noopener noreferrer">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
Preeclampsia is a leading cause worldwide of maternal morbidity and mortality, premature birth, stillbirth, and neonatal death. Preeclampsia is a placental disease caused by two different pathologies during pregnancy. Early-onset disease, caused by reduced uteroplacental blood supply, is a major driver of fetal mortality. Late-onset disease, caused by increased fetoplacental demands, is a major driver of maternal morbidity and mortality. These two pathologies converge on elevated levels of the protein sFlt1 and concomitant decreases in PlGF.
This mechanistic understanding is being translated into new strategies to reduce the burden of preeclampsia. Therapeutic candidates are being developed that target sFlt1 activity, and levels of this protein can be used in screening for preeclampsia risk. Effective screening and low-dose aspirin therapy early in pregnancy has been shown to prevent early-onset preeclampsia and to ameliorate the disease's consequences for the fetus.
Despite the growing understanding of preeclampsia biology, questions remain about heterogeneity of the disease across patients and the degree to which there are distinct subtypes and etiologies. New approaches are also needed to more quickly and comprehensively reduce the burden of preeclampsia, especially those suitable for the health care infrastructure in the countries with the highest burden.
<h2>The Challenge</h2>
We seek proposals for innovative solutions for the early detection, prevention, and treatment of preeclampsia, particularly in low- and middle-income countries where maternal mortality rates are high. To support this focus, we are looking for collaborations, including those with research institutions, health care providers, and global health organizations, that enable cross-sector insights and ensure that solutions are adaptable and practical.
The objectives of the challenge are:
<ol>
<li>Early prediction and detection of preeclampsia. We seek novel biomarkers as well as novel approaches to measurement of sFlt1 and PlGF, diagnostic tests, and point-of-care technologies to predict early in pregnancy the risk of preeclampsia and to diagnose it before symptoms become severe.</li>
<li>Understanding the pathophysiology of preeclampsia and its heterogeneity. We seek to understand the biological mechanisms driving the disease and its subtypes so that new interventions can be effectively tailored to the underlying etiology.</li>
<li>Preventive and therapeutic interventions. We seek new approaches to known targets or new targets to reduce the incidence and severity of preeclampsia, mitigate disease progression, and prevent the cardiovascular and metabolic complications that often follow it.</li>
</ol>
Funding Level
We will consider proposals for awards of up to $500,000 USD for each project, with a grant term of up to 2 years. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered, and should be included in the budget for the up to $500,000 USD award (subject to the <a href="https://docs.gatesfoundation.org/Documents/Indirect_Cost_Policy.pdf" target="_blank" rel="noopener noreferrer">Gates Foundation's indirect cost policy</a>).
Eligibility Criteria
This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. We particularly encourage applications involving projects led by women or from women-led organizations and applications from institutions based in low- and middle-income countries.
We are looking for proposals that:
<ul>
<li>Identify biomarkers that easily, reliably, and affordably predict preeclampsia risk early in pregnancy</li>
<li>Identify biochemical, genetic, epigenetic, or metabolomic signatures that can be translated into point-of-care tests</li>
<li>Leverage innovations in mobile health, wearable sensors, or simple clinical algorithms to identify women at risk before symptoms become severe</li>
<li>Identify the underlying biological mechanisms driving preeclampsia and its subtypes, including the roles of the placenta, endothelial function, immune response, and gut microbiota</li>
<li>Identify preventive interventions synergistic with or additive to low-dose aspirin, such as nutritional, pharmacological, or lifestyle-related approaches to reduce the incidence or severity of preeclampsia</li>
<li>Identify new drug candidates, therapeutics, or repurposed medications that safely mitigate preeclampsia progression without harming the fetus</li>
</ul>
We will not fund proposals that:
<ul>
<li>Focus on implementation science, health systems integration, or social determinants (although these are all important elements, they are not in the scope of this request for proposals)</li>
<li>Do not have the potential to become affordable and scalable in resource-limited settings</li>
<li>Represent basic research without clear relevance to the objectives of this challenge</li>
<li>Lack a clearly articulated and testable hypothesis</li>
<li>Present unacceptable safety risks or detract from or interfere with beneficial practices</li>
<li>Approaches that leverage previously failed biomarker exploration</li>
</ul>

We seek proposals for innovative solutions for the early detection, prevention, and treatment of preeclampsia, particularly in low- and middle-income countries where maternal mortality rates are high. To support this focus, we are looking for collaborations, including those with research institutions, health care providers, and global health organizations, that enable cross-sector insights and ensure that solutions are adaptable and practical.