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 is a family of initiatives fostering innovation to solve key global health and development problems. Each initiative is an experiment in the use of challenges to focus innovation on making an impact. Individual challenges address some of the same problems, but from differing perspectives.

Challenges

Grand Challenges

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

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.