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

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">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 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">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.

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.

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">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 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.

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">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/5878/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 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">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

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

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.

This Challenge is in Honor of our late colleague, Dr. Steve Hadley, former Senior Program Officer at the Gates Foundation, who long championed the reduction of mAbs manufacturing costs to make them affordable to low- and middle-income countries. * * * * * * * * * * * * * *Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the descriptive <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low-cost_mab_manufacturing_white_paper.pdf" target="_blank">White Paper</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low-cost_mab_manufacturing_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low-cost_mab_manufacturing_application_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/innovations-exceptionally-low-cost-monoclonal-antibody-mab-manufacturing-frequently-asked-questions" target="_blank">Frequently Asked Questions</a>.<h2>Background</h2>Monoclonal antibodies (mAbs) are one of the most powerful tools in modern medicine, offering a highly specific and effective treatment for a range of conditions - from infectious diseases like COVID-19 to chronic illnesses such as cancer and autoimmune disorders. These biologic therapies provide targeted interventions that can save lives and improve the quality of life for millions of patients globally. Yet, the high production costs associated with mAbs limit access to these lifesaving treatments for patients in low- and middle-income settings.With efforts to improve technology and affordability, mAb costs have decreased significantly in the last 30 years and have stagnated at around $50-100 per gram. These high costs are driven by the complexity of the manufacturing process, which involves sophisticated methods, strict regulatory compliance, expensive raw materials, and significant infrastructure investments. Reducing production costs is critical, as many applications of anti-infective antibodies may require doses on the order of hundreds of milligrams (as seen for the antibodies that achieved emergency use authorization and/or approvals for COVID-19). In order to improve mAb affordability in low- and middle-income countries, we will need to reach a final drug substance cost-of-goods of $10 per gram - a goal long championed by our late colleague, Dr. Steve Hadley, former Senior Program Officer at the Gates Foundation.To reach our goal, we will need to draw on innovation and novel approaches from a wide range of scientific and engineering disciplines. While those in the biopharmaceutical field are already deeply engaged in the challenge of reducing mAb manufacturing costs, there is tremendous potential for breakthroughs as we incorporate learnings from adjacent industries, such as dewatering and filtration, blood fractionation, industrial enzymes, and food and beverages. By bringing together diverse expertise and encouraging out-of-the-box thinking, we believe it is possible to achieve this ambitious goal.The Grand Challenges family of initiatives seeks to source and seed innovations and accelerate the development of transformational solutions. The Gates Foundation, in collaboration with LifeArc, a self-funded medical research charity in the UK, is calling on innovators, scientists, engineers, and entrepreneurs- whether they are seasoned experts in biologics or pioneers in related fields- to join us in this Grand Challenge. Together, we can unlock new pathways to reduce costs, enhance production efficiency, and ultimately expand access to life-saving treatments for all.This Grand Challenge is calling for proposals that are bold in their vision and approach, offering clear pathways to achieving the $10 per gram target. This is not just a technical challenge; it is an opportunity to make a lasting impact on the lives of millions of people worldwide. We invite you to bring your expertise, creativity, and passion to this effort and help shape a future where the best medical treatments are available to everyone, everywhere.<h2>The Challenge</h2>The Gates Foundation and LifeArc are soliciting proposals to develop proof-of-concept for manufacturing platforms that produce monoclonal antibodies at a final drug substance cost-of-goods of $10 per gram (Option A). The goal is to catalyze and accelerate multiple, diverse, innovative bioprocessing approaches that hold the promise of low cost-of-goods mAbs.Additionally, the Gates Foundation is interested in hearing from organizations that have already completed proof-of-concept work that could result in cost-of-goods of $10 per gram and may be interested in additional support (Option B).Applicants can apply with solutions meeting the criteria for either Option A or Option B but should not submit entries to both options.Option A: Proof-of-ConceptThe primary outputs of this challenge will be (1) development of a conceptual facility design, and (2) generation of bench or lab-scale process data with sufficient analytical data to demonstrate the ability to produce an antibody at a final drug substance cost-of-goods of $10 per gram that could meet requirements for human applications and would support a rigorous cost-of-goods assessment by a third-party organization (chosen by the Foundation). A full physical demonstration that the manufacturing platform meets specific manufacturing cost targets is not required at this stage. If the success criteria from this process are met and if additional funding is available, Option A applicants may be eligible for further support in a follow-on phase of work.To apply for the Option A opportunity, please click the "Apply Now" button at the top of this page, or visit this <a href="https://submit.gatesfoundation.org/prog/grandchallenges_mAb_Option_A" target="_blank">link</a>.Option B: Operationalization and Economic ViabilityIndependent of the Proof-of-Concept (Option A), the Gates Foundation recognizes that some organizations may already have proof-of-concept data that could support a final drug substance cost-of-goods of $10 per gram and would like to partner for further development funding. If you have existing data meeting <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low-cost_mab_manufacturing_trl.pdf" target="_blank">Technical Readiness Level 3-5</a> (POC Defined, Lab Scale Demonstrated, or Pilot Scale Demonstrated) please share a solution with additional information listed below, as well as any non-confidential data demonstrating Technical Readiness Level 3-5 for production of a monoclonal antibody at a final drug substance cost-of-goods of $10 per gram. The proposal review committee will evaluate this information and reach out to you if there is interest in exploring further. To apply for the Option B opportunity, please visit <a href="https://submit.gatesfoundation.org/prog/grandchallenges_mAb_Option_B" target="_blank">this link</a>.Objectives of the challenge (both Option A and Option B)<ul><li>Advance innovative and bold ideas that enhance production efficiency and improve overall process economics for mAb production, resulting in a final drug substance cost-of-goods of $10 per gram. This includes, but is not limited to:<ul><li>Alternative hosts to mammalian cell culture</li><li>Alternative to standard downstream purification methods</li><li>Reduction in material costs</li></ul></li><li>Push the boundaries of current technology by harnessing disruptive innovations, possibly from parallel industries, and identify process improvements to reduce manufacturing costs</li><li>Rethink existing methods of working such as release testing process and costs, high-quality and affordable raw materials and critical reagents</li></ul>Funding LevelOption A: The Gates Foundation and LifeArc will consider several proposals for awards of up to $750,000 USD for each project, with a grant term of up to 18 months. Each organization will make coordinated but independent award decisions. Application budgets should be commensurate with the scope of work proposed.Option B: Potential funding and grant terms will be evaluated on a per-project basis. The funding and timeline are intentionally open given that the work is exploratory at this time. Application budgets should be commensurate with the scope of work being proposed.Eligibility Criteria – Options A and BThis 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 / in collaboration with women-led organizations, and/or applications from / in collaboration with institutions based in low- and middle-income countries. Only individuals who are applying through a legally recognized corporate entity are eligible.We are looking for proposals that:<ul><li>Would work with the <a href="https://www.ncbi.nlm.nih.gov/nuccore/?term=ms-1797" target="_blank">MAM01 malaria antibodies</a> (Option A applicants) or malaria, RSV, or HIV antibodies (Option B applicants) requiring high doses<ul><li>We are focused on applications capable of producing antibodies at volumes of a metric ton per year and are modeled assuming tonnage demand (1000 kg per year)</li></ul></li><li>Include fully loaded costs inclusive of reagents, consumables, labor, facility-related costs, QC/QA (quality control, quality assurance) costs, fill-finish, and licensing costs</li><li>Outline solutions with specific steps and/or end-to-end solutions</li><li>Provide technological solutions to reach the target rather than solutions relying upon multi-use facilities, brown-field facilities and other non-technological solutions<ul><li>For the purposes of calculating costs, assume a "green-field" facility producing just a single product</li></ul></li><li>Clearly outline the capabilities of the team, including a level of demonstrated applicability to a related problem and/or credibility for pharmaceutical applications</li><li>Demonstrate technical quality and the ability to generate data within 12 months</li><li>Include a justification of costs, which will also be analyzed by an external third-party</li><li>We encourage applications that may include a number of collaborators who each bring specific expertise. If applicants need partners with specific expertise, please identify so within your proposal submission and we will consider areas to encourage collaboration amongst different applicants to enable end-to-end solutions</li><li>Articulate solutions that could enable manufacturing in LMICs</li><li>For applicants interested in Option B: Please share any non-confidential data sharing that technical readiness level 3-5 has been met for low-cost production of HIV, RSV, or malaria antibodies</li></ul>For this challenge we are not seeking proposals that:<ul><li>Include changes to an existing licensed molecule</li><li>Require changes to the coding of sequence of standard human- or humanized-IgG1s.<ul><li>Since the foundation is separately funding the development of protein molecules with improved affinity and potency, this particular RFP is focused on manufacturing solutions</li></ul></li><li>Are focused on solutions for lower-cost delivery and administration of antibodies<ul><li>This RFP is focused on drug substance only so applications on DP (drug product), filled container and alternative administration routes (oral, nasal, ID, etc.) are outside the scope of this RFP</li></ul></li><li>Are focused on technologies like in-vivo expression of antibodies using nucleic acid and gene delivery<ul><li>The Gates Foundation is pursuing alternative paths to these technologies, and they are outside the scope of this RFP</li></ul></li><li>Include cost reductions resulting from price negotiations (e.g., buying materials in bulk)</li><li>Are focused on stepwise or incremental improvements that result in nominal cost reductions</li><li>Are not applicable to global-health target diseases</li></ul>The Option A (Proof-of-Concept) part of this Grand Challenge is a collaboration between the Gates Foundation and LifeArc, however each funder will make independent funding decisions. Following the RFP process, organizations with successful applications will be invited to submit their proposal on Gates Foundation or LifeArc standard proposal templates in alignment with each potential funder's due diligence process as applicable.The Gates Foundation is accepting proposals for Option B independently from LifeArc.

Low-Cost mAb Manufacturing - Frequently Asked Questions (FAQs)

Innovations for Exceptionally Low-Cost Monoclonal Antibody (mAb) Manufacturing

This Challenge is in Honor of our late colleague, Dr. Steve Hadley, former Senior Program Officer at the Gates Foundation, who long championed the reduction of mAbs manufacturing costs to make them affordable to low- and middle-income countries. * * * * * * * * * * * * * *
Note that Option A is now closed but Option B will be open until May 31, 2025 11:30 AM PDT
Before applying, applicants should familiarize themselves with the supporting documents for this Grand Challenge, including the descriptive <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low-cost_mab_manufacturing_white_paper.pdf" target="_blank">White Paper</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low-cost_mab_manufacturing_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low-cost_mab_manufacturing_application_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/innovations-exceptionally-low-cost-monoclonal-antibody-mab-manufacturing-frequently-asked-questions" target="_blank">Frequently Asked Questions</a>.
<h2>Background</h2>
Monoclonal antibodies (mAbs) are one of the most powerful tools in modern medicine, offering a highly specific and effective treatment for a range of conditions - from infectious diseases like COVID-19 to chronic illnesses such as cancer and autoimmune disorders. These biologic therapies provide targeted interventions that can save lives and improve the quality of life for millions of patients globally. Yet, the high production costs associated with mAbs limit access to these lifesaving treatments for patients in low- and middle-income settings.
With efforts to improve technology and affordability, mAb costs have decreased significantly in the last 30 years and have stagnated at around $50-100 per gram. These high costs are driven by the complexity of the manufacturing process, which involves sophisticated methods, strict regulatory compliance, expensive raw materials, and significant infrastructure investments. Reducing production costs is critical, as many applications of anti-infective antibodies may require doses on the order of hundreds of milligrams (as seen for the antibodies that achieved emergency use authorization and/or approvals for COVID-19). In order to improve mAb affordability in low- and middle-income countries, we will need to reach a final drug substance cost-of-goods of $10 per gram - a goal long championed by our late colleague, Dr. Steve Hadley, former Senior Program Officer at the Gates Foundation.
To reach our goal, we will need to draw on innovation and novel approaches from a wide range of scientific and engineering disciplines. While those in the biopharmaceutical field are already deeply engaged in the challenge of reducing mAb manufacturing costs, there is tremendous potential for breakthroughs as we incorporate learnings from adjacent industries, such as dewatering and filtration, blood fractionation, industrial enzymes, and food and beverages. By bringing together diverse expertise and encouraging out-of-the-box thinking, we believe it is possible to achieve this ambitious goal.
The Grand Challenges family of initiatives seeks to source and seed innovations and accelerate the development of transformational solutions. The Gates Foundation, in collaboration with LifeArc, a self-funded medical research charity in the UK, is calling on innovators, scientists, engineers, and entrepreneurs- whether they are seasoned experts in biologics or pioneers in related fields- to join us in this Grand Challenge. Together, we can unlock new pathways to reduce costs, enhance production efficiency, and ultimately expand access to life-saving treatments for all.
This Grand Challenge is calling for proposals that are bold in their vision and approach, offering clear pathways to achieving the $10 per gram target. This is not just a technical challenge; it is an opportunity to make a lasting impact on the lives of millions of people worldwide. We invite you to bring your expertise, creativity, and passion to this effort and help shape a future where the best medical treatments are available to everyone, everywhere.
<h2>The Challenge</h2>
The Gates Foundation and LifeArc are soliciting proposals to develop proof-of-concept for manufacturing platforms that produce monoclonal antibodies at a final drug substance cost-of-goods of $10 per gram (Option A). The goal is to catalyze and accelerate multiple, diverse, innovative bioprocessing approaches that hold the promise of low cost-of-goods mAbs.
Additionally, the Gates Foundation is interested in hearing from organizations that have already completed proof-of-concept work that could result in cost-of-goods of $10 per gram and may be interested in additional support (Option B).
Applicants can apply with solutions meeting the criteria for either Option A or Option B but should not submit entries to both options.
Option A: Proof-of-Concept
The primary outputs of this challenge will be (1) development of a conceptual facility design, and (2) generation of bench or lab-scale process data with sufficient analytical data to demonstrate the ability to produce an antibody at a final drug substance cost-of-goods of $10 per gram that could meet requirements for human applications and would support a rigorous cost-of-goods assessment by a third-party organization (chosen by the Foundation). A full physical demonstration that the manufacturing platform meets specific manufacturing cost targets is not required at this stage. If the success criteria from this process are met and if additional funding is available, Option A applicants may be eligible for further support in a follow-on phase of work.
Option B: Operationalization and Economic Viability
Independent of the Proof-of-Concept (Option A), the Gates Foundation recognizes that some organizations may already have proof-of-concept data that could support a final drug substance cost-of-goods of $10 per gram and would like to partner for further development funding. If you have existing data meeting <a href="https://gcgh.grandchallenges.org/sites/default/files/files/low-cost_mab_manufacturing_trl.pdf" target="_blank">Technical Readiness Level 3-5</a> (POC Defined, Lab Scale Demonstrated, or Pilot Scale Demonstrated) please share a solution with additional information listed below, as well as any non-confidential data demonstrating Technical Readiness Level 3-5 for production of a monoclonal antibody at a final drug substance cost-of-goods of $10 per gram. The proposal review committee will evaluate this information and reach out to you if there is interest in exploring further. To apply for the Option B opportunity, please visit <a href="https://submit.gatesfoundation.org/prog/grandchallenges_mAb_Option_B" target="_blank">this link</a>.
Objectives of the challenge (both Option A and Option B)
<ul>
<li>Advance innovative and bold ideas that enhance production efficiency and improve overall process economics for mAb production, resulting in a final drug substance cost-of-goods of $10 per gram. This includes, but is not limited to:
<ul>
<li>Alternative hosts to mammalian cell culture</li>
<li>Alternative to standard downstream purification methods</li>
<li>Reduction in material costs</li>
</ul>
</li>
<li>Push the boundaries of current technology by harnessing disruptive innovations, possibly from parallel industries, and identify process improvements to reduce manufacturing costs</li>
<li>Rethink existing methods of working such as release testing process and costs, high-quality and affordable raw materials and critical reagents</li>
</ul>
Funding Level
Option A: The Gates Foundation and LifeArc will consider several proposals for awards of up to $750,000 USD for each project, with a grant term of up to 18 months. Each organization will make coordinated but independent award decisions. Application budgets should be commensurate with the scope of work proposed.
Option B: Potential funding and grant terms will be evaluated on a per-project basis. The funding and timeline are intentionally open given that the work is exploratory at this time. Application budgets should be commensurate with the scope of work being proposed.
Eligibility Criteria – Options A and B
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 / in collaboration with women-led organizations, and/or applications from / in collaboration with institutions based in low- and middle-income countries. Only individuals who are applying through a legally recognized corporate entity are eligible.
We are looking for proposals that:
<ul>
<li>Would work with the <a href="https://www.ncbi.nlm.nih.gov/nuccore/?term=ms-1797" target="_blank">MAM01 malaria antibodies</a> (Option A applicants) or malaria, RSV, or HIV antibodies (Option B applicants) requiring high doses
<ul>
<li>We are focused on applications capable of producing antibodies at volumes of a metric ton per year and are modeled assuming tonnage demand (1000 kg per year)</li>
</ul>
</li>
<li>Include fully loaded costs inclusive of reagents, consumables, labor, facility-related costs, QC/QA (quality control, quality assurance) costs, fill-finish, and licensing costs</li>
<li>Outline solutions with specific steps and/or end-to-end solutions</li>
<li>Provide technological solutions to reach the target rather than solutions relying upon multi-use facilities, brown-field facilities and other non-technological solutions
<ul>
<li>For the purposes of calculating costs, assume a "green-field" facility producing just a single product</li>
</ul>
</li>
<li>Clearly outline the capabilities of the team, including a level of demonstrated applicability to a related problem and/or credibility for pharmaceutical applications</li>
<li>Demonstrate technical quality and the ability to generate data within 12 months</li>
<li>Include a justification of costs, which will also be analyzed by an external third-party</li>
<li>We encourage applications that may include a number of collaborators who each bring specific expertise. If applicants need partners with specific expertise, please identify so within your proposal submission and we will consider areas to encourage collaboration amongst different applicants to enable end-to-end solutions</li>
<li>Articulate solutions that could enable manufacturing in LMICs</li>
<li>For applicants interested in Option B: Please share any non-confidential data sharing that technical readiness level 3-5 has been met for low-cost production of HIV, RSV, or malaria antibodies</li>
</ul>
For this challenge we are not seeking proposals that:
<ul>
<li>Include changes to an existing licensed molecule</li>
<li>Require changes to the coding of sequence of standard human- or humanized-IgG1s.
<ul>
<li>Since the foundation is separately funding the development of protein molecules with improved affinity and potency, this particular RFP is focused on manufacturing solutions</li>
</ul>
</li>
<li>Are focused on solutions for lower-cost delivery and administration of antibodies
<ul>
<li>This RFP is focused on drug substance only so applications on DP (drug product), filled container and alternative administration routes (oral, nasal, ID, etc.) are outside the scope of this RFP</li>
</ul>
</li>
<li>Are focused on technologies like in-vivo expression of antibodies using nucleic acid and gene delivery
<ul>
<li>The Gates Foundation is pursuing alternative paths to these technologies, and they are outside the scope of this RFP</li>
</ul>
</li>
<li>Include cost reductions resulting from price negotiations (e.g., buying materials in bulk)</li>
<li>Are focused on stepwise or incremental improvements that result in nominal cost reductions</li>
<li>Are not applicable to global-health target diseases</li>
</ul>
The Option A (Proof-of-Concept) part of this Grand Challenge is a collaboration between the Gates Foundation and LifeArc, however each funder will make independent funding decisions. Following the RFP process, organizations with successful applications will be invited to submit their proposal on Gates Foundation or LifeArc standard proposal templates in alignment with each potential funder's due diligence process as applicable.
The Gates Foundation is accepting proposals for Option B independently from LifeArc.

The Gates Foundation and Life Arc are soliciting proposals to develop proofs-of-concept for manufacturing platforms that produce monoclonal antibodies at a final drug substance cost-of-goods of $10 per gram. This Grand Challenge is calling for proposals that are bold in their vision and approach, offering clear pathways to achieving the $10 per gram target. This is not just a technical challenge; it is an opportunity to make a lasting impact on the lives of millions of people worldwide. We invite you to bring your expertise, creativity, and passion to this effort and help shape a future where the best medical treatments are available to everyone, everywhere.

Note that this RFP is being launched by multiple partners, across variable geographies, topic areas, and funding levels. Please review the requirements for each RFP to determine your eligibility. The individual RFPs are listed separately <a href="https://gcgh.grandchallenges.org/challenges/JTdCJTIyc29ydCUyMiUzQSUyMmRlc2NlbmRpbmclMjIlMkMlMjJzb3J0RmllbGQlMjIlM0ElMjJkYXRlJTIyJTJDJTIybnVtYmVyUGVyUGFnZSUyMiUzQTEwJTJDJTIycGFnZU51bWJlciUyMiUzQTAlN0Q=/JTdCJTIyeWVhcnMlMjIlM0ElNUIlNUQlMkMlMjJjaGFsbGVuZ2VzJTIyJTNBJTVCJTIyMzI1JTIyJTVEJTJDJTIydGVybXMlMjIlM0ElNUIlNUQlMkMlMjJpbml0aWF0aXZlcyUyMiUzQSU1QiU1RCUyQyUyMmxvY2F0aW9ucyUyMiUzQSU1QiU1RCU3RA==" target="_blank">here</a>. If you are eligible for multiple RFPs, please choose the RFP that most closely aligns with your proposed project.<h2>Background</h2>Climate change threatens hard-earned global health and development progress and puts the health, well-being, and livelihoods of future generations in jeopardy, with a special impact on women. The 2015 Paris Agreement and the Sustainable Development Goals signaled a promise from global leaders to act - to limit global average temperature rise to within 1.5°C by 2040 and prevent the worst health and development effects of climate change. While no one is safe from these risks, the people whose health and wellbeing are being harmed first and worst by the climate crisis are also the ones who contribute least to its causes, and who are least able to protect themselves and their families against it - namely people in low-income and disadvantaged countries and communities. In low-income settings, rising heat, extreme weather events, changes in precipitation patterns, climate-related undernutrition, shifts in duration and climate-event-driven surges of malaria and other vector borne diseases such as malaria,&nbsp;foodborne and water-borne diseases, and increased potential for the emergence of novel diseases damage already weak primary health care systems and community structures for health. This compromises accessibility, availability, provision, and uptake of essential health services for the most vulnerable populations. Climate change can also disproportionately affect the health and financial well-being of women and girls: extreme heat increases the incidences of stillbirth, the rampant spread of vector-borne diseases worsens maternal and neonatal outcomes, and gender disparities amplified by climate change can decrease the women's share of economic agricultural gains. Those same changes in climate and weather also negatively impact all aspects of agricultural activities, a major source of income for those in low-income settings.Catalytic research and development (R&amp;D) as well as innovations to scale the impact of existing green technologies are essential to cut greenhouse gas emissions to net-zero and address the unprecedented health, agricultural and environmental challenges posed by climate change, which have an outsized impact on women. It is crucial to understand the emerging problems in health and agriculture, either directly triggered by climate change, or as a result of disruptions (e.g., operational) downstream of crises created by climate change. Consequently, there is an urgent need to invest in creative solutions to help vulnerable populations adapt and build their resilience to the existing and future climate related challenges impacting health and agriculture and build alternative livelihoods. This work will involve making those most affected, especially women, major stakeholders in discussions about how new climate resistant and adaptive innovations will be deployed, as well as giving them a deliberate choice and advantage in the creation of new economic opportunities that result from these investments.In recent years, global leaders, philanthropies, and private investors have begun committing significant resources to climate change mitigation R&amp;D. However, more is needed to unite partners across sectors and accelerate innovations addressing challenges at the intersections of climate, health, gender, and agriculture, particularly for underserved regions and groups.The Grand Challenges family of initiatives seeks to source and seed innovations and accelerate the development of transformational solutions. To this end, Grand Challenges (GC) partners including GC Africa (Science for Africa Foundation), GC Brazil (Ministry of Health of Brazil), GC Ethiopia (Armauer Hansen Research Institute (AHRI)), GC India (Department of Biotechnology of India), and GC Rwanda (National Council for Science and Technology), along with the Bill &amp; Melinda Gates Foundation and the Pasteur Network, and supported by Wellcome, Foundation S-the Sanofi Collective, and the Rockefeller Foundation are launching this request for proposals (RFP) to identify and support promising innovations.<h2>The Challenge</h2>This Grand Challenges request for proposals seeks innovative research and pilot/feasibility projects utilizing transdisciplinary approaches to better adapt to, mitigate, or reverse the combined, deleterious effects of climate change on health, women's lives, and agriculture in the geographies of interest. These innovations include early warning and disease surveillance systems to respond to climate-event-driven surges in malaria and other vector borne diseases, as well as improved mapping of expanded vector ranges and vector-borne disease transmission. Preference will be given to innovations that are formulated locally or adapted from other contexts. We are especially interested in 1) locally led, system-level innovations that are scalable and sustainable and 2) cross-cutting solutions at the intersection of multiple scientific and engineering disciplines.This RFP focuses on the topic areas listed below. Under each of the topic areas, we provide examples of innovations we would like to see, but innovators are also encouraged to propose their own ideas related to these topics.Topic Areas:<ol><li>Health Outcomes -&nbsp;including systemic and compounding impacts of climate change on health. We are seeking solutions targeting: &nbsp;<ol type="a"><li>Early Warning and Disease Surveillance: We seek proposals that build resilient systems to mitigate health impact of climate change. Solutions may include accurate surveillance systems for early detection of vector-borne, waterborne, and zoonotic diseases; that predict the impact of climate-related events (heat, flood, population, vegetation, and zoonotic migration), and vectors and diseases introduced to new localities. Where possible, employment opportunities should be created for rural women. (Geographies of interest: sub-Saharan Africa; Brazil)</li><li>Gender Equality, Diversity, and Inclusion: Women are disproportionately impacted by climate-sensitive health risks. Women are themselves a vulnerable group, and they can also fall into many other vulnerable groups. As such, we&nbsp;seek solutions that address the increased risks related to maternal, newborn, and child health. Solutions should address gender disparities in access to food, health care, education, and economic well-being. Also of interest are solutions that address the vulnerability to forms of gender-based violence and post-traumatic stress disorders arising from climate change-driven conflict. (Geographies of interest: sub-Saharan Africa; Brazil)</li><li>Community Health Ecosystems: We are looking for proposals that strengthen the resilience and adaptability of health care service delivery and supply chains to climate related changes. These solutions can include anticipatory action, adaptation of provisions, quality, and accessibility of essential services to vulnerable communities, especially women, capacity building for health care professionals and community health actors. We are also interested in solutions that help individuals and families respond locally to new ailments and challenges brought about by climate-related events. (Geographies of interest: sub-Saharan Africa; Brazil)</li><li>Measurement &amp; Evaluation (M&amp;E): We encourage proposals focused on development of harmonized M&amp;E frameworks and systems for programs that better incorporate climate considerations. (Geographies of interest: sub-Saharan Africa; Brazil) &nbsp;</li></ol></li><li>Nutrition - Undernutrition is a consequence of climate change - and it makes people more susceptible to its effects, particularly extreme heat exposure which poses unique risks for pregnant women, newborns, and infants under 2 years old. We are seeking solutions that address:<ol type="a"><li>Heat stress and nutritional status, in particular gestation weight gain, low birth weight, preterm birth, small for gestational age, early growth faltering (in children &lt;6 months), and child wasting. (Geographies of interest: sub-Saharan Africa; South Asia; Brazil)</li><li>Heat stress and micronutrient status, including anemia and breastmilk quality.</li><li>Improved real-time monitoring and surveillance of wasting and the spatial relationship between climate vulnerability and undernutrition. (Geographies of interest: sub-Saharan Africa; South Asia; Brazil)</li><li>Integration of climate risk into social protection schemes and the inclusion of nutrition products and services as part of an essential nutrition package within social safety net programs. (Geographies of interest: sub-Saharan Africa; South Asia; Brazil)</li><li>Innovation in the composition of specialized nutritious foods (e.g., RUTFs to treat severe acute malnutrition), considering susceptibility of raw ingredients to climate shocks, price volatility, and decreased nutritional quality. (Geographies of interest: sub-Saharan Africa; South Asia; Brazil) &nbsp;</li></ol></li><li>Adaptation Strategies for Agriculture and Income Development, with a focus on women's agriculture livelihoods.<ol type="a"><li>The production of synthetic nitrogen fertilizers is energy-intensive and contributes to greenhouse gas (GHG) emissions. For every kilogram of Nitrogen (N) produced by synthetic process, 10.1Kg of CO2 is emitted. Biofertilizers present great promise in reducing&nbsp;emissions associated with synthetic fertilizer production and providing nitrogen fixation needed for productive plants. The technological gap in validating this innovation lies in the lack of robust field measurements, which, when addressed by accurately measuring Biological Nitrogen Fixation (BNF), can help develop strategies to reduce GHG emissions, fertilizer runoff, and water pollution. We are looking for in-situ methods for measuring BNF at field level to help validate climate-smart biofertilizers as next generation inputs.&nbsp;Research topics may include novel biosensors, spectral analysis, infra-red, or any other fast and low-cost methodology for measuring nitrogen fixation and release of fixed nitrogen to plants, by free-living, associative symbiotic and non-symbiotic microbes. Research may also comprise innovative methods for proving candidate microbes are indeed drawing nitrogen from the atmosphere for direct or indirect crop benefit, rather than mining the soil. (Geographies of interest: sub-Saharan Africa; South Asia; Brazil)</li><li>Climate and weather information are fundamental for agricultural decision making and become even more essential amid changes in temperature and rainfall patterns. Women are typically underrepresented as users of climate decision support, due to cultural norms or technological gaps, and even more underrepresented as innovators and providers of climate services. We are looking for innovation solutions for scaling access to climate decision support provided by women- and youth-run, micro, small, and medium enterprises (MSMEs). This may include women- and youth-run small and medium enterprises (SMEs) integrating climate information services or a climate service provider innovating ways to partner with women- and youth-run SMEs. (Geography of interest: sub-Saharan Africa)</li><li>Women face multiple systemic disadvantages that reduce their capacity to adapt to climate change. We seek proposals on three topics related to women's resilience: (1) Climate-smart labor-saving technologies for rural women that are affordable and accessible with potential for scale, (2) Identifying opportunities for rural women's organizations to influence national climate adaptation plans, and (3) Gender transformative climate-smart innovations for livelihood diversification on and off farm in food systems. Cross-cutting topics of interest include access to capital, upskilling, digital tools, social norms, expanding market access, and support for young women and adolescent girls. (Geographies of interest: sub-Saharan Africa; South Asia) &nbsp;</li></ol></li><li>Knowledge Management and Data Integration of Climate and Health Databases - Many vector-borne diseases may increase in localities that were not prepared for them before the advent of climate-change. We seek solutions that integrate data from climate scientists, disease modelers, and government health officials to help address the rise of specific diseases. Potential areas of interest include, but are not limited to:<ol type="a"><li>Facilitating community participation in/crowd-sourcing data collection to track climate change impact at local level (e.g., changes in weather patterns or detection of invasive vector species) (Geographies of interest: sub-Saharan Africa; Brazil)</li><li>Integrating commercially available databases and local data into early warning systems that can drive decision making, working to ensure sex-disaggregated data when relevant. (Geographies of interest: sub-Saharan Africa; Brazil)</li><li>Researching the relationship between climate change and the spread of vector-borne diseases (e.g., changes to vector populations or disease transmission dynamics) to develop early warning systems to prevent outbreaks. (Geographies of interest: sub-Saharan Africa; Brazil) &nbsp;</li></ol></li><li>Effective Response and Resilient Supply Chains for Crisis Management – Maintaining routine health delivery or non-routine campaigns such as humanitarian aid and vaccination efforts will be an increasingly multifaceted problem as the need for rapid, directed humanitarian aid increases in the face of extreme climate events, examples include changing landscapes for roads and bridges; Internally Displaced People (IDPs) and armed conflicts; and disrupted daily routines for affected populations. We are seeking to implement agile, resilient supply chains that allow for the re-deployment of interventions based on need, e.g., malaria insecticide-treated nets, preventive chemotherapies, etc. against vector-borne diseases. (Geography of interest: sub-Saharan Africa)</li></ol>Funding Level, Period of Performance, and Geography of InterestThe funding level is up to USD $200,000.00, for each grant. The period of performance is up to two years. The geography of interest is outlined within the topic/sub-topic areas listed above. This means that the effort needs to be led by investigators in the specified geographies above. Global collaborators may be included, but at least 80% of the funding must go to an organization within the specified geographies. Application budgets should be commensurate with the scope of work proposed.We are looking for proposals that:<ul><li>Demonstrate that projects are led by (Low- and Middle-Income Countries (LMIC)<a href="#_ftn1" title="" id="_ftnref1" name="_ftnref1">[1]</a> investigators, local stakeholders, or community-led organizations. Global partners may be included, but proposals must demonstrate at least 80% of the funding is going to an investigator in an LMIC institution within the geography of interest. Teams comprising multiple LMIC institutions will be given preference over applicants from single institutions. We also encourage multi-country collaborations.</li><li>Come from women-led organizations or involve projects led by women and focused on reaching women.</li><li>Articulate how the project will lead to near-term impact and how the impact will be sustained over the lifetime of the project and beyond.</li><li>Articulate the scalability of the solution beyond a small local region or population. Strong consideration will be given to approaches that can scale to multiple geographic areas, demographic groups, etc.</li><li>Demonstrate engagement with local and/or regional communities, decision-makers, and adopters.</li><li>Promote inter-sectoral co-ordination and collaboration.</li></ul>We will not fund proposals that:<ul><li>Do not support communities and countries to adapt and be resilient to the effects of climate change on agriculture, health and gender in the geography of interest.</li><li>Do not demonstrate that the majority of the work proposed will be undertaken by investigators and/or local stakeholders living in the geography of interest.&nbsp;</li><li>Do not plan for or demonstrate a pathway to sustainable impact and scalability.</li><li>Are not linked to or have no plan to engage relevant key stakeholders and decision makers from the affected communities.</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- &amp; Middle-Income Countries</a> for definitions.

Accelerating Catalyzing Solutions for Climate Change's Impact on Health, Agriculture, and Gender

Note that this RFP is being launched by multiple partners, across variable geographies, topic areas, and funding levels. Please review the requirements for each RFP to determine your eligibility. The individual RFPs are listed separately <a href="https://gcgh.grandchallenges.org/grant-opportunities" target="_blank" rel="noopener noreferrer">here</a>. If you are eligible for multiple RFPs, please choose the RFP that most closely aligns with your proposed project.
<h2>Background</h2>
Climate change threatens hard-earned global health and development progress and puts the health, well-being, and livelihoods of future generations in jeopardy, with a special impact on women. The 2015 Paris Agreement and the Sustainable Development Goals signaled a promise from global leaders to act - to limit global average temperature rise to within 1.5°C by 2040 and prevent the worst health and development effects of climate change. While no one is safe from these risks, the people whose health and wellbeing are being harmed first and worst by the climate crisis are also the ones who contribute least to its causes, and who are least able to protect themselves and their families against it - namely people in low-income and disadvantaged countries and communities. In low-income settings, rising heat, extreme weather events, changes in precipitation patterns, climate-related undernutrition, shifts in duration and climate-event-driven surges of malaria and other vector borne diseases such as malaria,&nbsp;foodborne and water-borne diseases, and increased potential for the emergence of novel diseases damage already weak primary health care systems and community structures for health. This compromises accessibility, availability, provision, and uptake of essential health services for the most vulnerable populations. Climate change can also disproportionately affect the health and financial well-being of women and girls: extreme heat increases the incidences of stillbirth, the rampant spread of vector-borne diseases worsens maternal and neonatal outcomes, and gender disparities amplified by climate change can decrease the women's share of economic agricultural gains. Those same changes in climate and weather also negatively impact all aspects of agricultural activities, a major source of income for those in low-income settings.
Catalytic research and development (R&amp;D) as well as innovations to scale the impact of existing green technologies are essential to cut greenhouse gas emissions to net-zero and address the unprecedented health, agricultural and environmental challenges posed by climate change, which have an outsized impact on women. It is crucial to understand the emerging problems in health and agriculture, either directly triggered by climate change, or as a result of disruptions (e.g., operational) downstream of crises created by climate change. Consequently, there is an urgent need to invest in creative solutions to help vulnerable populations adapt and build their resilience to the existing and future climate related challenges impacting health and agriculture and build alternative livelihoods. This work will involve making those most affected, especially women, major stakeholders in discussions about how new climate resistant and adaptive innovations will be deployed, as well as giving them a deliberate choice and advantage in the creation of new economic opportunities that result from these investments.
In recent years, global leaders, philanthropies, and private investors have begun committing significant resources to climate change mitigation R&amp;D. However, more is needed to unite partners across sectors and accelerate innovations addressing challenges at the intersections of climate, health, gender, and agriculture, particularly for underserved regions and groups.
The Grand Challenges family of initiatives seeks to source and seed innovations and accelerate the development of transformational solutions. To this end, Grand Challenges (GC) partners including GC Africa (Science for Africa Foundation), GC Brazil (Ministry of Health of Brazil), GC Ethiopia (Armauer Hansen Research Institute (AHRI)), GC India (Department of Biotechnology of India), and GC Rwanda (National Council for Science and Technology), along with the Bill &amp; Melinda Gates Foundation and the Pasteur Network, and supported by Wellcome, Foundation S-the Sanofi Collective, and the Rockefeller Foundation are launching this request for proposals (RFP) to identify and support promising innovations.
<h2>The Challenge</h2>
This Grand Challenges request for proposals seeks innovative research and pilot/feasibility projects utilizing transdisciplinary approaches to better adapt to, mitigate, or reverse the combined, deleterious effects of climate change on health, women's lives, and agriculture in the geographies of interest. These innovations include early warning and disease surveillance systems to respond to climate-event-driven surges in malaria and other vector borne diseases, as well as improved mapping of expanded vector ranges and vector-borne disease transmission. Preference will be given to innovations that are formulated locally or adapted from other contexts. We are especially interested in 1) locally led, system-level innovations that are scalable and sustainable and 2) cross-cutting solutions at the intersection of multiple scientific and engineering disciplines.
This RFP focuses on the topic areas listed below. Under each of the topic areas, we provide examples of innovations we would like to see, but innovators are also encouraged to propose their own ideas related to these topics.
Topic Areas:
<ol>
<li>Health Outcomes -&nbsp;including systemic and compounding impacts of climate change on health. We are seeking solutions targeting: &nbsp; 
<ol type="a">
<li>Early Warning and Disease Surveillance: We seek proposals that build resilient systems to mitigate health impact of climate change. Solutions may include accurate surveillance systems for early detection of vector-borne, waterborne, and zoonotic diseases; that predict the impact of climate-related events (heat, flood, population, vegetation, and zoonotic migration), and vectors and diseases introduced to new localities. Where possible, employment opportunities should be created for rural women. (Geographies of interest: sub-Saharan Africa; Brazil)</li>
<li>Gender Equality, Diversity, and Inclusion: Women are disproportionately impacted by climate-sensitive health risks. Women are themselves a vulnerable group, and they can also fall into many other vulnerable groups. As such, we&nbsp;seek solutions that address the increased risks related to maternal, newborn, and child health. Solutions should address gender disparities in access to food, health care, education, and economic well-being. Also of interest are solutions that address the vulnerability to forms of gender-based violence and post-traumatic stress disorders arising from climate change-driven conflict. (Geographies of interest: sub-Saharan Africa; Brazil)</li>
<li>Community Health Ecosystems: We are looking for proposals that strengthen the resilience and adaptability of health care service delivery and supply chains to climate related changes. These solutions can include anticipatory action, adaptation of provisions, quality, and accessibility of essential services to vulnerable communities, especially women, capacity building for health care professionals and community health actors. We are also interested in solutions that help individuals and families respond locally to new ailments and challenges brought about by climate-related events. (Geographies of interest: sub-Saharan Africa; Brazil)</li>
<li>Measurement &amp; Evaluation (M&amp;E): We encourage proposals focused on development of harmonized M&amp;E frameworks and systems for programs that better incorporate climate considerations. (Geographies of interest: sub-Saharan Africa; Brazil) &nbsp;</li>
</ol>
</li>
<li>Nutrition - Undernutrition is a consequence of climate change - and it makes people more susceptible to its effects, particularly extreme heat exposure which poses unique risks for pregnant women, newborns, and infants under 2 years old. We are seeking solutions that address: 
<ol type="a">
<li>Heat stress and nutritional status, in particular gestation weight gain, low birth weight, preterm birth, small for gestational age, early growth faltering (in children &lt;6 months), and child wasting. (Geographies of interest: sub-Saharan Africa; South Asia; Brazil)</li>
<li>Heat stress and micronutrient status, including anemia and breastmilk quality.</li>
<li>Improved real-time monitoring and surveillance of wasting and the spatial relationship between climate vulnerability and undernutrition. (Geographies of interest: sub-Saharan Africa; South Asia; Brazil)</li>
<li>Integration of climate risk into social protection schemes and the inclusion of nutrition products and services as part of an essential nutrition package within social safety net programs. (Geographies of interest: sub-Saharan Africa; South Asia; Brazil)</li>
<li>Innovation in the composition of specialized nutritious foods (e.g., RUTFs to treat severe acute malnutrition), considering susceptibility of raw ingredients to climate shocks, price volatility, and decreased nutritional quality. (Geographies of interest: sub-Saharan Africa; South Asia; Brazil) &nbsp;</li>
</ol>
</li>
<li>Adaptation Strategies for Agriculture and Income Development, with a focus on women's agriculture livelihoods. 
<ol type="a">
<li>The production of synthetic nitrogen fertilizers is energy-intensive and contributes to greenhouse gas (GHG) emissions. For every kilogram of Nitrogen (N) produced by synthetic process, 10.1Kg of CO2 is emitted. Biofertilizers present great promise in reducing&nbsp;emissions associated with synthetic fertilizer production and providing nitrogen fixation needed for productive plants. The technological gap in validating this innovation lies in the lack of robust field measurements, which, when addressed by accurately measuring Biological Nitrogen Fixation (BNF), can help develop strategies to reduce GHG emissions, fertilizer runoff, and water pollution. We are looking for in-situ methods for measuring BNF at field level to help validate climate-smart biofertilizers as next generation inputs.&nbsp;Research topics may include novel biosensors, spectral analysis, infra-red, or any other fast and low-cost methodology for measuring nitrogen fixation and release of fixed nitrogen to plants, by free-living, associative symbiotic and non-symbiotic microbes. Research may also comprise innovative methods for proving candidate microbes are indeed drawing nitrogen from the atmosphere for direct or indirect crop benefit, rather than mining the soil. (Geographies of interest: sub-Saharan Africa; South Asia; Brazil)</li>
<li>Climate and weather information are fundamental for agricultural decision making and become even more essential amid changes in temperature and rainfall patterns. Women are typically underrepresented as users of climate decision support, due to cultural norms or technological gaps, and even more underrepresented as innovators and providers of climate services. We are looking for innovation solutions for scaling access to climate decision support provided by women- and youth-run, micro, small, and medium enterprises (MSMEs). This may include women- and youth-run small and medium enterprises (SMEs) integrating climate information services or a climate service provider innovating ways to partner with women- and youth-run SMEs. (Geography of interest: sub-Saharan Africa)</li>
<li>Women face multiple systemic disadvantages that reduce their capacity to adapt to climate change. We seek proposals on three topics related to women's resilience: (1) Climate-smart labor-saving technologies for rural women that are affordable and accessible with potential for scale, (2) Identifying opportunities for rural women's organizations to influence national climate adaptation plans, and (3) Gender transformative climate-smart innovations for livelihood diversification on and off farm in food systems. Cross-cutting topics of interest include access to capital, upskilling, digital tools, social norms, expanding market access, and support for young women and adolescent girls. (Geographies of interest: sub-Saharan Africa; South Asia) &nbsp;</li>
</ol>
</li>
<li>Knowledge Management and Data Integration of Climate and Health Databases - Many vector-borne diseases may increase in localities that were not prepared for them before the advent of climate-change. We seek solutions that integrate data from climate scientists, disease modelers, and government health officials to help address the rise of specific diseases. Potential areas of interest include, but are not limited to: 
<ol type="a">
<li>Facilitating community participation in/crowd-sourcing data collection to track climate change impact at local level (e.g., changes in weather patterns or detection of invasive vector species) (Geographies of interest: sub-Saharan Africa; Brazil)</li>
<li>Integrating commercially available databases and local data into early warning systems that can drive decision making, working to ensure sex-disaggregated data when relevant. (Geographies of interest: sub-Saharan Africa; Brazil)</li>
<li>Researching the relationship between climate change and the spread of vector-borne diseases (e.g., changes to vector populations or disease transmission dynamics) to develop early warning systems to prevent outbreaks. (Geographies of interest: sub-Saharan Africa; Brazil) &nbsp;</li>
</ol>
</li>
<li>Effective Response and Resilient Supply Chains for Crisis Management – Maintaining routine health delivery or non-routine campaigns such as humanitarian aid and vaccination efforts will be an increasingly multifaceted problem as the need for rapid, directed humanitarian aid increases in the face of extreme climate events, examples include changing landscapes for roads and bridges; Internally Displaced People (IDPs) and armed conflicts; and disrupted daily routines for affected populations. We are seeking to implement agile, resilient supply chains that allow for the re-deployment of interventions based on need, e.g., malaria insecticide-treated nets, preventive chemotherapies, etc. against vector-borne diseases. (Geography of interest: sub-Saharan Africa)</li>
</ol>
Funding Level, Period of Performance, and Geography of Interest
The funding level is up to USD $200,000.00, for each grant. The period of performance is up to two years. The geography of interest is outlined within the topic/sub-topic areas listed above. This means that the effort needs to be led by investigators in the specified geographies above. Global collaborators may be included, but at least 80% of the funding must go to an organization within the specified geographies. Application budgets should be commensurate with the scope of work proposed.
We are looking for proposals that:
<ul>
<li>Demonstrate that projects are led by (Low- and Middle-Income Countries (LMIC)<a href="#_ftn1" title name="_ftnref1" id="_ftnref1">[1]</a> investigators, local stakeholders, or community-led organizations. Global partners may be included, but proposals must demonstrate at least 80% of the funding is going to an investigator in an LMIC institution within the geography of interest. Teams comprising multiple LMIC institutions will be given preference over applicants from single institutions. We also encourage multi-country collaborations.</li>
<li>Come from women-led organizations or involve projects led by women and focused on reaching women.</li>
<li>Articulate how the project will lead to near-term impact and how the impact will be sustained over the lifetime of the project and beyond.</li>
<li>Articulate the scalability of the solution beyond a small local region or population. Strong consideration will be given to approaches that can scale to multiple geographic areas, demographic groups, etc.</li>
<li>Demonstrate engagement with local and/or regional communities, decision-makers, and adopters.</li>
<li>Promote inter-sectoral co-ordination and collaboration.</li>
</ul>
We will not fund proposals that:
<ul>
<li>Do not support communities and countries to adapt and be resilient to the effects of climate change on agriculture, health and gender in the geography of interest.</li>
<li>Do not demonstrate that the majority of the work proposed will be undertaken by investigators and/or local stakeholders living in the geography of interest.&nbsp;</li>
<li>Do not plan for or demonstrate a pathway to sustainable impact and scalability.</li>
<li>Are not linked to or have no plan to engage relevant key stakeholders and decision makers from the affected communities.</li>
</ul>
<a href="#_ftnref1" title name="_ftn1" id="_ftn1">[1]</a> See <a href="https://data.worldbank.org/country/XO" target="_blank" rel="noopener noreferrer">World Bank - Low- &amp; Middle-Income Countries</a> for definitions.

This Grand Challenges request for proposals seeks innovative research and pilot/feasibility projects utilizing transdisciplinary approaches to better adapt to, mitigate, or reverse the combined, deleterious effects of climate change on health, women's lives, and agriculture in the geographies of interest. These innovations include early warning and disease surveillance systems to respond to climate-event-driven surges in malaria and other vector borne diseases, as well as improved mapping of expanded vector ranges and vector-borne disease transmission.

Accelerating Catalyzing Solutions for Climate Changes Impact on Health Agriculture and Gender

**NOTE: This opportunity was open only to participants who registered for and attended the 2023 Grand Challenges Annual Meeting.<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 <a href="https://grandchallenges.org/annual-meeting" target="_blank">12 countries</a> over the past 18 years and in a virtual format for two years. The 2023 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 Grand Challenges Annual Meeting participants to take action based on ideas they developed and people they met at the meeting. As noted by past applicants in their submitted proposals, the meeting provides diverse ways to combine expertise and perspectives to speed 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>&nbsp;for past Call-to-Action opportunities show this, and we hope that this year’ meeting will also provide ways to catalyze collaborative projects that yield a tangible solution to a key problem by the end of the grant.Please note that there are multiple grant opportunities being launched at the Annual Meeting:<ul><li>Two that are open to meeting participants:<ol><li>This 2023 Grand Challenges Annual Meeting Call-to-Action</li><li><a href="https://gcgh.grandchallenges.org/challenge/collaboratory-platforms-2023-democratizing-access-technologies" target="_blank">Collaboratory Platforms 2023: Democratizing Access to Technologies</a></li></ol></li><li>Additional <a href="https://grandchallenges.org/grant-opportunities" target="_blank">grant opportunities</a> that are publicly open, launched across the Grand Challenges family of initiatives</li></ul>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 at least two meeting participants 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.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. We will prioritize 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 likely to yield a tangible answer to a question or solution to a problem within the grant term.</li><li>Are explicitly aligned with the content within the meeting's scientific track sessions. Please note that individual proposals will be reviewed based on their alignment with one primary track and the specific content presented there (see <a href="https://www.cvent.com/api/email/dispatch/v1/click/q4pj6gq6zkcl4l/wl5lgk4j/aHR0cHMlM0ElMkYlMkZjdXN0b20uY3ZlbnQuY29tJTJGQjZFNTk2REVBQzZBNEE3RkIxNDY3NDk3QUU0RkY1NEIlMkZmaWxlcyUyRmV2ZW50JTJGZWEyZGNlMGQ2ZjlhNDAxM2E3OTBhNTg0ZDRiMGNkZTIlMkYzZTdiOTJkMzlkNmI0MDM1YWQ5ZmQ3OWM5ODU4YjJlMy5wZGYmaXB3OFdDM0w2VWJCWVZzek56NGNxdWZ6MTBGZTh5WmZndmJZaWRETTYzcyUzRCZHcmFuZCtDaGFsbGVuZ2VzK0FubnVhbCtNZWV0aW5nK0FnZW5kYQ" 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 met during their 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>Advancing Drug Discovery for Global Health</li><li>Applying a Translational Lens to Global Health</li><li>Artificial Intelligence &amp; Medical Devices: Strengthening the Ecosystem for Development, Implementation, and Scale in LMICs</li><li>Catalyzing Systems-level Agriculture Climate Adaptation in Africa</li><li>Enhancing African Vaccine Manufacturing Through Technology and Training</li><li>The Evolving Role of Pathogen Genomics in Public Health Surveillance</li><li>Global Health Discovery Collaboratory: Enabling a Global Health R&amp;D Network</li><li>Innovations in Reproductive Health Technologies for Advancement of Global Health</li><li>Key Ingredients for R&amp;D Ecosystems and Accelerating Innovation in LMICs</li><li>Malaria: Innovation for Eradication</li><li>The Road Ahead: Opportunities for HIV Prevention and Cure</li><li>Sickle Cell Disease: Global Burden and Therapeutic Opportunities</li><li>Vaccine and Biologics Innovations for Global Health</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 tracks that are not part of this request for proposals:&nbsp;Global Network and Partnership Building to Combat the Effects of Climate Change on Health and Looking Ahead to the Next 20 Years: Sharing Learnings and Best Practices for Grand Challenge Implementation and Partnership.</li></ul>

2023 Grand Challenges Annual Meeting Call-to-Action

**NOTE: This opportunity is open only to participants who registered for and are attending the 2023 Grand Challenges Annual Meeting.
<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 <a href="https://grandchallenges.org/annual-meeting" target="_blank" rel="noopener noreferrer">12 countries</a> over the past 18 years and in a virtual format for two years. The 2023 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 Grand Challenges Annual Meeting participants to take action based on ideas they developed and people they met at the meeting. As noted by past applicants in their submitted proposals, the meeting provides diverse ways to combine expertise and perspectives to speed 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>&nbsp;for past Call-to-Action opportunities show this, and we hope that this year’ meeting will also provide ways to catalyze collaborative projects that yield a tangible solution to a key problem by the end of the grant.
Please note that there are multiple grant opportunities being launched at the Annual Meeting:
<ul>
<li>Two that are open to meeting participants:
<ol>
<li>This 2023 Grand Challenges Annual Meeting Call-to-Action</li>
<li><a href="https://gcgh.grandchallenges.org/challenge/collaboratory-platforms-2023-democratizing-access-technologies" target="_blank" rel="noopener noreferrer">Collaboratory Platforms 2023: Democratizing Access to Technologies</a></li>
</ol>
</li>
<li>Additional <a href="https://grandchallenges.org/grant-opportunities" target="_blank" rel="noopener noreferrer">grant opportunities</a> that are publicly open, launched across the Grand Challenges family of initiatives</li>
</ul>
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 at least two meeting participants 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.
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. We will prioritize 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 likely to yield a tangible answer to a question or solution to a problem within the grant term.</li>
<li>Are explicitly aligned with the content within the meeting's scientific track sessions. Please note that individual proposals will be reviewed based on their alignment with one primary track and the specific content presented there (see <a href="https://www.cvent.com/api/email/dispatch/v1/click/q4pj6gq6zkcl4l/wl5lgk4j/aHR0cHMlM0ElMkYlMkZjdXN0b20uY3ZlbnQuY29tJTJGQjZFNTk2REVBQzZBNEE3RkIxNDY3NDk3QUU0RkY1NEIlMkZmaWxlcyUyRmV2ZW50JTJGZWEyZGNlMGQ2ZjlhNDAxM2E3OTBhNTg0ZDRiMGNkZTIlMkYzZTdiOTJkMzlkNmI0MDM1YWQ5ZmQ3OWM5ODU4YjJlMy5wZGYmaXB3OFdDM0w2VWJCWVZzek56NGNxdWZ6MTBGZTh5WmZndmJZaWRETTYzcyUzRCZHcmFuZCtDaGFsbGVuZ2VzK0FubnVhbCtNZWV0aW5nK0FnZW5kYQ" 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 met during their 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>Advancing Drug Discovery for Global Health</li>
<li>Applying a Translational Lens to Global Health</li>
<li>Artificial Intelligence &amp; Medical Devices: Strengthening the Ecosystem for Development, Implementation, and Scale in LMICs</li>
<li>Catalyzing Systems-level Agriculture Climate Adaptation in Africa</li>
<li>Enhancing African Vaccine Manufacturing Through Technology and Training</li>
<li>The Evolving Role of Pathogen Genomics in Public Health Surveillance</li>
<li>Global Health Discovery Collaboratory: Enabling a Global Health R&amp;D Network</li>
<li>Innovations in Reproductive Health Technologies for Advancement of Global Health</li>
<li>Key Ingredients for R&amp;D Ecosystems and Accelerating Innovation in LMICs</li>
<li>Malaria: Innovation for Eradication</li>
<li>The Road Ahead: Opportunities for HIV Prevention and Cure</li>
<li>Sickle Cell Disease: Global Burden and Therapeutic Opportunities</li>
<li>Vaccine and Biologics Innovations for Global Health</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 tracks that are not part of this request for proposals:&nbsp;Global Network and Partnership Building to Combat the Effects of Climate Change on Health and Looking Ahead to the Next 20 Years: Sharing Learnings and Best Practices for Grand Challenge Implementation and Partnership.</li>
</ul>

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 12 countries&nbsp;over the past 18 years and in a virtual format for two years. The 2023 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.

Opportunities to Advance Women's Health Innovation

The Bill &amp; Melinda Gates Foundation and the U.S. National Institutes of Health initiated an inclusive, consultative, cross-sector effort to generate a Women’s Health Innovation Opportunity Map 2023 as a collaborative framework to advance women’s health innovation. The Opportunity Map was created by the Innovation Equity Forum (IEF). The aim of the IEF was to bring a broad range of multidisciplinary expertise from various levels and sectors of the biomedical enterprise to provide diverse viewpoints in order to develop an inclusive, globally-focused, and widely accepted Opportunity Map of topics in women’s health R&amp;D. The Women’s Health Innovation team at the Bill &amp; Melinda Gates Foundation is looking for innovations and ideas that address opportunities outlined in the Opportunity Map.

Opportunities to Advance Womens Health Innovation

<h2>The Opportunity</h2>Insufficient access to quality, safe, efficacious, and affordable medical products in Africa has posed a significant challenge to public health for decades. The establishment of the African Medicines Agency (AMA)<a href="#_ftn1" title="" id="_ftnref1" name="_ftnref1">[1]</a> will help to facilitate coordination of regulatory activities and further harmonization across Member States and help drive access.Over the last decade, the Bill &amp; Melinda Gates Foundation (the Foundation) among other funders and stakeholders has supported the harmonization of regulatory technical standards and optimization of regulatory processes in Africa. The Foundation's Africa regulatory systems strategy addresses all aspects of the newly emerging African tri-level regulatory ecosystem – continental, regional (Regional Economic Communities (RECs)), and national. While AMA will be a key catalyst of Africa's new regulatory ecosystem, it is designed to work within a regulatory network drawing on expertise and other resources from the RECs and National Regulatory Authorities (NRAs). Without strong NRAs, this ecosystem cannot function. At the national level, the Foundation is supporting a number of NRAs to reach WHO maturity level 3 (ML3), and ultimately to become WHO listed Authorities (WLA). This important effort is supported by African governments, the African Union, WHO, and several international partners. As part of the process to attain ML3 and WLA, NRAs need to establish clear Key Performance Indicators (KPIs), and to track and publish these in a transparent manner.<a href="#_ftn2" title="" id="_ftnref2" name="_ftnref2">[2]</a><h2>The Challenge</h2>While harmonization of technical standards and processes has been ongoing in Africa for more than a decade, there remain disparities between different NRAs and regions. While maturity levels vary, so do processes for managing marketing authorization, clinical trials, and other regulatory applications and services, with many NRAs performing these manually without the support of a robust digital environment. Many NRAs have published public service charters committing to achieve certain levels of performance (based on clearly defined KPIs), but without a structured approach to measuring these KPIs, it is impossible for NRA leadership to track progress, take corrective action, or share performance with stakeholders. The lack of fit-for-purpose tracking systems prevents NRAs from accurately defining and overseeing their end-to-end processes, which in turn impacts their organizational strategic planning and execution.The ability to track and report these metrics is also important when NRAs seek support from their government and partners in order to improve their environment, as they need to report the impact of these investments to their governments, local stakeholders, and partners.Most NRAs do not have data systems, nor staff dedicated to the generation and reporting of data on KPIs. Where staff play such a role, in many instances these staff have other responsibilities and only do the data generation, analysis and reporting as additional duties or in their spare time. This has been evident in regional regulatory work-sharing/cooperation with RECs struggling to obtain data on products submitted to NRAs following regional recommendations and the associated regulatory timelines. This too applies to some NRAs participating in WHO's prequalification collaborative registration procedure, as well as for clinical trial review timelines they are expected to publish.In summary, we seek to address four problems: i) Lack of clear internal processes to manage different regulatory pathways available at NRAs; ii) Lack of clearly defined KPIs by some NRAs; iii) Lack of, or sub-optimal data systems for capturing and reporting key data and metrics to inform process improvement and demonstrate performance against KPIs and iv) lack of harmonized solutions that are interoperable across multiple NRAs and built to scale.The funded projects will be part of a larger coordinated program aimed at further strengthening African National Regulatory Authorities data systems to enhance and track performance. The project teams funded through this RFP will be expected to work together on shared areas of interest including, but not limited to, knowledge exchange and harmonization of solutions. This effort, while expected to contribute to NRAs attainment of ML3, will not support wider efforts at attaining ML3, but be limited to data systems, performance measurement, and advancing transparency.Funded projects will work closely with a coordinating entity (that will provide technical support to NRAs on data systems). An advisory committee comprised of key stakeholders will be constituted to guide this work including representatives from relevant African Union organizations.Proposals are required to allocate funds for staff time and travel to participate in the cross-project collaborative activities at least once a year agreed upon by the governance committees.What we are looking for:Applications are invited from African National Regulatory Agencies (NRAs). Each proposal should be submitted by one primary applicant, but the awards require active collaboration between at least two NRAs per application. In addition, proposals should address at least two (2) of the following categories:Regulatory review process management:<ul><li>Create or improve regulatory digital data management systems and end-to-end processes including structured approaches to data generation, analysis, sharing at the regional level. and reporting of KPIs. Priority will be given to proposals including a solid plan for reporting on KPIs, this includes:<ol><li>regulatory timelines for national marketing authorization,</li><li>clinical trial applications,</li><li>facilitated regulatory pathways; we would prioritize proposals including REC products, WHO PQ CRP, global pathway (and AMA pathways in future)</li></ol></li><li>Design and structure data management systems that contribute to NRAs achieving WHO ML3/WLA status along with other important efforts addressing the rest of the GBT requirement outside of performance management.</li></ul>Metrics systems and performance indicators improvement:<ul><li>Develop data systems and processes and engage in continuous improvement to establish key performance indicators and to assess process effectiveness. These should be based on the WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory Systems of Medical Products.</li><li>Develop best practices for regulatory metrics monitoring and evaluation systems.</li><li>Develop, and/or update key performance indicators, organization client charter and publish on NRA website.</li></ul>Regulatory Data Standardization and data vocabulary:&nbsp;<ul><li>Enable data integration both from various sources within the same agency and beyond including other NRAs, other governmental agencies.</li><li>Develop/improve data structures and vocabularies to enable interoperability across countries and regions and that would support the AMA/continental RIMS development.</li><li>Develop guidelines and Standard Operating Procedures (SOPs) that support data systems at the NRA(s) participating in this call for proposals.</li></ul>Artificial Intelligence (AI) centered tools:&nbsp;<ul><li>Enable/design data systems that would enable the use of AI to facilitate regulatory activities including screening, reviews, and scanning large databases for potential quality and safety signals.</li></ul>Funding levelWe seek to fund up to 5 proposals. Successful proposals will receive an award of up to USD $300,000 with an 18- to 24-month grant duration. Proposals must demonstrate that at least 80% of the funding is going to NRAs. While proposals require the collaborative participation of at least two investigators at different NRAs, proposals should be submitted by one primary applicant/NRA. While restricted to one application per institution as the primary applicant, applicants may participate as collaborators in multiple collaborative applications.Selected proposals will be part of a coordinated program and will work closely with a coordinating entity (that will provide technical support to NRAs on data systems). An advisory committee comprised of key stakeholders will be constituted to guide this work including representatives from relevant African Union organizations.Successful proposals to be considered should:<ul><li>Involve at least an NRA operating at WHO (Maturity Level) ML3 level.</li><li>Demonstrate at least 80% of the funding is going to NRAs.</li><li>Demonstrate how they would enable other countries to achieve WHO ML3 level.</li><li>Involve substantial collaboration between at least 2 NRAs. The suggested collaboration should be key to advancing the project goals and yield insights that are unlikely in the absence of co-produced approaches. In addition, however, applications could include collaborations with institutions in other geographical areas including from outside Africa.</li><li>Have the potential to demonstrate impact on the areas proposed and within the proposed budget and timeframe of 18 -24 months.</li><li>Explain how resources for the project (including personnel) will be procured within the 1st 3-4 months to ensure that activities take off in time, and the project is completed in time (18-24 months).</li><li>Be driven by a shared commitment for collaboration, protocols and processes sharing and advancing information management systems and processes.</li><li>Plan for change management and implementation of new data systems and processes.</li><li>Demonstrate how sustainability of established systems will be achieved beyond this grant including key personnel like statisticians. An example might be securing written commitment from the agency Board (of all NRAs participating in the project) to fund the continued use of developed systems and personnel at the end of the project. Proposals that commit to start transition of ownership of personnel after 12-15 months of the project will be preferred.</li></ul>We will not consider for funding:<ul><li>Proposals that do not involve an ML3 NRA</li><li>Proposals led by institutions not based in Africa</li><li>Proposals that don't demonstrate a clear commitment to collaborating with other funded proposals/teams and the coordination team</li><li>Proposals that are not accomplishable within the grant term</li><li>Proposals outside the scope of this call even when what is proposed is highly relevant for the regulatory authorities involved.</li><li>Proposals seeking to support efforts at attaining ML3 that go beyond creating and enabling data systems.</li></ul><a href="#_ftnref1" title="" id="_ftn1" name="_ftn1">[1]</a> <a href="https://joppp.biomedcentral.com/articles/10.1186/s40545-020-00281-9">https://joppp.biomedcentral.com/articles/10.1186/s40545-020-00281-9</a><a href="#_ftnref2" title="" id="_ftn2" name="_ftn2">[2]</a> <a href="https://www.who.int/tools/global-benchmarking-tools">https://www.who.int/tools/global-benchmarking-tools</a>

Strengthening African National Regulatory Authorities Data Systems to Enhance and Track Performance

Note: The deadline for submitting applications to this Challenge has been extended to February 14, 2024, 2:00 p.m. PST.
<h2>The Opportunity</h2>
Insufficient access to quality, safe, efficacious, and affordable medical products in Africa has posed a significant challenge to public health for decades. The establishment of the African Medicines Agency (AMA)<a href="#_ftn1" title name="_ftnref1" id="_ftnref1">[1]</a> will help to facilitate coordination of regulatory activities and further harmonization across Member States and help drive access.
Over the last decade, the Bill &amp; Melinda Gates Foundation (the Foundation) among other funders and stakeholders has supported the harmonization of regulatory technical standards and optimization of regulatory processes in Africa. The Foundation's Africa regulatory systems strategy addresses all aspects of the newly emerging African tri-level regulatory ecosystem – continental, regional (Regional Economic Communities (RECs)), and national. While AMA will be a key catalyst of Africa's new regulatory ecosystem, it is designed to work within a regulatory network drawing on expertise and other resources from the RECs and National Regulatory Authorities (NRAs). Without strong NRAs, this ecosystem cannot function. At the national level, the Foundation is supporting a number of NRAs to reach WHO maturity level 3 (ML3), and ultimately to become WHO listed Authorities (WLA). This important effort is supported by African governments, the African Union, WHO, and several international partners. As part of the process to attain ML3 and WLA, NRAs need to establish clear Key Performance Indicators (KPIs), and to track and publish these in a transparent manner.<a href="#_ftn2" title name="_ftnref2" id="_ftnref2">[2]</a>
<h2>The Challenge</h2>
While harmonization of technical standards and processes has been ongoing in Africa for more than a decade, there remain disparities between different NRAs and regions. While maturity levels vary, so do processes for managing marketing authorization, clinical trials, and other regulatory applications and services, with many NRAs performing these manually without the support of a robust digital environment. Many NRAs have published public service charters committing to achieve certain levels of performance (based on clearly defined KPIs), but without a structured approach to measuring these KPIs, it is impossible for NRA leadership to track progress, take corrective action, or share performance with stakeholders. The lack of fit-for-purpose tracking systems prevents NRAs from accurately defining and overseeing their end-to-end processes, which in turn impacts their organizational strategic planning and execution.
The ability to track and report these metrics is also important when NRAs seek support from their government and partners in order to improve their environment, as they need to report the impact of these investments to their governments, local stakeholders, and partners.
Most NRAs do not have data systems, nor staff dedicated to the generation and reporting of data on KPIs. Where staff play such a role, in many instances these staff have other responsibilities and only do the data generation, analysis and reporting as additional duties or in their spare time. This has been evident in regional regulatory work-sharing/cooperation with RECs struggling to obtain data on products submitted to NRAs following regional recommendations and the associated regulatory timelines. This too applies to some NRAs participating in WHO's prequalification collaborative registration procedure, as well as for clinical trial review timelines they are expected to publish.
In summary, we seek to address four problems: i) Lack of clear internal processes to manage different regulatory pathways available at NRAs; ii) Lack of clearly defined KPIs by some NRAs; iii) Lack of, or sub-optimal data systems for capturing and reporting key data and metrics to inform process improvement and demonstrate performance against KPIs and iv) lack of harmonized solutions that are interoperable across multiple NRAs and built to scale.
The funded projects will be part of a larger coordinated program aimed at further strengthening African National Regulatory Authorities data systems to enhance and track performance. The project teams funded through this RFP will be expected to work together on shared areas of interest including, but not limited to, knowledge exchange and harmonization of solutions. This effort, while expected to contribute to NRAs attainment of ML3, will not support wider efforts at attaining ML3, but be limited to data systems, performance measurement, and advancing transparency.
Funded projects will work closely with a coordinating entity (that will provide technical support to NRAs on data systems). An advisory committee comprised of key stakeholders will be constituted to guide this work including representatives from relevant African Union organizations.
Proposals are required to allocate funds for staff time and travel to participate in the cross-project collaborative activities at least once a year agreed upon by the governance committees.
What we are looking for:
Applications are invited from African National Regulatory Agencies (NRAs). Each proposal should be submitted by one primary applicant, but the awards require active collaboration between at least two NRAs per application. In addition, proposals should address at least two (2) of the following categories:
Regulatory review process management:
<ul>
<li>Create or improve regulatory digital data management systems and end-to-end processes including structured approaches to data generation, analysis, sharing at the regional level. and reporting of KPIs. Priority will be given to proposals including a solid plan for reporting on KPIs, this includes:
<ol>
<li>regulatory timelines for national marketing authorization,</li>
<li>clinical trial applications,</li>
<li>facilitated regulatory pathways; we would prioritize proposals including REC products, WHO PQ CRP, global pathway (and AMA pathways in future)</li>
</ol>
</li>
<li>Design and structure data management systems that contribute to NRAs achieving WHO ML3/WLA status along with other important efforts addressing the rest of the GBT requirement outside of performance management.</li>
</ul>
Metrics systems and performance indicators improvement:
<ul>
<li>Develop data systems and processes and engage in continuous improvement to establish key performance indicators and to assess process effectiveness. These should be based on the WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory Systems of Medical Products.</li>
<li>Develop best practices for regulatory metrics monitoring and evaluation systems.</li>
<li>Develop, and/or update key performance indicators, organization client charter and publish on NRA website.</li>
</ul>
Regulatory Data Standardization and data vocabulary:&nbsp;
<ul>
<li>Enable data integration both from various sources within the same agency and beyond including other NRAs, other governmental agencies.</li>
<li>Develop/improve data structures and vocabularies to enable interoperability across countries and regions and that would support the AMA/continental RIMS development.</li>
<li>Develop guidelines and Standard Operating Procedures (SOPs) that support data systems at the NRA(s) participating in this call for proposals.</li>
</ul>
Artificial Intelligence (AI) centered tools:&nbsp;
<ul>
<li>Enable/design data systems that would enable the use of AI to facilitate regulatory activities including screening, reviews, and scanning large databases for potential quality and safety signals.</li>
</ul>
Funding level
We seek to fund up to 5 proposals. Successful proposals will receive an award of up to USD $300,000 with an 18- to 24-month grant duration. Proposals must demonstrate that at least 80% of the funding is going to NRAs. While proposals require the collaborative participation of at least two investigators at different NRAs, proposals should be submitted by one primary applicant/NRA. While restricted to one application per institution as the primary applicant, applicants may participate as collaborators in multiple collaborative applications.
Selected proposals will be part of a coordinated program and will work closely with a coordinating entity (that will provide technical support to NRAs on data systems). An advisory committee comprised of key stakeholders will be constituted to guide this work including representatives from relevant African Union organizations.
Successful proposals to be considered should:
<ul>
<li>Involve at least an NRA operating at WHO (Maturity Level) ML3 level.</li>
<li>Demonstrate at least 80% of the funding is going to NRAs.</li>
<li>Demonstrate how they would enable other countries to achieve WHO ML3 level.</li>
<li>Involve substantial collaboration between at least 2 NRAs. The suggested collaboration should be key to advancing the project goals and yield insights that are unlikely in the absence of co-produced approaches. In addition, however, applications could include collaborations with institutions in other geographical areas including from outside Africa.</li>
<li>Have the potential to demonstrate impact on the areas proposed and within the proposed budget and timeframe of 18 -24 months.</li>
<li>Explain how resources for the project (including personnel) will be procured within the 1st 3-4 months to ensure that activities take off in time, and the project is completed in time (18-24 months).</li>
<li>Be driven by a shared commitment for collaboration, protocols and processes sharing and advancing information management systems and processes.</li>
<li>Plan for change management and implementation of new data systems and processes.</li>
<li>Demonstrate how sustainability of established systems will be achieved beyond this grant including key personnel like statisticians. An example might be securing written commitment from the agency Board (of all NRAs participating in the project) to fund the continued use of developed systems and personnel at the end of the project. Proposals that commit to start transition of ownership of personnel after 12-15 months of the project will be preferred.</li>
</ul>
We will not consider for funding:
<ul>
<li>Proposals that do not involve an ML3 NRA</li>
<li>Proposals led by institutions not based in Africa</li>
<li>Proposals that don't demonstrate a clear commitment to collaborating with other funded proposals/teams and the coordination team</li>
<li>Proposals that are not accomplishable within the grant term</li>
<li>Proposals outside the scope of this call even when what is proposed is highly relevant for the regulatory authorities involved.</li>
<li>Proposals seeking to support efforts at attaining ML3 that go beyond creating and enabling data systems.</li>
</ul>
<a href="#_ftnref1" title name="_ftn1" id="_ftn1">[1]</a> <a href="https://joppp.biomedcentral.com/articles/10.1186/s40545-020-00281-9">https://joppp.biomedcentral.com/articles/10.1186/s40545-020-00281-9</a>
<a href="#_ftnref2" title name="_ftn2" id="_ftn2">[2]</a> <a href="https://www.who.int/tools/global-benchmarking-tools">https://www.who.int/tools/global-benchmarking-tools</a>

Insufficient access to quality, safe, efficacious, and affordable medical products in Africa has posed a significant challenge to public health for decades. The establishment of the African Medicines Agency (AMA) will help to facilitate coordination of regulatory activities and further harmonization across Member States and help drive access.