The Grand Challenges family of initiatives fosters innovation to solve key health and development problems. See below for Grand Challenges grant opportunities with the Bill &amp; Melinda Gates Foundation as sole or contributing funder.

Grant Opportunities

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. Proposals not focused on direct acting small molecules (e.g. vaccines, phages, peptides, microbiome) would not be 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 organizations or individuals 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.

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">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/reducing_the_burden_of_preeclampsia_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/reducing_the_burden_of_preeclampsia_application_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/reducing-burden-preeclampsia-frequently-asked-questions-faqs" target="_blank">Frequently Asked Questions</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on February 27, from 7:30 to 8:30 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/84005cbd-aeaa-4c95-814b-99e4441d6551@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="https://events.teams.microsoft.com/event/73a86f86-39cf-419c-8eff-333f5dc22ca7@296b3838-4bd5-496c-bd4b-f456ea743b74" id="menur1bd">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddUQjJKQVJVWlc5VE01TlZVMjBYS1hHNE4yUi4u" target="_blank" title="https://forms.office.com/pages/responsepage.aspx?id=odhrkdvlbem9s_rw6nq7dnyuf4phutfbmfmat6jkpdduqk5dtlk1tvjqwldktdbpreduntrlqzjrtc4u" id="menur1bf">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
Preeclampsia is a leading cause worldwide of maternal morbidity and mortality, premature birth, stillbirth, and neonatal death. Preeclampsia is a placental disease caused by two different pathologies during pregnancy. Early-onset disease, caused by reduced uteroplacental blood supply, is a major driver of fetal mortality. Late-onset disease, caused by increased fetoplacental demands, is a major driver of maternal morbidity and mortality. These two pathologies converge on elevated levels of the protein sFlt1 and concomitant decreases in PlGF.
This mechanistic understanding is being translated into new strategies to reduce the burden of preeclampsia. Therapeutic candidates are being developed that target sFlt1 activity, and levels of this protein can be used in screening for preeclampsia risk. Effective screening and low-dose aspirin therapy early in pregnancy has been shown to prevent early-onset preeclampsia and to ameliorate the disease's consequences for the fetus.
Despite the growing understanding of preeclampsia biology, questions remain about heterogeneity of the disease across patients and the degree to which there are distinct subtypes and etiologies. New approaches are also needed to more quickly and comprehensively reduce the burden of preeclampsia, especially those suitable for the health care infrastructure in the countries with the highest burden.
<h2>The Challenge</h2>
We seek proposals for innovative solutions for the early detection, prevention, and treatment of preeclampsia, particularly in low- and middle-income countries where maternal mortality rates are high. To support this focus, we are looking for collaborations, including those with research institutions, health care providers, and global health organizations, that enable cross-sector insights and ensure that solutions are adaptable and practical.
The objectives of the challenge are:
<ol>
<li>Early prediction and detection of preeclampsia. We seek biomarkers (including other than 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">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.

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">Gates Foundation</a>, the <a href="https://gcgh.grandchallenges.org/sites/default/files/files/data_and_modeling_for_womens_health_rules_and_guidelines.pdf" target="_blank">Rules and Guidelines</a>, <a href="https://gcgh.grandchallenges.org/sites/default/files/files/data_and_modeling_for_womens_health_applications_instructions.pdf" target="_blank">Application Instructions</a>, and <a href="https://gcgh.grandchallenges.org/innovative-data-and-modeling-approaches-measure-womens-health-frequently-asked-questions-faqs" target="_blank">Frequently Asked Questions</a>.
If you are planning to apply to this RFP, we will be hosting a dedicated webinar on March 4, from 7:00 to 8:00 AM Pacific Time. This session will provide a comprehensive overview of the RFP details and an opportunity to have your questions answered. To participate in the webinar, please <a href="https://events.teams.microsoft.com/event/4a0d45a6-1ef5-45ff-aeaa-216f6047b6ad@296b3838-4bd5-496c-bd4b-f456ea743b74" target="_blank" title="Register for this webinar" id="menur1bd">register</a> and <a href="https://forms.office.com/Pages/ResponsePage.aspx?id=ODhrKdVLbEm9S_RW6nQ7dNyUf4PhutFBmFMAT6JKpddURFg2UDgyVlRLSE1JVVhKS0NVMklBODAzUC4u" target="_blank" title="Submit your questions" id="menur1bf">submit your questions in advance</a>. If you cannot attend live, the webinar will be recorded and available on this challenge page after the session.
<h2>Background</h2>
Women's health continues to be under-represented and poorly measured in global health frameworks.
Now is the time to address this challenge. Current measurement frameworks, such as the Disability-Adjusted Life Year (DALY), fail to capture the full complexity of women's health outcomes, as they do not account for the multidimensional factors that shape health burdens and progress. These dominant metrics often overlook gendered conditions and social determinants of health, limiting the ability to generate actionable insights. Harmful norms and gender-related discrimination often contribute to poorer health outcomes in women, yet they remain inadequately reflected in existing indicators. Without alternative approaches that incorporate gender-sensitive and multidimensional factors, policies and interventions risk being misaligned with the real needs of women globally. This gap leaves critical gender-related conditions and non-health interventions unmeasured, further hindering progress in advancing women's health.
This Grand Challenge aims to bridge this gap by fostering innovative modeling approaches that rethink how women's health is measured, using available data, or easily obtainable, in new ways to provide a more holistic and actionable understanding of health outcomes. Advances in data science, modeling techniques, technological development, and gender-sensitive approaches present a unique opportunity to innovate; especially when global systems are facing unprecedented shifts that could further increase gaps in equity. This Grand Challenge builds on the <a href="https://cambercollective.com/wp-content/uploads/2025/01/Womens-Health-RD-Opportunity-Map-2023.pdf" target="_blank">Women's Health Innovation Opportunity Map 2023</a>, developed collaboratively by over 250 global stakeholders across 50 countries through the Innovation Equity Forum (IEF). The Opportunity Map identified key gaps and priorities in women's health, emphasizing the need for innovation across multiple areas, including data and modeling, health and economic impact, supply and access to services, and skills, knowledge, and networks. The Opportunity Map serves as a roadmap for transformative solutions that address systemic barriers and advance gender-equitable health outcomes for women.
This Grand Challenge on Innovative Data and Modeling Approaches to Measure Women's Health seeks to advance innovative ways to measure women's health by either developing new measurement models or adapting existing ones to better capture the full scope of women's health burdens and progress. This Grand Challenge prioritizes solutions that leverage data sources that are existing or under development rather than relying on new, large-scale data collection efforts, ensuring sustainability and feasibility.
Applicants are encouraged to build upon existing work, whether by enhancing ongoing projects with a stronger gender-sensitive approach, refining existing models, or expanding available datasets in ways that align with the Challenge's objectives. While this Grand Challenge does not fund broad new data collection efforts, proposals that require small-scale dataset expansion - where such an extension would significantly improve gendered analysis that generate policy-relevant measurement approaches that improve how women's health is understood and addressed globally - may be considered.
<h2>The Challenge</h2>
We invite applicants to explore bold, innovative approaches. Specifically, the objectives of the Challenge will be to:
<ul>
<li>Reimagine new ways to understand and measure women's health that extend beyond the limitations of existing composite indicators such as DALY.</li>
<li>Use existing data sets or easily collectible datasets to quantify women's health outcomes across countries. While this Grand Challenge does not fund large-scale data collection, proposals may include small-scale data expansion where it is feasible, policy-relevant, and significantly enhances gendered analysis.</li>
<li>Design innovative methodologies that incorporate gendered, socio-cultural, economic, and structural determinants of health, ensuring a comprehensive gender-sensitive approach (A gender-sensitive approach takes into consideration how one's gender impacts access to services, risk and protective factors and barriers that are uniquely experienced because of one's gender in a society).</li>
<li>Create tools or frameworks that enable cross-cultural or subnational comparative analysis, identifying context-specific gaps and progress.</li>
<li>Reflect the interconnected dimensions of women's health across the life course</li>
<li>Incorporate gaps in the measurement of:
<ul>
<li>Skills, knowledge, and networks: addressing how gender disparities in education, training, and professional networks impact health access, decision-making, and service delivery.</li>
<li>Supply and access to services: examining how health systems, financing mechanisms, and gender-based barriers affect the availability, affordability, and accessibility of essential services for women</li>
<li>Health and economic impacts: capturing the intersection of health outcomes with economic participation, caregiving burdens, workforce inclusion, and financial independence.</li>
</ul>
</li>
<li>Produce outputs that are:
<ul>
<li>Methodologically rigorous: applying sound data science, statistical modeling, or analytical techniques that enhance the validity and reliability of women's health measurements.</li>
<li>Interpretable and actionable: ensuring results can be understood and applied by policymakers and implementers.</li>
<li>Comparative and scalable: enabling cross-cultural or subnational analysis to identify patterns, disparities, and opportunities for intervention.</li>
<li>Gender-sensitive and intersectional: incorporating the social, economic, and structural determinants that affect women's health outcomes.</li>
<li>Policy-relevant and decision-oriented: providing insights that have the potential to directly inform policies, resource allocation, or program design to improve women's health measurement and action.</li>
</ul>
</li>
</ul>
Funding 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">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

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.

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.