Accelerating Innovation in Vaginal Formulations in Support of Women's Health - Frequently Asked Questions (FAQs)

Eligibility and Geography

Who is eligible for grants?
This initiative is open to research institutes, nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. Please note that all applicants will be expected to comply with the Foundation's global access clause. We encourage groups to build upon existing and/or complimentary projects/studies/trials and to collaborate with other institutions. We particularly encourage applications from projects led by women and/or researchers at institutions based in LMICs and/or involving collaboration with women-led or LMIC-based organizations. Only individuals who are applying through a legally recognized corporate entity are eligible.

Upon registration, applicants must provide information about the tax status of their organization as different terms and conditions may apply. You should confirm your organization's tax status with the appropriate advisor or entity within your organization such as your grants or contracts department, finance, or office of sponsored research. The foundation may request additional information regarding your tax status. For information about tax statuses, you may check with your own advisors and review information provided on the Internal Revenue Service web site at: www.irs.gov.

Is my organization eligible to apply?
Each RFP may differ in geographic focus, topic areas, and funding levels. Please review the eligibility criteria and specific requirements for each RFP carefully.

Can a U.S. institution developing a low-cost vaginal product apply on its own if there aren't partnering institutions in LMICs already finalized?
Yes, although partnerships with LMIC institutions are encouraged.

Can research organizations in the U.S. apply to the general challenge, or must the organization be within LMICs?
U.S. organizations are welcome to apply. We encourage applications from LMIC organizations, but it is not a requirement.

Are there priority geographies for research?
Yes. Low- and middle-income countries (LMICs) are a priority, and projects conducted in or in partnership with LMIC institutions are encouraged.

Can applicants from Africa apply directly to the Gates Foundation?
Yes. Applicants from Sub-Saharan Africa may apply to the Gates Foundation, but the same proposal cannot be submitted both to the Foundation and to Grand Challenges Africa or South Africa.

Is there a required number of countries where the research must be conducted?
No. There is no set number of countries required.

Is it acceptable for a study to be conducted in just one country?
Yes. A single-country study is acceptable as long as the idea is strong and innovative.

If my organization is in a high-income country but collaborates with an LMIC partner, would my proposal be classified as LMIC?
The primary organization must be located in an LMIC to be classified as such. While collaborations with LMIC-based institutions are encouraged, this is not a requirement.

Which RFP should I apply to if I am eligible for multiple?
Apply to the RFP that best aligns with your proposed project and geographical location.

Does the study need to be conducted in one of the specified countries (Africa, Brazil, India, South Africa), or can it be conducted elsewhere - e.g., in the U.S.?
Please review the details for each RFP, as criteria vary slightly by region.

Is there a platform to connect African organizations with partners from other regions?
No. The organizers cannot facilitate collaborations at this stage. However, complementary proposals may be encouraged to collaborate later in the process.

Will investigators be disqualified if they don't have external collaborators?
No. What matters most is the innovativeness and responsiveness to the technical question.

Application Process

What must my application include?
Please refer to the Application Instructions document.

Am I able to edit my proposal once submitted?
Yes, you may edit your proposal up until the specified deadline.

What amount of indirect cost is available?
Details of the foundation indirect cost policy guidelines can be found here: Gates Foundation's indirect cost policy.

Review Process

How does the review process work?
Please refer to the Rules and Guidelines document.

Can I get a list of potential reviewers who might be assigned to my application?
No. We do not make public the roster of reviewers.

Can I request that my application not be reviewed by a specific individual?
No. However, we will ask reviewers to self-identify conflicts of interest and will not assign reviewers with conflicts.

Will I receive specific feedback on my application if it is not selected?
Due to the rapid proposal and review timelines applicable to this RFP, applicants with proposals that are not selected for award may receive a notification of decline without specific feedback.

Award Information

Are grant awards made directly to individuals?
No. All awards are made to the organization where the individual holds their primary appointment. Institutions must agree to the terms and conditions governing each grant award prior to award activation.

How much money will each grant provide?
Projects with a duration of up to two years and a maximum requested budget of $250,000USD are eligible for funding. Exploratory projects with shorter durations/lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority. Budgets should be commensurate with the scope of work proposed. Indirect costs should be included in the budget and should not exceed 10-15% of the total award (subject to the Gates Foundation's indirect cost policy).

Scientific Scope and Technical Topics

Are IUDs included or outside the RFP's scope?
A sole focus on IUDs is outside the scope. If well-studied, existing technology such as IUDs are used as a comparator for a an innovative new technology, then that is within scope. Novel modifications to existing technologies, such as making them naturally degradable (not requiring retrievall) is also within scope. .

Can animal or rodent models be used, or are only human studies acceptable?
Preclinical models, including animal or on-a-chip systems, are within scope if they help evaluate delivery platforms and generate robust, reproducible and, translatable data.

Are studies involving peri/post-menopausal women eligible?
No, our focus is solely on reproductive-age persons with vaginas. Post- and per-menopausal women are out of scope. .

What exactly is meant by "muco-adhesive"?
It refers to a formulation's ability to adhere to mucosal surfaces, enhancing retention time and delivery efficacy.

Would a vaginal product that users can remove themselves fit the scope?
Products that require retrieval, whether by the user or a healthcare provider, would not be considered in scope.

How should microbial biology considerations be integrated into formulation design?
The microbiome is a key part of the vaginal environment. Applicants should propose technologies that maintain a healthy microbiome and avoid disruption. Products need not target specific microbial strains but should demonstrate awareness of these interactions.

What technological advancements are of interest for studying user desirability?
Innovations that improve comfort, discretion, and ease of use - particularly those combining technical performance with user-centered design.

Are you seeking a drug therapy or a non-drug OTC option?
The RFP is API-agnostic. It aims to evaluate novel vaginal delivery platforms that leverage biological features of the vagina. Development of specific APIs is not the focus. If the technology includes an API, measurements of API activity can be used to evaluate the performance of a delivery technology, but should not be the focus of the proposal. In this case, it does not matter when the API would go down a drug or OTC pathway.

Would a device to facilitate intravaginal delivery be considered within scope?
Only if the device is on-demand and either naturally degradable or does not require retrieval, either by the user or a healthcare provider, and if it includes assessment of interaction with the vaginal milieu.

Can the proposed therapeutic mechanism be photon-based rather than drug-based?
Possibly. Non-drug delivery mechanisms are acceptable if they focus on vaginal delivery, not development of the therapeutic itself.

Are non-human primate studies allowed?
Yes, if they fit within the budget and timeline.

Study Design and Methodology

Do proposed studies have to include human participants?
No. Preclinical or translational studies are acceptable, but findings should be translatable.

What types of preclinical validation and scale-up activities are responsive?
Validation or testing of novel approaches leveraging the vaginal milieu is within scope; projects focused solely on scale-up are not.

Are studies on bacterial vaginosis eligible?
Only if the work focuses on delivery platforms or vaginal milieu interaction - not treatment of specific conditions.

Are combinations of existing products responsive?
Yes, if the combination represents a novel approach.

Are intravaginal rings (IVRs) within scope?
Only if they are degradable or do not require retrieval.

Data and Evidence Requirements

Are preliminary data required?
Strongly encouraged, but not mandatory. Data can be drawn from literature or prior experiments.

Can multiple formulations be proposed?
Yes. Applicants should describe rationale and testing plans for selection.

Would advanced modeling (e.g., machine learning) be supported?
Yes. Data science approaches that enhance prediction or insight generation are within scope.

User Research and Qualitative Methods

What qualitative methods are preferred for user feedback?
Mixed-methods approaches combining interviews with other forms of data collection are encouraged.

Are questionnaires or surveys acceptable?
Yes, but studies should generate generalizable and actionable insights beyond anecdotal evidence.

Please clarify the statement that proposals should not be "centered solely on focus groups and interviews".

As the RFP notes, "these methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes." We are interested in user insights that generate generalizable, trustworthy evidence that will inform decision making. Focus groups and interviews may be included; mixed-methods approaches are preferrable because they include multiple independent data sources.

Administrative and Submission Details

Do references, tables, and figures count toward the 2-page limit?
Yes, all must fit within the two-page limit.

Which dropdown option should be selected for a project on vaginal product characteristics?
The system allows selection of both "vaginal milieu" and "vaginal product characteristics" as applicable.

How much weight does the budget carry in funding decisions?
Budgets are reviewed for alignment with scope, but initial review focuses on proposal quality and innovation.

Population and Inclusion

Can studies include postmenopausal women or transgender men?
The primary focus is reproductive-age persons with vaginas, including transgender men.

Are studies including disabled or vulnerable women eligible?
Yes. Studies may focus on these groups if results can be analyzed in a broader context relevant to all users.

How can women-led organizations in low-resource settings collaborate?
Women-led and community-rooted organizations are encouraged to apply and to develop locally relevant studies in collaboration with suitable partners.

Technical Support

I forgot my password. How do I reset my password?
You can request to update your password within the application site. If you continue to have issues, please reach out to [email protected].

How will I know if my application was submitted?
Once an application is submitted, an email confirmation will be sent.

I'm having trouble uploading my application file. What should I do?
If you are having issues submitting your application, we would encourage you to submit from a different browser. If the issue persists, please email the specifics of your problem to [email protected].

How often do you intend to update the Frequently Asked Questions, and do you plan to provide answers to all questions submitted?
We will periodically post answers to questions as they are submitted, but do not have a specific schedule. We will provide answers on this page that are of relevance and of general interest to potential applicants. For answers to specific questions that are not covered here, please email [email protected]