Background

Local delivery of drugs into the vagina for prevention and treatment of female-specific conditions remains understudied and under-utilized despite clear potential advantages such as discreetness, potent local efficacy, large surface area for drug absorption, high potential for API dosage sparing, and potential for fewer systemic side effects.  Several key drivers may be responsible for this lag, including paucity of mechanistic biological data, particularly from high-burden settings such as low- and middle-income countries (LMICs), to support the development of specific formulations for vaginal use as well as a persistent misconception that vaginally delivered products may not be embraced by women and their sexual partners. Several of our priorities for impactful products for sexual and reproductive health will require vaginal delivery for immediate, on-demand use. We seek to catalyse the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. We expect these approaches to have user appeal, including promotion of self-care capability and other beneficial features that women seek, hence the need to couple discovery research with high-quality end-user input. 

The Challenge

We are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure. We anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women’s health.  We welcome innovations at any stage of development that meet the scope of this call.

Applicants may apply to address one or more of the following objectives of this challenge:

• Define characteristics of an ideal vaginal product: In this objective, we seek to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, ‘what would you hope to achieve when using this product in your vagina?’).  We are particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. We acknowledge that there may be regional, cultural, demographic or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, we aim to gather insights into preferred and achievable characteristics that would transform vaginal products from ‘tolerable’ to ‘desirable’. 

 

• Leverage biology for vaginally administered products: In this objective, we seek: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g.  films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefit to the vaginal mucosal epithelium.  Specifically, we seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).

Funding Level

It is expected that successful awardees will be awarded grants in the range of $100,000–200,000. With a funding duration of up to 24 months. Exploratory projects with shorter durations/lower budgets that focus on high-risk, innovative areas are strongly encouraged and will be given priority. Budgets should be commensurate with the scope of work proposed. Indirect costs should be included in the budget and should not exceed 10-15% of the total award

Eligibility Criteria

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

We are looking for proposals that:

• Focus on vaginal delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.
• Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.  
• Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection and privacy.
• Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.
• Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists then the proposal should be limited in scope.
• 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.
• Promote a diverse, inclusive, and supportive research environment, with priority for collaborations involving LMIC-based experts in reproductive health.

We will not fund proposals that:

• Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g. menstrual products, contraceptive devices, over-the-counter probiotics, etc.).
• Focus on approaches that would not be feasible or affordable in low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.
• Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.
• Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.
• Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.
•  Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.
• Primarily depend on traditional acceptability questionnaires or surveys (e.g., “if x hypothetical product existed, how interested would you be in using it?”).
• Do not directly address one of the core objectives as outlined above.
• Cannot be accomplished within a two-year maximum project duration or within the stipulated budget maximum.
• Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.