Evolving MCI’s 2025 RFA

Unintended pregnancies remain a persistent global health challenge, highlighting the critical need for more diverse contraceptive options for men. Currently, available choices are limited, with condoms and vasectomy serving as the primary options. Male Contraceptive Initiative (MCI) plays a vital role in addressing this need by funding research and advocating for safe, effective, and reversible contraceptive solutions for sperm-producing individuals. Our grantmaking strategy is evolving to optimize our impact in the field, as reflected in our 2025 Request for Applications (RFA).

The concept of a "funnel" is often used to describe the stages of research and development. Projects begin at the starting point, represented by the wide end of the funnel - early discovery and basic research. As individual projects demonstrate promise, they progress down the narrowing funnel, and funding becomes more focused on the projects that can continue into late-stage development and clinical trials with the intent of a marketed product coming out at the end.

​Our grantmaking approach at MCI embraces the concept of a development funnel. Multiple projects in the nonhormonal male contraceptive field are in active development, and a small bolus of programs have moved from the wide, discovery end of the funnel toward the middle stages of drug development. It is this first generation of products that we choose to support into and through clinical trials. This strategic prioritization is especially important because support for male contraceptives is fragmented, and unreliable funding streams exist for companies focused in this particularly risky stage of drug development. By enhancing our focus on the stages of development where we see opportunity, we aim to 1) support programs advancing to the point where they are eligible for other funding streams including venture capital (VC) funding, 2) accelerate the development of multiple product types, and 3) bring new products to market more efficiently.

Male Contraceptive Priorities
Our 2025 RFA includes key changes that illustrate this evolution in our funding priorities:

1. Emphasis on Nonclinical Development
This RFA supports research on preclinical, drug-based, non-hormonal, reversible male contraceptives, specifically in stages ranging from hit-to-lead chemistry up to IND-enabling studies. This is a prioritization of projects that have progressed beyond early-stage discovery in male contraceptive research, but are not yet advanced to clinical status and are positioned to generate development candidate molecules. In supporting this stage, MCI is particularly interested in generating drug candidates appropriate for Good Laboratory Practice / Good Manufacturing Practice (GLP/GMP) stage development and IND-enabling studies - crucial steps in non-hormonal contraceptive drug development, and places where there is a small appetite from VC for programs that have advanced to this level of development. 

2. More Specific Eligibility Criteria
The eligibility criteria for our 2025 RFA are also more stringent than in previous announcements. For example, the RFA specifies many exclusion criteria that help to illustrate our focus on the critical preclinical development phase. It also specifies many new exclusion criteria that help to narrow the focus towards products with the highest chances of success both in development and marketing.

3. Focus on Drug-Based Contraceptives
Our 2025 RFA focuses very specifically on non-hormonal drug-based male contraceptives. This is a continuation of many of MCI’s stated priorities, but in this particular RFA we intend to hone our focus on generating novel male contraceptive drugs with mechanisms of action, delivery modalities, or other characteristics that make a unique product profile, thus working towards building a pipeline of diverse products for men. While this RFA’s focus on drug-based approaches excludes device development, it does not dampen our existing support or overall enthusiasm for device-based products, but rather seeks to bring about a bolus of novel pharmacological products.

4. Flexible Project Budgets
Previous RFAs from MCI contained multiple funding tracks. This year, we are offering applicants the chance to name their budget within a specified range as a single funding track. We encourage applicants to carefully assess their project needs and propose a budget that is realistically aligned with their specific research activities and timelines. 

While we are committed to maximizing the impact of our funding, we also recognize the importance of leveraging additional resources within the field. Therefore, cost sharing is viewed favorably, as this not only extends the reach of our funding but also indicates broader support and commitment to the project's success.

5. Detailed Project Requirements
Our 2025 RFA includes detailed requirements for project proposals. In addition to our continued requests for a detailed project management plan with quantifiable milestones, we expect applicants to provide a comprehensive rationale for their proposed target and a well-defined Target Product Profile (TPP) outlining the desired characteristics of the final contraceptive product.

Why We Are Narrowing the Funnel
There are several reasons for this shift in our funding strategy:

1. Accelerating Progress
By focusing on projects in translational development, we aim to accelerate the timeline for bringing new male contraceptives to market. This strategic shift acknowledges the urgency of addressing the unmet need for more contraceptive options.

2. Increasing Efficiency
Concentrating resources on translational or otherwise pre-clinical development can be a more efficient use of funding. Projects in clinical stages generally require significant resources beyond the capacity of MCI, and are also appropriate for other funding streams such as VC investment. Similarly, projects that have already demonstrated proof-of-concept are more likely to succeed, reducing the risk of investing in research that may not yield results.

3. Attracting Additional Investment
A strong pipeline of preclinical candidates can attract further investment from other sources, such as pharmaceutical companies and venture capitalists. By de-risking early-stage development, we can pave the way for the larger investments needed to support clinical trials and commercialization.

4. Demonstrating Impact
Ultimately, our goal is to have a tangible impact on global health by increasing the availability of male contraceptives. By focusing on projects with a clear path to clinical translation, we can more effectively demonstrate our impact to donors, partners, and the public.

 Conclusion
Our decision to narrow our funding funnel reflects an evolution in our grantmaking. By prioritizing preclinical development and focusing on projects with a path to clinical translation, we aim to accelerate the development of new male contraceptives and address a critical global health need.