Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), supports a broad research portfolio aimed at combating infectious, immunologic, and allergic diseases. This includes efforts to translate promising scientific discoveries into therapeutic and preventive strategies. Through the Planning for Product Development Strategy (R34 Clinical Trial Not Allowed) funding opportunity, NIAID provides financial assistance to research teams preparing to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The goal of this Notice of Funding Opportunity (NOFO) is to fund structured, multidisciplinary planning processes that enable advancement of new HIV treatments and prevention strategies, including those targeting HIV-associated comorbidities, coinfections, and complications. This grant program targets development of next-generation HIV therapies and preventive strategies, such as sustained-release antiretrovirals or long-acting prophylactic technologies, as well as new interventions for related health conditions. While the grant does not support clinical trials or basic laboratory research, it enables recipients to generate detailed development strategies, including Chemistry, Manufacturing, and Controls (CMC) planning, toxicology, pharmacology, and regulatory pathways. The goal is to create a comprehensive roadmap that supports a timely and well-substantiated IND submission. Applicants may also include efforts to finalize their IND package if prior preclinical work has been completed. Funding under this opportunity is available for a single year, with direct costs limited to $225,000. NIH anticipates making two to three awards in Fiscal Year 2025, totaling approximately $1 million. Eligible applicants include a wide range of entities—academic institutions, nonprofit organizations, for-profit companies (including small businesses), and government agencies. Foreign organizations and components are also eligible. Cost sharing is not required. Multidisciplinary teams are encouraged, and may include clinicians, regulatory experts, and contract research organizations. Applications are expected to align with FDA guidance on IND submissions and demonstrate how the development strategy addresses essential components such as target product profile, regulatory strategy, go/no-go milestones, and risk mitigation. Proposals must justify the market need and potential clinical impact of the product, and detail competitive advantages and intellectual property status. Projects must include a clearly defined timeline, risk analysis, and plans for addressing critical regulatory and manufacturing challenges. Applications are submitted via NIH’s ASSIST platform, Grants.gov Workspace, or through institutionally approved system-to-system methods. All applicants must comply with NIH’s electronic submission requirements and complete relevant registrations (e.g., SAM, eRA Commons). No pre-application is required for this opportunity. While the funding opportunity is now expired, recurring due dates suggest annual opportunities may return, and late applications may be accepted on a case-by-case basis per NIH policies. For scientific inquiries, applicants may contact Marina Protopopova, Ph.D. (treatment focus) at [email protected] or James Cummins, Jr., Ph.D. (prevention focus) at [email protected]. Peer review contact is Vishakha Sharma, Ph.D. ([email protected]), and financial inquiries may be directed to Lily Campbell, Ph.D. ([email protected]). The last application due date was December 4, 2025. Following standard NIH cycles, the next anticipated submission round would be in December 2026. Each grant supports a one-year planning period to facilitate readiness for IND application and subsequent clinical testing phases.

Ensure alignment with IND requirements; include FDA-aligned risk mitigation plans and go/no-go milestones; include clinical and regulatory team members.