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

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), under the Department of Health and Human Services (HHS), is a major federal research institution with a mandate to study infectious and immune-mediated diseases. As part of its ongoing efforts to advance the understanding and treatment of HIV and related conditions, NIAID has reissued a Notice of Funding Opportunity (NOFO) titled "Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)." This NOFO supports the early-stage planning required for investigational drug development targeting HIV treatment or prevention, and associated comorbidities, coinfections, and complications. This planning grant (R34 mechanism) specifically aims to facilitate the development of well-structured, FDA Investigational New Drug (IND)-directed strategies that guide applicants through critical preparatory phases prior to IND submission. The purpose is to build a robust roadmap encompassing product indication, preclinical and clinical program alignment, Chemistry, Manufacturing, and Controls (CMC) plans, and risk mitigation approaches. Eligible projects should aim to develop innovative HIV therapies, novel prevention strategies, or treatments addressing HIV-associated conditions. The intent is not to fund clinical trials, but rather multidisciplinary preparatory activities that ensure future clinical trials are feasible and well-supported by foundational data and regulatory readiness. Eligible applicants include a wide array of U.S.-based and international institutions, including higher education institutions (public and private), nonprofits, small businesses, for-profits, government bodies (state, county, city), tribal entities, housing authorities, and international organizations. Applications must be prepared and submitted electronically using the NIH ASSIST system, institutional system-to-system platforms, or Grants.gov Workspace, and applicants must comply with several mandatory registrations including SAM, UEI, Grants.gov, and eRA Commons. The NOFO outlines a non-clinical project structure with a one-year performance period and budget capped at $225,000 in direct costs. A total program funding of approximately $1,000,000 is anticipated in fiscal year 2025, with 2–3 awards expected. No cost sharing or matching is required. Applications are reviewed in cycles with specific AIDS-related submission dates (e.g., March 13, 2025; December 4, 2025; March 13, 2026) followed by peer review, advisory council review, and earliest start dates staggered over 6–9 months. Applications are due by 5:00 PM local time of the applicant organization. Successful applicants are evaluated based on three core factors: the significance and innovation of the research; the rigor and feasibility of the approach; and the expertise and resources available to execute the project. Applications are expected to include a detailed plan describing milestones, risk assessments, regulatory strategies, and team capabilities. Contact points for applicants include specific scientific/research, peer review, and grants management officials listed in the NOFO. The program is anticipated to be recurring, and based on established deadlines, the next expected cycle after March 2026 is December 2026. The updated expiration date for this NOFO is May 8, 2026.

Ensure IND strategy includes CMC, toxicology, and preclinical alignment; establish clear milestones and go/no-go points; include regulatory and clinical expertise on the team.