Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)
This grant aims to develop a strategic plan for new HIV treatments and preventive strategies to lead to FDA drug product applications.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: March 13, 2025 | December 4, 2025 | February 19, 2026
Funding Amounts: Up to $225,000 in direct costs for a 1-year project; NIH anticipates 2–3 awards per cycle.
Summary: Supports planning and strategy development for next-generation HIV treatments and prevention, enabling IND submission to FDA.
Key Information: Clinical trials are not allowed; funding supports preclinical planning and IND-enabling activities only.
Description
This funding opportunity supports the development of comprehensive product development strategies for next-generation treatments and preventive interventions for HIV, as well as HIV-associated comorbidities, coinfections, and complications. The goal is to facilitate the translation of research findings into drug products and enable submission of Investigational New Drug (IND) applications to the FDA. Funding is intended for multidisciplinary planning activities—such as defining target product profiles, identifying required studies, aligning preclinical and clinical programs, and developing regulatory strategies. Clinical trials (all phases) are not permitted under this announcement.
