Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)
National Institutes of Health (NIH)
Estimated funding amount: $225,000 per year
Maximum project period: 1 year
Support the development of comprehensive product development strategies for next-generation treatments for HIV.
Facilitate the translation of research findings into drug products for IND applications.
Public and private nonprofit institutions
Individuals involved in biomedical research
Patients with HIV and associated comorbidities
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, and tribal governments.
Specific qualifications include being a public or state-controlled institution, private institution, or nonprofit with or without 501(c)(3) status.
Eligible organizations can be based in the U.S. or be foreign organizations.
Non-domestic components of U.S. organizations are also eligible.
Projects must focus on HIV treatment or prevention, or HIV-associated comorbidities.
Applications proposing clinical trials are not allowed.
Application budgets are limited to $225,000/year in direct costs.
No cost-sharing is required.
Application due date: December 4, 2026.
Open date for submissions: February 13, 2025.
Applicant organizations may submit more than one application, provided each is scientifically distinct.
The NIH will not accept duplicate or overlapping applications.
Applications must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.
Specific forms include SF424(R&R) Cover and Project/Performance Site Locations.
Applications will be evaluated based on scientific and technical merit.
Review criteria include importance of the research, rigor and feasibility, and expertise and resources.
Applications will undergo peer review and receive a written critique.
Funding decisions will consider scientific merit and relevance to program priorities.
Applications deemed to have the highest scientific and technical merit will be prioritized.
Applications must not propose clinical trials.
A well-defined product development strategy is essential.
Complexities in drug development require multidisciplinary expertise and partnerships.
Collaboration with Contract Research Organizations (CROs) and regulatory professionals is recommended.
Strong emphasis on innovative approaches to HIV treatment and prevention.
Develop a comprehensive and well-defined product development strategy.
Engage a multidisciplinary team with relevant expertise.
Avoid submitting overlapping applications.
Ensure compliance with all application instructions.
Start the registration process early to avoid delays.
Consider potential funding gaps and plan accordingly.
Highlight innovative aspects of the proposed product development strategy.