NIAID will support the development of a comprehensive and well-defined product development strategy for next-generation treatments for HIV and related comorbidities and preventive strategies for HIV through the notice of funding opportunity (NOFO) Planning for Product Development Strategy (R34, Clinical Trial Not Allowed).
The process of turning newly discovered treatment and prevention methods into an investigational new drug stage and into clinical trials requires significant investments and a comprehensive understanding of FDA requirements, multidisciplinary expertise, multiple partnerships, and reliable teams.
Research Objectives
The purpose of this NOFO is to accelerate development of next-generation treatments for HIV and HIV-associated comorbidities, co-infections, and complications, and preventative strategies for HIV, and facilitate translation of research findings into a drug product.
Additionally, this NOFO will seek to establish a multidisciplinary team which may include business professionals; contract research organizations (CROs); and chemistry, manufacturing, and controls (CMC) experts and regulatory professionals. We strongly recommend applicants include clinical investigators to bridge the preclinical and clinical development activities.
You may also consider applying to request access to DAIDS preclinical contracts services through the NOFO Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program (X01, Clinical Trial Not Allowed) to fill gaps in your product development program.
Nonresponsive Applications for this NOFO
If your application proposes research in any of the following areas, NIAID will consider it nonresponsive and not review it.
- Product development activities for indications that do not involve HIV treatment or prevention, or HIV-associated comorbidities, co-infections, and complications.
- Applications for interventions from well-established, known drug classes that lack novelty in their treatment approach.
- Laboratory studies.
- Clinical trials (all phases).
Award Information
NIAID will fund two or three awards in fiscal year 2025. Future year amounts will depend on annual appropriations.
Application budgets are limited to $225,000 in direct costs. The maximum project period is 1 year.
Applications are due twice annually, on March 13 and December 4 in 2024, 2025, and 2026, respectively, by 5 p.m. local time of the applicant organization.
We encourage you to apply early to allow adequate time to correct any technical errors in your applications before the due date.
Contact Information
For inquiries about treatment, contact Dr. Marina Protopopova at marina.protopopova@nih.gov or 301-761-7653. For prevention-related inquiries, contact Dr. James E. Cummins at cumminsje@niaid.nih.gov or 240-292-4800.
If you have questions related to peer review, contact Dr. Vishakha Sharma at vishakha.sharma@nih.gov or 301-761-7036.