Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)
Funding Agency:
- National Institutes of Health
The purpose of this Notice of Funding Opportunity (NOFO) is to provide support for product development planning activities that will accelerate development of next-generation treatments for HIV and HIV-associated comorbidities, coinfections, and complications, and preventive strategies for HIV, and facilitate translation of research findings into a drug product. This NOFO supports the NIAID mission to conduct and support basic and applied research to prevent and treat infectious diseases in adult and pediatric populations with a focus on:
- Development of Next-Generation HIV Therapies (drugs and biologics with improved safety and ease of use, e.g., sustained release antiretrovirals; novel HIV targets & inhibitors; novel immune-based therapies),
- Development of Next-Generation HIV Prevention Strategies (e.g., long-acting, sustained release or multi-purpose prevention technologies), and
- Development of New Treatments for HIV-associated comorbidities, coinfections, and complications.
This NOFO will support multidisciplinary planning activities to develop a well-defined product development strategy that enables an IND submission. The IND-directed product development strategy will comprise the required components in concordance with FDA guidance, such as: product indication, route of administration and dosing, CMC strategy, pharmacology and toxicology program strategies, and clinical protocol design. Finalized clinical protocols are not expected at the conclusion of the project period.
This NOFO will also support establishment of a multidisciplinary team with expertise to develop and implement the product development strategy. This team may include business professionals, Contract Research Organizations (CROs), CMC experts and regulatory professionals, and it is strongly recommended to include clinical investigators to bridge the preclinical and clinical development activities.
For treatment or prevention strategies that have already completed IND-directed studies, this NOFO will support preparation of an IND application.
Applicants may consider applying to DAIDS preclinical contracts services (PAR-22-185) to fill gaps in their product development programs.
Applications Non-Responsive to this NOFO
Applications that propose to conduct research in the following areas will be considered non-responsive and will not be reviewed:
- Product development planning activities for indications that do not involve HIV treatment or prevention, or HIV-associated comorbidities, coinfections, and complications
- Applications for interventions from known drug classes that are already well-established for clinical use and lack novelty in their treatment approach
- Laboratory studies
- Clinical trials (all phases)
Application budgets are limited to $225,000/year in direct costs.
March 13, 2024
Treatment
Marina Protopopova, Ph.D.
National Institute of Allergy and infectious Diseases (NIAID)
Telephone: 301-761-7653
Email: marina.protopopova@nih.gov
Prevention
James E. Cummins, Jr., Ph.D.
National Institute of Allergy and infectious Diseases (NIAID)
Telephone: 240-292-4800
Email: cumminsje@niaid.nih.gov