NIH Announces Interventional Development (RAID) Pilot Program
December 16, 2008 – The National Institutes of Health (NIH) Roadmap has established a pilot program called the NIH-RAID Pilot (Rapid Access to Interventional Development), similar to the National Cancer Institute’s (NCI) RAID program, to make available, on a competitive basis, certain critical resources needed for the development of new small molecule therapeutic agents.
This program, part of the Translational Research component of Reengineering the Clinical Research Enterprise, uses resources of NCI’s Developmental Therapeutics Program. The services provided will depend upon the stage of the project and the strength of the preliminary data. Services potentially available include: production, bulk supply, GMP manufacturing, formulation, development of an assay suitable for pharmacokinetic testing, and animal toxicology.
Assistance also will be provided in the regulatory process, through access to independent product development planning expertise.
In the program’s pilot phase, animal efficacy studies, and synthesis of recombinant proteins, monoclonal antibodies or reagents for gene therapy will not be supported. However, the NIH-RAID Pilot will now consider requests for services to support later-stage preclinical development of monoclonal antibodies, recombinant proteins, and gene therapy agents.Additionally, the NIH-RAID Pilot will now consider requests for manufacture of material for any clinical study. For more information click here. http://grants.nih.gov/grants/guide/notice-files/NOT-RM-08-005.html
The NIH-RAID Pilot is not a grant program. Successful projects will gain access to the government’s contract resources, as well as the assistance of the NIH in establishing and implementing a product development plan. Funds to support individual projects will come both from Roadmap funds and from individual Institutes, with Institutes assuming the bulk of support in the specific disease areas germane to their mission. This co-sponsorship is critical because of the resource and expertise needs and because the NIH-RAID Pilot cannot support the full developmental pipeline; an Institute partnership may therefore be important for subsequent translational efforts.
To obtain access to NIH-RAID Pilot resources, applications must be submitted electronically through Grants.gov using SF424. Applications are screened to determine whether the resources requested are appropriate for this program. Applications are then reviewed by the NIH Center for Scientific Research. The results of that evaluation along with supplemental information from the lead investigator will guide final Institute and Roadmap resource allocation.
The main tasks that are supported by the NIH-RAID Pilot are as follows:
- Synthesis in bulk of small molecules
- Synthesis of oligonucleotides
- Chemical synthesis of peptides
- Scale-up production
- Development of analytical methods
- Isolation and purification of naturally occurring substances
- Pharmacokinetic/ADME studies including bioanalytical method development
- Development of suitable formulations
- Manufacture of drug supplies
- Range-finding initial toxicology
- IND-directed toxicology
- Product development planning and advice in IND preparation
- Later-stage preclinical development of monoclonal antibodies, recombinant proteins, and gene therapy agents
The NIH-RAID Pilot is intended for use by academic discovery laboratories, not-for-profit organizations and small businesses. The program is also open to non-U.S. applicants. Applications will not be accepted for the synthesis of therapeutic agents without demonstrated activity against a disease related target or in a disease model.
A grant application can be downloaded here.
Upcoming Receipt Dates:
- January 15, 2009
- May 15, 2009
- September 15, 2009