Notice Number: NOT-RM-05-004

Key Dates
Release Date: December 23, 2004

The National Institutes of Health Roadmap is establishing a program called the NIH-RAID PILOT (Rapid Access to Interventional Development) to make available, on a competitive basis, certain critical resources needed for the development of new small molecule therapeutic agents. This pilot program is developed as an NIH Roadmap for Medical Research initiative (http://nihroadmap.nih.gov/), and it will be administered jointly by the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI) on behalf of all NIH Institutes.

Services available will include: production, bulk supply, GMP manufacturing, formulation, development of an assay suitable for pharmacokinetic testing, pharmacokinetic studies, and animal toxicology. The resources of NCI's Developmental Therapeutics Program will be used to implement this program. Services actually provided for accepted projects will depend upon the stage of the project and the strength of the preliminary data. Assistance will also be provided in the regulatory process through access to independent product development planning expertise. In the pilot phase, in vitro or animal efficacy studies and synthesis of recombinant proteins, monoclonal antibodies, or reagents for gene therapy will not be supported.

The NIH-RAID PILOT is not a grant program. Successful projects gain access to government contract resources, as well as 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. Co-sponsorship is critical because of the resources and expertise needed and because the NIH-RAID pilot cannot support the full developmental pipeline, and an Institute partnership may therefore be important for subsequent translational efforts. Each Institute has specified its priority areas for the NIH-RAID pilot.

The request review utilizes a two-stage evaluation process. The preliminary administrative assessment, based on a short project summary (the Preliminary Request), will determine whether the resources requested are appropriate for this program and whether one or more Institutes are prepared to provide co-sponsorship. Institutes will assess whether or not public sector funds are needed in the topic area to overcome translational barriers and fulfill needs not being met by private sector support. Based on the preliminary evaluation, selected applicants will be invited to submit a formal request for resources. The request will be evaluated a panel of external reviewers and the results of that evaluation will guide final Institute and Roadmap resource allocation.

Detailed information on available resources, eligibility, areas of Institute priority, receipt dates and the request and review process are available at the following site: http://nihroadmap.nih.gov/raid/. The Preliminary Request is to be submitted electronically as explained on the website.

Inquiries

Inquiries are encouraged, and the opportunity to clarify issues or questions is welcome. Questions regarding this initiative may be directed to the NIH-RAID Office listed below.

NIH-RAID Program Office
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 634
Bethesda, MD 20892-5460
Telephone (301) 594-4660
Email: NIH-RAID@niddk.nih.gov

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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