New pilot research program aims to facilitate new drug development

New pilot research program aims to facilitate new drug development

The National Institutes of Health (NIH) are 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 (nihroadmap.nih.gov/), and 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. Each Institute has specified its priority areas for the NIH-RAID pilot.

Review of proposals 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. A panel of external reviewers will evaluate the request 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: nihroadmap.nih.gov/raid/. Questions regarding this initiative may be directed to the NIH-RAID Office at (301) 594-4660 NIH-RAID@niddk.nih.gov.

Source: NIH Guide, week ending 12/24/2004, NOT-RM-05-004—NIH-RAID PILOT: Translational Cores Resources Pilot Project