The National Institutes of Health (NIH) Roadmap has established a program called NIH-RAID (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 therapeutic agents. This program, part of the Translational Research component of Reengineering the Clinical Research Enterprise, uses resources of NCI's Developmental Therapeutics Program and the National Heart Lung and Blood Institute?s (NHLBI) Gene Therapy Resource Program. The services provided will depend upon the stage of the project and the strength of the preliminary data. Services 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. Proposals in support of animal efficacy studies or synthesis and formulation of recombinant proteins or monoclonal antibodies will not be accepted. NIH-RAID 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 the Roadmap 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 NIH-RAID cannot support the full developmental pipeline;an Institute partnership may therefore be important for subsequent translational efforts.
