Correspondence: David G. Badman, NIH, NINDS, 6001 Executive Blvd, RM 2141 Bethesda, MD 20892, USA. E-mail: nih-raid@mail.nih.gov

¹Has 30 years experience in directing the extramural Hematology Program of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH). Among his responsibilities was oversight of contracts intended to develop new drugs for the treatment of iron overload. In addition, he was Deputy Director of the Division of Kidney, Urologic and Hematologic Diseases, NIDDK from 1999 to 2004. He received recognition of his work on numerous occasions, including two NIH Director's Awards. He retired from the Federal Civil Service in December 2004, and, as a consultant, assumed responsibility for coordinating the NIH-Rapid Access to Interventional Development (RAID) Pilot, a Roadmap program designed to assist academic investigators to develop new therapeutic agents.

Received 12 September 2008; Revised 12 September 2008; Published online 28 October 2008.

Abstract

The National Institutes of Health (NIH) wishes to alert the biotech/medical research community to an opportunity to obtain assistance in the development of new therapeutic agents. The NIH Roadmap has established a pilot programme, the NIH-Rapid Access to Interventional Development (RAID) Pilot, to make available, on a competitive basis, critical resources needed for the development of new small-molecule or natural product-derived therapeutic agents. This programme, part of the Translational Research component of Reengineering the Clinical Research Enterprise, uses resources of NCI's Developmental Therapeutics Program. Services provided depend upon the project and strength of the preliminary data. Services potentially available include bulk supply, GMP manufacturing, formulation, assay development suitable for pharmacokinetic testing, and animal toxicology. Assistance can also be provided in the regulatory process. Currently, animal efficacy studies and synthesis of recombinant proteins, monoclonal antibodies, or reagents for gene therapy are not supported. The NIH-RAID Pilot will, however, 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 the manufacture of small-molecule or natural product material for any clinical study. Proposals must originate from academic or non-profit investigators, but collaboration with industry partners is encouraged.