NIH assistance for new therapeutic development: NIH-RAID Pilot Program

David G Badman

DOI:https://doi.org/10.5912/jcb268

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.

Keywords:drug development ,pharmacokinetics ,preclinical toxicology ,en ,