Resource Summary Report  New Search Previous Search Results

URL: http://www.ninds.nih.gov/funding/nindsnotes/200707/NIH%20Rapid%20Access%20to%20Interventional%20Development.htm

Proper Citation: NIH - Rapid Access to Interventional Development (RRID:SCR_000713)

Description: THIS RESOURCE IS NO LONGER IN SERVICE. Documented on August 14, 2025.NIH-RAID makes available at no cost to researchers and organizations 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 Institutes (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 governments 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. To obtain access to NIH-RAID resources, applications must be submitted electronically through Grants.gov using SF424. Applications are initially screened to determine whether the resources requested are appropriate for this program. Then they are reviewed by the NIH Center for Scientific Research. The results of that evaluation along with supplemental information from the lead investigator will guide final Institute and Roadmap resource allocation. The services provided will depend upon the stage of the project and the strength of the preliminary data. When a lead therapeutic agent has been selected and proposed for preclinical development, the following services are available: For small molecules, natural products, peptides, oligonucleotides, and gene vectors: Synthesis, Scale-up production, Development of analytical methods, Development of suitable formulations, Isolation and purification of natural products, Pharmacokinetic/ADME studies including bioanalytical method development, Range-finding initial toxicology, IND-directed toxicology, Manufacture of clinical trial supplies, Product development planning and advice in IND preparation For recombinant proteins and monoclonal antibodies: Pharmacokinetic/ADME studies including bioanalytical method development, Range-finding initial toxicology, IND-directed toxicology, Product development planning and advice in IND preparation When a lead therapeutic agent has not yet been selected and proposed for preclinical development, the following services are available: For small molecules, natural products, peptides, oligonucleotides, and gene vectors: Synthesis, Development of analytical methods, Isolation and purification of natural products, Preliminary Pharmacokinetic/ADME studies, including bioanalytical method development, Preliminary toxicology For recombinant proteins and monoclonal antibodies, Preliminary Pharmacokinetic/ADME studies, including bioanalytical method development, Preliminary toxicology In some cases the NIH-RAID program will support only one or two key steps for preclinical development, while in other cases it may be possible to provide assistance with most of the development tasks needed to file an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). When the NIH-RAID program does not provide all of the remaining services required for IND submission, it is expected that other resources will be in place to complete development steps not supported by NIH-RAID. Funding Resource,.

Synonyms: NIH-RAID

Resource Type: funding resource, biomaterial analysis service, analysis service resource, material analysis service, biomaterial manufacture, production service resource, service resource, material service resource

Keywords: adme, applied, biomaterial method development, clinical, pharmacology, student, toxicology