Resource Report

URL: http://www.t1diabetes.nih.gov/t1d-raid/index.shtml

Proper Citation: Type 1 Diabetes - Rapid Access to Intervention Development (RRID:SCR_000203)

Description: NOTE: The T1D-RAID program is not currently accepting applications. Cooperative program that makes available, on a competitive basis, NCI resources for the pre-clinical development of drugs, natural products, and biologics to facilitate translation to the clinic of novel, scientifically meritorious therapeutic interventions for type 1 diabetes and its complications. A partial listing of those services includes: high-throughput screening, studies in animal models, formulation, pharmacology and toxicology studies, and bulk substances acquisition. Requests to T1D-RAID are brief (20 pages or less), and should clearly outline the resources required to ready the proposed therapeutic agent for clinical trials. T1D-RAID should enable entry into the clinic of promising molecules that are not otherwise likely to receive an adequate and timely clinical test. T1D-RAID is designed to accomplish the tasks that are rate-limiting in bringing discoveries from the laboratory to the clinic. Once a project has been approved, NIDDKstaff interact directly with the Principal Investigator (PI). NCI contractors perform the T1D-RAID-approved tasks under the direction of NIDDKand NCI staff. The required tasks will vary from project to project. In some cases T1D-RAID will support only one or two key missing steps necessary to bring a compound to the clinic; in other cases it may be necessary to supply the entire portfolio of development requirements needed to file an IND. Examples of tasks that can be supported by T1D-RAID include, but are not limited to: * Definition or optimization of dose and schedule for in vivo activity * Development of pharmacology assays * Conduct of pharmacology studies with a pre-determined assay * Acquisition of bulk substance (GMP and non-GMP) * Scale-up production from lab-scale to clinical-trials lot scale * Development of suitable formulations * Development of analytical methods for bulk substances * Production of dosage forms * Stability assurance of dosage forms * Range-finding initial toxicology * IND-directed toxicology, with correlative pharmacology and histopathology * Planning of clinical trials * Regulatory affairs, so that FDA requirements are likely to be satisfied by participating investigators seeking to test new molecular entities in the clinic * IND filing advice The output of T1D-RAID activities will be both products and information that will be made fully available to the originating investigator for support of an IND application and clinical trials. T1D-RAID does not sponsor clinical trials.

Abbreviations: T1D-RAID

Synonyms: Type 1 Diabetes - Rapid Access to Intervention Development (T1D-RAID)

Resource Type: service resource, resource

Keywords: therapeutic, drug, drug development, pharmacogenomics