BrIDGs In-Kind Services
BrIDGs is not a grant program. Instead of receiving grant funds, successful applicants gain access to the government’s contract resources, as well as assistance with establishing and implementing product development plans. Applicants may request as many services as are needed to generate sufficient data for an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA).
Applications are accepted for the development of the following therapeutic agents:
- Small molecules
- Gene vectors
- Recombinant proteins
- Monoclonal antibodies
Through the BrIDGs program, researchers have access to the following services:
- Scale-up production
- Development of analytical methods
- Development of suitable formulations
- 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
Lead agents will be considered for development when pharmacological activity has been demonstrated in an appropriate disease model via the intended clinical route of administration. If efficacy studies have been conducted by a route that differs from that proposed for initial clinical trials, then data obtained by the different routes must be available to compare exposure levels in target organs. BrIDGs provides limited support, including:
- Manufacture of gene vectors is limited to non–Good Manufacturing Practice (GMP) and GMP-grade adeno-associated virus and lentivirus vectors.
- In general, manufacture of clinical trial material will be limited to supplies for Phase I trials.
- Formulation, pharmacokinetic and toxicology studies in support of Phase II or later trials (including carcinogenicity and reproductive toxicity studies) are not available.
- Regulatory affairs support is not offered by BrIDGs. Applicants must identify other resources for preparing their INDs.
- Funding for clinical trials of any phase is not available.
- Vaccines, devices and diagnostic agents are ineligible for the program.
Additionally, projects requiring earlier-stage resources, including assay development, high-throughput screening, medicinal chemistry optimization or additional in vitro/in vivo efficacy testing are not appropriate for BrIDGs. Researchers interested in these resources should consider the Molecular Libraries Program, the Therapeutics for Rare and Neglected Diseases program, or consult with extramural program staff at the appropriate NIH Institute to discuss other funding options.