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 a product development plan. 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.
Available services include:
- 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.
The output of BrIDGs activities, in the form of research material and data, will be made fully available to the applicant organization in support of their IND application and Phase I clinical trials. Data and material will be transferred under the terms of a non-negotiable Material Transfer Agreement.
Regulatory affairs support is not offered by BrIDGs. Applicants must identify other resources for preparing their IND.
Preclinical studies in support of Phase II or later trials (including carcinogenicity and reproductive toxicity studies) and funding for clinical trials of any phase are not available.
Manufacture of gene vectors is limited to non-GMP viral and nonviral gene vectors and GMP-grade adeno-associated virus and lentivirus vectors. Because not all gene vectors can be manufactured, applicants are encouraged to contact BrIDGs regarding their specific vector.
Vaccines, devices and diagnostic agents are ineligible for the program. Only lead agents with demonstrated pharmacological activity in an appropriate disease model will be considered for development. Projects requiring earlier-stage resources, including assay development, high-throughput screening, medicinal chemistry optimization or in vitro/in vivo efficacy testing are not appropriate for BrIDGs. Researchers interested in these resources should consider the Molecular Libraries Program, the (TRND) program or consult with extramural program staff at the appropriate NIH institute to discuss other funding options.