Bridging Interventional Development Gaps

Led by the NCATS Division of Pre-Clinical Innovation, Bridging Interventional Development Gaps (BrIDGs) makes available, on a competitive basis, certain critical resources needed for the development of new therapeutic agents for both common and rare diseases. Investigators do not receive grant funds through this program. Instead, successful applicants receive access to NIH contractors who conduct preclinical studies at no cost to the investigator. In general, synthesis, formulation, pharmacokinetic and toxicology services in support of investigator-held Investigational New Drug (IND) applications to the Food and Drug Administration (FDA) are available. Contract costs are supported by NCATS and collaborating NIH Institutes and Centers. Access to contracts is based on a peer-reviewed application process. The number of awards made will depend on the number of applications received, their scientific merit, and the availability of NIH funds. BrIDGs formerly was supported by the NIH Common Fund. As of November 2013, BrIDGs has generated data to support 13 INDs that have been cleared by the FDA and one clinical trial application that has been cleared by Health Canada. Twelve projects have been evaluated in clinical trials. Three BrIDGs-supported agents have gone as far as Phase II human clinical trials, in which researchers give an experimental therapy to a group of patients to evaluate the effectiveness and safety of a treatment. Third-party investors have licensed seven agents during or after their development by BrIDGs.