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 pre-clinical 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 October 2014, BrIDGs has generated data to support 15 INDs that have been cleared by the FDA and one clinical trial application that has been cleared by Health Canada. Thirteen projects have been evaluated in clinical trials. Four 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 eight agents during or after their development by BrIDGs.
A study published online in Science Translational Medicine on Feb. 25, 2015, found that NCATS’ TRND and BrIDGs programs have led to the reduced cost of developing new drugs and reduced financial risks. Read the full feature.
New BrIDGs Projects
On Oct. 29, 2014, NCATS announced two new pre-clinical drug development projects aimed at finding treatments for diabetic keratopathy — a condition that often leads to blindness — and severe heart attacks. Read the announcement.