The Bridging Interventional Development Gaps (BrIDGs) program enables research collaborations to advance candidate therapeutics for both common and rare diseases into clinical testing. Investigators do not receive grant funds through this program. Instead, selected researchers partner with NCATS experts to generate preclinical data and clinical-grade material through government contracts for use in Investigational New Drug (IND) applications to a regulatory authority such as the Food and Drug Administration (FDA). In general, BrIDGs provides synthesis, formulation, pharmacokinetic and toxicology expertise and resources to its collaborators.
NIH contractors conduct preclinical studies under the direction of NCATS staff. NCATS, along with any co-funding NIH Institutes and Centers, supports contract costs. The decision to collaborate on a proposed project is based on an internal assessment of scientific merit, programmatic fit and the availability of NIH funds. Find out how to submit a proposal to BrIDGs.
As of fall 2015, BrIDGs has generated data to support 18 investigator-initiated INDs that have been cleared by the FDA and one clinical trial application cleared by Health Canada. A total of 14 projects have been evaluated in clinical trials. Five BrIDGs-supported agents have been evaluated in 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 organizations have licensed or invested in 10 agents during or after their development by BrIDGs. Learn more about BrIDGs projects.