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GEN News Highlights : Dec 5, 2012

NIH Builds BrIDGs

NIH selected three drug development projects demonstrating efficacy in disease models for no-cost access to preclinical expertise, through the agency’s Bridging Interventional Development Gaps (BrIDGs) program.

Chosen by NIH were projects aimed at developing potential new treatments for a variety of cancers, spinal cord injury, and a rare disease that can lead to kidney failure. Those projects, as with previous BrIDGs selections, can tap into providers of toxicology studies and other preclinical services that work under NIH contracts. NIH does not fund BrIDGs researchers directly.

The latest BrIDGs-approved projects, their sponsors and overseeing executives: 

  • Tumor Penetrating Microparticles for Peritoneal Cancers—Optimum Therapeutics; Jessie Au, Pharm.D., Ph.D., chief scientific officer and acting CEO
  • Development of Assays to Detect Anti-drug Antibodies against ACP-501 [recombinant human Lecithin-cholesterol acyltransferase (LCAT) for LCAT deficiency syndrome]—Alphacore Pharma; Brian Krause, Ph.D., chief scientific officer
  • Development of Nogo Receptor Decoy for the Treatment of Spinal Cord Injury—Axerion Therapeutics; George Maynard, Ph.D., vp, Preclinical Development

Most BrIDGs projects are designed to enable submission of an IND application to FDA. To date, BrIDGs projects have generated data to support 12 INDs, as well as a clinical trial application to Health Canada. All but one of the 13 approved projects have been evaluated in clinical trials, with three BrIDGs-supported therapeutic agents going as far as Phase II. Third-party investors have licensed six agents during or after their development through BrIDGs. 

BrIDGs solicits applications once a year. The next opportunity to submit applications began Dec. 1 and will end Feb. 1, 2013. Information about BrIDGs, including application instructions, is available at www.ncats.nih.gov/bridgs.html.

BrIDGs, an eight-year-old program formerly called NIH Rapid Access to Interventional Development, is led by the NIH’s National Center for Advancing Translational Sciences (NCATS), and supported by the NIH Common Fund.