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FDA and Industry Collaborate to Predict Liver Toxicity in Human Drug Trials

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The FDA and BG Medicine  have agreed to collaborate on a project designed to overcome one of the obstacles to efficient development of safe drugs.

The Liver Toxicology Biomarker Study (LTBS) , to be conducted under a Cooperative R&D Agreement (CRADA) between the FDA's National Center for Toxicological Research (NCTR)  and the pharmaceutical industry, aims to discover signs of human liver toxicity in a standard test used in the initial stages of drug development.

"Liver toxicity is a common reason for drug development failure," said Dr. Janet Woodcock, FDA's Deputy Commissioner for Operations and the principal author of the FDA's March 2004 report, Innovation/Stagnation: Challenge & Opportunity on the Critical Path to New Medical Products.

"In part, this is due to the fact that the safety evaluation relies on decades-old technologies that may recognize safety problems only after extensive clinical studies," Dr. Woodcock noted.

"By identifying biomarkers for liver toxicity at the start of the development process, this research should yield important benefits for industry, FDA and the public" The CRADA procedure routinely governs FDA's collaborative studies with the private sector.

The LTBS has been designed by FDA and BG Medicine with input from other pharmaceutical companies, and will be conducted, with their collaboration, at the NCTR lab in Jefferson AR and BG Medicine in Waltham MA.

Participating companies will receive access to all project data and a perpetual license to any discovered biomarkers.