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

Part of FDA’s Critical Path Initiative to Modernizing Drug Development

The U.S. Food and Drug Administration and BG Medicine, a Massachusetts-based biotechnology research company, 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 Research and Development 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. Early detection of potential safety problems is one of the main objectives of the FDA's Critical Path Initiative, which seeks to modernize drug development by making the process more predictable and successful, and less costly.

"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 FDA's March, 2004 report, Innovation/Stagnation: Challenge and 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. By identifying biomarkers for liver toxicity at the start of the development process, this research should yield important benefits for industry, the 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 laboratory in Jefferson, Ark. and BG Medicine in Waltham, Mass. Participating companies will receive access to all project data and a perpetual license to any discovered biomarkers.

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