Two Leading Researchers Named to Scientific Advisory Committee for Liver Toxicology Study

Waltham, Mass, November 18, 2005 – Dr. Paul Watkins, MD, Professor of Medicine and Pharmacotherapy, and Director of the General Clinical Research Center at the University of North Carolina, and Dr. Neil Kaplowitz, MD, Professor of Medicine and Chief, Division of Gastrointestinal and Liver Disease at the University of California Department of Medicine, have been named to the Scientific Advisory Committee for the Liver Toxicology Biomarker Study (LTBS) recently announced by the FDA and BG Medicine. The study, which is one of the FDA Critical Path initiatives, aims to discover biomarkers of human hepatotoxicity in the standard test used by pharmaceutical manufacturers in the initial stages of drug development.

Dr. Watkins, who will chair the committee, is a hepatologist with a special interest in liver toxicity. He has consulted widely in both industry and government on issues involving drug- and toxin-induced liver disease, and is one of the world’s leading researchers in the field of liver toxicity. Dr Watkins also currently chairs the Steering Committee of the Drug Induced Liver Injury Network (DILIN), a network of five clinical centers and a data coordinating center funded by the National Institutes of Health.

Dr. Kaplowitz is the former President of the American Association for the Study of Liver Diseases and Vice Chair for Research of the American Liver Foundation. He has authored more than 200 publications, has edited several textbooks on liver diseases and served as associate editor of major medical journals including Hepatology, Gastroenterology and the American Journal of Physiology.

"Drug induced liver toxicity is a very serious challenge for the pharmaceutical and healthcare industries," said Dr. Watkins. "The discovery of preclinical biomarkers that can be used to provide indications of liver toxicity early in the development process will have a significant impact on the development of safe and effective drugs."

"Animal toxicology has been disappointing in predicting human hepatotoxicity," Dr. Kaplowicz said. "The approach of integrating cutting edge technologies holds considerable promise in overcoming this obstacle in drug development by identifying predictive biomarkers in the preclinical setting."

Additional members of the Scientific Advisory Committee will consist of representatives of pharmaceutical manufacturers, BG Medicine and the FDA. The Scientific Advisory Committee will provide guidance for research design, execution and interpretation of the LTSB.

The LTBS will be conducted at the FDA’s NCTR laboratory in Jefferson, Arkansas and at BG Medicine in Waltham, Massachusetts. The study is open to participation by all pharmaceutical manufacturers. Participating companies will receive a paid-up perpetual license to any biomarkers discovered and access to all project data.

BG Medicine is pioneering the commercial application of Systems Pharmacology, which is based on scientific advances in the Systems Biology field. For more information about BG Medicine please visit www.bg-medicine.com.

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