Gastroenterologists Named to Scientific Advisory Committee for Liver Toxicology Study

Abstract

Dr. Paul Watkins, MD, Professor of Medicine and Director of the General Clinical Research Center at the University of North Carolina at Chapel Hill, and Dr. Neil Kaplowitz, MD, Professor of Medicine and Chief, Division of Gastrointestinal and Liver Disease at the University of Southern California, have been named to the scientific advisory committee for the Liver Toxicology Biomarker Study (LTBS) recently announced by the FDA. 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. Watkins also currently chairs the Steering Committee of the Drug Induced Liver Injury Network (DILIN), a network of 5 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 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.” According to Kaplowitz, “animal toxicology has been disappointing in predicting human hepatotoxicity. 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.” The Scientific Advisory Committee will provide guidance for research design, execution, and interpretation of the LTBS. The study will be conducted at the FDA’s NCTR laboratory in Jefferson, Arkansas and at BG Medicine in Waltham, Massachusetts. Additional committee members will include representatives from pharmaceutical manufacturers, BG medicine, and the FDA.