KEYNOTE PANEL DISCUSSION
Moderator: Peter Siegl, Ph.D., Independent Consultant,
Siegl Pharma Consulting LLC

PRECLINICAL STRATEGIES FOR EARLY RISK ASSESSMENTS

Integration of Preclinical Studies into the Hepatic Safety Assessment Continuum
William B. Mattes, Ph.D., D.A.B.T., Director, Toxicology, The Critical Path Institute

In Vitro-In Vivo Correlations of Drug-Induced Liver Injury
Jinghai Xu, Ph.D., Director, Automated Biotechnology, Merck and Co.

CLINICAL METHODOLOGIES FOR
DETECTION AND MONITORING OF
ADVERSE EVENTS

Early Prediction of Drug Induced Hepatotoxicity: Where Are We Now and Where Are We Going?
Arie Regev, M.D., Hepatology Consultant and Chair, Liver Safety Committee, Global Patient Safety, Eli Lilly and Company

Causality and Severity Assessment in Idiosyncratic Drug-Induced Liver Injury
Naga Chalasani, M.D., Professor, Medicine; Director, Division of Gastroenterology and Hepatology, Indiana University School of Medicine

NOVEL APPROACHES FOR
BETTER PREDICTION OF TOXICITIES

The Liver Toxicity Biomarker Study: A Systems Biology Approach to Idiosyncratic Liver Toxicity
James C. Fuscoe, Ph.D., Director, Center for Functional Genomics, U.S. Food and Drug Administration, National Center for Toxicological Research

Investigation of Drug-Induced Hepatotoxicity from a Drug Metabolism Perspective
Wei Tang, Ph.D., Distinguished Senior Investigator, Drug Metabolism and Pharmacokinetics, Merck Research Laboratories

Repression of PXR Activity and CYP3A4 Expression in Populations with Proliferating Hepatocytes
Taosheng Chen, Ph.D., Assistant Member, Chemical Biology and Therapeutics; Director, High-Throughput Screening, St. Jude Children’s Research Hospital

Once Initiated, How Does Liver Injury Progress?
Harihara M. Mehendale, Ph.D., Professor and Kitty DeGree Endowed Chair of Toxicology Department of Toxicology, College of Pharmacy, University of Louisiana at Monroe

Drug Safety Executive Council

The Drug Safety Executive Council (DSEC) is a peer-to-peer membership of drug safety leaders with the common objective of advancing the development of better and safer medicines worldwide. Membership in DSEC is limited to leaders representing companies who develop small and large molecule pharmaceuticals only.