AASLD-FDA-NIH-PhRMA Hepatotoxicity Steering Group Meeting, 2006 Presentations

Session I. Non-Clinical Prediction (Patrick Wier, Moderator)
Can pre/non-clinical studies really predict that a drug will be hepatotoxic to people?

• Patrick J. Wier, PhD, GlaxoSmithKline, Integrating liver toxicogenomics with clinical pathology, histopathology and drug metabolism data in preclinical studies – GSK perspective
• Donald G. Robertson, PhD, DABT, Pfizer, Metabonomics in Preclinical Assessment of Hepatic Toxicity
• Craig E. Thomas, PhD, Lilly Research Laboratories, Metabonomics: Using biofluid metabolite profiling to assess pre-clinical hepatotoxicity
• James E. Sanders, DVM, PhD, DABT, Johnson and Johnson, New developments in preclinical prediction of human hepatotoxicity
• Robert N. McBurney, PhD, BG Medicine, Inc., The Liver Toxicity Biomarkers Study CRADA
• Yvonne P Dragan, PhD, Food and Drug Administration, The critical path to new medical products

Session I Questions and Answers [PDF]

Session II. Liver Adaptation to Injury (Paul Watkins, Moderator)
How does the liver adapt to xenobiotic injury and become tolerant?

• John R. Senior, MD, Food and Drug Administration, Adaptation to Liver Injury: Tacrine, Isoniazid, Ethanol, Experimental Drugs
• Lance R. Pohl, Pharm.D., PhD, NHLBI, NIH, Role of cytokines and other factors in protecting the liver from drug-induced disease
• Harihara M. Mehendale, PhD, University of Louisiana, Liver tissue repair, survival factors, and adaptation to injury
• Rebecca Taub, MD, Hoffmann- La Roche, Interplay Between Liver Regeneration and Hepatoprotection
• Jack Uetrecht, MD, PhD, University of Toronto Tolerance
• Paul B. Watkins, MD, University of North Carolina, Chapel Hill, The way forward toward improved biomarkers
• Daniel K. Burns, PhD, GlaxoSmithKline, Investigating the role of inheritance in drug induced hepatotoxicity

Session II Questions and Answers [PDF]

Session III. Attribution of Causality (Len Seeff, Moderator)
How likely is it that a drug really caused the injury, and if so which drug?

• Leonard B. Seeff, MD,  NIDDK, NIH, The problems of establishing causality
• James Freston, MD, PhD, University of Connecticut School of Medicine, Use and limitations of the RUCAM
• Don Rockey, MD, University of Texas Southwestern, Method of DILIN in establishing causality
• William M. Lee, MD, University of Texas, Criteria for causality assessment in drug-induced liver injury (DILI): results from the Acute Liver Failure (ALF) Study Group
• Herbert L. Bonkovsky, MD, University of Connecticut, Immunological tests for improving causality assessment
• Tim Davern, MD, University of California San Francisco, Can we replace opinion consensus with a Bayesian process?
• Mark Avigan, MD CM, Food and Drug Administration, Characterization of risk for drug-induced serious liver injury prompted by a series of spontaneously reported post-marketing cases
• Naga Chalasani, MD, Indiana University, Update on the DILIN

Session III Summary [PDF]