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]