Hyman J. Zimmerman Hepatotoxicity State-of-the-Art Lecture

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Recorded On: 11/12/2018

Patients with underlying chronic liver disease (CLD) may develop drug-induced liver injury during clinical care or in clinical trials, and it is associated with poor outcomes. This lecture discusses medications and herbal agents that are commonly implicated in DILI, risk factors, strategies for  monitoring patients in clinical trials, guidelines for adjudicating suspected DILI events and outcomes associated with DILI in CLD.

Mark I. Avigan (Moderator)

Mark Avigan, MD, CM, FAASLD received his medical degree from McGill University and was a medical resident and GI fellow in the Georgetown VA Medical Center. Dr. Avigan is Associate Director for Critical Path Initiatives in the Office of Pharmacovigilance and Epidemiology at the U.S. Food and Drug Administration.  As a clinical hepatologist with expertise both in drug safety science and cellular regulation, he served as a division director at FDA in drug safety and more recently as an expert consultant for the evaluation of risk surrounding drug-induced liver injury during the life-cycle of drugs and biological agents.  Prior to joining FDA, Dr. Avigan served as a staff fellow at the NIH and then became a faculty member at the Georgetown University School of Medicine where he attended patients on the GI/Liver Service.  During that period, he led an NIH-funded laboratory as principal investigator to elucidate basic mechanisms in the transcriptional and post-transcriptional regulation of pathways critical for cellular growth and differentiation.  He   Dr. Avigan is currently an Adjunct Professor of Medicine at the GUMC and is a fellow of the American Association for the Study of Liver Diseases.  He has authored or co-authored approximately 140 scientific publications, book chapters and professional meeting abstracts.  He has been a long-standing member of the Drug Safety Oversight Board at the agency’s Center for Drug Evaluation and Research and continues to have an active role in national and international public-private partnerships that support enhancement in the scientific and clinical analysis of hepatotoxicity associated with pharmaceuticals and biological agents.

Naga P. Chalasani

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DILI in Chronic Liver Disease – The Next Major Hurdle
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Open to view video. Moderator: Raymond Chung Presenter: Naga Chalasani
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