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Pharmacovigilance and Risk Management Strategies Conference

NEW! The 2019 meeting will be a full three days, allowing maximum learning opportunities!

Session 12: Drug-Induced Liver Injury: What Is New, the Impact of Immuno-Oncology Products on the Liver and Perspectives on Causality Assessments

Session Chair(s)

Stephen  Knowles, MD, MRCP

Stephen Knowles, MD, MRCP

  • Chief Medical Officer
  • Halozyme Therapeutics, United States
William  Gregory, PhD

William Gregory, PhD

  • Senior Director, Safety and Risk Management
  • Pfizer Inc, United States
It is critical to detect the hepatotoxic potential of drugs and to identify susceptible individuals at risk for both predictive and idiosyncratic liver toxicities. This is particularly important as immuno-oncology (IO) agents, e.g., checkpoint inhibitors, known to cause immune-mediated hepatitis, are used in increasingly broad populations as first-line treatment of malignancies and there is increasing understanding of drug-induced liver injury (DILI) in the setting of chronic liver disease. Recent advances in knowledge of immune-mediated hepatotoxicity secondary to IO agents and DILI application to classical will be reviewed. This will be followed by a discussion on DILI in patients with underlying liver disease, focusing on NASH. A panel discussion will conclude the session addressing points to consider in the pragmatic causality assessment of liver injury in the setting of exposure to IO agents.
Learning Objective : Upon completion of this session, the participant should be able to:
    Describe immune-related liver injury associated with immuno-oncology agents
  • Have an understanding of drug-induced liver injury in the setting of chronic liver disease
  • List practical points to consider in assessing and communicating causality of immune-mediated liver injury


David  Paar

Immuno-oncology (IO) Agents and Drug Induced Liver Injury (DILI)

David Paar

  • Associate Medical Director, Medical Safety Assessment
  • Bristol-Myers Squibb, United States
Arie  Regev, MD

Detection and Assessment of Drug Induced Liver Injury (DILI) in Patients with NASH

Arie Regev, MD

  • Chair, Liver and GI Safety Committee
  • Eli Lilly and Company , United States
Mark I. Avigan, MD

Speaker (no slides)

Mark I. Avigan, MD

  • Associate Director, Office of Pharmacovigilance and Epidemiology, OPE, CDER
  • FDA, United States