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Session 9: Advancing Hepatic Safety: Innovations in Predicting, Assessing, and Managing Drug-Induced Liver Toxicity
Session Chair(s)
Barbara Hendrickson, DrMed, MD
Clinical Associate, Pediatric Infectious Diseases, University of Chicago, United States
Hepatotoxicity is a leading cause of drug development discontinuation as well as drug withdrawal from the market due to safety reasons. Consequently, the prediction, assessment and management of potential drug induced liver toxicity is critical. In addition, the safe use of drugs in patients with underlying liver disease is an important issue. This session will discuss new thinking related to the hepatic safety of drugs.
Learning Objective : - Describe FDA's ISTAND Pilot Program and its role in advancing innovative science and technology, including applying predictive organ-chip technology to assess drug-induced liver toxicity (DILI) potential
- Appraise different approaches to the assessment of hepatic safety data
- List regulatory challenges in DILI risk assessment
Speaker(s)
Arie Regev, MD
Vice President, Medical Global Patient Safety , Eli Lilly and Company , United States
Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressing or Immunomodulating Drugs
Eric B Cohen, MD
Senior Medical Director, AbbVie, United States
DILI in the Elderly