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Session 9: New Thinking Impacting Hepatic Drug Safety
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 the FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program and the exploration of predictive organ-chip technology to screen for 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)
Screening, Monitoring, and Managing of Hepatitis B Virus (HBV) Reactivation in Clinical Trials with Immunosuppressing or Immunomodulating Drugs
Arie Regev, MD
Eli Lilly and Company , United States
Vice President, Medical Global Patient Safety
Speaker
Representative Invited
FDA, United States
Speaker
Representative Invited
Abbvie, United States