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Wednesday, June 17 • 11:30am - 12:30pm
#316 SL: Report of CIOMS DILI Working Group

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-672-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the principles in the detection, characterization and risk assessment of DILI in clinical trials and post-marketing, liver safety biomarkers and DILI risk stratification, risk minimization measures and risk communication.

Learning Objectives

Describe the accurate identification, assessment, and management of DILI risk; Discuss a new initiative to tackle this problem undertaken by an international working group of industry, academic, and regulatory experts; Examine the findings by CIOMS for best practices in DILI risk assessment and& management and biomarker development in clinical trials and the post-market.


Mark I. Avigan, MD


Introduction to the CIOMS Working Group
Mark I. Avigan, MD

Goals, Initiatives, and Context of the 2020 DILI Report
Herve Le Louet, DrMed, DrSc, MD, PhD, MS

Principles in the Detection, Characterization, and Risk Assessment of DILI in Clinical Trials
Arie Regev, MD

Steps Towards the Identification and Utilization of Liver Safety Biomarkers
Robert J. Fontana, MD

Best Practices in Postmarket DILI Risk Assessment, Risk Minimization, and Communication
Walter Straus

avatar for Walter Straus

Walter Straus

Vice President, Safety and PV, Moderna, United States
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →
avatar for Herve Le Louet

Herve Le Louet

President, Head of PV Coordination, CIOMS and APHP
Herve Le Louet is Professor of Clinical Pharmacology. He is currently head of Pharmacovigilance department of Paris University Hospitals (AP-HP). He is an hepatologist by training and has a PhD in Pharmacogenetic from the Paris University. He is the President of CIOMS and immediate... Read More →
avatar for Arie Regev

Arie Regev

Chair, Liver and GI Safety Committee, Eli Lilly and Company
Dr. Regev heads the safety advisory hub and chairs the liver and GI safety advisory committee at Eli Lilly. He serves as co-chair of the CIOMS drug induced liver injury (DILI) working group and co-chair of the immunotherapy working group of the IQ DILI initiative. He is an associate... Read More →
avatar for Mark Avigan

Mark Avigan

Associate Director, Office of Pharmacovigilance and Epidemiology, OPE, CDER, FDA
Mark Avigan, MD, CM, is Associate Director for Critical Path Initiatives in the Office of Pharmacovigilance and Epidemiology at the FDA. As a clinical hepatologist with expertise both in drug safety science and cellular regulation, he served as a division director in drug safety at... Read More →

Robert Fontana

Professor of Medicine, University of Michigan
Dr. Fontana is a clinical investigator with research interests in drug induced liver injury, viral hepatitis and acute liver failure. Dr. Fontana completed his gastroenterology/ hepatology training and is currently a Professor of Medicine and Medical Director of Liver Transplantation... Read More →

Wednesday June 17, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session