Rechallenge After Drug-Induced Liver Injury: A Debate of the Merits and Hazards From Industry, the US Food and Drug Administration, and Clinical Academia | AASLD

Rechallenge After Drug-Induced Liver Injury: A Debate of the Merits and Hazards From Industry, the US Food and Drug Administration, and Clinical Academia

Nov 10 2025
Convention Center: Room 143, Level 1
9:45 AM - 10:45 AM

World Class Speakers

Mark Avigan, MD, CM, FAASLD
Presenter

Mark Avigan, MD, CM, FAASLD

Food and Drug Adminstration
Eric Cohen, MD
Presenter

Eric Cohen, MD

AbbVie
James H Lewis, MD, FAASLD
Presenter

James H Lewis, MD, FAASLD

Georgetown University Hospital
Arie Regev, MD, MD, FAASLD
Panelist

Arie Regev, MD, MD, FAASLD

Eli Lilly and Company
Don C. Rockey, MD, FAASLD
Panelist

Don C. Rockey, MD, FAASLD

Medical University of South Carolina
Melissa Palmer, MD, MD, FAASLD
Presenter

Melissa Palmer, MD, MD, FAASLD

CEO Liver Consulting LLC
Raul J. Andrade, MD, PhD, FAASLD
Moderator

Raul J. Andrade, MD, PhD, FAASLD

UNIVERSIDAD DE MÁLAGA
Melissa Palmer, MD, MD, FAASLD
Moderator

Melissa Palmer, MD, MD, FAASLD

CEO Liver Consulting LLC

Description

Hepatologists are often asked if a patient can restart a medication after an episode of DILI. Utilizing a friendly debate format, presenters highlight key points about the risk/benefit analysis in rechallenge and how to indentify patients suitable for a rechallenge trial. In addition, specific case scenarios with common medications are addressed. Given the nuances involved, the panel comprises stakeholders from academia, the pharmaceutical industry, and regulatory agencies to provide their perspective on the issue of rechallenge after DILI.

Journey Maps

Presentations

9:45 AM - 9:55 AM
Oct 09 2026
Convention Center - Room 143, Level 1

Introduction and Conclusion

Melissa Palmer, MD, MD, FAASLD , Presenter
Drug-Induced Liver Injury
9:55 AM - 10:05 AM
Oct 09 2026
Convention Center - Room 143, Level 1

Rechallenge: A Regulatory Perspective on Pros and Cons

Mark Avigan, MD, CM, FAASLD , Presenter
Drug-Induced Liver Injury
10:05 AM - 10:15 AM
Oct 09 2026
Convention Center - Room 143, Level 1

Pros and Cons of Rechallenge During Drug Development and Clinical Trials

Eric Cohen, MD , Presenter
Drug-Induced Liver Injury
10:15 AM - 10:25 AM
Oct 09 2026
Convention Center - Room 143, Level 1

Rechallenge: Pros and Cons From a Scientific Causality Perspective

James H Lewis, MD, FAASLD , Presenter
Drug-Induced Liver Injury
10:25 AM - 10:45 AM
Oct 09 2026
Convention Center - Room 143, Level 1

Panel Discussion

Raul J. Andrade, MD, PhD, FAASLD , Moderator
Drug-Induced Liver Injury

Objectives

  • Summarize the existing data regarding rechallenge after an episode of DILI.
  • Review the considerations to be weighed in determining whether to give an alternative medication from the same drug class after DILI from the original medication.
  • Describe the circumstances in which to consider rechallenge.