Materials

Session I: Liver Forum Overview

• Introduction & Liver Forum Updates
  Katherine Greene, Forum for Collaborative Research
• Regulatory Perspective Updates:
  
  1. FDA Regulatory Project Managers: What We Do and the Changes Coming for You
  Anissa Davis-Williams, U.S. Food and Drug Administration
  
  2. FDA Introductory Remarks
  Stephanie Omokaro,U.S. Food and Drug Administration
  
  3. Regulatory update from Europe: Interim Endpoints in Phase 3 NASH Trials
  Elmer Schabel, European Medicines Agency

Session II: Fibrosis in the Context of NASH

• Session Introduction
  Vlad Ratziu, Hôpital Pitié Salpêtrière
• Liver Fibrosis in NASH: A Roadmap for Drug Discovery and Pharmacotherapy
  Detlef Schuppan, Mainz University Medical Center
  
• Challenges and Opportunities in Clinical Trials Focusing on Fibrosis
  Arun Sanyal, Virginia Commonwealth University
  

Session III: Clinical Trial Management

• Common Issues in Clinical Trials: Patient Recruitment, Retention, Eligibility, and Screening Failure
  Sven Francque, University Hospital Antwerp
  

Session IV: Working Groups

• Case Definitions Working Group
  Sophie Megnien, Genfit
• Pediatric Issues Working Group
  Miriam Vos, Emory University
• Placebo Arm Data Working Group
  Eric Lefebvre, Allergan
  Veronica Miller, Forum for Collaborative Research