The eighth Liver Forum was held on April 10, 2018 in Paris, France.
262 people attended Liver Forum 8. Of those, 167 attended in-person, and 95 people registered for the webcast.
Materials:
Presentations:
Session I:
- Welcome and Introduction
Katherine Greene, Forum for Collaborative Research - Champion of Collaboration Award
Awarded to CDR. Cheronda Cherry-France, U.S. Food and Drug Administration - Core Outcomes in NASH Project
Donna Messner, Center for Medical Technology Policy - U.S. Food and Drug Administration Regulatory Update
Lara Dimick-Santos, U.S. Food and Drug Administration
Session II: Breakout Sessions
- European Payer Perspective
Clinical Development of New Technologies for Non-Alcoholic Steatohepatitis: NICE Perspective
Francois Maignen, National Institute for Health and Care Excellence
EMA-HTA Parallel Scientific Advice
Samuel Mettam, Boehringer Ingelheim - NASH Biomarkers Update
CDER DDT Qualification: Impacts of 21st Century Cures Act, PDUFA VI, and Other Recent Changes
Christopher Leptak, U.S. Food and Drug Administration
NIMBLE Updates
Roberto Calle, FNIH Biomarkers Consortium
Rohit Loomba, University of California, San Diego
LITMUS Updates
Quentin Anstee, Newcastle University
LITMUS: Update on Fibrosis Markers
Detlef Schuppan, Mainz University Medical Center - NASH Cirrhosis Working Group
Working Group Overview
Arun Sanyal, Virginia Commonwealth University
Session III: Breakout Session & Working Group Reports
- Standard of Care: Lifestyle
Oliver Glass, Duke University - Standard of Care: Comorbidities
Vlad Ratziu, Université Pierre et Marie Curie Hopital Pitie Salpetriere - Case Definitions
Stephen Harrison, Pinnacle Clinical Research
Session IV: Combination Therapy
- EU Requirements for Fixed Dose Combinations and Lessons Learned from Hypertension and Diabetes: Implications for NASH
Elmer Schabel, European Medicines Agency/ BfArM - FDA Regulatory Considerations for Co-Development of Two or More New Investigational Drugs for Use in Combination in NASH
Stephanie Omokaro, U.S. Food and Drug Administration
