The seventh Liver Forum was held on October 19, 2017 in Washington, D.C.
271 people attended Liver Forum 7. Of those, 189 people attended in-person, and 82 people registered for the webcast.
271 people attended Liver Forum 7. Of those, 189 people attended in-person, and 82 people registered for the webcast.
Materials
Presentations
Session I: Liver Forum Overview
- Introduction & Liver Forum Updates
Katherine Greene, Forum for Collaborative Research - Regulatory Perspective Updates:
1. FDA Introductory Remarks
Lara Dimick-Santos, CDER, U.S. Food and Drug Administration
2. The Liver Forum: Regulatory update from Europe
Elmer Schabel, European Medicines Agency
3. FDA/CDRH perspectives on validation of IVD biomarkers
Irene Tebbs, CDRH, U.S. Food and Drug Administration
4. FDA/CDRH perspectives on imaging biomarkers: technical performance and analytical validation
Dan Krainak, CDRH, U.S. Food and Drug Administration
- Compensated Cirrhosis & Clinically Meaningful Benefit
Naga Chalasani, Indiana University School of Medicine - Cirrhosis Endpoints: ACLF and MELD
Rajiv Jalan, University College London - Decompensated Cirrhosis: Endpoints and Experience in U.S. Phase 2B/3 Trials
Arun Sanyal, Virginia Commonwealth University
Session III: U.S. Payer and Care Delivery Perspectives
- Medicare Coverage: A Review
Louis Jacques, ADVI
Session IV: Working Groups
- Case Definitions Working Group
Brent Tetri, Saint Louis University
Sophie Megnien, Genfit - Pediatric Issues Working Group
Miriam Vos, Emory University - Placebo Arm Data Working Group
Eric Lefebvre, Allergan - Standard of Care Working Group
Manal Abdelmalek, Duke University
Sven Francque, Antwerp University Hospital