Materials
Session I: Clinical Trials for MASH: Anticipating Marketing Approval(s)
Welcome and Introductions
Veronica Miller, ForumUpdates from regulators
Joachim Musaus, EMA*Overview of clinical trials once therapeutics are approved for marketing
Veronica Miller, Forum
Session II: Lessons Learned
OCA Month 48 (histology, efficacy and safety) from the NASH / MASH program
Michelle Berrey, Intercept Pharmaceuticals
Challenges in continuing long-term randomization with drugs approved for marketing: COBALT
Michelle Berrey, Intercept Pharmaceuticals
Challenges with RWD-RWE in the liver disease space: HEROES STUDY
Paul Nitschmann, Intercept PharmaceuticalsResmetirom program updates
Becky Taub, Madrigal Pharmaceuticals
Session III: Collaboration for Greater Efficiency
Updates: Placebo Arm Database (PDB) Project
Chris Hoffman, Forum
Veronica Miller, Forum
Introduction to Clinical Research Data Sharing Alliance: Avenues for Collaboration with LF
Aaron Mann, Clinical Research Data Sharing Alliance (CRDSA)
Foundation for the National Institute of Health (FNIH)- NIMBLE
Alex Pasek, Foundation for the National Institutes of Health (FNIH)
Radiology Liver Diseases (RLD) Program
Michael Middleton, UCSD
Claude Sirlin, UCSD
Session IV: Standardizing for Greater Efficiency
Standardizing MASH NITs
Veronica Miller, Forum
Michelle Long, Novo Nordisk
Standardizing clinical outcomes assessments
Manal Abdelmalek , Mayo Clinic
Session V: Working Groups (WG) Updates
Combination Therapy
Michelle Long, Novo Nordisk
Pooling of Endpoints Across Trials
Michelle Long, Novo Nordisk
MetALD Program
Maja Thiele, Odense University
Nikhil Vergis, GSK
Session VI: Where Do We Go from Here?
Where Do We Go from Here?
Veronica Miller, Forum
*Remote participation
