Materials
Session I: Introductory Remarks and Program Overview
Introductions and Welcome
Judith Ertle, Boehringer Ingelheim
Veronica Miller, The Forum for Collaborative Research
Arun Sanyal, Virginia Commonwealth University
Session II: Treatment Response
Recap on NITs for Diagnosis and Prognosis
Arun Sanyal, Virginia Commonwealth University
Patient Monitoring using the ELF™ Test: The evidence so far…
Matthew Gee, Siemens Healthineers
NIT's and Treatment Response: MRE, MRI-PDFF and cT1
Michael Middleton, University of California, San Diego
Monitoring of Treatment Response with FibroScan-based Biomarkers
Céline Fournier, Echosens
Session III: Learning Lessions from Current Programs: Ocaliva
OCA Program Learnings
Michelle Berrey, Intercept Pharmaceuticals
Resmetirom: A Thyroid hormone Receptor-β Agonist for the Treatment of NASH PHASE 3 Results
Becky Taub, Madrigal Pharmaceuticals
Session IV: Cirrhosis Working Group Updates
Overview: Trials in Patients with Cirrhosis
Arun Sanyal, Virginia Commonwealth University
Compensated Cirrhosis Risk Stratification
Mazen Noureddin, Houston Research Institute
Application to Clinical Trials
Naga Chalasani, Indiana University School of Medicine and Indiana University Health
Session V: Placebo Arm Database and Digital AI/ML Histology Working Group Updates
Placebo Arm Database Working Group Update
Manal Abdelmalek, Mayo Clinic Rochester
Michael Cooreman, Inventiva Pharma
Digital AI/ML Histology Working Group Update
David Kleiner, National Institutes of Health
Session VI: Dialogue on AASLD Guidance for NASH, Employing NIT-based Referral Pathways for Clinical Trials
Understanding NIT to Optimize Enrollment in NASH Clinical Trials
M. Shadab Siddiqui, Virginia Commonwealth University
Session VII: Additional Working Group Updates and Day 1 Recap
Histology Working Group
Melissa Palmer, Liver Consulting LLC
Pooling of Endpoints and Combination Therapy Working Groups
Michelle Long, Novo Nordisk
Session VIII: Stretch Exercise: New Look at Statistics
Desirability of Outcome Ranking (DOOR) Analysis
Scott Evans, George Washington University
Hybrid Randomized/Real-World Data Designs: A Case Study of Semaglutide and Cardiovascular Outcomes
Lauren Dang, University of California, Berkeley
Session IX: NASH Drug Development in the Era of Approved Drugs
Session X: Wrap-Up: Where do we go from here?
