8:10 am Chair’s Opening Remarks

One Cell at a Time: Harnessing Diseased Liver Tissues to Understand Human NASH

8:15 am Non-Canonical Functions of Cell Death Proteins in Murine Models

  • Laura Nagy Professor Molecular Medicine, Staff in Pathobiology & Gastroenterology, Lerner Research Institute, Cleveland Clinic

The Rationale Behind the Guidelines: Navigating FDA’s Regulatory Considerations for NASH

8:45 am Regulatory Guidance for NASH with Compensated Cirrhosis

  • Frank Anania Acting Clinical Team Leader, Division of Gastroenterology & Inborn Errors Products, FDA

9:15 am Regulatory Considerations for NASH with Liver Fibrosis & with Compensated Cirrhosis (Keynote)

  • Joachim Musaeus Scientific Administrator & Product Lead Gastroenterology , European Medicines Agency (EMA)

Recruiting Patients who Don’t Know They Have NASH

9:45 am Secrets to Designing a Winning NASH Trial

10:15 am Morning Break & Networking

10:45 – 11:15 Tech Slam & Poster Session Presentations

1:15 pm Lunch & Networking

Forward Thinking Questions for the Next Generation of Clinical Results

2:15 pm Similarities & Differences in NASH & Alcoholic Steatohepatitis (ASH)

  • Vijay Shah Consultant, Division of Gastroenterology & Hepatology, Department of Internal Medicine, Mayo Clinic

2:45 pm Discussing NASH in the context of Cardiovascular Disease

  • Kathleen Corey Director, MGH Fatty Liver Clinic, MGH Gastrointestinal Unit , Massachusetts General Hospital

3:15 pm NASH Improvement or Resolution as a Predictor of Fibrosis Benefit

  • Becky Taub Chief Medical Officer, Executive Vice President, Research & Development, Madrigal Pharmaceuticals

3:45 pm Chair’s Closing Remarks