*All times Eastern Standard Time*

8:10 am Chair’s Opening Remarks

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

8:15 am Pediatric NAFLD/NASH Drug Development: Regulatory Guidelines, Challenges & Opportunities (Keynote)

  • Johannes Taminiau Pediatric Committee (PDCO), European Medicines Agency (EMA), Pediatric Gastroenterologist, European Medicines Agency (EMA)

8:45 am Revisiting US FDA Regulatory Guidance for Developing Therapy for Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Liver Fibrosis: What’s New?

  • Frank Anania Deputy Director for the Division of Hepatology & Nutrition (DHN), 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

  • Arun Khazanchi Principal Investigator, Florida Research Institute President, Florida Digestive Health Specialists
  • Catherine Kelly Director of Site Operations, Florida Research Institute

10:15 am Morning Break, Networking & Online Poster Session Opened

12:30 pm Lunch Break & Speed Networking Session Two

Looking Forwards: Key Points of Discussion for Future NASH Drug Development

1:30 pm Aramchol, Scientific Rationale & Clinical Development Targeting both NASH Resolution & Fibrosis Improvement

2:00 pm Rapidly & Directly Targeting Fibrosis: Progress and Promise

2:30 pm PXL770 – AMP-kinase Activator & PXL065 – Single Isomer of Pioglitazone: Novel First-in-Class Therapeutic Candidates for NASH

3:00 pm NASH Improvement or Resolution as a Predictor of Fibrosis Benefit

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

3:30 pm Afternoon Break & Networking

Looking Forwards: Key Points of Discussion for Future NASH Drug Development

4:00 pm Similarities & Differences in NASH & Alcoholic Steatohepatitis (ASH) in the clinic

  • Alina Allen Assistant Professor of Medicine, Director NAFLD Clinic, Mayo Clinic

4:30 pm Discussing NASH in the context of Cardiovascular Disease

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

5:00 pm Patient & Caregiver Fireside Chat: Outlook for 2021 from the Perspective of Patients & Caregivers

5:30 pm Chair’s Closing Remarks