Session VI: Deep-dive Innovations in Design

The final session will focus on clinical trial endpoints in NASH cirrhosis trials as well as genetic targets for both non-cirrhotic and cirrhotic NASH trials. The meeting will wrap up with an update from the FDA on regulatory guidance for therapeutic development in NASH with fibrosis. 

SPEAKERS

Moderators:
Rohit Loomba, MD 
Mary E. McCarthy Rinella, MD, FAASLD

Presenters:
Juan G. Abraldes, MD - Clinical Endpoints, Sample-size for Phase 2b and Phase 3 Trials in NASH Cirrhosis
Quentin M. Anstee, MBBS, PhD, FRCP - Genetic (PNPLA3, TM6SF2 and HSD17B13) Targetting of Therapies of NASH and Cirrhosis
Frank A. Anania, MD, FAASLD, FACP, AGAF - FDA Regulatory Guidance for Developing Therapy for Non-cirrhotic Non-Alcoholic Steatohepatitis (NASH) with Liver Fibrosis: What’s New?