The third PSC Forum and tenth Liver Forum were held September 19-20, 2019 in Bethesda, Maryland. 247 people attended and Of those, 160 attended in-person, and 87 people registered for the webcast.
Materials:
Presentations:
Day 1
Session I: PSC Forum Updates
PSC Forum Project Updates
Jessica Weber, Forum for Collaborative Research
IQ DILI Consensus Guidelines PSC
Melissa Palmer, Takeda
IPSCSG & Meta-Analysis Project
Gideon Hirschfield, Toronto Centre for Liver Disease
PSC Endpoints Working Group
David Assis, Yale University School of Medicine
Update from PSC Partners Seeking a Cure
Ricky Safer, PSC Partners Seeking a Cure
Session II: PSC Regulatory & Clinical Trials Update
PSC Regulatory Updates - PSC Clinical Trials Design
Elmer Schabel, BfArM/ European Medicines Agency
Primary Sclerosing Cholangitis Regulatory Updates And Knowledge Gaps
Ruby Mehta, U.S. Food and Drug Administration
Landscape of Clinical Trials
Keith Lindor, Arizona State University
Phase 3 Trial Endpoints
Gideon Hirschfield, University of Toronto
Session IV: Liver Forum Updates
Liver Forum Project Updates
Katherine Barradas, Forum for Collaborative Research
Session V: Biomarker Development
Biomarkers and Drug Development: Regulatory Perspective
Christopher Leptak, U.S. Food and Drug Administration
NASH Consortia Update - LITMUS
Quentin Anstee, Newcastle University
NASH Consortia Update- NIMBLE Project
Arun Sanyal, Virginia Commonwealth University
Day 2
Session I: NASH Combination Therapy
Combination Development for Pre-Cirrhotic NASH
Brent Neuschwander-Tetri, Saint Louis University
Combination Therapy in Cirrhotic NASH
Julia Wattacheril, Columbia University
Session II: NASH Regulatory Considerations
NASH Regulatory Update: EMA
Elmer Schabel, BfArM/ European Medicines Agency Non-Alcoholic Steatohepatitis (NASH) - The FDA Perspective
Yao-Yao Zhu, U.S. Food and Drug Administration
Innovations in Clinical Trial Designs for NASH
Arun Sanyal, Virginia Commonwealth University
Session III: Parallel Breakout Sessions
NASH Cirrhosis Working Group Compensated NASH Cirrhosis: Risk Stratification
Mazen Noureddin, Cedars-Sinai Medical Center NASH Cirrhosis
Jasmohan Bajaj, Virginia Commonwealth University
Pediatric Issues in NASH Working Group Defining Response in Pediatric NAFLD - Surrogate Biomarkers
Miriam Vos, Emory University Type 2 Diabetes as a Clinical Endpoint in Pediatric NASH
Stavra Xanthakos, Cincinnati Children's Hospital
Biomarker Development: Diagnostics Diagnostic/Biomarker Development
John Sninsky, Independent
