The second PSC Forum meeting was held on Tuesday, April 10, 2018 in Paris, France. 63 people attended PSC Forum 2. Of those, 55 attended in person and 8 attended remotely. 

 

Materials 

Agenda 

Participant List

Meeting Summary

Presentations

Session I: Overview & PSC Project Updates

Welcome & Introduction

Veronica Miller, Forum for Collaborative Research

Rob Myers, Gilead Sciences, Inc

Jessica Weber, Forum for Collaborative Research

PSC Project & Working Group Updates

PSC Patient Databases Working Group

Rachel Gomel, PSC Partners Seeking a Cure

PSC PRO Working Group

Doug Thorburn, Royal Free Hospital

PSC Inclusion/Exclusion Criteria Working Group

Gideon Hirschfield, University of Birmingham

Session II: Regulatory Perspectives 

Biomarkers of PSC Disease Progression

Lara Dimick-Santos, U.S. Food and Drug Administration

FDA: PSC Regulatory Updates

Veronica Pei, U.S. Food and Drug Administration

EMA: EU Perspective

Elmer Schabel, European Medicines Agency

Session III: Clinical Trial Management

Patient Recruitment, Retention, Eligibility and Screen Failure Rates

The Patient Perspective

Ricky Safer, PSC Partners Seeking a Cure

Academic Perspectives on Trials

Gideon Hirschfield, University of Birmingham

NGM282 Phase 2a Study in PSC

Stephen Rossi, NGM Biopharmaceuticals

Patient Recruitment and Retention in Phase 2 PSC Studies

Rob Myers, Gilead Sciences, Inc.

747-207 AESOP Overview and Inclusion/Exclusion Criteria

Richard Pencek, Intercept

Session IV: Wrap-Up

Additional Topics for Discussion

Veronica Miller, Forum for Collaborative Research