PSC Forum 1

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The first PSC Forum meeting was held on Thursday, October 19, 2017 in Washington D.C. 63 people attended PSC Forum 1. Of those, 60 people attended in person and 3 attended remotely.

 

Materials

Presentations

Session I: Overview & PSC Project Updates

Welcome & Introduction

Veronica Miller, Forum for Collaborative Research

Keith Lindor, Arizona State University

Rob Myers, Gilead Sciences, Inc

 

PSC Project & Working Group Updates
PSC-Specific ICD-10 Code

Ricky Safer, PSC Partners Seeking a Cure

Quality of Life Measure for PSC

Martine Walmsley, PSC Support

PSC Inclusion/ Exclusion Criteria and iPSCsg Update

Gideon Hirschfield, University of Birmingham

PSC Patient Databases

Rachel Gomel, PSC Partners Seeking a Cure 

 

Session II: Regulatory Perspectives

FDA: PSC Pathways and Endpoints

Suna Seo, U.S. Food and Drug Administration

EMA: EU Perspective

Elmer Schabel, European Medicines Agency 

 

Session III: Clinical Trial Management Session

Lessons Learned: Simtuzumab Program

Rob Myers, Gilead Sciences, Inc.