American Society of Hematology

2018 Schedule and Program for the FDA-ASH Sickle Cell Disease (SCD) Clinical Endpoints Workshop

The FDA-ASH SCD Clinical Endpoints Workshop took place over the course of two days; below is an overview of each day.

7:00 a.m.
Registration and Breakfast Available
8:00 a.m.
Welcome and Introductions
Alexis A. Thompson, MD, MPH
ASH President
Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University
8:15 a.m.
Workshop Objectives and Regulatory Background
Ann Farrell, MD
Workshop Co-Chair
U.S. Food and Drug Administration
8:30 a.m.
Overview of SCD Endpoints: Then, Now, and Beyond
Julie Panepinto, MD, MSPH
Workshop Co-Chair
Medical College of Wisconsin
9:00 a.m.
Panel Session: Patient Reported Outcomes (PROs)
Patrick Carroll, MD
Panel Chair
Johns Hopkins University
10:30 a.m.
Coffee Break
10:45 a.m.
Panel Session: Pain (non-PROs)
Deepika S. Darbari, MD
Panel Chair
Children’s National Medical Center
12:15 p.m.
Lunch
1:15 p.m.
Panel Session: Brain
Allison King, MD, MPH
Panel Chair
Washington University in St. Louis
2:45 p.m.
Coffee Break
3:00 p.m.
Panel Session: End Organ Considerations
Panel Chair
Jeffrey Lebensburger, DO
University of Alabama at Birmingham
4:30 p.m.
Workshop Day 1 Wrap-Up
5:00 p.m.
Adjournment
Monday
December 3
7:00 a.m.
Registration and Breakfast Available
7:30 a.m.
Panel Session: Biomarkers
Ankit Desai, MD
Panel Chair
Indiana University
9:00 a.m.
Coffee Break
9:15 a.m.
Panel Session: Endpoints for How to Measure Cure
Mark Walters, MD
Panel Chair
Children’s Hospital of Oakland
10:45 a.m.
Coffee Break
11:00 a.m.
Panel Session: Considerations of Endpoints for Low Resource Settings
Adetola A. Kassim, MD, MS
Panel Chair
Vanderbilt University
12:15 p.m.
Lunch
1:00 p.m.
Patient Panel
1:50 p.m.
Industry Panel
2:40 p.m.
Research Organization Panel
3:30 p.m.
Workshop Summary and Closing Remarks
4:00 p.m.
Adjournment
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