Name
                                    Gene Therapy Breakout: Unique Ethical and Operational Issues in Gene Therapy Research
                                        Date & Time
                                    Tuesday, October 18, 2022, 11:30 AM - 12:15 PM
                                        Location Name
                                    Melrose 3
                                        Description
                                    This session will address special ethical considerations for gene therapy clinical trials for sites, IRBs, and sponsors. Discussion will include a case study of a pediatric gene therapy clinical for a neurodevelopmental disorder.
Speakers
                                    Daniel Kavanagh - Senior Scientific Advisor - WCG
Rafael Escandon - Principal - DGBI Consulting, LLC
Emma James - VP Medical & Patient Affairs - Encoded Therapeutics
                                Rafael Escandon - Principal - DGBI Consulting, LLC
Emma James - VP Medical & Patient Affairs - Encoded Therapeutics
 
  
 
Learning Objectives
                                    - Describe ethical considerations for gene therapy (GT) clinical trials
- Identify how do GT clinical trials differ from others (e.g., small molecules & biologics)
- Discuss what do sponsors need to consider prior to initiating GT development programs
This Module is Eligible for
                                    ACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
                                        CIP CEU Credits
                                    0.75
                                        ACRP CE Points
                                    0.75