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Gene Therapy Symposium

Track:
Nonclinical and Translational Development/Early Phase Clinical Development

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
285

Room Number:
7B

Level:
Intermediate

Type:
Symposium

Title:
Gene Therapy Symposium

Chair(s):
Barry Mangum, MD
Director, Clinical Pharmacology
Duke University Medical Center, United States

Description:
This symposium will include presentations that address the concept of biosafety with respect to gene therapy and application to clinical trials, discuss the potential pitfalls that could affect the development and approval of advanced therapies which are by nature complex, and examine how the various stakeholders can achieve benefit-risk assessments that satisfy their responsibilities for diligence.

Learning Objective(s):
List characteristics of gene therapy products that determine logistics at clinical sites; Explain how to plan the nonclinical and clinical development of complex biologicals such as advanced therapies; Discuss challenges presented by each stakeholder’s responsibilities in conducting early phase studies of products that entail potentially high and/or unanticipated risks; Explain how to plan the nonclinical and clinical development of complex biologicals such as advanced therapies.

Presentation(s) & Speaker(s):
How to Achieve Regulatory Approval of Cell and Gene Therapies
Gopalan Narayanan, MD, MRCP, FFPM, FRCP
Biologicals and ATMP Expert
NDA Regulatory Science Ltd., United Kingdom

Human Gene Therapy: Biosafety to Bedside
Chris Jenkins, PhD, MPH
Senior Director of IBC Services and Biosafety Consulting
WCG Clinical, United States

Stakeholder Challenges in Early-Phase Studies of Potentially High-Risk Products
Royce A. Morrison, MD, MS
Principal Consultant
RMD Insight LLC, United States