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Gene Therapy Symposium
Session Chair(s)
Barry Mangum, PharmD
Chief Executive Officer
Paidion Research, Inc., United States
Human Gene Therapy: Biosafety to Bedside
Learning Objective : 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.
Speaker(s)
How to Achieve Regulatory Approval of Cell and Gene Therapies
Gopalan Narayanan, MD, FFPM, FRCP
Voisin Consulting Life Sciences, United Kingdom
Vice President, Disruptive Biologics
Human Gene Therapy: Biosafety to Bedside
Chris Jenkins, PhD, MPH
Clinical Biosafety Services, LLC, United States
Principal Partner and Chief Gene Therapy Biosafety Officer
Stakeholder Challenges in Early-Phase Studies of Potentially High-Risk Products
Royce A. Morrison, MD, MS, FACP
Pacific Pharma Group, LLC, United States
Senior Consultant
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