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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)
Gopalan Narayanan, MD, FFPM, FRCP
Vice President, Disruptive Biologics, Voisin Consulting Life Sciences, United Kingdom
How to Achieve Regulatory Approval of Cell and Gene Therapies
Chris Jenkins, PHD, MPH
Principal Partner and Chief Gene Therapy Biosafety Officer, Clinical Biosafety Services, LLC, United States
Human Gene Therapy: Biosafety to Bedside
Royce A. Morrison, MD, MS, FACP
Senior Consultant, Pacific Pharma Group, LLC, United States
Stakeholder Challenges in Early-Phase Studies of Potentially High-Risk Products
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