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The Evolving Gene Therapy Regulatory Framework: A Brave New World
Session Chair(s)
Snehal Naik, PhD, MA
Regulatory Policy and Strategy Leader, Spark Therapeutics, United States
This forum will bring together panelists with regulatory expertise in gene therapy to present an update on recent changes to the regulatory framework and discuss its impact on the development of gene therapy products.
Learning Objective : Outline recent changes to the regulatory framework for gene therapies. Discuss impact on progression of new and existing development programs in gene, genetically-modified cells and genome editing; Identify areas and disciplines where gene therapy sponsors would like to see further change.
Speaker(s)
Peter Marks, MD, PhD
Senior Vice President, Molecul, Eli Lilly and Company, United States
Panelist
Anne-Virginie L. Eggimann, MS
Chief Regulatory Offcer, bluebird bio, Inc., United States
Panelist
Sandy Macrae, PhD
Chief Executive Officer, Sangamo Therapeutics, United States
Panelist
Robert Pietrusko, PharmD
Senior Vice President, Regulatory Affairs and Quality Assurance, Voyager Therapeutics, United States
Panelist
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