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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)
Panelist
Peter W. Marks, MD, PhD
FDA, United States
Director, Center for Biologics Evaluation and Research
Panelist
Anne-Virginie L. Eggimann, MS
bluebird bio, Inc., United States
Chief Regulatory Offcer
Panelist
Sandy Macrae, PhD
Sangamo Therapeutics, United States
Chief Executive Officer
Panelist
Robert Pietrusko, PharmD
Voyager Therapeutics, United States
Senior Vice President, Regulatory Affairs and Quality Assurance
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