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Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle?
Session Chair(s)
Nancy Bradish Myers, JD
CEO and Founder
Catalyst Healthcare Consulting, Inc, United States
FDA at multiple levels, from the Commissioner to CBER Director to reviewers, has identified manufacturing as the most crucial issue in gene therapy. The panel will focus on innovation in this area and how the pioneers hope to overcome capacity limits
Learning Objective : Describe the current state of gene therapy manufacturing; Analyze the challenges associated with manufacturing of gene therapies; Identify potential solutions to issues related to gene therapy manufacturing.
Speaker(s)
Panelist
Peter W. Marks, MD, PhD
FDA, United States
Director, Center for Biologics Evaluation and Research
Panelist
Karen Walker
Genentech, A Member of the Roche Group, United States
Senior Advisor, Cell and Gene Manufacturing
Panelist
Mike Paglia
ElevateBio, United States
Senior Vice President, CMC Operations
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