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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, 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
Senior Vice President, Molecule Discovery and Head of Infectious Disease, Eli Lilly and Company, United States
Panelist
Senior Advisor, Cell and Gene Manufacturing, Genentech, A Member of the Roche Group, United States
Panelist
Senior Vice President, CMC Operations, ElevateBio, United States
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