The Learning Center

Regulatory Landscape for Approval of New Products


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This is the recording and slides of the session presented live at the 2023 AcCELLerate Forum: Creating a Sustainable Ecosystem of Cell and Gene Therapy. The event aired live on Monday, October 2, 2023. 

Topics include:

  • Engineered Cell Therapies: Where Were We? Where Are We? Where Are We Going? 
  • Approval Strategies for New Therapies
  • Regulatory Process for Approval in the CD 19 Space and Beyond

Session Chairs:

  • Marcelo Pasquini, MD, MS; CIBMTR and MCW
  • Peter Marks, MD, PhD; FDA

Speakers: 

  • Bruce Levine, PhD; University of Pennsylvania
  • David Chang, MD, PhD; Allogene
  • Nicole Verdun, MD; FDA

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Engineered Cell Therapies: Where Were We? Where Are We? Where Are We Going?
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Approval Strategies for New Therapies
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Regulatory Process for Approval in the CD 19 Space and Beyond
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Panel Discussion
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Session Slides
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