PDA Pacific NW: The Commercialization of Gene and Cellular Therapies Dinner

Seattle, WA
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The PDA Pacific NW chapter invites you to an in-depth and informative dinner discussion with Dr. Kimberley Buytaert-Hoefen, PhD who will lead the talk on incorporating cGMP into the manufacturing environment as required by regulatory authorities to ensure safety and efficacy of gene and cellular therapy products.  This presentation will cover the various aspects of commercializing gene and cellular therapy. It discusses the pathway from early concept discovery through to pre-clinical, clinical and commercial manufacturing including the application process for Initial Targeted Engagement for Regulatory Advice for CBER products (INTERACT), Investigational New Drug (IND) and Biological License Application

Day 1

  • 5:30 pm Doors Open for Networking
  • 6:00 pm - 6:45 pmBuffet Dinner Served
  • 6:45 pm Presentation and Discussion
  • 8:15 pm Closing Remarks
Agenda is subject to change.

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