• June 3-6, 2024
  • San Diego Convention Center, California

Sessions

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Quality Standards for Final Preparation of CGT Product at Point of Care (POC)

Monday, June 03, 2024
Breakout Session
Cell and Gene Therapy and Genome Editing
31AB
This session will focus on the considerations for global harmonization of quality standards and the definition of the steps required after batch release and prior to administration to the patient (in an opened, closed or hybrid system) at a site close to patient care (POC, e.g., hospital). Representatives from EMA and FDA will be invited to share their perspective and current thinking on the topic. Panelists will present a summary of the BIO survey on current industry practice at POC, points of consideration on quality standards for cell and gene therapy reconstitution steps taking place at POC, including studies to support the quality standards to ensure patient safety, and case studies and innovative approaches at POC to frame the discussion.
Moderator
Maria Amaya
Lead External Advocacy, Quality Policy and Advocacy
Genentech, A member of the Roche Group
Speakers
Lesbeth Rodriguez
Director, Regulatory Affairs, Policy and Innovation
Bayer
Maria Sørensen, PhD
Specialist, RA CMC Lead
Novo Nordisk
Steffen Thirstrup, MD, PhD
Chief Medical Officer
European Medicines Agency (EMA)
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