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Enhance your knowledge with a pre-conference workshop

PRE -CONFERENCE WORKSHOPS

Applying new technologies to ATMPs: Gene Editing and CRISPR
  • A brief introduction and assessment of CRISPR technology and other gene editing approaches: pros and cons
  • Case studies of major players in the CRISPR space
  • The CRISPR market and how it is expected to grow and change in the near future based on analysis of pre-clinical research
  • Update on the IP landscape for CRISPR
  • Analysis of the research literature to determine long term expected change
  • The application of CRISPR to cell therapies, e.g. CAR-T
  • Early regulatory considerations for CRISPR – analysis of ATMPs and extrapolation to CRISPR
Comparability for ATMPs
  • What is comparability?
  • Why is meeting existing specifications not comparability?
  • How do I apply the principles of comparability to highly variable products?
  • Case studies: Common mistakes with comparability and their consequences.
  • Interactive exercise: Spot the weaknesses and propose improvements to a worked comparability study.
Viral Safety for ATMPs
  • Regulatory Overview
  • Human-derived Raw Materials
  • Animal-derived & Recombinant Raw Materials
  • Viral Safety Concepts for ATMPs