PRE -CONFERENCE WORKSHOPS
Monday 5th December 2017
Join one of our 3 pre-conference workshops to enhance your know-how
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