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Event Highlights

Immerse yourself in the latest information, approaches and successes from industry

HIGHLIGHTS FROM THE 2018 EVENT

Day One - 28th February 2018
  • How did Novartis win the CAR-T race in Europe?
  • What are the updates for the use of CAR-T therapies when it comes to solid tumours?
  • What can the EU/US and Asia learn from each other?
  • What biodegradable microcarriers are there for stem cell production and tissue implantation?
  • How can in process monitoring be used as part of a closed-cell culture system?
  • A closer look at expansion cell culture and cost saving and safety considerations
  • What are the best methods for conducting cost of goods calculations for cell therapy products?
Day Two - 1st March 2018
  • What are the regulatory and development status’ in both China and Taiwan?
  • The conditional and time-limited approval systems for new regenerative medicine in Japan
  • What considerations are there when taking allogeneic T cell therapies from bench to bedside?
  • How can you develop serum free culture conditions for CAR-T cell expansion?
  • What are the best methods for choosing your development partner?
  • What capabilities should your CDMO have?
  • How do you alleviate bottlenecks with regards to transportation strategies from manufacture to patient?
Additional Learning Opportunities

Workshops:

Tuesday 27th February - Comparability Testing for ATMPs

  • Introduction to comparability
  • Regulatory framework
  • Process and product characterisation
  • Comparability expectations during clinical development and post-approval
  • Examples of changes and comparability strategies and Case study exercise

Friday 2nd March  - Understanding Potency and Developing Potency Assays for ATMPs

Both workshops will be led by: Christopher Bravery, Consulting on Advanced Biologicals Ltd., Member, ISCT EU Legal and Regulatory Affairs Committee, UK