February 2019
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Morning Workshop
Tuesday 20th February 2018

09.00 - 12.00

Accessibility and Affordability: How Do We Ensure This?


Workshop Leader: Mark McCall, Centre for Biological Engineering, Loughborough University Workshop Leader: Detlev Parow, Head, Care Management Development, DAK-Gesundheit Workshop Leader: Grace Hampson, Senior Economist, The Office of Health Economics

The first CAR-T was priced at $475,000 and the second at $373,000. Whilst not the most expensive, these therapies offer life-changing treatment options and thus the affordability debate has to be balanced with the accessibility debate.

Attend this session to discuss:
 

  • Pricing and market access
  • Value based pricing for non-paediatric indications
  • Pricing launch insights
  • Alternative pricing models
  • Health economics across the globe
  • Global payer systems
  • CAR-T pricing and insurance coverage
  • Ensuring accessibility to all patients

Leave with a full understanding of the various pricing and reimbursement strategies and business models for CAR-T and TCR therapies and how we can ensure affordability and accessibility of these ground-breaking therapies.

Mark McCall, Centre for Biological Engineering, Loughborough University

Detlev Parow, Head, Care Management Development, DAK-Gesundheit

Grace Hampson, Senior Economist, The Office of Health Economics

Afternoon Workshop
Tuesday 20th February 2018

13.00 - 16.00

Navigating the Regulatory Minefield: From Trials to Approval


Workshop Leader: Martina Schussler-Lenz, Chair CAT, EMA

With the next CAR-T approval set to come from the EMA, understanding the regulations from IND submission through to drug approval is important to ensure the success of your therapeutic.

Attend this session with the Chair of the CAT at the EMA to discuss:

  • Regulator’s point of view and experiences
  • Emerging FDA policies for CGT development
  • Regulatory frameworks for autologous cell therapies
  • Regulatory guidelines for allogeneic therapies
  • Chances of obtaining Breakthrough/PRIME Designation
  • Regulatory expectations from safety criteria through to CMC
  • Regulatory expectations for drug approvals in developing nations
  • Registration of CART products

Leave this session with the regulatory perspectives and guidelines for the development and approval of novel cell and gene immunotherapies.

Martina Schussler-Lenz, Chair CAT, EMA