14:00pm Chair Introduction

Chairperson: Katrien Reynders, Board Member, HollandBIO

14:05pm Presentation: The Updated European Ecosystem for Cell and Gene Therapies – What Does the Future of ATMP Policy and Access Look Like?

• The proposed changes to the pharmaceutical package impacting the attractiveness of the EU as a place for investment and launch: 

• Key changes that will impact the future of ATMPs in the EU include: 

• A revision of the GMO framework, hospital exemption provisions, and EMA structure represents an important update to the regulatory system; 
• The changes to the incentive structure, including a UMN concept and ‘launch conditionality’ will be particularly acute in the case of novel therapies like ATMPs. How will that impact investment decisions as well as pricing and launching considerations? 

• The current state of play of the EU HTA and its impact on ATMP launches in the EU; ATMPs will be subject to the EU HTA in less than 2 years – is the EU ready 

Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

14:20pm Presentation: Successful Implementation of CAR-T Requires a Private–Public Partnership

• Early preparation and planning 
• New ways of working  
• SWECARNET  – a unique network

Åse Rosenqvist, Nordic Business Unit Lead Cell Therapy, Janssen

14:35pm Closing Panel with Q&A

With all session participants and joined by: 

Bernd Eschgfäller, Independant Board Member, T-CURX