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Innovative Therapies in Europe

DIA-EUCOPE Workshop: 5 Years of ATMPs on the Market - Lessons Learned

Session 4: Early Access Paths in Europe

Session Chair(s)

Michela  Gabaldo, PharmD, MSc

Michela Gabaldo, PharmD, MSc

  • Evotec, Italy

Topics covered in this session include:

  • How unified is the approach to early access?
  • Available Early Access Schemes
  • Challenges with ATMPs
  • Return on Investment issues
  • Chronic vs. one-time use drugs
  • Outcome based agreements
  • Compassionate use vs. Early Access Schemes


Sandra  Petraglia, MD, PhD

Sandra Petraglia, MD, PhD

  • Head of Pre Authorisation Department
  • AIFA - Agenzia Italiana Del Farmaco, Italy
Oswald  Bentinck

Industry Perspective: Available Early Access Schemes

Oswald Bentinck

  • Vice President, Global Head of Value & Access
  • Rocket Pharmaceuticals, Inc., United States
Nicolas  Koebel

Case Study: Early Access Paths working for ATMPs

Nicolas Koebel

  • Chief Executive Officer of EpilepsyGTx Limited
  • EpilepsyGTx Limited, United Kingdom

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