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Innovative Therapies in Europe
Session 4: Early Access Paths in Europe
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
- Head of Pre Authorisation Department
- AIFA - Agenzia Italiana Del Farmaco, Italy
Industry Perspective: Available Early Access Schemes
- Vice President, Global Head of Value & Access
- Rocket Pharmaceuticals, Inc., United States
Case Study: Early Access Paths working for ATMPs
- Chief Executive Officer of EpilepsyGTx Limited
- EpilepsyGTx Limited, United Kingdom