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Value, Access and Regulatory Strategy Workshop
Session 2: Adaptive Pathways and Innovative Medicines Development for Improved Access
Session Chair(s)
Solange Corriol-Rohou, DrMed, MD, PhD
- Senior Director, Global Regulatory Affairs & Policy, Europe
- Astrazeneca Research & Development, France
Adaptive Pathways should enable patients’ earlier access to promising treatments in areas of high unmet medical needs. This is certainly a sensitive and controversial concept which value is currently explored through the EMA Adaptive Pathways initiative and the IMI ADAPT SMART project. Numerous questions need to be addressed to make this concept a viable and efficient approach in Europe and beyond. What evidence should be generated, which tools and methods should be used or need to be developed, what criteria to fulfil to enter the adaptive pathways, when to leave the pathways, how to deal with product value uncertainties, how to address the criticisms, and what could be the impact on managed entry agreements?
Speaker(s)
Adaptive Pathways: An HTA Perspective
Jacoline Bouvy, PhD
- Scientific Adviser, Science Policy and Research Programme
- National Institute for Health and Care Excellence (NICE), United Kingdom
Adaptive Pathways: An Industry’s Perspective
Claudine Sapède, PharmD
- Director, Global HTA Policy
- Novartis Pharma AG, Switzerland
Richard Barker, PhD
- Founding Director
- Centre for the Advancement of Sustainable Medical Innovation (CASMI), United Kingdom
Adaptive Pathways: A Clinician's Perspective
Rosa Giuliani, MD
- Consultant in Medical Oncology, S. Camillo-Forlanini Hospital, Italy
- European Society for Medical Oncology (ESMO), Switzerland
