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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

Solange Corriol-Rohou, DrMed, MD, PhD

  • Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
  • AstraZeneca , 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)

Jacoline Bouvy, PhD

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
Claudine Sapède, PharmD

Adaptive Pathways: An Industry’s Perspective

Claudine Sapède, PharmD

  • Director, Global HTA Policy
  • Novartis Pharma AG, Switzerland
Richard Barker, PhD

Richard Barker, PhD

  • Founding Director
  • Centre for the Advancement of Sustainable Medical Innovation (CASMI), United Kingdom
Rosa Giuliani, MD

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