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Radisson Blu

Oct 25, 2017 8:00 AM - Oct 26, 2017 3:30 PM

Steinentorstrasse 25, 4001 Basel, Switzerland

Value, Access and Regulatory Strategy Workshop

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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 INTERNATIONAL, 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

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