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Session 5 Track A - Regulatory Leadership: Challenges with Increasingly Smaller and Specific Patient Populations in Oncology
Session Chair(s)
Vratislav Hadrava, MD, PhD
Vice President and Medical Director, Global Innovative Products
Pfizer Canada, Inc., Canada
Development of new generations of innovative medicines is focusing on more and more specific molecular targets and on more and more specific patient populations. It is particularly evident in Oncology with increasingly specific and narrowed lines of therapies. The challenges associated with this trend are not dissimilar from those in rare disease and personalized medicine areas. In this session we will hear how regulators, industry and clinicians/researchers are seeing these challenges and their possible solutions.
Speaker(s)
Health Canada Perspective
Kelly Robinson, MSc
Health Canada, Canada
Director General, Marketed Health Products Directorate
Health Technology Assessment (HTA) Perspective
Mona Sabharwal
pCODR (pan-Canadian Oncology Drug Review) at CADTH, Canada
Executive Director
Industry Perspective
Christine Mormont, PhD
Merck Canada, Canada
Director, Medical Affairs - Oncology
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