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Session 5: Plenary Session: International Collaboration Part 1
Session Chair(s)
Melissa Hunt, MSc
Director
Health Canada, Canada
Yatika Kohli, PhD, MBA
Chief Regulatory and Strategy Officer
NoNO Inc, Canada
Judith Mergl, MSc
Director, Regulatory Affairs and Operational Services
AbbVie Corporation, Canada
Following the FDA, Health Canada and Australia Therapeutic Goods Administration’s first Project ORBIS action in September 2019, the international community has seen an increase in earlier approvals of oncology products in countries where there can be timing delays of regulatory submissions when compared to the United States. This initiative from the FDA’s Oncology Center of Excellence (OCE) brings together regulators from multiple countries (such as Canada, Australia, Singapore and Switzerland) to collaborate on the review of cancer drugs so that patients can receive earlier access to needed treatments. This plenary session will showcase this new initiative from a regulatory perspective, and will also include a patient organization’s perspective on Project ORBIS, and what this may mean for Canadian patients.
Learning Objective : At the conclusion of this session, participants should be able to:- Explain Project ORBIS and its future direction
- Recognize what drug candidates may be considered for a Project ORBIS collaboration
- Discuss what this initiative may mean for Canadian patients
Speaker(s)
Project ORBIS- A New Way of Collaborating
Dianne Spillman
U.S. Food and Drug Administration , United States
Associate Director, Global Regulatory Outreach, OCE
Health Canada’s Experience with Project ORBIS
Kelly Robinson, MSc
Health Canada, Canada
Director General, Marketed Health Products Directorate
Patient Perspectives on Project Orbis for Novel Cancer Therapies and Beyond
Durhane Wong-Rieger, PhD, MA
Canadian Organization For Rare Disorders, Canada
President and Chief Executive Officer