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Session 11 – HOT TOPIC PANEL: Earlier Access vs. Additional Safety?
Session Chair(s)
Dipti Kalra, RPh
Team Leader, Office of Scientific Investigations, OC, CDER
FDA, United States
Annette Stemhagen, DrPH, PhD, FISPE
Chief Science Officer
UBC, United States
Patients need faster access to innovative, effective and safe medicines, especially in cases where there are no adequate treatments available. In 2012, the US Food and Drug Administration (FDA) introduced a new regulatory pathway called Breakthrough Therapy Designation, which aims to accelerate the development and review of drugs to treat serious or life-threatening conditions. The European Medicines Agency’s (EMA) Adaptive Pathways pilot is part of efforts to get patients suffering from serious conditions with an unmet medical need faster access to new drugs. Meanwhile, other regulators around the world are also exploring the adaptive licensing model (e.g. Singapore’s HSA, Health Canada). One critical question in accelerating the approval process is how much safety data is needed before breakthrough therapies can be approved. This session will explore this issue from multiple perspectives in a Q&A panel discussion format. Submit your questions for the panel at the DIA registration desk.
Speaker(s)
Panelists
Hans-Georg Eichler, MD, MSc
Austrian Association of Social Security Bodies, Austria
Consulting Physician
Annie Kennedy
EveryLife Foundation for Rare Diseases, United States
Chief of Policy, Advocacy, and Patient Engagement
Don A. Gabriel, MD, PhD, AHIP
University of North Carolina, United States
Division of Hemotalogy
Heidi F. Gertner
Hogan Lovells US LLP, United States
Partner
Joanna Haas, MD, MSc, FACP, FISPE
Haas and Partners LLC, United States
Founding Partner
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