

#154: Impact of Accelerated Pathways on Patients in Five Countries/Regions
Monday, June 17, 2024 3:30 PM to 4:30 PM · 1 hr. (US/Pacific)
Room 11AB
09: Regulatory
Information
Several global regulatory authorities have similar expedited pathways in which a regulatory approval can be granted that would fulfill an unmet medical need based on preliminary/early data from clinical studies. This session will use a recent Oncology case study comparing the different outcomes resulting from using these five different systems aiming to accelerate development and speed up availability of new treatments to patients. This will be followed by a panel with senior regulators and a patient representative to discuss the regulatory perspective and experience with accelerated approvals. The objective is to identify potential opportunities that could help to achieve more collaboration and equity of access for patients across multiple countries/regions.
CE
ACPECMERN
Session Level
Intermediate
Featured Topics
Patient Focused
Speakers

Francesco Pignatti
Scientific Adviser for OncologyEuropean Medicines Agency
R. Angelo De Claro
Deputy Director (Acting), Oncology Center of ExcellenceFDA
Yoko Aoi
Coordination Director - Office of Review ManagementPharmaceuticals and Medical Devices Agency (PMDA)SZ
Sunita Zalani
Vice President, Regulatory Affairs, OncologyMerck & Co., Inc.
Isabelle Rousse
Associate Director, Bureau of Metabolism, Oncology, Reproductive Sciences, PDDHealth CanadaKW
Kathleen Winson
Executive Group Director, Product Development RegulatoryGenentech, A Member of the Roche Group

