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Recent Evolution of the Accelerated Approval Pathway: Impacts on Use and Implementation
Session Chair(s)
Danielle Friend Economo, PhD
Senior Director, US Head Regulatory Policy and Intelligence
Johnson & Johnson Innovative Medicine, United States
Thought leaders will be brought together in a fireside chat to discuss impacts observed due to recent changes to Accelerated Approval as well as current trends in how the pathway is being used and implemented.
Learning Objective : Identify the changes to Accelerated Approval resulting from the passage of FDORA; Describe the benefits and challenges encountered by regulators, industry, and patient organizations when it comes to the use of Accelerated Approval; Discuss the impacts of the changes to the Accelerated Approval pathway and how it is currently being implemented.
Speaker(s)
Industry Update
Alexis Miller, JD
Merck & Co., Inc., United States
Acting Global Lead, Global Regulatory Policy and Intelligence
FDA Update
Peter W. Marks, MD, PhD
FDA, United States
Director, Center for Biologics Evaluation and Research
Academic Update
Edward Neilan, MD, PhD
National Organization for Rare Disorders (NORD), United States
Chief Medical and Scientific Officer
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