2023 Combo Products Summit Agenda
session
Platform Drug-Delivery Devices: Regulatory And Technical Considerations
November 29, 2023 @ 11:00 am
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12:25 pm
Moderator
Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech
Speaker
James Bertram, Director of the Office of Combination Products (OCP), FDA
Jiaying Shen, Distinguished Scientist, Merck
Kent Abrahamson, Director, Combination Product and Device Development, Abbvie
Patricia Love, Deputy Director, FDA’s Office of Combination Products (OCP), FDA (Invited)
Regulatory and technical perspectives for the following topics will be explored during this session: (a) definition of platform for drug-delivery devices, (b) set realistic expectation of “Device Platform” Approach, (c) approaches to develop these platforms, and (d) approaches to apply platform data (molecule-agnostic) and the need to create molecule-specific data. Join in the discussion and help us find a common understanding of what a “platform” means and the implications!