Platform Drug-Delivery Devices: Regulatory and Technical Considerations

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!

Moderator

• Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech

Speakers

• 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)