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2024 Combo Products Summit Agenda

session

Opportunities for Platform Technologies to Streamline Combination Product Development

October 9, 2024 @ 2:25 pm

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3:25 pm

Moderator

Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie

Speakers

Tina Kiang Director, Division of Regulation and Guidance (DRG), Office of Policy for Pharmaceutical Quality (OPPQ), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), FDA
Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health,(CDRH), FDA 
Chelsea O’Connell, Director, Global Regulatory and R&D Policy, Amgen
Jiaying Shen, Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality, Merck
Lisa Wright, Director of Regulatory Policy, Novo Nordisk

Platform technologies in the combination product development space are not clearly defined, and there are misconceptions about the appropriate technical and regulatory considerations for leveraging platform drug delivery systems. This session aims to discuss current approaches (e.g., master files) and the unique challenges for utilizing platform drug delivery systems across different product and therapeutic development programs, and some industry case studies on platform strategy implementation. This session will also discuss the implications of FDA’s Platform Technology Designation Program under section 506K of the Food, Drug, and Cosmetic Act and the potential opportunities for streamlining combination product development.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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