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2023 Combo Products Summit Agenda


Next-Generation Combination Products

November 29, 2023 @ 4:45 pm


5:30 pm


Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC

Sandy Boyd, Independent Consultant


Dan Groszmann, Director of Engineering, Amgen

Geoff Hamilton, Chief Executive Officer, Stemson Therapeutics

Steven Oh, Deputy Office Director, Office of Cellular Therapy and Human Tissue, Center for Biologics Evaluation and Research (CBER), FDA

James Wabby, Global Head, Regulatory Affairs (CoE) – Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow – Regulatory Science, Abbvie

Emerging innovations (like cell-gene therapy and regenerative medicine products) can provide cures for previously untreatable conditions, which will change the face of the industry. Join us as we look forward to these emerging technologies and discuss regulatory approaches to adapt to the fast-paced dynamics of technology evolution!

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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