Next-Generation Combination Products

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!

Moderator

• Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC
• Sandy Boyd, Independent Consultant

Speakers

• 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