Challenges and Opportunities in Advancing the Use of AI Technologies Across the Combination Product and Combined Use Lifecycle

Thursday, November 13, 2025

1:40 PM - 2:25 PM East Coast USA Time

Moderator(s)

Ryan Hoshi

Director, Regulatory Policy and Intelligence
AbbVie, Inc.

Speaker(s)

KD

Kathryn Drzewiecki

Digital Health Policy Team Lead, Center for Devices and Radiological Health (CDRH)
FDA (Virtual)
XH

Xia Huang

Project Manager for CE Certification of Medical Devices
DEKRA
Christina Kuhn

Special Counsel
Covington & Burling

There are growing opportunities to leverage the use of AI technologies across the combination product lifecycle from nonclinical and clinical development to post-market surveillance for enhancing safety, efficacy, and quality. However, stakeholders are challenged with understanding emerging global regulatory frameworks on the use of AI and ensuring that AI models are developed responsibly. This session will explore industry and health authority use cases and perspectives on the safe and responsible adoption of AI technologies in the combination product lifecycle.