Navigating Clinical Strategies for Combination Products with Investigational Devices

Friday, November 14, 2025

1:15 PM - 2:30 PM East Coast USA Time

Moderator(s)

Andrea Redd

Associate Vice-President, Global Regulatory Affairs, Drug Delivery and Combination Products
Eli Lilly
James Wabby

Global Head, Regulatory Affairs (CoE) - Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow - Regulatory Science,
AbbVie, Inc.

This session will cover global clinical and registration strategies for investigational devices used in the development and registration of complex combination products. The areas of focus include: integral investigational devices in drug-led combination product clinical applications; co-packaged or reusable devices filed in a separate device led application; gene and cell therapy such as a biodegradable scaffold. The use of a digital health technology (DHT) to collect primary and/or secondary end-points in a clinical trial will also be explored.