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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.

    • Speaker(s)

  • Carolyn Dorgan

    Director of Technical Services
    Suttons Creek

  • Andrea Gray

    Biomedical Engineering Advisor, Center for Biologics Evaluation and Research (CBER)
    FDA

  • Alan Stevens

    Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices
    AbbVie, Inc.

  • Amy Wise

    Associate Director, Regulatory Affairs CMC
    AbbVie, Inc.

  • JW

    Jerzy Wojcik

    VP Regulatory and Quality Services
    Edgeone Medical

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.