Skip to main content
2025 CP Summit Main banner

Drug-Delivery Device Clinical Bridging: Leveraging Platform Approach and Prior Knowledge

Friday, November 14, 2025
10:55 AM - 12:10 PM East Coast USA Time
Location: Narragansett Ballroom

    Moderator(s)

  • Chin-Wei Soo (he/him/his)

    Vice President, Global Regulatory Head, Devices and Combination Products
    Genentech/Roche, California, United States

    View Slides

    • Speaker(s)

  • DC

    Dez Crisolo

    Principal Regulatory Program Director
    Genentech

  • PL

    Patricia Love

    Deputy Director, Office of Combination Products
    FDA (Virtual)

  • Andrea Redd

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

  • Lisa Wright

    Director - Regulatory Policy
    Novo Nordisk

Pharmaceutical companies are developing platform drug-delivery devices for molecules to accelerate clinical development, commercialization, and lifecycle management. When the to-be-marketed device is not included in the pivotal clinical study, a strategy is needed to bridge from the device to the to-be-marketed device presentation. The bridging strategy utilizing both device platform and prior knowledge represents a relatively new area. This session will demystify these strategies by explaining core PK/BE principles, illustrating practical industry case studies, and outlining regulatory expectations.