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

Moderator(s)

Chin-Wei Soo

Vice President Regulatory Head, Devices and Combination Products
Genentech/Roche

Speaker(s)

DC

Dez Crisolo

Principal Regulatory Program Director
Genentech
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.