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
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.