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

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.