"Product development is changing to reflect the potential of applying new analytic tools, diagnostic technologies and clinical knowledge. This work will lead to "the right drug
at the right time to the right patient." These efforts have
implications for adaptive trial design strategies and may lead to
significant change in the current phases of drug development.
Concurrently, FDA guidance development is under way to determine how best biomarkers can be validated in clinical trials, enabling the simultaneous launch of a linked diagnostic and therapeutic for more personalized medicine."

Objective1: Provide update on how development programs use companion diagnostics in support of efficient trial design.

Objective2: Explore the regulatory challenges of this approach.

Objective3: Encourage new scientific approaches in product development focusing on the promise of personalized medicine.