Five strategies for meeting the requirements of Project Optimus and improving the chances of approval
The study designs and dose-finding strategies that have dominated decades of oncology drug development are becoming obsolete as the FDA’s Project Optimus takes full effect. The agency is now heavily scrutinizing Phase 1 and 2 studies to see whether they identify the safest and most effective dose—while this change seems abrupt, it’s loomed over the field for a long time.
We’ve helped our clients adapt to the new standards with five best practices outlined in this article.