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.


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