Project Optimus Series: Navigating the Realities of Project Optimus

Launched in 2021 by the FDA's Oncology Center of Excellence, Project Optimus seeks to reshape traditional oncology trial designs and dosing paradigms, shifting from maximum tolerated doses to precision dosing strategies. While the FDA's hope was that the added time and cost of collecting comprehensive dose and exposure response data would benefit both patients and sponsors, there is also concern and debate in the biotech community that, if the Optimus formula is closely followed, the addition...