Imagine a world where cancer treatments are more effective while also being safer for patients. This vision is quickly becoming a reality with Project Optimus, the U.S. Food and Drug Administration’s (FDA) groundbreaking initiative from its Oncology Center of Excellence (OCE).
Newer next-generation oncology treatment modalities often achieve optimal efficacy at doses lower than the maximum tolerated dose.
The initiative, which brings a stronger focus on the patient, has altered many aspects of oncology clinical development. Specifically, for small to mid-sized biotechs, the impact of Project Optimus on clinical development planning, timelines, and funding needs are significant. Understanding and leveraging this initiative is key to enhancing patient safety while maximizing the chances of regulatory success in oncology drug development.
