The New Era Of Project Optimus: Implications for Oncology Development Strategy

In August 2024, the FDA finalized its landmark guidance under Project Optimus: “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.” This initiative marks a fundamental shift in oncology drug development, urging sponsors to move beyond the long-standing reliance on maximum tolerated dose and instead embed dose optimization strategies throughout clinical development.

Since the guidance was released, early-phase oncology trials have undergone a dramatic transformation. Traditional 3+3 dose escalation models are being replaced with more adaptive designs. These changes also necessitate broader global participation to ensure timely access to eligible patients. In this webinar, expert speakers bring the impact of Project Optimus to life through real-world case studies and practical examples. They will share lessons learned from operationalizing these new approaches, highlight best practices for interpreting and applying the FDA guidance, and explore how shifting regulatory expectations are reshaping study design and execution. Attendees will walk away with actionable insights to navigate this new era of oncology development with greater confidence and success.