The FDA’s updates to Project Optimus are shifting how researchers are approaching oncology clinical trials. Emphasizing changes in the early phase, where they now expect optimal dose data rather than the maximum tolerated dose, and randomized trials, we are seeing a change in the approach to oncology development strategy. The oncology development strategy must also account for the more robust data requirements for program success.
Watch our webinar where Andrew Zupnick, PhD, Worldwide’s VP of Oncology Drug Development, and three other oncology experts discuss how Project Optimus is changing the way we approach oncology development strategies and provide guidance on best practices for an effective clinical oncology program.
The New Era of Project Optimus: Implications for Oncology Development Strategy
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