The FDA’s Project Optimus is transforming how oncology drug developers approach dose selection — shifting the focus from identifying the Maximum Tolerated Dose (MTD) to optimizing for both efficacy and patient safety. This new paradigm directly impacts how sponsors design, analyze, and justify their dose-finding strategies to regulators.
With the 2024 FDA Guidance on Optimizing Dosage in Oncology, the expectations are clear: more robust dose–response evaluations, smarter trial designs, and data-driven simulations are no longer optional — they’re essential for regulatory and clinical success.
Join us to learn how innovative designs and strategies, and AI-enabled simulations can help you stay ahead of evolving FDA expectations, accelerate development timelines, make more confident dose-selection decisions, and ultimately improve chances of program success.
- What Project Optimus means for oncology sponsors and upcoming submissions
- Smarter study designs and simulation strategies aligned with FDA guidance
- How AI can transform dose-finding and decision-making efficiency
