The Project Optimus Playbook: How to Build Smarter Early Phase Oncology Trials
Navigate the FDA’s Project Optimus guidance with strategies for smarter early phase oncology trials, optimized dose design and accelerated timelines.
The FDA’s Project Optimus is transforming early phase oncology trials, moving beyond maximum tolerated dose (MTD) toward model-informed, patient-centered dose optimization. This tactical guide equips biopharma decision makers with proven strategies to design smarter trials and dives into topics including:
- Why MTD alone no longer meets the standard for dose selection
- Making the case for adaptive, multi-dose, model-informed trial architectures
- Using PK/PD, Bayesian and simulation tools to de-risk dose decisions pre-IND
- Emerging patterns in operationalizing Project Optimus
Fill out the form below to download the full Project Optimus Playbook and unlock our actionable insights, real-world lessons and tools you can apply immediately to your early oncology development strategy.
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