The FDA’s Project Optimus has reformed dose optimization and selection requirements. Sponsors who understand the new framework are seeing more predictable regulatory interactions and stronger clinical programs.
For years, oncology trials defaulted to maximum tolerated dose. But today’s targeted therapies and immunotherapies often achieve optimal efficacy below MTD. Project Optimus reflects this reality—requiring sponsors to justify dose selection with more comprehensive data than ever before.
The challenge: FDA’s expectations are evolving fast. Pre-IND meetings are revealing new requirements around dose-exposure relationships, multi-dose comparisons, and patient-reported outcomes that many teams aren’t prepared for.
What This Guide Provides
Whether you’re preparing for IND, designing Phase I/II trials, or refining a combination regimen, you’ll get:
- FDA’s current expectations – Based on recent IND reviews and pre-IND feedback patterns
- Dose selection frameworks – Practical approaches for parallel dose evaluation and PK/PD modeling
- Biomarker integration strategies – How to incorporate biomarker-informed dosing without extending timelines
- Adaptive design considerations – When and how to build in dose optimization decision points
- Real-world case examples – Specific approaches from recent successful IND packages
These insights are based on direct experience with Project Optimus requirements across multiple programs in 2024.
Get your copy and build a dose strategy that holds up to FDA scrutiny.
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