Get Ready for Project Optimus: Success Favors the Prepared
In this blog, I will reflect on why this agency guidance is so important for new oncology therapeutics.
What should oncology drug developers expect from the FDA’s Project Optimus?
What is the MTD approach? Why is the FDA now moving away from it?
What does this shift in dose optimization mean for you and what steps should you take?
How does Optimus impact medical writing and submissions?
What are implications on Phase 1 programs and potential implications for products in Phases 2 and 3?
AAPS eChalk Talk on preparing for Optimus
Start asking the right questions to prepare for FDA’s dose optimization initiative.
What does Optimus mean for the future of the oncology drug pipeline?