WEBINAR | Redefining Early Phase Oncology: What Project Optimus Means for You
Are your early phase oncology trials ready for what the FDA expects next? Can your dose strategy stand up to Project Optimus without slowing down? Are you still relying on classical models like 3+3, even as regulators demand real-time data, adaptive designs and patient-centered outcomes?
Watch the recording of this insightful webinar, which breaks down how Project Optimus is reshaping early phase oncology—and what it means for sponsors navigating today’s regulatory and operational challenges.
Learn:
- What early FDA engagement looks like under Project Optimus—and how to get it right
- Why 3+3 is out—and what smarter, regulator-ready models look like
- How to generate dose-exposure-response data that accelerates development and satisfies FDA expectations
- What adaptive trial design really means in practice: formulation, cohort size, data density and more
- How tolerability and real-world adherence are reshaping benefit-risk assessments
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