In this free webinar, learn what early FDA engagement looks like under Project Optimus — and how to get it right. Attendees will gain insight into why 3+3 is out — and what smarter, regulator-ready models look like. The featured speakers will share how to generate dose-exposure-response data that accelerates development and satisfies FDA expectations. Attendees will learn what adaptive trial design really means in practice: formulation, cohort size, data density and more. The speakers will discuss how tolerability and real-world adherence are reshaping benefit-risk assessments.
TORONTO, June 26, 2025 /PRNewswire-PRWeb/ -- 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?
Join the featured speakers for an insightful webinar that breaks down how Project Optimus is reshaping early phase oncology — and what it means for sponsors navigating today's regulatory and operational challenges.
This webinar is a must-attend for sponsors looking to stay competitive in the evolving world of early phase oncology. Whether you're rethinking outdated dose-escalation models or seeking practical strategies to meet FDA expectations without derailing timelines, the experts will equip you with the insights needed to design smarter trials, reduce regulatory risk and accelerate development with confidence.
Register for this webinar to learn how Project Optimus is redefining dose optimization in early phase oncology and what practical steps sponsors can take to align with FDA guidance.
Join experts from Syneos Health, Wael Harb, MD, Vice President, Medical Management, Oncology; X.Q Xue, Vice President, Biostatistics; and Patrick Melvin, Vice President, Therapeutic Strategy & Innovation, for the live webinar on Thursday, July 17, 2025, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Redefining Early Phase Oncology: What Project Optimus Means for You.
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