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 Whether you’re rethinking outdated dose-escalation models or seeking practical strategies to meet FDA expectations without derailing timelines, the experts will equip you with the insights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.
Speakers
Wael Harb, MD, Vice President, Medical Management, Oncology, Syneos Health
Dr. Wael Harb brings 23 years of medical oncology and hematology practice and 15 years of broad drug development experience to his role at Syneos Health. Previously, Dr. Harb established Horizon Oncology Center (HOC) in Lafayette, Indiana, later becoming the launching pad for Verdi Oncology, a national oncology management company. He also founded Horizon Oncology Research (HOR) as a premier site for early phase oncology trials in North America, where he supervised over 100 trials with over 1,000 patients enrolled. Based in California, Dr. Harb is recognized for his leadership in advancing personalized cancer care.
Message Presenter
X.Q Xue, Vice President, Biostatistics, Syneos Health
X.Q Xue has 16 years of experience in biostatistics and 14 years in the CRO industry as a project statistician and consultant on adaptive design, complex innovative study design and statistical analyses. He holds a DrPH in Biostatistics from the University of North Carolina at Chapel Hill and an MS in Statistics from North Carolina State University. X.Q has published works on optimal experiment design, adaptive design, dose escalation and dose finding, Bayesian adaptive design and survival data analysis.
Message Presenter
Patrick Melvin, Vice President, Therapeutic Strategy & Innovation, Syneos Health
Patrick Melvin is a highly experienced clinical research executive who has dedicated the last 20 years to leadership in hematology and oncology clinical drug development. This hematology and oncology experience includes oversight of programs ranging from first-in-human (FIH) studies through hybrid Phase I/II registration programs and large Phase III registration programs, including extensive experience in the immuno-oncology and in advanced therapy medicinal products (ATMP) space. He has overseen more than 25 pivotal/registration programs, over a dozen of which have now resulted in US and global marketing authorizations, including marketing authorization for a “first-in-class” adoptive cell therapy. Patrick is a member of the American Society of Clinical Oncology (ASCO) and the European Hematology Association.
Message PresenterWho Should Attend?
Biopharmaceutical sponsors with upcoming early phase oncology trials, particularly small- and mid-cap (SMID) companies/biotech.
Job titles include:
- Clinical Research Directors, Oncology
- Directors, Oncology Patient Advocacy
- Heads of Clinical Development
- Medical Directors
- Scientific Advisors/Chief Science Officers
- Chief Medical Officers
What You Will Learn
In this webinar, attendees will 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
Xtalks Partner
Syneos Health®
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together they share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. They support a diverse, equitable and inclusive culture.
To learn more about how we are shortening the distance from lab to life®, visit syneoshealth.com or subscribe to our podcast.
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