Executing MRD in Oncology Trials: From Protocol Design to Commercial Impact

 As MRD (minimal residual disease) becomes more central to oncology development, sponsors face a growing challenge: how to operationalize it reliably at scale. Success requires more than selecting the right assay. It depends on aligning protocol design, site capabilities, sample workflows, data integrity and cross-functional governance so MRD data can support meaningful clinical and regulatory decisions.

This webinar examines where MRD-based trials most often break down in practice. It will explore protocol decisions that affect feasibility, site burden, patient retention and data completeness, including site selection, laboratory alignment, specimen handling and realistic sampling windows. The session will also discuss how medical, scientific and operational teams can work together to support consistent execution of biomarker-driven protocols.

The webinar will also address how early operational decisions shape downstream outcomes, including regulatory positioning, payer value narratives, competitive differentiation and commercialization strategy. Attendees will gain practical guidance for global and regional studies across hematologic malignancies and solid tumors, with a focus on maintaining quality across sites, vendors and internal teams.

Register for this webinar to learn how to strengthen execution and improve the value of MRD data in oncology trials.

Speakers

(Moderator) Wael Harb, MD, MBA, Head of R&D and Scientific Strategy, Early Phase Oncology, Syneos Health

Dr. Wael Harb brings 23 years of medical oncology and hematology practice and 15 years of drug development experience to his role at Syneos Health. Previously, he established Horizon Oncology Center (HOC) in Lafayette, Indiana, which later became the launching pad for Verdi Oncology, a national oncology management company. He also founded Horizon Oncology Research (HOR), a premier site for early phase oncology trials in North America, where he supervised more than 100 trials with over 1,000 patients enrolled. Based in California, Dr. Harb is recognized for his leadership in advancing personalized cancer care.

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Patrick Melvin, Vice President, Therapeutic Strategy & Innovation, Syneos Health

Patrick Melvin is a highly experienced clinical research executive with over 20 years of leadership in hematology and oncology drug development. His experience spans programs from first-in-human (FIH) studies through hybrid Phase I/II registration programs and large Phase III trials, including work in immuno-oncology and advanced therapy medicinal products (ATMPs). He has overseen more than 25 pivotal or registration programs, over a dozen of which have resulted in US and global marketing authorizations, including a first-in-class adoptive cell therapy.

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Jacquelyn Ritchie, MPH, Therapeutic Area Head of Hematology/Oncology, Syneos Health

Jacquelyn Ritchie has extensive experience in the pharmaceutical and clinical research industry and has held leadership roles at organizations including Exelixis, IQVIA, NanoString Technologies, GSK, University of Pennsylvania, Merck and AstraZeneca. Throughout her career, she has demonstrated expertise in clinical operations, strategic planning, leadership and alliance building.

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Muaiad Kittaneh, MD, MBA, FACP, Global Head of R&D and Scientific Strategy, Syneos Health

Muaiad Kittaneh is a board-certified Hematologist, Medical Oncologist and Internist with extensive global experience in clinical development, scientific strategy and cross-functional leadership. He has led complex oncology programs across the full drug development lifecycle, from early-phase experimental therapeutics to late-phase global registration and post-marketing strategy. His expertise includes clinical trial design, regulatory alignment and the integration of biomarkers, precision medicine and innovative therapeutic modalities such as cell therapy, gene therapy and radiopharmaceuticals.

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Rob Lentz, MD, Medical Director, Natera

Dr. Rob Lentz is a Medical Director at Natera and GI Medical Oncologist. Dr. Lentz earned his BS from the University of Michigan, MD from Vanderbilt, residency at Northwestern, and fellowship at University of Colorado. Before joining Natera, he was on faculty at the University of Colorado, where he cared for patients with and led clinical and translational research in gastrointestinal malignancies. At Natera, Rob leads Medical Affairs efforts in colorectal and anal cancers.

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David Shames, PhD, VP of Clinical Biomarkers and CDx Partnerships, Natera

David Shames, PhD, is Vice President of Clinical Biomarkers and CDx Partnering at Natera, where he leads biomarker and diagnostic strategy development for our biopharma partners. He brings more than 15 years of experience in translational research, biomarker development, companion diagnostics, and oncology drug development, including leadership roles at Genentech and BeOne Medicines.

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