MRD-Driven Oncology Trials: Regulatory, Clinical and Pharmacology Considerations

Minimal residual disease (MRD) is becoming one of the most important response biomarkers in oncology development. Once viewed primarily as a hematologic endpoint, MRD is now influencing broader development strategy by enabling earlier readouts of therapeutic activity, sharper patient stratification and more efficient trial design.

In 2026, sponsors are under growing pressure to generate faster, more decision-ready data while maintaining scientific rigor, regulatory alignment and operational feasibility. MRD has therefore moved from a translational research topic to a central strategic consideration in modern oncology programs.

This webinar will examine how sponsors can thoughtfully incorporate MRD across early-phase and registrational development, with emphasis on regulatory positioning, clinical pharmacology implications and clinical development strategy. The discussion will address how MRD can support dose selection, cohort expansion decisions, proof-of-concept evaluation and potentially registration-enabling pathways when integrated with the totality of evidence.

The featured speakers will also discuss assay sensitivity, sampling timing, fit-for-purpose validation, concordance with clinical outcomes and the importance of prospective statistical planning when MRD is included as a biomarker or endpoint.

A key focus will be practical execution in the real world. Sponsors often face challenges in selecting the right assay platform, defining clinically meaningful thresholds, standardizing sample collection across sites and interpreting MRD data in the context of imaging, clinical response and treatment exposure. The webinar will explore how cross-functional alignment among regulatory, clinical pharmacology, medical, biomarker, and operations teams can reduce development risk and improve the utility of MRD data in interactions with health authorities.

Attendees will leave with a clearer framework for evaluating where MRD fits in an oncology program, what evidence regulators and development teams will expect and how a strategic CRO partner can help sponsors operationalize MRD efficiently across global studies. The session is designed to help biotech and biopharma teams move beyond conceptual interest and toward practical application of MRD in development plans.

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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Zohra Lomri, Executive Director, Regulatory Affairs, Syneos Health

Zohra Lomri is Executive Director of Regulatory Affairs at Syneos Health with over 20 years of experience in global regulatory strategy and drug development. She has supported programs across the full development lifecycle, from early-phase clinical development through NDA, BLA and IND submissions, with expertise in regulatory strategy, health authority interactions, expedited pathways and labeling. At Syneos Health, Zohra provides strategic regulatory guidance to biopharmaceutical clients, helping align development programs with evolving global regulatory requirements.

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Pierre-Olivier Tremblay, Vice President, Clinical Pharmacology, Syneos Health

Pierre-Olivier Tremblay has 27 years of experience in the clinical drug development space and is an expert in clinical pharmacology.  He is currently Vice-President, Clinical Pharmacology at Syneos Health. Following the completion of his graduate studies in the pharmacology of antipsychotics in 1998, Pierre-Olivier started a pharmaceutical industry career supporting numerous organizations with early phase clinical pharmacology strategy, using quantitative pharmacology approaches in multiple indications and assets.  For the last 10 years, Pierre-Olivier has been active in the oncology space, working to accelerate drug development through modeling methodologies research and directly supporting pharmaceutical and biotech companies.

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

Dr. 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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Rafat Abonour, MD, Professor of Clinical Medicine, University of Miami, Miller School of Medicine

Dr. Rafat Abonour is a Professor of Clinical Medicine in the Division of Myeloma at the University of Miami Miller School of Medicine. A hematologist and oncologist, he specializes in the treatment and clinical research of multiple myeloma, with experience spanning early- and late-phase clinical trials and translational research. Dr. Abonour has contributed extensively to advancing therapeutic strategies and improving outcomes for patients with hematologic malignancies.

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