MRD-Driven Oncology Trials: Regulatory, Clinical and Pharmacology Considerations, Upcoming Webinar Hosted by Xtalks

In this free webinar, gain a clearer framework for evaluating where minimal residual disease (MRD) fits in an oncology program. Attendees will understand where MRD adds the greatest value across dose escalation, dose optimization, expansion cohorts and registrational strategy. The featured speakers will share key regulatory and clinical pharmacology considerations when positioning MRD as a biomarker, intermediate endpoint or decision-enabling data stream. Attendees will learn practical approaches to assay selection, sample timing, cross-functional governance and interpretation of MRD results in oncology trials.

TORONTO, April 16, 2026 /PRNewswire/ -- 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.

Register for this webinar to gain 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.

Join Wael Harb, MD, MBA, Head of R&D and Scientific Strategy, Early Phase Oncology, Syneos Health; Zohra Lomri, Executive Director, Regulatory Affairs, Syneos Health; Pierre-Olivier Tremblay, Vice President, Clinical Pharmacology, Syneos Health; Muaiad Kittaneh, MD, MBA, FACP, Global Head of R&D and Scientific Strategy, Syneos Health; and Rafat Abonour, MD, Professor of Clinical Medicine, University of Miami, Miller School of Medicine, for the live webinar on Wednesday, May 6, 2026, at 11am EDT (5pm CEST/EU-Central).

For more information, or to register for this event, visit MRD-Driven Oncology Trials: Regulatory, Clinical and Pharmacology Considerations.

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