Redefining Hematologic Malignancy Drug Development: How Molecular Reclassification, MRD, & AI is Reshaping Precision Hematology

In recent years, hematological malignancies have been fundamentally redefined at the molecular level. Disease classification has shifted from morphology-based frameworks to biologically precise entities driven by specific genetic alterations. This molecular reclassification is reshaping patient stratification, refining risk assessment, and narrowing therapeutic populations, creating both unprecedented precision and new operational complexity for drug developers. As eligibility criteria evolve and trial cohorts become genomically defined, early integration of comprehensive molecular diagnostics has become a strategic necessity rather than a secondary consideration.

Building on this foundation, molecular residual disease (MRD) is emerging as a powerful surrogate for clinical endpoints, enabling earlier assessment of therapeutic impact and supporting accelerated development pathways.

Simultaneously, AI-driven digital hematopathology is transforming traditionally subjective morphologic evaluation into quantitative, reproducible data streams, enhancing consistency across global trials. AI-enabled digital pathology, multi-omic integration, and predictive modeling allow for quantitative disease characterization, earlier detection of therapeutic response or resistance, and improved patient stratification.

This webinar session will provide a strategic roadmap for integrating advanced methodologies into hematologic drug development. When combined, these innovations shift hematologic development from static, endpoint-driven studies to continuous learning systems, accelerating decision-making, reducing development risk and improving the probability of clinical and commercial success.

Speakers

Maria Prendes, PhD, Head of Scientific Affairs, NeoGenomics Laboratories

Maria J. Prendes, PhD, is an experienced Oncology Translational and Clinical Medicine Expert with a strong track record of advancing biomarker-driven strategies in clinical drug development. She currently serves as Head of Scientific Affairs at NeoGenomics, where she collaborates with global biopharma partners to design and implement biomarker strategies that support precision medicine and clinical trial innovation. Over the course of her career, Dr. Prendes has contributed to scientific leadership in nearly 4,000 clinical oncology development programs, offering extensive expertise in molecular diagnostics, digital pathology and companion diagnostics. An inventor of 49 patents and author of multiple scientific publications and white papers, she is recognized for translating complex biomarker science into actionable strategies that accelerate oncology drug development.

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Maria Ignacia Berraondo, MD, Executive Medical Director, Head of Americas Oncology Medical Team, Fortrea

Maria Ignacia Berraondo, MD, is an Executive Medical Director and Head of Americas for the Oncology Medical Team, with over 15 years of experience in oncology and hematology drug development. She leads medical strategy, scientific oversight and operational execution for Phase I–III clinical programs across North and South America, with expertise in hematologic malignancies, early-phase development and precision oncology. Dr. Berraondo has served as Global Project Physician on multinational trials, ensuring patient safety, scientific integrity, regulatory compliance and cross-functional alignment. She is recognized for building and mentoring high-performing regional medical teams and for strengthening strategic sponsor and vendor partnerships. Her background uniquely integrates clinical hematology practice with global CRO leadership, enabling her to bridge innovation, clinical excellence and scalable development strategy.

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