Hematological malignancy drug development is becoming more complex as disease classification shifts from morphology-based models to genetically defined subtypes. This change is improving patient stratification and risk assessment, but it is also narrowing trial populations and increasing operational demands across biomarker strategy, diagnostics and study design. This webinar explores how sponsors can adapt by integrating molecular diagnostics earlier and more strategically across development.
As these diseases are redefined at the molecular level, measurable residual disease (MRD) is gaining traction as a surrogate for clinical endpoints, creating opportunities to assess therapeutic impact earlier and support more efficient development pathways. At the same time, AI-enabled digital pathology is helping convert subjective morphologic assessment into more quantitative and reproducible data, supporting greater consistency across sites and studies.
The featured speakers will examine how molecular reclassification, MRD and AI-enabled digital pathology are reshaping drug development for hematological malignancies. They will highlight how these approaches improve patient stratification, enable earlier response assessment and strengthen clinical trial strategy.
Attendees will also receive 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.
Register for this webinar to learn how hematological malignancy drug development can be strengthened through molecular reclassification, MRD and AI.
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.
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.
Who Should Attend?
This webinar will appeal to:
- CEO/Chairman/CSO (Chief Scientific Officer)/CDO (Chief Development Officer)/ CMO (Chief Medical Officer)
- VP/SVP/EVP R&D
- VP Translational Science
- Director, Lab Head, Department Head, Project Lead R&D
- Discovery & Preclinical Leaders
- Biomarker Lead
- Head, Translational Research
- VP Clinical Science
What You Will Learn
Attendees will gain insights into:
- New changes in molecular reclassification of HEME malignancies and their effects in precision medicine
- The use of MRD as a surrogate endpoint in hematological cancers
- The applicability of AI to heme cancers: diagnostics, practical implications and challenges
Xtalks Partner
NeoGenomics
NeoGenomics, Inc. is a premier cancer diagnostics company, specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to help them diagnose and treat cancer. Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP accredited and CLIA certified laboratories for full-service sample processing and analysis services throughout the US; and a CAP accredited full-service, sample-processing laboratory in Cambridge, United Kingdom.
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