Reflections on the Global Operationalization Webinar

Reflections from the DPA Webinar | November 20, 2025

On November 20, 2025, the Digital Pathology Association (DPA) convened a global panel of experts for a timely and practical webinar titled “Operationalizing Digital Pathology: A Global Blueprint to Tailor for Your Institute.” The session brought together leaders from academia, industry, contract research organizations (CROs), and private practice to share real-world experiences implementing digital pathology across diverse geographies and operational contexts.

The panel featured Dr. Orly Ardon, PhD, MBA (Memorial Sloan Kettering Cancer Center, USA), Dr. Monika Lamba Saini, MD, PhD (ADC Therapeutics, United Kingdom), Dr. Swapnil Rane, MD, MRes, FRCPath (Tata Memorial Center, India), and Dr. Yannick Waumans, PhD (CellCarta, Belgium). Together, they offered a candid, global view of what it truly means to move from aspiration to execution in digital pathology.

Global Journeys: From Early Adoption to Scale

The webinar opened with each panelist reflecting on their institution’s digital pathology journey across Asia, Europe, and North America.

Dr. Orly Ardon described the role of the Memorial Sloan Kettering Cancer Center (MSKCC) as an early adopter of digital pathology, supported by deep institutional expertise and long-term investment. MSKCC is approaching a significant milestone, with nearly 10 million slides scanned, underscoring both the scale and maturity of its digital operations.

Dr. Monika Lamba Saini shared her perspective from biopharma and CRO environments, where digital pathology and AI are increasingly embedded across the translational research continuum—from discovery and mechanism-of-action studies to clinical development and companion diagnostics. She also emphasized that the integration of DP in clinical trial workflows is also important for central review, training, and has also accelerated the trial timeline by reducing pathological evaluation time.

Dr. Swapnil Rane provided a perspective often underrepresented in such discussions: implementing digital pathology in resource-limited settings. At Tata Memorial Center, his team has taken a pragmatic, incremental approach—starting with a single scanner and steadily building toward a nationally distributed digital and computational oncology program.

Dr. Yannick Waumans traced CellCarta’s evolution from operating a single slide scanner to managing a global digital pathology ecosystem with more than 20 instruments across China, Europe, and the United States.

What Does It Mean to "Operationalize" Digital Pathology?

A central theme quickly emerged: digital pathology is not a single tool—it is an ecosystem.

From a CRO perspective, Dr. Waumans emphasized that operationalizing digital pathology requires orchestrating a complex chain of scanners, IT infrastructure, storage, image management systems, displays, algorithms, and databases. True operational success depends on interoperability across all components, a challenge compounded in CRO environments where sponsors and collaborators often prefer different platforms. Regulatory compliance and system validation have also become increasingly prominent as standards continue to evolve.

Dr. Ardon echoed these challenges from an academic medical center viewpoint, highlighting three core issues:

• End-to-end workflow reliability, ensuring the right quality image reaches the right pathologist at the right time
• Transition and training, particularly for staff managing hybrid analog–digital workflows with periodic updates, as needed
• Sustainability and future planning, balancing current operational needs with long-term scalability

As digital sign-out becomes routine, reliability and quality expectations mirror those of glass slides-digital images must be consistently accessible, without exception.

Dr. Lamba Saini identified four recurring challenges across organizations: lack of early multistakeholder engagement, IT integration and interoperability, data storage and security, and change management. She emphasized that successful digital pathology adoption requires not only technical training but also a conceptual shift in mindset, supported by continuous communication and demonstration of clinical value.

Dr. Rane offered a pragmatic blueprint for resource-limited settings. By starting small and solving problems incrementally—scanner by scanner, workflow by workflow—his team has been able to scale to digitizing 2,000–3,000 slides per day, with a long-term goal of 10,000. He also underscored challenges related to slide preparation, scanner compatibility, cybersecurity, and governance across a growing national network.

Building on these points, Dr. Lamba Saini stressed the often-overlooked importance of pre-analytical processes—from tissue preparation to barcode readability—which can determine the success or failure of digitization before scanning even begins.

Where Are the Opportunities?

As the discussion shifted from challenges to opportunities, the tone became decidedly forward-looking.

From an industry and biopharma perspective, Dr. Lamba Saini highlighted three major opportunities:

• Centralized review and collaboration, particularly for clinical trials and hub-and-spoke models
• Computational and AI-driven analysis, extending the value of digital pathology beyond routine workflows
• An expanded role for pathology across the full R&D continuum, strengthening its impact on precision medicine

Dr. Waumans emphasized the additive value of computational pathology, noting that algorithms can extract information not visible to the human eye. Digital pathology also enables scalability-both in handling high slide volumes and in supporting global operations under unified quality systems. Speed and efficiency gains, particularly through same-day staining, scanning, and annotation, were highlighted as transformative for CRO workflows.

What Does Scale Enable at Large Academic Centers?

Responding to a question on scale and speed, Dr. Ardon outlined a compelling vision of what mature digital pathology enables at institutions like MSKCC.

She highlighted improved patient-centered care, faster diagnostic turnaround times, reduced slide loss and damage, expanded research and academic collaboration, more efficient handling of external consults, and enhanced operational sustainability amid global workforce shortages. Importantly, she emphasized that digital pathology is no longer a future opportunity— it is already essential to maintaining current operations at scale.

Algorithms, AI, and Clinical Integration

The panel also addressed the current state of AI adoption. Dr. Ardon noted that while both commercial and internally developed tools are in use at MSKCC, AI remains firmly within a human-in-the-loop model. Pathologists continue to retain ultimate responsibility for diagnosis.

Dr. Rane shared how Tata Memorial Center has expanded digital pathology services to support both clinical and basic science research teams, enabling computational analysis and improving slide preparation quality across the organization. Adoption remains voluntary, recognizing that change occurs gradually—particularly for pathologists with decades of experience using glass slides.

Dr. Lamba Saini reinforced the idea that digitization unlocks the true value of tissue. Once slides are digitized, they are no longer confined to basements or archives—they become active assets for discovery, collaboration, and innovation.

Regulation and Standards

Audience questions highlighted the growing need for clarity around remote digital primary diagnosis and state-specific regulations. Dr. Ardon encouraged the DPA to play a central role in curating and sharing validation templates, regulatory guidance, and best practices-an idea echoed by the moderator, Dr. Chhavi Chauhan, who pointed to the DPA’s Regulatory and Standards Task Force as a natural home for such efforts. The panelists also discussed the regulatory landscape in different continents, and also highlighted the recent initiative from the European Society for Medical Oncology (ESMO) for a framework for AI-based biomarkers for needed validation. Core requirements include a defined ground truth, robust performance, and proven generalizability, and alignment with regulatory standards like the European Union’s In Vitro Diagnostic Medical Devices Regulation (EU IVDR) and the US Food and Drug Administration (US FDA) to ensure safe and equitable deployment.

Key Takeaways

• Digital pathology is an ecosystem, not a single tool.
• Interoperability and early IT engagement are foundational.
• Operational challenges extend well beyond infrastructure.
• Resource-limited settings benefit from pragmatic, incremental approaches.
• Pre-analytical quality is critical to success.
• Data storage, security, and cybersecurity cannot be afterthoughts.
• Change management is as important as technical training.
• Digital pathology unlocks new opportunities at scale.
• The role of pathology is expanding across research, trials, and precision medicine.
• Patient-centered impact remains the ultimate goal.

The webinar underscored a shared message across geographies and practice settings: while the path to operationalizing digital pathology is complex, the opportunities—for patients, pathologists, and the broader healthcare ecosystem—are transformative.

Authors

Chhavi Chauhan, PhD

Executive Officer, Open Pathology Education Network (OPEN)

Brenda Baltodano, MD

Faculty of Medicine, San Martin de Porres University, Lima, Peru