Pharma Fundamentals: Digital Pathology in Drug Development, Part 1

Digital pathology is shifting from a lab-bench convenience to a validated, GxP-governed data system, which may have implications for drug manufacturing and quality organizations. In this episode of PharmTech’s Pharma Fundamentals series, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development and explains that digitization’s value is how it can convert a one-time tissue observation into a persistent, traceable data source that follows the sample from collection through processing, scanning, quality control, and final image. Pathology itself touches nearly every stage of the development processes, says Zuraw, from lead selection and tox/safety work through clinical biomarker studies to post-market diagnosis; therefore, a connected digital pipeline pays off at multiple points.

Traceability, Validation, and AI-Ready Data

That traceability requires the same validation as any computerized system used in a GxP environment. Charles River validated its digital pathology pipeline under 21 Code of Federal Regulations Part 11, running a non-inferiority study led by 2 board-certified veterinary pathologists to confirm digital slides lose no diagnostic detail versus glass, tested across H&E, immunohistochemistry, and special stains, and across multiple species.

Zuraw dispels 2 misconceptions relevant to any organization piloting artificial intelligence (AI). One misconception is that “AI-readiness” is a property of the data rather than the organization, requiring a defined use case, validated tools, and standard operating procedures, repeated per tool and use case. The other misconception is that FDA guidance lags the technology, when in fact whole-slide-imaging guidance already exists1 and a January 2025 draft AI guidance2 applies the same risk-based, context-of-use framework good laboratory practice (GLP) organizations already use.

The Impact on Workflows and Staffing

For drug manufacturers, this type of automation reshapes staffing and workflow. Linking slide production to scanning can automate manual checks currently performed by several people per slide, but Zuraw notes this may worry technicians who fear losing varied, skilled work to hours of digital slide review. In addition, moving pathology data at scale is its own IT and compliance project; a single image can rival a 2-hour HD video in file size. Peer review illustrates the stakes: what once meant shipping glass slides and traveling to share a microscope now happens almost instantaneously online, provided both sides are on validated, interoperable systems. When a partner or sponsor isn't at the same level of digital or GLP readiness, a familiar challenge in multi-site and contract organization relationships, the organization must choose between a documented compliance exception or falling back to physical media.

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References

1. FDA. Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry. May 2023. https://www.fda.gov/media/168431/download
2. FDA. Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, Draft Guidance for Industry and Other Interested Parties. January 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological

About the Speaker

Dr. Aleksandra Zuraw is a board-certified senior toxicologic pathologist at Charles River Laboratories and a long-time leader in digital pathology and image analysis. She has worked extensively with AI tools and digital workflows since the early stages of her career, contributing to the development and validation of image analysis solutions across several organizations. Dr. Zuraw is the coauthor of several peer-reviewed publications on digital pathology and image analysis, and the author of the book "Digital Pathology 101: Everything you need to know to start and continue your digital pathology journey." Originally from Poland, she completed her pathology training in Berlin, Germany, and has worked across six countries. She also founded the online educational platform Digital Pathology Place, where she creates content and training materials that help bridge the gap between digital pathology innovation and practical application.