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.