White paper on current state and future of digital pathology in nonclinical (D5.06)

After an initial review of the regulatory landscape of guidelines, standards and regulatory requirements for the use of digital pathology and AI-based methods in nonclinical safety evaluation (D5.02, 31st January 2022), it is the aim of this Deliverable Report to give an update of this rapidly evolving field after two more years of the project and, especially, the publication of new guidances and three interaction meetings of WP5 with regulatory agencies (USA, Europe, Japan). A lack of specific regulatory guidance for the use of digital pathology in the Good Laboratory Practice (GLP) environment is still perceived as a gap in regulatory frameworks by many potential users creating uncertainty for pathologists and scientists in recent years. Therefore, the toxicologic pathology community will benefit from an update on these advancements that can be used to aid drug development.In order to ensure widespread dissemination of the current knowledge about the use of digital and AI-assisted toxicologic pathology in the regulated nonclinical drug development, D5.06 is conceived as an open-source scientific paper in the peer-reviewed journal Toxicologic Pathology, titled: “Digital pathology and AI applied to Nonclinical Toxicology Pathology – the Current State, Challenges, and Future Directions”.