AI-enabled computational pathology is transforming cancer therapeutic target assessment, delivering precision, accuracy, and reproducibility that far exceed visual scoring by pathologists. By detecting and quantifying target expression heterogeneity, new biological insights can be derived to enable novel biomarkers for patient selection and therapeutic response prediction. Over the past 6+ years, AstraZeneca has developed Quantitative Continue Scoring (QCS) technology, a supervised AI-based computational pathology solution. Trained on expert pathologist-annotated digital images, QCS algorithm can detect and segment tumor regions, tumor cells and their subcellular components automatically, and subsequently quantify therapeutic target expression on cell membrane and cytoplasm. Notably, based on pre-specified human-interpretable features, QCS algorithm can derive additional biological characteristics, including target internalization and target heterogeneity, which can be utilized for the prediction of therapy response to antibody-drug conjugates (ADCs), given that the quantification of the target expression on the membrane and cytoplasm of tumor cells may provide insights into target internalization. These AI-based advancements in computational pathology hold the promise of transforming diagnostic pathology and unlocking new frontiers in companion diagnostic solutions, thereby maximizing the potential of personalized oncology with unprecedented precision.

Over the past year, the Digital Pathology Association’s Regulatory and Standards Task Force has made measurable strides in shaping the regulatory and technical landscape of digital pathology. This session will highlight key initiatives and cross-functional collaborations that are accelerating the field's readiness for clinical and real-world deployment at scale.

Structured around the Task Force’s four core working groups—FDA Collaboration, AI/ML Oversight, Interoperability, and Best Practices—this 50-minute session will feature multiple presenters offering rapid-fire updates on achievements and future objectives. Topics will include how the DPA is working with the FDA to clarify regulatory pathways, evolving consensus on validating AI-enabled workflows, progress toward plug-and-play interoperability, and the development of practical best practice guidelines to guide adoption.

Opening remarks from Task Force leaders Dr. John Groth and Dr. Laura Chang will set the stage with reflections on the regulatory momentum gained over the past year and the shared goals driving this multi-stakeholder effort. Attendees will leave with an up-to-date understanding of where standards are headed—and how they can contribute to shaping the next wave of digital pathology innovation.

Learning Objectives: 

1. Understand the Current Regulatory Landscape: Gain insight into how the Digital Pathology Association is collaborating with the FDA and other stakeholders to clarify and shape regulatory expectations for digital pathology platforms and AI-enabled tools.

2. Explore the Latest Standards Development Efforts: Learn about recent progress in interoperability frameworks, validation best practices, and data standards that support the scalable, reliable implementation of digital pathology in both clinical and research settings.

3. Identify Opportunities for Engagement and Adoption: Discover how you and your organization can contribute to or benefit from ongoing Task Force initiatives—whether by aligning with emerging best practices, participating in workgroup efforts, or preparing for regulatory trends.

FDA - DPA collaboration announcement. Join industry leaders and vendors for an open, collaborative townhall focused on advancing digital pathology regulatory science, developing open-source tools, and fostering vendor-neutral, efficient technical assessment - while ensuring fairness, transparency, and broad participation across the digital pathology ecosystem.

**PathVisions25 registration required. 

FDA - DPA collaboration announcement. Join industry leaders and vendors for an open, collaborative townhall focused on advancing digital pathology regulatory science, developing open-source tools, and fostering vendor-neutral, efficient technical assessment - while ensuring fairness, transparency, and broad participation across the digital pathology ecosystem.

**PathVisions25 registration required. 

FDA - DPA collaboration announcement. Join industry leaders and vendors for an open, collaborative townhall focused on advancing digital pathology regulatory science, developing open-source tools, and fostering vendor-neutral, efficient technical assessment - while ensuring fairness, transparency, and broad participation across the digital pathology ecosystem.

**PathVisions25 registration required. 

FDA - DPA collaboration announcement. Join industry leaders and vendors for an open, collaborative townhall focused on advancing digital pathology regulatory science, developing open-source tools, and fostering vendor-neutral, efficient technical assessment - while ensuring fairness, transparency, and broad participation across the digital pathology ecosystem.

**PathVisions25 registration required.