Thursday September 11, 2025
8:00 am Registration, Light Breakfast & Networking
8:50 am Chair’s Opening Remarks
Exploring the Application of Digital Pathology in Precision Medicine to Align the Right Patient with the Right Drug
9:00 am Patient Stratification Strategy: Digital Pathology in Bladder Cancer
Synopsis
- We describe potential applications of digital pathology technology to patient stratification
- We examine the complexities and the process of developing a digital pathology biomarkers
- We present our findings developing digital pathology biomarker to support our ongoing clinical trial CLINPRO-1 in metastatic bladder cancer
9:30 am Panel Discussion: Driving Patient Selection with Digital Pathology for Streamlined Clinical Trials
Synopsis
- How can digital pathology improve the identification and stratification of patients for biomarker-driven therapies, and where is it already making a measurable impact?
- What steps should biopharma take to integrate digital pathology into trial design early, so it meaningfully contributes to patient enrichment, rather than becoming an afterthought?
- What are the key considerations when validating digital pathology as a patient selection tool for CDx use, particularly in terms of model generalizability and clinical utility?
10:30 am Optimizing Clinical Trial Design through Digital Pathology
Synopsis
- Enhancing consistency through centralized pathology reads: Centralized reads of digital histology images by domain expert pathologists reduces inter-reader variability, supporting regulatory confidence in trial outcomes
- Standardized protocols and advanced image analysis tools: Unified protocols and quantitative image analysis tools ensure precise, highly reproducible endpoint assessments throughout the trial
- Operational efficiency through integrated digital workflows: combining streamlined operational workflows with automated slide quality control, data capture and reporting substantially reduces time to final report, enabling efficient trial design
10:40 am Roundtable Discussion: Advancing Companion Diagnostics with Digital Pathology to Enable Personalized for Safer Clinical Trials
Synopsis
- What are the biggest technical and operational challenges in developing digital pathology-based companion diagnostics, and how can they be overcome?
- How can cross-functional collaboration between pharma, diagnostics, and regulatory stakeholders accelerate the path to CDx approval?
- What emerging technologies (e.g., multiplex imaging, AI/ML, spatial biology) hold the greatest promise for improving CDx development and clinical impact?
11:15 am Morning Networking Break
Accelerating Target & Biomarker Exploration with Digital Image Analysis in Early R&D to Enhance Decision Making for Safer Trials
12:15 pm Harnessing Bioinformatics, Genomics & AI to Advance Digital Pathology & Unravel the Tumor Microenvironment Across Patient Subtypes
Synopsis
- How can H&E-based digital pathology, integrated with genomics and bioinformatics, provide deeper insights into the tumor microenvironment and reveal actionable differences across patient subtypes?
- What are the key challenges and opportunities in combining spatial biology, NGS, and histopathology data to define more precise biomarkers and stratify patients in clinical trials?
- How can biopharma organizations develop the cross-functional infrastructure needed to scale AI-driven digital pathology innovations from discovery to clinical application and therapeutic impact?
12:45 pm Panel Discussion: Ensuring Fit for Purpose AI in Translational & Clinical Pathology to Accelerate Meaningful & Scalable Adoption
Synopsis
- How does biopharma define and measure whether a digital pathology tool is fit for its intended use case in drug development or diagnostics?
- What benchmarking strategies help distinguish generalizable models from those validated for specific clinical or biomarker contexts?
- How can pathologists and data scientists work together to align model development with real-world use requirements?
1:15 pm Lunch Break & Networking
Navigating Regulatory Barriers to Integrating Digital Pathology into Clinical Workflow to Streamline Approvals for Faster Market Entry
2:15 pm AI-Enabled Histologic Assessment of Bile Duct Hyperplasia in Mice
Synopsis
- A segmentation model a U-Net architecture and EfficientNet backbone was developed to interrogate hyperplastic biliary epithelium in H&E stained mouse liver sections
- The model revealed high sensitivity (95%) and specificity (97%), indicating robust model accuracy. The model-predicted grades showed strong correlation (R² = 0.86) with pathologists’ scores
- This innovative AI-driven approach not only enhances accuracy and efficiency of bile duct hyperplasia assessment in rodent studies and paves the way for more standardized, objective, and high-throughput histopathological evaluations in preclinical research and toxicology studies
2:45 pm Translating Discovery to Companion Diagnostics for Antibody-Drug Conjugates Through AI-Driven Image Analysis
Synopsis
- Digital pathology offers exciting opportunities for novel biomarker discovery, development, and clinical diagnostics
- Efficacy of antibody-drug conjugates may depend on target antigen expression or other histopathologic features that can be developed as a predictive signature
- Drug developers are eager to identify digital pathology solutions to optimally support pipelines and patient identification
3:15 pm Unlocking the Power of Spatial Analysis for H&E Biomarker Development
Synopsis
- In what ways can spatial analysis of standard H&E stains reveal biomarker patterns that were previously undetectable?
- Challenges with integrating spatial biology into clinical trials
- Towards a CDx with digital pathology