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 witht 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?
10:15 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?
11:00 am Morning Break & Speed Networking
Accelerating Target & Biomarker Exploration with Digital Image Analysis in Early R&D to Enhance Decision Making for Safer Trials
11:45 am Integrating AI-Powered Algorithms into Digital Pathology Workflows to Advance Preclinical Decision-Making & Toxicological Insights
Synopsis
- Exploring how AI-powered tools are being embedded into digital pathology workflows to support faster, more consistent decision-making in preclinical research
- Highlighting strategies to improve the detection of tissue abnormalities and enhance pathology assessments through AI-driven insights
- Discussing the broader potential of AI integration to elevate translational research, accelerate drug development, and support regulatory readiness
12:15 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?
12:45 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
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 Panel Discussion: Closing the Gaps in Regulatory Guidance to Improve Biopharma Adherence to Ambiguous Guidelines
Synopsis
- Navigating pre-submission & cohort design: meeting fda expectations for AI tools
- Where do current regulatory frameworks fall short in addressing AI and digital pathology integration?
- What pre-submission strategies are most effective when engaging regulators on AI-based pathology tools?
- What guidance is needed to support the clinical use of exploratory tools for biomarker and CDx development?
- How can industry work collaboratively with regulators to shape fit-for-purpose standards?
3:15 pm Overcoming Regulatory Hurdles for Black Box Signatures in Digital Pathology for Accelerated Approvals
Synopsis
- How can developers validate algorithms that identify complex, non-interpretable patterns with no clear human comparator?
- What new approaches are emerging to measure trust, transparency, and performance in these “black-box” models?
- How can biopharma balance innovation with the need for explainability and clinical accountability?