Wednesday September 10, 2025
8:00 am Registration, Light Breakfast & Networking
8:50 am Chair’s Opening Remarks
Embracing the Application of Digital Pathology for Antibody-Drug-Conjugates (ADCs) to Optimize Therapeutic Effect
9:00 am Enhancing ADC Patient Selection Through Digitally Quantified Biomarkers & Morphology
Synopsis
- Describe how digital pathology may improve the quantification of biomarkers to more accurately identify patients most likely to benefit from ADC therapies
- Define tumor morphologic features, tumor cell and TME-related, that should be assessed as the field works to expand its understanding of predictive biomarkers for ADC therapies
- Discuss how AI-driven image analysis may support more nuanced stratification in tumors with heterogeneous target expression
9:30 am Session Details to be Confirmed
10:00 am Speed Networking Break & Morning Refreshments
Synopsis
Kick off your summit experience by building valuable new connections across the digital pathology and AI community. This interactive session is designed to ensure all attendees have the chance to quickly meet peers facing similar challenges and opportunities, helping you spark conversations that last well beyond the summit.
The Next Frontier: Leveraging AI & Spatial Biology to Unlock Unprecedented Insights into Disease Populations
11:00 am Integrating Image Analysis & Spatial Technologies to Advance Quantitative Biomarker Discovery in Preclinical Studies
Synopsis
- Showcasing workflows to automate H&E and IHC image analysis for improved biomarker quantitation in rodent and human tissues
- Exploring the integration of spatial proteomics and transcriptomics to enhance biomarker validation and tissue segmentation
- Sharing key challenges, practical lessons, and future opportunities for applying spatial image analysis in preclinical drug discovery
11:30 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
12:00 pm Lunch Break & Networking
Driving Confidence Through Rigorous Validation of Technologies to Boost Clinical Adoption of Digital Pathology
1:00 pm Understanding Pathologist Variability Helps Define Endpoints & Support Digital Pathology Processes In Celiac Disease
Synopsis
- Celiac disease clinical trials are expected by regulators to show changes in histology endpoints
- Digital pathology makes measurement and storage of data much easier but still requires clear alignment among pathologists for how their measurements will be done
- Application of feedback from pathologists can support improvements in the digital pathology process for late stage clinical trials and provide a grounding point for automation
1:30 pm Exploration of an AI ready Digital Pathology Reference Dataset to Address Emerging Technical and Regulatory Requirements
Synopsis
- Introduction to BioIVTs data and AI brand VisionaireTM
- Rationale for developing high quality Digital Pathology reference resources
- Review of the technical and biological variation challenges within Digital Pathology
- Relevance of compliance and regulations within Digital Pathology
- Need for future proof data resources linked to biospecimens and RWD within Digital Pathology
- Role of spatial multiomic characterization within Digital Pathology
- Customer Case studies with Panakiea and PathAI
1:40 pm Panel Discussion: Ensuring High-Quality, Diverse Data Inputs & Regulatory Alignment for Robust AI in Digital Pathology
Synopsis
- How do quality and diversity of biospecimens directly impact the robustness, reproducibility, and clinical relevance of AI models in digital pathology?
- How can the industry navigate evolving regulatory requirements around data quality, consent, and diversity to ensure AI tools meet compliance and accelerate approvals?
- How can trusted data partnerships help build sustainable reference sets and enable continuous validation to future-proof AI and digital pathology solutions?
2:30 pm Afternoon Networking Break
Forging Strategic Partnerships as Catalysts for Scaling Digital Pathology in Clinical Trials & Creating Long-Term Value
3:30 pm Deep Dive Session: Commercial Considerations for Digital Pathology Assets Supporting Therapeutics
Synopsis
- Mapping the landscape of digital & computational pathology, key stakeholders & value drivers for pharma
- Strategic considerations for pharma: build vs buy decisions, defining value & demonstrating ROI
- Addressing reimbursement challenges, business models & real-world barriers to adoption