Conference Day One

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

  • Robin Edwards Vice President - Translational Medicine, MacroGenics

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 Translating Discovery to Companion Diagnostics for Antibody-Drug Conjugates Through AI-Driven Image Analysis

  • Tom Richardson Principal Pathologist & Lead - Companion Diagnostic, Merck & Co

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

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 Unlocking the Power of Spatial Analysis for H&E Biomarker Development

  • Michail Shipitsin Vice President - Biomarker Research & Development, Acrivon Therapeutics

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

11:30 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

12:00 pm Harnessing Bioinformatics, Genomics & AI to Advance Digital Pathology & Unravel the Tumor Microenvironment Across Patient Subtypes

  • David Soong Director - Translational Data Science, Genmab

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?

12:30 pm Lunch Break & Networking

Driving Confidence Through Rigorous Validation of Technologies to Boost Clinical Adoption of Digital Pathology

1:30 pm Understanding Pathologist Variability Helps Define Endpoints & Support Digital Pathology Processes In Celiac Disease

  • Joseph Maxwell Director - Early Clinical Development, Translational Biomarker Lead, GI-TAU, Takeda Pharmaceutical

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

2:00 pm Validating Self-Supervised Models for Digital Pathology: Considerations Across H&E & IHC Modalities

Synopsis

  • How can we define meaningful validation criteria for digital pathology models across staining formats and modalities?
  • What challenges exist when applying self-supervised approaches to chromogenic and multiplexed workflows?
  • What lessons can be drawn from validating algorithms in real-world biomarker discovery and translational applications?

2:30 pm Afternoon Networking Break & Scientific Poster Session

Synopsis

Contribute to the conversation and share your cutting-edge research with your fellow digital pathology and AI community to showcase your breakthrough discoveries to a vast audience of experts.

Register your place to submit an abstract for review to showcase your poster, for more information get in touch at info@hansonwade.com.

Forging Strategic Partnerships as Catalysts for Scaling Digital Pathology in Clinical Trials & Creating Long-Term Value

3:30 pm Roundtable Discussion: Aligning Innovation with Regulatory & Operational Confidence to Drive Scalable Adoption of Digital Pathology

Synopsis

  • What practical steps can digital pathology developers take to align with current regulatory expectations and avoid delays in clinical development?
  • How can biopharma, diagnostics companies, and regulators collaborate earlier to de-risk implementation and improve standardization across trials?
  • What role can cross-industry initiatives play in setting shared benchmarks for validation, data quality, and clinical utility to accelerate adoption?

4:30 pm Partnering for success: What Biopharma Needs for Digital Pathology Vendors to be Considered as a Commercialization Partner

  • Jennifer Quigley Senior Director & Head Precision Health & Partnerships, BioNTech RNA Pharmaceuticals

Synopsis

  • What criteria is most important?
  • How can vendors demonstrate commercial readiness across criteria?
  • Ensuring global readiness and our collective efforts

5:00 pm Chair’s Closing Remarks

5:05 pm End of Conference Day One