Agenda times shown in EDT

9:30 am Registration & Networking Coffee

Harnessing the True Value of Multiplex Immunofluorescence in Digital Pathology

Sessions Moderated by Mark Rees, Vice President of Corporate Development, Ultivue

10:00 am Hanson Wade Opening Remarks

10:05 am Ultivue Opening Remarks

10:15 am Multidimensional Multiplexing for Spatially Resolved Immune Tumor Heterogeneity

  • Ralf Huss Director, Institute for Digital Medicine & Deputy Director Pathology & Molecular Diagnostics , University Hospital Augsburg

Synopsis

• The relevance to understand the entire tumor heterogeneity, itsimmune environment and contextual relationship requires the spatial quantification of different immune and tumor cells along with the genetic background of the individual cancer
• We apply multiplexing technologies to visualize biomarker candidates on a single slide with the assistance of machine intelligence including images digitization, computer-based image analysis, and further (molecular) data breakdown through machine learning tools
• The availability of digital tools in histopathology allows interpreting the high-dimensional complexity of the spatial and immunological heterogeneity in tissue and integrating big (molecular) data to select the best and most effective treatment including combination and advanced therapies

10:45 am Utilizing Image Analysis to Gain Insights of the Immune Landscape within the Tumor Microenvironment

Synopsis

• Image analysis technologies facilitate the analysis of complex phenotypes and spatial relationships between immune cell populations and the tumor microenvironment
• Deep learning methods can be trained to detect cell phenotypes and classify tissue morphologies
• Challenges exist towards a fully automated, reproducible mIF biomarker assay

11:15 am Insights into the Tumor Microenvironment Using Multiplexed Immunofluorescence

Synopsis

• Focusing on the development of tools to overcome the limitations associated with traditional IHC protocols
• Highlighting several recent clinical case studies enabling biomarker multiplexing in tissue samples with an automated workflow to support high sample throughput

11:45 am Break

12:00 pm Keynote Presentation: Precision Medicine Begets Precision Pathology

  • Clive Taylor Professor of Pathology, Keck School of Medicine at the University of Southern California

Synopsis

• In order to achieve “Precision Medicine” in biomarker testing the pathologist must provide the precision
• “Precision Pathology” applies to the Total Test, throughout the preanalytic, analytic and post-analytic phases, inclusive of computer assisted analysis, scoring and report generation
• Similar exacting requirements exist for all biomarker testing, whether upon whole tissue sections, as by multiplex IF methods, or employing extracts of FFPE tissues for molecular assays

12:30 pm Panel Discussion: Evaluating Biomarker Technologies for Immunotherapy

Synopsis

• How can multiplex immunofluorescence improve validation of protein biomarkers in tissue when evaluating clinical utility of compounds of interest?
• Evaluating the reliability of results across technology types to allow you to match to your specific study
• Practicalities and obstacles in implementing digital pathology into a clinical setting
• Core hurdles to change a broken testing ecosystem. How can immunotherapy stakeholders work together so targeted treatment benefits can be seen by more patients?

1:30 pm Networking Break

Networking Break: Translational
Breakout Room

Moderated by Shana Tetrault, Senior Director of Marketing, Ultivue

Networking Break: Pathology
Breakout Room

Moderated by Mark Rees, Vice President of Corporate Development, Ultivue

Enabling Robust Validation of Protein Biomarkers in Tissue with Clinical Utility in Mind

Sessions Moderated by Angela Vasaturo, Associate Director Biomarker Strategy and Applications, Ultivue

2:00 pm Hanson Wade Opening Remarks

2:05 pm Ultivue Opening Remarks

  • Mark Rees Vice President of Corporate Development, Ultivue

2:15 pm Molecular Testing in Early-Stage Lung Cancer: Is it Warranted?

  • Peter Illei Associate Professor, Johns Hopkins University

Synopsis

• Molecular testing for targetable alterations is standard of care in advanced-stage lung cancer and is mandated by professional guidelines. However, the same guidelines state that testing in early-stage lung cancer can be performed but is not mandated
• Recent approval of adjuvant EGFR targeted therapy in EGFR positive early-stage lung cancer as well as numerous ongoing clinical trials investigating the role of targeted therapy and immunotherapy raises the need of routine testing
• Discuss the rationale for testing, as well as when and how to perform biomarker testing in early-stage lung cancer

2:45 pm Leveraging Clinical Biomarker Data to Improve Patient Response to Immunotherapies

  • Jaclyn Neely Associate Director, Translational Medicine, Bristol Myers Squibb

Synopsis

• Key challenges in collecting tumor samples from patients
• Maximizing exploratory biomarker data from clinical trials
• Utilizing retrospective data

3:15 pm Developing Next Generation, Tissue Based, CDx Assays

  • William Powell Director of Product Technology & Strategy, Leica Biosystems

Synopsis

• CDx development is an expanding network of partners (Pharma, Dx companies and CROs) to build a clinical ecosystem to identify responding patients
• Multiplexing in the immuno-oncology space is a key driver of biopharma requirements from diagnostic companies for validating selective biomarkers
• What are the challenges in moving multiplex assays into the clinical labs and how can we mitigate technological, regulatory and adoption barriers?

3:45 pm Afternoon Break

4:00 pm More than Pretty Pictures – New Directions for Tissue Technology in Immuno-Oncology Biomarker Research and Development

  • Jennifer Giltnane Senior Scientist, Pathologist & Scientific & Translational Tissue Technologies Lead, Genentech

Synopsis

• Tissue technologies including new approaches for immuno-oncology biomarker multiplexing are expanding rapidly, while timelines and clinical trial tissue samples are shrinking
• Biomarker research and development requires a delicate balance between complexity and throughput when choosing technology platform
• Future directions in multiplexing will employ multimodality integration with basic stains (H&E), omics data, and ML/AI image modeling to allow amplification of tissue data

4:30 pm Panel Discussion: Translational to Ecosystem – How to Connect all the Dots

Synopsis

• How do Biopharma, Academics, CROs and Regulatory agencies all function together? How can we improve collaboration to develop more effective immunotherapies?
• What hurdles exist in the overlap of each of these groups to bring forth successful biomarker programs and immunotherapies?
• What does the ecosystem look like to each individual party and what is the glue keeping it all together? Can we harmonize the way research is conducted in the academic and commercial setting?

5:30 pm Closing Remarks & End of Biomarker Insights Summit