Specialized Workshop Th2 - Thursday June 22, 2023: 7am to 6pm - Discussion Topic List

"Cell-Based & Flow Cytometry Assays - Latest Developments, Challenges, and Solutions"

NEW Case Studies on Cell-Based & Flow Cytometry Innovative Approaches and Technology Advancements for Exploratory/Clinical Cellular Biomarkers, Cellular Immunogenicity, Cellular Kinetics for CAR-T/Cell Therapy, and Vaccine Functional Assays/CMI/ICS; Novel Techniques to Extend Flow Cytometry Capabilities for Quality Data Generation; Auto-Gating, Modular Approach Developments; High Dimensional Cytometry; Overcoming Sample Stability Limitations; Newest Innovations in Spectral Cytometry, Mass Cytometry, and Imagine Cytometry

Session 1: Novel Strategies for Method Development/Validation

  • Topic 1:

    Strategies on Validation of Modifications & Amendments to existing Flow Cytometry Assays: Equivalency, Bridging and Validation Addendum studies maintain or Extending Claims through validation studies, and manage Assay Changes through amending an existing validation vs. opening a new validation, Demonstrating Maintenance of Performance 
    Dr. Steven Eck, Director, Integrated Bioanalysis, AstraZeneca

  • Topic 2:

    Use of Dried Antibody Tubes as a Platform for Clinical Flow Cytometry Assays: Drying Process to create a Uniform Reagent Layer at the bottom of the tube; Performance Comparison with Liquid Reagents, Pros/Cons, and Benefits, Replacing Reagent Cocktail Preparation, Pipetting Errors and Reagent Mix-ups
    Dr. Michael Nathan Hedrick, Senior Scientific Director Clinical Flow Cytometry, BMS

  • Topic 3:

    Overcoming Sample Stability Limitations for Flow Cytometry Assays: Platforms & Strategies for ensuring Fresh Blood Sample Stability/Integrity, Comparison with other Platforms/Approaches to manage samples, Operational Strategies for Sample Integrity, Alternate Platforms to Inform Immunophenotyping
    Dr. Erin Stevens, Associate Research Fellow, Pfizer

  • Topic 4:

    Modular Approach for Cytometry Assay Development/Validation in context of Clinical Trials: Recent Developments of Modular FC Assay, Concept & Design, Applications/Challenges in High Dimensional Cytometry in clinical settings highlighting the benefits of implementing Full Spectral Cytometry
    Dr. Enrique Gomez Alcaide, Strategy Area Leader Cellular Biomarkers, Roche

Session 2: Quality Data Generation in in High Dimensional Cytometry

  • Topic 5:

    Generation of Large Data Set in Flow Cytometry in the Clinical Space to Advance Therapeutics and Identify Novel Targets/Biology: Full Spectrum Cytometry Limitations in the Clinic, Reporting limited to Hierarchical/Boolean Gating, Considerations on Size of data, Processing power, Best AI/ML algorithms, No AI/ML reportable from vendors  
    Mr. Luis Mendez, Director Flow Cytometry, Merck

  • Topic 6:

    Focus on Quality Data Generation during Method Development/Validation for Spectral Cytometry assays in Clinical Bioanalysis: Harmonization of Panels to enable Comparability between Clinical studies, Strategies for Core markers, fluorochrome choice and staining protocols, Stability Assessments with different fixatives
    Dr. Vilma Decman, Senior Director, Head of Cellular Biomarkers, GSK

  • Topic 7:

    Automated Gating, Supervised and Unsupervised: Where do we stand in its applications in clinical trials? Applications of Supervised Data Analysis from Global Clinical Trials, Unsupervised data analysis in Biomarker Discovery, Challenges and Limitations for automated gating in Multicentric Clinical Trials, Validating Automated Gating
    Dr. Christele Gonneau, Principal Scientist, LabCorp

Session 3: Biomarkers Novel Approaches for Method Development/Validation

  • Topic 8:

    Current issues in Flow-Based Receptor Occupancy (RO): Direct or Indirect format, Target Population, Blood vs PBMC vs Tumor? Selection of assay formats from MoA and Reagent Availability, Gaps between Peripheral blood and Diseased Sites, Tissue RO Direct Target Engagement (TE) Information, RO Controls Isotype, FMM, Isoclonal Control
    Dr. Yongliang "Steve" Sun, Associate Director, Bristol Myers Squibb

  • Topic 9:

    Cytometry Analysis of Solid Tissues for Biomarkers/Biomeasures: Recent Advances, Challenges, Calibration-free analysis of Membrane Target Level based on kinetic biding of target-specific antibodies, Current approaches for Receptor Quantification, Cell-specific Simultaneous Analysis of Transgene mRNA & Protein in Biodistribution studies 
    Dr. Polina Goihberg, Discipline Lead, Pfizer

  • Topic 10:

    Recent Advances in using Extracellular Vesicles as Biomarkers by AMP Glo assay and Flow Cytometry assay: Potential of using Exosomes for development of Novel Biomarkers for CD73 , Importance to Translate findings to Cancer Patient Plasma Samples for determining the activity and expression of CD73 
    Dr. Sarita Sehra, Senior Research Investigator, Incyte

  • Topic 11:

    Advanced Cellular Biomarkers Development using Spectral Cytometry: Application in Clinical Trials, Opportunities, Risks, Recommendations, Pathway to Platform Adoption, Instrument Harmonization/Standardization, Assay Performance at Standardized Settings, Minimizing variation to ensure Data Reproducibility across multiple instruments and/or multiple sites
    Ms. Megan McCausland, Director, Assay Development, Q Squared Solutions

Session 4: Cell Therapy and Vaccine Novel Approaches for Method Development/Validation

  • Topic 12:

    Cell-Mediated Immunity Assays (CMI): Strategies for Flow Cytometry based Intracellular Cytokine Staining (ICS) Assay, Development of Assays to measure T Cell immune responses, Workflows for Assay Qualification and for Validating CMI Assays, Measuring CMI Responses in Clinical Studies and CMI Assay Standardization 
    Dr. Jakob Loschko, Associate Director, Pfizer

  • Topic 13:

    Importance of Cytometry in Vaccine Development Clinical Testing, ICS and CMI: Complex Assay development to support Vaccine, Functional Profiling Types/Methods/Reagents to investigate the immune response, Other Assay Type to Investigate Cell-mediated Immune Response, Best Practices and Regulatory Perspective
    Mr. Paul Trampont, Senior Scientific Director, Moderna

  • Topic 14:

    CAR-T Bioanalysis by Mass Cytometry in Clinical Trials: High Applicability to understanding CAR-T Treatment, Detection of Transgene Positive Cells, Importance of Product Activity throughout Manufacturing/Treatment, Supporting Multiple Programs by custom/commercial solutions with Core Markers at the center of Panels 
    Mr. Gregory Hopkins, Associate Manager, 2seventybio

  • Topic 15:

    Patient-Centric Cytometry Assay for Next Generation CAR-T Cell Therapies: Advanced Strategies for the Development & Validation, Clinical Trials enlisting Pediatric and/or Sickest Patients, Importance of Reducing Specimen Volume/Site Visits, Needs for CAR-T Full Spectrum Cytometry assays providing Multiple Readouts from Single Tube
    Dr. Shabnam Tangri, Chief Scientific Officer, Navigate

Session 5: 2023 White Paper in Bioanalysis

  • 2023 White Paper on Cell-Based & Flow Cytometry Assays - Latest Developments, Challenges, and Solutions

    Consensus & Conclusions on Cell-Based & Flow Cytometry Assays - Latest Developments, Challenges, and Solutions for 2023 White Paper

Agenda at a Glance Agenda at a Glance