Main Workshop DAY 1 - Tuesday June 20, 2023: 7am - 6pm - Discussion Topic List

"Ligand-binding, Flow Cytometry, PCR and ELISpot Assays"

Session 1: Immunogenicity Assays, Regulatory Challenges, and Impact on PK Assays

  • Topic 1:

    Universal ADA Assay Formats for Maximizing Efficiency: Strategies for Development/Validation of these Assays during Large Molecule Development, Understanding the Concept & Consideration of this Universal Format, Continued Evolution of the ADA Assay System to Support Novel Biotherapeutics
    Dr. Shalini Gupta, Director, Amgen

  • Topic 2:

    Development of Generic ADA Assays Drug Tolerant to Measure Unusual ADA Activity with Effects on PK Assay: Understanding ADA Informed Problems with the PK Assay, and when a PK Total Antibody Assay and Free Antibody Assay can substitute ADA determination
    Dr. Christine ODay, Sr. Director, Seattle Genetics

  • Topic 3:

    ISR for ADA Assays: Importance for Monitoring of ADA Assay Performance, Regulatory Challenges, Issues with PC/NC not representative of Incurred Samples, Importance of Monitoring ISR as more informative than PC/NC, Use of Cohen's Weighted Kappa Test as basis for ADA Assay ISR
    Dr. Robert Kubiak, Associate Director, Astra Zeneca

  • Topic 4:

    Multi-Specific Biologics Immunogenicity: Strategies to Distinguish between Clinical Pre-Existing Antibodies (PEA) and Treatment Emergent Antibodies (TEA), Flow Chart for how to perform ADA Characterization, and Strategy/Plan/Reagent Tools needed to be able to develop ADA Assays to differentiate PEA/TEA
    Ms. Kelly Coble, Director of Bioanalytical Sciences, Boehringer Ingelheim

Session 2: Biomarker Development, IVD/CDx Assays, and BAV

  • Topic 5:

    Biomarker Assays Difference: What is our Biomarker Assay Actually Measuring? Can we Compare Results from one Biomarker Assay to Another? or one Platform to another?  How are the Pre-analytical Variables Impacting what your Biomarker Assay is Measuring? Is there a need to use Orthogonal Methods to Confirm Results from Untargeted Biomarker Assay? 
    Mr. Joel Mathews, Director, Ionis

  • Topic 6:

    Free Target Assays for Drug Candidates Targeting Soluble Targets: Should be Free or Total Target Concentrations Measured? Or both? What are the Challenges in Developing these Assays? What's the Value of Free Soluble/Shed Target Assays? Are Free Assays always needed to monitor Target Engagement (TE)?
    Dr. Giane Oliveira Sumner, Executive Director - Assay Development, Regeneron

  • Topic 7:

    IVD Kits Biomarker Assay Validation (BAV) for Primary and Secondary Endpoint: What parameters do we need to Assess/Re-asses in fit-for-purpose BAV and when to refer to IVD Documentation? What is needed from the Kit Manufacturers to perform BAV? Unclarity on Differences in IVD Assay Purposes/Validation Requirements
    Dr. Stephanie Vauleon, Lab Head Regulated Bioanalysis (GxP), F. Hoffmann-La Roche

  • Topic 8:

    Measurement of Biomarkers at Patient Bedside: Point of Care (PoC) Assays Development and Fit for Purpose Biomarker Assay Validation (FFP BAV) in Clinical Trials, Challenges with Smart Sample Home Collection, Real-time Readers or Shipping to Lab, Evaluation of Operational, Pre-analytical and Bioanalytical Aspects to ensure reliable data
    Dr. Arvind Kinhikar, Associate Director, Novartis

Session 3: Gene/Cell Therapy Assays and Biodistribution

  • Topic 9:

    An Orthogonal Method to ELISpot for CAR-T Cellular Immunogenicity: Is ELISpot still the Gold Standard for Assessing Cellular Immunogenicity? ELISpot Pros/Cons, Method Development & Peptide Selection Best Practice, Recent Findings from an Orthogonal Platform, Current Understanding of Cellular Immunogenicity for Cell Therapy Programs
    Dr. Johanna Mora, Senior Director, BMS

  • Topic 10:

    The Rise of ddPCR: Considerations for when ddPCR platform is Preferred over Traditional qPCR, ddPCR superior Exon Skipping Quantification & Inhibitor/Interfering Factors Tolerance, LLOQ Determination, Vector Shedding and Tissue Biodistribution Assays, Linkage Analysis for Investigating off-target Tissue RNA Detection
    Dr. Andrew Melton, Director, BioMarin Pharmaceutical, Inc.

  • Topic 11:

    AAV NAb Assessment: Important Considerations/Improvements for Developing AAV NAb Assay with Shorter Turn-around Time, ADA/NAb Assessment Strategy for Pre-dose/Post-treatment Sample Selection for Normalization Control Preparation, Cut Point Determination, ADA/NAb Data Correlation, Positive Samples Classification in the presence of Pre-existing Ab  
    Dr. Bonnie Wu, Associate Scientific Director, Janssen

  • Topic 12:

    Anti-AAV Total Antibody (TAb) for Immunogenicity Assessment: What is the most efficient and practical Testing Strategy to analyze Post-dose Samples? Is there any Alternative Approach to get the Post-dose Results? Do we really need to Evaluate Post-dose results for titers? Challenges Encountered using Traditional Tier-based Approach 
    Dr. Yuanxin Xu, SVP, Early Development and Translational Medicine, Intellia Therapeutics

Session 4: Vaccine Clinical Assays

  • Topic 13:

    Further Considerations on LNP Immunogenicity and Anti-PEG Antibodies Bioanalysis in Post-Covid Era: With an Increased Prevalence of Pre-existing anti-PEG Antibodies should these assays be developed more like Vaccine Assays? Regulatory Concerns, High Heterogeneity of Immune Responses, Assessing Clinical Impacts & Appropriate Bioanalytical Methods 
    Dr. Jean-Claude Marshall, Head of Clinical Biomarkers, Moderna

  • Topic 14:

    Issues with International Reference Standards for Vaccine Clinical Assay: Current RSM Limitations for the Comparison between Assays and Data Produced with Different Assays, Importance of having reliable RSM to Correlate with or as Surrogate to Protection, What Factors are to be Considered when Comparing Data?
    Mr. Karl Walravens, Head Clinical Immunology and Microbiology Sciences, GSK

  • Topic 15:

    Vaccine Clinical Assays Life Cycle Management: Modernizing of Legacy Vaccine Assays, Industry Best Practices to Introduce New/Emerging Methodologies/Technologies, how to Interact with Regulatory Agencies, Maintain Compliance with Updated Regulatory Guidance, Challenges with Long-term Platform Support & Critical Reagent Supply
    Dr. Katrina Nolan, Director, Merck

Session 5: 2023 White Paper in Bioanalysis

  • 2023 White Paper on Ligand-binding, Flow Cytometry, PCR and ELISpot Assays

    Consensus & Conclusions on Ligand-binding, Flow Cytometry, PCR and ELISpot Assays for 2023 White Paper

Agenda at a Glance Agenda at a Glance