Main Workshop DAY 1Tuesday September 27, 2022: 7am - 6:30pm - Discussion Topic List

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

Part 1: Immunogenicity Assays

  • Topic 1:

    How to think about Immunogenicity & Bioanalysis for Drugs that have a Prolongation Effect in vivo

  • Topic 2:

    T-cell Engager (BiTE) Immunogenicity & Associated Cytokine Release: Pasotuximab Lesson Learned and Cytokine Measurement Strategy

  • Topic 3:

    Target Interference on Screening Assays Cut Point & Importance of Risk Assessment for pH Sensitive Multi-domain Biotherapeutic (MDB): Lessons learned from Immunogenicity Assays for MDB

  • Topic 4:

    Characterization of “high” Incidence Clinical ADA beyond ADA and NAb Assay Testing: What would drive additional characterization and its timing?

  • Topic 5:

    Understanding the Affinity of ADA in Clinical Samples in Connection with LBA: What expected & What unexpected

Part 2: Biomarker Assays & PK Assays

  • Topic 6:

    The Evolving in the Field of Extracellular Vesicles Bioanalysis: Latest Developments and Next Steps

  • Topic 7:

    Challenges in Biomarker Assay Validation (BAV) for Primary/Secondary End Points in Clinical Studies: CAP/CLIA beyond BMV Guidance & Using newly developed non-IVD vs. FDA approved IVD

  • Topic 8:

    A decade of Free/Total Assays Discussions for Biomarker Assays & PK Assays: Where do we stand and what could be the next step in developing the “ultimate” strategy?

    • Importance of Clearly Defined Free/Total Bioanalytical Data to Evaluate the Pharmacokinetic Behavior of Therapeutic Proteins and to Enable PK/PD assessment - Topic 8a
    • Target Assay Strategy: Why do we Measure Target and How do we use the Data? - Topic 8b
    • Free/Complex/Total Target Engagement (TE) Measurements: Is there a real need to develop multiple assays with overlapping purposes? - Topic 8c

Part 3: Gene Therapy, Cell Therapy and Vaccine Assays

  • Topic 9:

    Challenges with the use of Cell-based Assays as Vaccine Clinical Studies Endpoints: Why not move to Plate-based assays?

  • Topic 10:

    Implementation of a Bridging LBA to assess ADA response to CAR-T therapy and correlation with Cell-Based/Flow Cytometry data

  • Topic 11:

    Lesson Learned on Gene Therapy Immunogenicity Strategy: Pre-existing Immunity, Utility of NAb assays, Cellular Immunity, ELISpot result… What data/assays are really needed?

  • Topic 12:

    Lesson Learned on CAR-T Bioanalytical Strategy: Cellular Immunity/CTL Response, Utility of NAb assays, ELISpot Inconsistent result, qPCR/ddPCR/NGS for Gene Expression Analysis...What data/assays are really needed?

Part 4: White Paper in Bioanalysis

  • 2022 White Paper on Ligand-binding, Flow Cytometry, PCR and ELISpot Assays:

    Consensus & Conclusions on Ligand-binding, Flow Cytometry, PCR and ELISpot Assays for 2022 White Paper

Agenda at a Glance Agenda at a Glance