Main Workshop DAY 3 - Thursday April 4, 2019, 7am to 6:30pm

"LBA, Cell-based Assays/Flow Cytometry, & Emerging Technologies DAY"

Day 3 Session List

Day 3A: LBA, Cell-based Assays/Flow Cytometry, and Emerging Technologies
  • Session 1:

    Novel Bioanalytical Developments in Cancer Immuno & Gene Therapy

  • Session 2:

    Immunogenicity: What’s New in Drug Tolerance & Sensitivity, Positive Controls (PC) Appropriateness, Clinical Relevance, PK, PD, ADA Data Correlation

  • Session 3:

    PK assays & Biomarkers assays: Soluble Target & ADA Impact in PK, Vaccine Clinical Assays, Exploratory Biomarkers – Who are they?, Accuracy in Biomarkers Assays?

  • Session 4:

    Panel Discussion on LBA, Cell-based Assays/Flow Cytometry, and Emerging Technologies - Consensus for 2019 White Paper in Bioanalysis

Day 3B: ICH M10 BMV Draft Guideline - LBA
  • Session 5:

    Harmonized Topics on LBA among US FDA, EU EMA, Health Canada, Japan MHLW regulations

  • Session 6:

    Unresolved Issues and On-going Industry/Regulators’ Discussions on LBA

  • Session 7:

    Panel Discussion on ICH M10 BMV Draft Guideline LBA - Provide official Recommendations to ICH

 

 

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