Training Session M1 - 7am to 5:30pm, Monday April 1, 2019

"New Insights in Biomarkers Assays Validation (BAV): From US FDA BMV (2018) Guidance, Revised C-Path (2018) White Paper and CLSI Draft Document H62 to Fit-for Purpose Validation - Case Studies from LBA and Flow Cytometry"

Evolution of BAV strategy based on New US FDA BMV Guidance, Revised C-Path White Paper and CLSI Draft Document H62 versus traditional Lee (2006) Fit-for-Purpose White Paper

Part 1: Novel Guidelines & White Papers for BAV
  • Lesson 1:

    Evolution of WRIB Recommendations on LBA BAV based on CoU from 2015 to 2018: Where are we now and what next?

  • Lesson 2:

    Flow Cytometry Biomarker Assay Validation (BAV) in Drug Development: Can the brand-new CLSI H62 document applied to pharmaceutical BAV?

  • Lesson 3:

    Understanding of the Biology of Biomarker for successfully BAV: How is the importance Biology of Biomarkers taken into consideration in the New US FDA BMV Guidance & Revised C-Path White Paper (2018) versus traditional Lee (2006) Fit-for-Purpose White Paper?

  • Lesson 4:

    How to deal with the Differences between a Bioanalytical Lab (GLP/GCP) for Clinical Trials and a Diagnostic Lab (CLIA): Focus on Conversion of a Clinical Trial Biomarker Assay to a Clinical Diagnostic test in CLIA

  • Panel Discussion:

    Novel Guidelines & White Papers for BAV Panel Discussion

Part 2: Evolving Scientific & Regulatory Challenges and Novel Solutions in BAV
  • Lesson 5:

    Progresses in Parallelisms, MRD, and Sensitivity Understandings in LBA BAV: New US FDA BMV Guidance & Revised C-Path White Paper (2018) versus traditional Lee (2006) Fit-for-Purpose White Paper

  • Lesson 6:

    Choosing the Most Appropriate Quality Control (QC) for LBA BAV: Case studies on the importance of QC to understand the difference between endogenous biomarker and calibrator material stability

  • Lesson 7:

    Flow Cytometry Reproducibility & Stability Evaluations in Biomarker Assay Validation: Minimizing variability by considering best selection of Calibration & Endogenous QC material and defining a core set of commonly used validation experiments to ensure reproducibility

  • Lesson 8:

    LBA Biomarkers Case Studies of Stability & Variability within Sample Collection Times, Matrix and Patient Biology and Background: How are these important factors taken into consideration in the New US FDA BMV Guidance & Revised C-Path White Paper (2018) versus traditional Lee (2006) Fit-for-Purpose White Paper?

  • Lesson 9:

    New/Current strategies to Optimize Kit-to-kit & Lot-to-lot variability in LBA & Flow Cytometry BAV: Evolution of strategy based on New US FDA BMV Guidance, Revised C-Path White Paper and CLSI Draft Document H62

  • Panel Discussion:

    Evolving Scientific & Regulatory Challenges and Novel Solutions in BAV Panel Discussion

Part 3: Complex Case Studies of BAV
  • Lesson 10:

    Complex Biomarker Assay Validation in Flow Cytometry for Clinical Diagnostic Implementation

  • Lesson 11:

    Importance of Flow Cytometry Cellular Biomarkers Assays Validation in Multi-Center Global Clinical Studies

  • Lesson 12:

    LBA Complex Cases of Biomarker Assays Validation for Free Assays: Lesson Learned

  • Panel Discussion:

    Complex Case Studies of BAV Panel Discussion

Part 4: Regulatory Perspectives
  • Lesson 13:

    Updates from the Biomarker Qualification Program at FDA

  • Lesson 14:

    A Regulatory Perspective on Japanese Points to Consider Documents on Biomarker Assay Validation

  • Ask the Regulators - Panel Discussin with Regulators:

    Address your questions on BAV and interact directly with US FDA, EU EMA, and Japan MHLW

 

 

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