Specialized Workshop M2Monday September 26, 2022: 7am - 5:30pm - Lecture List

"Biomarkers & CDx Innovative Strategies for Method Development, Validation, and Sample Collection/Analysis"

From Early-Stage Development to Clinical Translation/Commercialization; Complex & Challenging Applications; Regulatory CDx & BAV Guidelines; Biomarkers for Vaccine Study Endpoints

Part 1: Method Development/Validation Strategies for Biomarker & Companion Diagnostic (CDx)

  • Lecture 1:

    Ensuring Quality Biomarker & CDx Data: Method Development/Validation Strategies

  • Lecture 2:

    Point to Consider in CDx Method Development/Validation: When to start turning a Biomarker Assay into a CDx & Requirements for Validating Biomarker Assay as CDx

  • Lecture 3:

    Biomarkers & CDx Method Development/Validation for Gene Therapy

  • Lecture 4:

    Biomarkers & CDx Method Development/Validation in China: Challenges & Solutions

Part 2: FFP BAV for Mass Spectrometry, Multiplex Immunoassays and other Biomarker Assays

  • Lecture 5:

    Advanced Fit-For-Purpose Biomarker Assay Validation (FFP BAV) Strategies: What Parameters and Acceptance Criteria to choose for different Biomarkers Assays? Similarities and differences for Mass Spec (LCMS), Immuno (LBA), Molecular (qPCR) and Cell-Based (Flow) Biomarkers Assays

  • Lecture 6:

    Parallelism Test for Mass Spectrometry FFP BAV: When is it necessary and what does it inform on?

  • Lecture 7:

    Spike Recovery, Standard Addition and Dilutional Linearity for FFP BAV: What have we learnt from ICH M10 draft BMV Guideline Section 7.1 for Endogenous Compounds?

  • Lecture 8:

    Applications of Multiplex Biomarker Assays to Accelerate Drug Discovery & Development

  • Lecture 9:

    Strategies to Overcome the Challenges in FFP BAV for Multiplex Cytokine Measurements

Part 3: Biomarkers Development/Validation for Vaccine Study Endpoints

  • Lectures 10, 11, 12:

    Fit-For-Purpose Biomarker Assay Validation (FFP BAV) Strategies for Vaccine Immunoassay

    • Application of Assay Ranges & Interpretation of Dilutional Linearity in Biofunctional Assays - Lecture 10
    • Parallelism Difference between Clinical/ Incurred Samples & Convalescent Material and Evaluation of Data below the Starting Dilution - Lecture 11
    • What is the Appropriate “matrix” for Demonstrating Linearity for Vaccine Immunoassays? - Lecture 12

Part 4: Extremely Difficult Method Development/Validation for Biomarkers

  • Lecture 13:

    ROS (Reactive Oxygen Species) Biomarkers: Challenges & Considerations for Method Development, Sample collection, Sample Handling/Treatment, and Run variability

  • Lecture 14:

    Biomarkers in Disease Tissues and Complex Matrices: Challenges & Considerations for Operational, Preanalytical and Bioanalytical aspects

Part 5: White Paper in Bioanalysis

  • 2022 White Paper on Biomarker Topics:

    Consensus & Conclusions on Biomarker Topics for 2022 White Paper


  • Panel Discussion with All the Regulators:

    Have an Open Dialogue with the Regulators including US FDA, EU EMA, Japan MHLW
    Ask the Regulators any Questions You Have on Biomarkers and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes

Agenda at a Glance Agenda at a Glance