Training Session F1 - 7am to 5:30pm, Friday April 5, 2019

"Cut Points – 'The Evolution': Issues in Statistical Evaluation & current Regulatory Perspectives of Cut Points and impact on Immunogenicity Assay development"

Building on Industry/Regulators’ recommendations & Working together for harmonization

Part 1: Setting the Stage in Preparation of Final Recommendations
  • Lesson 1:

    Evolution of WRIB Recommendations on Cut Point from 2015 WP to 2018 WP: Where are we now and what next?

  • Lesson 2:

    Clarification on False Positive/Negative Rate for Screening/Confirmatory Assay Cut Point: Building on 2018 White Paper in Bioanalysis Recommendations

  • Lesson 3:

    Impact of Presence of Pre-Existing Antibodies on Cut Points Determination and Immunogenicity Assessment Strategy

  • Lesson 4:

    Practical Approaches to Cut Points Setting in Presence of Pre-Existing Antibodies: What Approach the Regulators Prefer?

  • Panel Discussion:

    Setting the Stage in Preparation of Final Recommendations Panel Discussion

Part 2: Industry Practical Experience in Cut Points Statistical Evaluation
  • Lesson 5:

    Issues & Solutions in Cut Points Statistical Evaluation: BMS Experience

  • Lesson 6:

    Issues & Solutions in Cut Points Statistical Evaluation: Genentech Experience

  • Lesson 7:

    Issues & Solutions in Cut Points Statistical Evaluation: Regeneron Experience

  • Lesson 8:

    Issues & Solutions in Cut Points Statistical Evaluation: Roche Experience

  • Panel Discussion:

    Industry Practical Experience in Cut Points Statistical Evaluation Panel Discussion

Part 3: What’s New and What Make Sense in Cut Point Determination
  • Lesson 9:

    Developing ADA Assays that Adequately Capture Biological Noise, so that Cut Points Make Clinical Sense

  • Lesson 10:

    Proposal for a New Approach for Cut Point Determination Able to Provide a More Meaningful Clinical & Biological Relevance

  • Lesson 11:

    Finalized Industry/Regulators Recommendations on Cut Point Determination

  • Panel Discussion:

    What’s New and What Make Sense in Cut Point Determination Panel Discussion

Part 4: Regulatory Experience and Perspectives
  • Lesson 12:

    FDA Experiences & Perspectives on Issues & Solutions in Cut Points Statistical Evaluation

  • Lesson 13:

    FDA Recently Issued 483s & Observations on ADA Assays Inspections and Cut Points

  • Ask the Regulators - Panel Discussin with Regulators:

    Address your questions on Cut Points and interact directly with US FDA, EU EMA, Health Canada and Japan MHLW

 

 

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