Specialized Workshop M1 - Monday September 26, 2022: 7am - 5:30pm - Lecture List

"Advanced Immunogenicity Testing, Reporting, and Risk Assessment of Biotherapeutics"

Prescription Drug Labeling new FDA Draft Guidance; Harmonization of Regulations; Enhanced Tiered / Cut Points Approaches; Clinical Relevance, Preclinical & Clinical Assessment; Risk-based Approaches, Prediction and Mitigation; NAb Assays, Integrated Approach and ADA Comparison & Monitoring

Part 1: Risk-based Approaches, Prediction and Mitigation

  • Lecture 1:

    Recent Advancements on Immunogenicity Prediction and Mitigation Tools and its actual Utility

  • Lecture 2:

    Biosimilars in vitro & in silico Immunogenicity Prediction Tools: Are they promising tools in Biosimilar Development?

  • Lecture 3:

    Challenges with T Cell Proliferation Assays for Immunogenicity Risk Assessment: What Regulatory Guidance to follow? How to design a Fit-for-purpose Validation for Flow Cytometry?

Part 2: Preclinical & Clinical Harmonization and Enhanced Tiered & Cut Point Approaches

  • Lecture 4:

    Non-GLP Immunogenicity support for GLP studies: What is the relevance of Immunogenicity in GLP studies?

  • Lecture 5:

    Current Points of Disagreement in Immunogenicity Harmonization

  • Lecture 6:

    How to reduce the Immunogenicity Tiered Testing Strategy by using Improved Methodologies and a better understanding of ADA Clinical Relevance

Part 3: NAb Assays and Integrated Approach

  • Lecture 7:

    Novel Case Studies in Support of an Integrated Data Approach versus in vitro NAb Assays: Lesson learned and feedbacks received by Regulatory Agencies

  • Lecture 8:

    Current Considerations on Domain Mapping ADA Characterization and its Complementary use in NAb strategy

Part 4: ADA Assay Comparison & Monitoring

  • Lecture 9:

    Recent Developments in ADA Assay Comparisons: New experience acquired following the 2021 Industry/Regulators’ recommendations on this topic

  • Lecture 10:

    ADA Assay Monitoring: Current Experience in Establishing a Process to Monitor ADA Assay Trending and Performance over time, Rules for Establishing criteria, Regulatory requirement

Part 5: New FDA Draft Guidance on Prescription Drug Labeling

  • Lecture 11:

    Immunogenicity Label Negotiations with the Agency: Lesson learned and impact of the new FDA draft Guidance?

  • Lecture 12:

    Clinical Significance & Immunogenicity Assessments: How does this change with new FDA Drug Label Draft Guidance?

  • Lecture 13:

    Experiences and Observations through Real life Immunogenicity Label Negotiations: Industry perspective on Immunogenicity Section of Labeling Draft guidance

  • Lecture 14:

    When Immunogenicity has no Clinical Impact: is it my bad assay or is it my unimpactful ADA? Lessons learned from immunogenicity reporting: Focus on the FDA Draft Guidance on Immunogenicity Labeling

Part 6: White Paper in Bioanalysis

  • 2022 White Paper on Immunogenicity Topics:

    Consensus & Conclusions on Immunogenicity Topics for 2022 White Paper


  • Panel Discussion with All the Regulators:

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

Agenda at a Glance Agenda at a Glance