Specialized Workshop M1 - Monday June 19, 2023: 7am to 5:30pm - Discussion Topic List

"Immunogenicity of Biotherapeutics - Latest Developments, Challenges, and Solutions"

NEW Case Studies and Lesson Learned on Immunogenicity Assessment, Interpretation and Clinical Relevance; Advancements on Harmonization of Immunogenicity Regulations, Risk-Based Approaches, Prediction, Mitigation and Management; Issues in ADA Validation Harmonization & ADA Assays Comparability; Improving Cut Point and FPR Calculation; Complex Biotherapeutics, Bispecific Antibody and Biosimilars S/N Immunogenicity Progresses; Industry/Regulators Interactive Discussions on Immunogenicity Reporting, Submissions Outcome and Recent Controversial Issues

Session 1: Immunogenicity Assay/Reporting HARMONIZATION: Focus on ADA/NAb Assay Validation and Signal to Noise (S/N) vs Titer

  • Topic 1:

    S/N Ratio vs Titer for Biosimilars: is S/N a more Sensitive Parameter to allow Meaningful Comparison of Biosimilar to Originator Immunogenicity? Limitations of Titer results in Comparing Magnitude of Biosimilar Immunogenicity vs Reference. Continuous Variable S/N vs Categorical Titer Results
    Dr. Johann Poetzl, Head Program Management Bioanalytics, Sandoz

  • Topic 2:

    Further Considerations on ADA Response using S/N based on the 2022 WRIB Regulatory Input on S/N vs Titer: Strong Correlation Observed, Simplified Analysis & Clinical Interpretation, Significant Reduction Testing, Time, Resources, Better Differentiation of Low-level ADA responses
    Mr. Fred McCush, Director, Clinical Bioanalytics (CBx), Pfizer

  • Topic 3:

    ADA Assay Validation Harmonization: Efficient Validation Operational Design to Provide Data Characterization and current Regulatory Expectations regarding ADA Assay Validation and Performance
    Dr. George Gunn, Head of Immunogenicity, Sr. Director, GSK

Session 2: Immunogenicity Risk-based Approaches, Prediction and Mitigation: Focus on Novel Monitoring Strategies and in vitro Immunogenicity Assessment

  • Topic 4:

    Immunogenicity Risk Assessment and Monitoring Strategy: Novel Case Studies, Roadmap for Integrated Summary for Immunogenicity (ISI), in silico and in vitro data on Intrinsic Immunogenicity Potential
    Dr. Swati Gupta, Executive Director, AbbVie

  • Topic 5:

    In vitro Immunogenicity Risk Assessments: Advanced Methods and Strategies for Data Analysis/Interpretation, Criteria for Method Establishment, Statistical Analysis Plan
    Dr. Michele Rasamoelisolo, Sr. Director, Teva

  • Topic 6:

    Advancements in Immunogenicity for Ophthalmology Indications: Focus on Immunogenicity Risk Assessment/Prediction using MAPPs and in vitro tools, automated method advantages vs manual workflow, assay robustness/reproducibility, Testing Clinical Benchmarks for Establishing MAPPs 
    Dr. Ola Saad, Distinguished Scientist, Genentech

Session 3: Lessons Learned from Immunogenicity Studies/Filings: Sharing Advanced Experience Related to Immunogenicity Strategies/Approaches

  • Topic 7:

    Immunogenicity Lessons Learned from Global Filings: Approach to Report and Analyze Drug Tolerance (DT) for ADA Assays, Addressing Regulatory Concerns on potentially False Negative Results, Navigating the Latest Challenges Related to China Human Genetic Resources Regulation (HGRAC)
    Dr. Yuan Song, Senior Director, Genentech

  • Topic 8:

    Challenges on Immunogenicity Assessment in the presence of Rheumatoid Factor (RF): Strategies for the Development of monovalent Fab Affinity-capture & Elution Bridging Immunoassay, Overcoming Interferences when assessing ADA in RA Patients
    Dr. Boris Calderon, Medical Director, Eli Lilly & Company

  • Topic 9:

    Investigation of the Clinical Impact of the Immunogenicity for Bispecific Antibodies: Immunogenicity Assessment Strategy based on the Totality of Data and Interpreted in the Context of Clinical Readouts, ADA Assay Technical Considerations
    Dr. Kate Peng, Sr Director, Genentech

Session 4: What’s NEW in Immunogenicity of Complex Biotherapeutics, Assay Comparability and Cut Point Assessment

  • Topic 10:

    Novel data on Complex Biotherapeutics with Half-life Extension: Experience from Recent Submissions, Domain Characterization, Bioanalytical Complexity of Multi-Domain Biotherapeutics (MDBs) , Use of Different Assay Formats, Clinically Relevance of ADA Reactivity 
    Dr. Susan Richards, Vice President, Sanofi

  • Topic 11:

    New Data in Support of Comparability of ADA Assays: How to Ensure Laboratories Generates Comparable Results, Lack of Regulatory Requirements for ADA assay comparability, Recommendations on Designing Experiments and Evaluating Results, Reassurance that Results Generated in Different Labs are Consistent and Comparable
    Dr. Robert Kubiak, Associate Director, Astra Zeneca

  • Topic 12:

    What's new in Cut Point? -  New Challenges and Solutions in In-study CP Assessment & FPR Calculation, Judgement Criteria for Study-specific CP (SSCP), What to do if FPR is still out of range even using SSCP? Should the baseline samples be analyzed multiple times? 
    Dr. Sam Song, Associate Director, Takeda

Session 5: 2023 White Paper in Bioanalysis

  • 2023 White Paper on Immunogenicity of Biotherapeutics - Latest Developments, Challenges, and Solutions

    Consensus & Conclusions on Immunogenicity of Biotherapeutics - Latest Developments, Challenges, and Solutions for 2023 White Paper

Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators

  • Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Immunogenicity

    Regulatory Panelists:

    • Dr. Daniela Verthelyi (US FDA CDER)
    • Dr. Joćo Pedras-Vasconcelos (US FDA CDER)
    • Dr. Kimberly Maxfield (US FDA CDER)
    • Dr. Sophie Shubow (US FDA CDER)
    • Dr. Kara Scheibner (US FDA CDER)
    • Dr. Mohsen Rajabi Abhari, (US FDA CDER)
    • Dr. Nirjal Bhattarai (US FDA CBER)
    • Dr. Meenu Wadhwa (UK MHRA)
    • Dr. Isabelle Cludts (UK MHRA)
    • Dr. Christian Mayer (Austria AGES/EU EMA)
    • Dr. Akiko Ishii (Japan MHLW)

Agenda at a Glance Agenda at a Glance