" Biotherapeutics/Biosimilars Immunogenicity Assessment & Clinical Relevance - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"
Understanding the Emerging Approaches for the Immunogenicity Assessment of Next-Generation Biotherapeutics; Advances/Challenges in Current ADA Testing, Reporting, Prediction, Mitigation and Management for Biotherapeutics & Biosimilars; Input from US FDA on Labeling Guidance and Integrated Summary of Immunogenicity (ISI); Advanced ADA-Domain-Characterization of Complex/Novel Biotherapeutics; Newest Case Studies in Immunogenicity Assessment, Risk-Based Approaches, Pre-Existing Antibodies Interpretation and Clinical Relevance; Impact of Drug, Soluble Target and Interferences on Clinical ADA Assessment; AND LASTLY WRIB Traditional KOL Industry/Regulators Focused and Highly Interactive Panel Discussions on Immunogenicity Reporting, Submissions Outcome and Recent Controversial Issues
Session 1: Evolution of Immunogenicity Assessment Beyond ADA and NAb: Focus on Clinical Relevance
Session 2: Complex Immunogenicity Characterization for Bispecific Therapeutic Proteins and mAb Therapy for Alzheimer Disease
Session 3: Final Proposal on Cross-validation for ADA/NAb Assays and Re-evaluation of Minimum Noise Reduction & False Positive Range
Session 4: Further Developments in Risk-Based Approaches for Immunogenicity Prediction & Mitigation
Session 5: 2024 White Paper in Bioanalysis
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2024 White Paper on Biotherapeutics/Biosimilars Immunogenicity Assessment & Clinical Relevance - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders
Consensus & Conclusions on Biotherapeutics/Biosimilars Immunogenicity Assessment & Clinical Relevance - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders for 2024 White Paper
Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
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Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Immunogenicity
Regulatory Panelists:
- Dr. Daniela Verthelyi (US FDA CDER)
- Dr. Zuben Sauna (US FDA CBER)
- Dr. Mohanraj Manangeeswaran (US FDA CDER)
- Dr. Seth Thacker (US FDA CDER)
- Dr. Vijaya Simhadri (US FDA CBER)
- Dr. Meenu Wadhwa (UK MHRA)
- Dr. Sandra Diebold (UK MHRA)
- Dr. Sandra Prior (UK MHRA)
- Mr. Christian Mayer (Austria AGES / EU EMA)
- Dr. Adrian Wong (Health Canada)
- Dr. Akiko Ishii (Japan MHLW)
