Specialized Workshop M1 - Monday April 07, 2025: 7am to 5:30pm
" AGENDA -
Biotherapeutics/Biosimilars Immunogenicity Assessment & Clinical Relevance
- Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders "
| 07:00am-08:00am: |
Start your day at WRIB with Continental Breakfast |
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: 2025 White Paper in Bioanalysis
| -08:00pm: |
"Recommendations on Immunogenicity of Biotherapeutics and Panel Discussions for 2025 White Paper in Bioanalysis"
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Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
| 08:00pm-09:05pm: |
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)
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| 05:30pm-07:00pm |
Welcome Reception Mark Twain Courtyard
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