Specialized Workshop M1 - Monday April 13, 2026: 7am to 5:45pm
"AGENDA - Biotherapeutics/Biosimilars Immunogenicity Assessment & Clinical Relevance "
07:00am-08:00am: | Start your day at WRIB with Continental Breakfast |
Session 1: Applications of Modeling in Immunogenicity and CBA for NAb Monitoring Strategy
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Special Session: ASK THE REGULATORS!
-07:50pm: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Immunogenicity Regulatory Panelists:
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Session 2: ADA Comparability Studies and Cross-validation
Session 3: Assessing Immunogenicity for Next Generation Biotherapeutics
Session 4: Immunogenicity Testing: Focus on Science rather than Workload Reduction & Perceptions
Session 5: 2026 White Paper in Bioanalysis
07:50pm-08:25pm: | "Recommendations on Immunogenicity of Biotherapeutics and Panel Discussions for 2026 White Paper in Bioanalysis" |
05:45pm-06:45pm |
Welcome Reception at Mark Twain Courtyard![]() |