Specialized Workshop M1 - Monday April 13, 2026: 7am to 5:45pm
"AGENDA - Biotherapeutics/Biosimilars Immunogenicity Assessment & Clinical Relevance
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| 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
Special Session: ASK THE REGULATORS!
| -07:50pm: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Immunogenicity
Regulatory Panelists:
- Dr. Zuben Sauna (US FDA)
- Dr. Sophie Shubow (US FDA)
- Dr. Montserrat Puig (US FDA)
- Dr. Wojciech Jankowski (US FDA)
- Dr. Mohanraj Manangeeswaran (US FDA)
- Dr. Sandra Prior (UK MHRA)
- Dr. Claire Kerridge (UK MHRA)
- Mr. Christian Mayer (Austria AGES / EU EMA)
- Dr. Adrian Wong (Health Canada)
- Dr. Omar Tounekti (Health Canada)
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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"
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| 05:45pm-06:45pm |
Welcome Reception at Mark Twain Courtyard
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