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Agenda Specialized Workshop M1
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:
  • 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)

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
Reception






Agenda at a Glance Agenda at a Glance