Specialized Workshop M1 - Monday April 12, 2027: 7am to 5:30pm - Discussion Topic List
"Immunogenicity Assessment & Clinical Relevance of Biotherapeutics & Biosimilars - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"
Session 1: Current Risk-based Approaches for Immunogenicity Assessment
Session 2: Future Directions & Innovation to Evaluate ADC & Peptides Immunogenicity
Session 3: When can S/N Complement/Replace Titers? New Trends & Innovations in Immunogenicity Assessment
Session 4: Why should the Industry/Regulators Consider Moving from Traditional 3-Tier to 1-Tier Approach?
Session 5: 2027 White Paper in Bioanalysis
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2027 White Paper on Immunogenicity Assessment & Clinical Relevance of Biotherapeutics & Biosimilars
Consensus & Conclusions on Immunogenicity Assessment & Clinical Relevance of Biotherapeutics & Biosimilars for 2027 White Paper
Finale: ASK THE REGULATORS!
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Panel Discussion with All the Regulators:
Have an Open Dialogue with the Regulators including US FDA, UK MHRA, Austria AGES / EU EMA, Health Canada
Ask the Regulators any Questions You Have on Immunogenicity of Biotherapeutics and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes