Immunogenicity Assessment and Management


Strategies and Tools for Safe and Efficacious Therapeutics 

Development and adoption of novel biologic therapies is accelerating, but complex immunogenicity considerations require early risk management, analytical capabilities, and mitigation strategies. The Immunogenicity Stream at PEGS begins with an introductory training seminar providing a comprehensive overview of immunogenicity. The stream then leads into the Immunogenicity Assessment and Management conference, which details tools for risk assessment and mitigation, Nab characterization, assay development and validation, and challenges faced in novel modalities. The stream concludes with an in-depth training seminar on bioassay design, development, analysis, validation, and monitoring. 

Conferences and Training Seminars Include:

May 13-14

Agenda 7Introduction to Immunogenicity

May 14-15

Agenda 7Immunogenicity Assessment and Management

May 16-17

Agenda 7Introduction to Bioassays

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