Immunogenicity Assessment and Management


Strategies and Technologies for Safe and Efficacious Therapeutics

This stream begins with an in-depth introductory training seminar providing a practical and comprehensive overview of immunogenicity. Leading into our Immunogenicity Assessment and Management conference delivering practical case studies on assay development and validation, clinical relevance, drug and target interference, regulatory perspectives, risk factors and management. New challenges posed by novel modalities including cell and gene therapies will be addressed. The conference is followed by an introduction to bioassay design and analysis training seminar including statistical concepts needed for bioassays. 


Conferences and Training Seminars Include:

May 15-16

Agenda 7Introduction to Immunogenicity

May 16-17

Agenda 7Immunogenicity Assessment and Management

May 18-19

Agenda 7Introduction to BioAssays

Keynote Presentation:

Innate Immune Response Modulating Impurities Testing for Generics and Biosimilars: Where We Are and What We Are Missing
Daniela VerthelyiDaniela Verthelyi, MD, PhD, Chief, Laboratory of Immunology, CDER, FDA

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