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Immunogenicity of Biologics: Clinical Consequences
Session Chair(s)
Michael Blum, MD, MPH
Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA, United States
This session addresses the clinical consequences of the immunogenicity of 1) biologics for autoimmune diseases, 2) biologics for oncology, and 3) biosimilars.
Learning Objective : Identify the immunologic basis for adverse events caused by biologics used for autoimmune and oncology indications; Recognize and manage the clinical consequences of immunogenicity; Discuss how to study the immunogenicity of biologics and biosimilars and manage the clinical risk.
Speaker(s)
Lessons Learned from Biologic Agents in Rheumatology – Immunogenicity
Adjunct Professor, Stanford U School of Medicine; Biopharmaceutical Consultant, Loftis/Strand Consulting, United States
Monitoring and Assessment of the Impact of Immunogenicity on Clinical Safety for Oncology Biologics in Development
SSRM Disease Area Cluster Lead - Oncology, Pfizer Inc, United States
Immunogenicity in the Biosimilars Space
Chief, Laboratory of Immunology, OBP, OPQ, CDER, FDA, United States
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