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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
Vibeke Strand, MD, FACP
Loftis/Strand Consulting, United States
Adjunct Professor, Stanford U School of Medicine; Biopharmaceutical Consultant
Monitoring and Assessment of the Impact of Immunogenicity on Clinical Safety for Oncology Biologics in Development
Dina Tresnan, DVM, PhD
Pfizer Inc, United States
SSRM Disease Area Cluster Lead - Oncology
Immunogenicity in the Biosimilars Space
Daniela Verthelyi, MD, PhD
FDA, United States
Chief, Laboratory of Immunology, OBP, OPQ, CDER
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