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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Immunogenicity of Biologics: Clinical Consequences

Session Chair(s)

Michael  Blum, MD, MPH

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)

Vibeke  Strand, MD, FACP

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

Dina  Tresnan, DVM, PhD

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

Daniela  Verthelyi, MD, PhD

Immunogenicity in the Biosimilars Space

Daniela Verthelyi, MD, PhD

FDA, United States

Chief, Laboratory of Immunology, OBP, OPQ, CDER

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