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Wednesday, June 17 • 4:00pm - 5:00pm
#338 L: Immunogenicity of Biologics: Clinical Consequences

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-693-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session addresses the clinical consequences of the immunogenicity of 1) biologics for autoimmune diseases, 2) biologics for oncology, and 3) biosimilars.

Learning Objectives

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.


Michael Blum, MD, MPH


Lessons Learned from Biologic Agents in Rheumatology – Immunogenicity
Vibeke Strand, MD, FACP

Monitoring and Assessment of the Impact of Immunogenicity on Clinical Safety for Oncology Biologics in Development
Dina Tresnan, DVM, PhD

Immunogenicity in the Biosimilars Space
Daniela Verthelyi, MD, PhD

avatar for Michael Blum

Michael Blum

Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA, United States
Michael Blum, MD, MPH is currently Deputy Director, Office of Pharmacovigilance and Epidemiology in FDA CDER. He is a pediatric infectious diseases specialist. Dr. Blum worked as a medical reviewer in the CDER Division of Anti-Infective Drug Products, followed by over 20 years in... Read More →
avatar for Vibeke Strand

Vibeke Strand

Adjunct Professor, Stanford U School of Medicine; Biopharmaceutical Consultant, Loftis/Strand Consulting
Vibeke Strand, MD, MACR, FACP is an Adjunct Clinical Professor, Division of Immunology /Rheumatology at Stanford University and has served as a biopharmaceutical consultant since 1991. She has participated in the development of new therapies in RA, SLE, gout, PsA, SpA, vasculitis... Read More →
avatar for Dina Tresnan

Dina Tresnan

SSRM Disease Area Cluster Lead - Oncology, Pfizer Inc
Dina directs the pharmacovigilance and development, implementation, and evaluation of global risk management strategies aimed at achieving optimum benefit-risk for medicinal products throughout their lifecycle, with a particular interest in biotherapeutics, advanced medicinal therapies... Read More →

Daniela Verthelyi

Chief, Laboratory of Immunology, OBP, OPQ, CDER, FDA
Dr. Verthelyi received her MD from the University of Buenos Aires and a PhD from the Virginia Tech in USA. She currently heads the Laboratory of Innate Immunity and chairs CDER’s newly formed Center for Excellence in Infectious Diseases and Inflammation. She directs a lab focused... Read More →

Wednesday June 17, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session