A drug-induced immune response can significantly alter the safety and efficacy of biotherapeutic drugs. Hence, early testing and prediction of potential immunogenicity and allergenicity caused by these drugs is essential, but can be quite challenging. Hosted by The Scientist, this live webinar brings together a panel of experts who will discuss the mechanisms underlying immune and allergenic responses and highlight some of the current and emerging bioanalytical techniques used for their assessment. The panelists will highlight the advantages and disadvantages of various assays that use ligand binding, electrochemical detection, surface plasmon resonance, and other methods for detection, and discuss ways to tackle inherent interferences and shortcomings particular to the various assays. They will also discuss some of the current Clinical Laboratory Standards Institute (CLSI) guidelines for assay design and validation for assessing the allergenicity of biotherapeutics.
Panelists and topics to be covered:
Immunogenicity Evaluation of Biotherapeutics: Bioanalytical Methods and Strategies
Dr. Boris Gorovits is a director in the Pharmacokinetics Pharmacodynamics and Metabolism department of Pfizer Inc. Boris earned his Ph.D. in Enzymology at the Moscow State University and then completed postdoctoral studies in Protein Biophysics at the Medical Center, University of Texas at San Antonio. Boris later joined Wyeth Research (now Pfizer) where he currently leads a Bioanalytical laboratory responsible for support of the R&D of protein based pharmaceuticals. His research is focused on developing and utilization of PK assays as well as the assays designed to evaluate development of immune responses to biotherapeutic compounds.
Developing Fit for Purpose Immunogenicity Assays
Dr. Maureen Deehan is head of pharmacology, in the Experimental Science & Translational Medicine Department at NovImmune SA, in Geneva, Switzerland. Novimmune SA is a biotechnology company with expertise in the development of fully human monoclonal antibodies. Her group supports preclinical and clinical programs by developing assays for target validation, in vitro pharmacology, pharmacokinetics, immunogenicity, safety, and biomarkers.
Design and Validation of Immunoassays for Assessment of Allergenicity of Biotherapeutics
Dr. Robert Hamilton is a professor of medicine and pathology and director of the Dermatology, Allergy and Clinical Immunology Reference Laboratory at the Johns Hopkins University School of Medicine. He teaches, performs research and directs a federally licensed clinical immunology laboratory that performs diagnostic allergy testing. His current research focuses on the assessment of immunogenicity and allergenicity of a selection of new drugs.