FDA Grand Rounds - Sept. 9, 2021

Please join us for the upcoming September FDA Grand Rounds!

If your email program has trouble displaying this email, view as a webpage. Immune System Responses to Therapeutic Proteins: Getting up close and personal An image of a scientist holding a test tube. Immune System Responses to Therapeutic Proteins: Getting up close and personal Thursday, September 9, 2021 12:00 p.m. - 1:00 p.m. EST Webcast About the Speaker Zuben E. Sauna, PhD Research Biologist Division of Plasma Protein Therapeutics Office of Tissues and Advanced Therapies Center for Biologics Evaluation and Research (CBER) Zuben E. Sauna is a Principal Investigator and a Chemistry, Manufacturing and Controls Reviewer at the US Food and Drug Administration. His research interests lie in understanding the pharmacogenetic basis of the immune response to proteins used in therapeutic interventions as these affect efficacy and safety. His laboratory exploits a combination of computational, in vitro and ex vivo approaches to understand why some individuals and/or sub-populations develop immune responses while others do not. Work from his laboratory has been published in high impact journals such as Nature Biotechnology, Nature Medicine, Science, Science Translational Medicine and Nature Reviews Genetics. He received his Ph.D. from Poona University, India. About the Presentation Proteins used as therapeutics have become an essential part of modern medicine. Immunogenicity (anti-drug antibodies that target the protein-therapeutic) is a significant impediment to development and licensure of any therapeutic-protein. The lecture will illustrate how judicious application of tools available for immunogenicity risk-assessment can permit better decision-making during drug-development, licensure, and clinical-trials.  Learning Objectives After completion of this activity, the participant will be able to: Identify the economic and personal costs of immunogenicity to protein therapeutic Explain the use of non-clinical immunogenicity assays for determining immunogenicity risk List some in silico, in vitro and ex vivo methods used to evaluate immunogenicity of therapeutic proteins To register, please visit the following site: www.FDA.gov/GrandRounds

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