- September 9, 2021
- Organized By:
About the Speaker:
Zuben E. Sauna, PhD
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.
After completion of this activity, the participant will be able to:
- Identify the economic and personal costs of immunogenicity to protein therapeutics
- 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
For technical assistance please contact: Niccole.Corbin@fda.hhs.gov
|Activity Outline FDA Grand Rounds: September 9, 2021||pdf (215.71 KB)|