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· 30 minutes

KEYNOTE PRESENTATION: The Role of Clinical Pharmacology and Clinical Relevance of Immunogenicity – A Regulatory Perspective

Wednesday, October 20, 2021 · 9:30 a.m. · Eastern Time (US & Canada)
About This Webinar

Immunogenicity developed against therapeutic biologics is undesirable and can have serious clinical consequences. While it remains challenging in assessing immune-related adverse reactions, advances in leveraging clinical pharmacology data have offered an option for evaluating clinical impacts, particularly for potential secondary treatment failures, and more emerging methodologies are becoming available. This presentation will discuss the successes, the remaining challenges, and potential future directions through the lens of a regulatory scientist.

Who can view: Everyone
Webinar Price: Free
Featured Presenters
Webinar hosting presenter
Assoc Dir Biosimilars & Therapeutic Biologics
Dr. Yow-Ming Wang is currently the Associate Director for Biosimilars and Therapeutic Biologics as well as Director of Therapeutic Biologics Program in the Office of Clinical Pharmacology at the FDA. From 2011 to September 2017, Dr. Wang served as the team leader of Biologics Team in Division of Clinical Pharmacology III; her team was responsible for reviewing submissions of biological products in three clinical divisions. Prior to joining the FDA, she worked in the pharmaceutical industry with experience in small molecules and large molecules. From 2004 to 2011, she worked at Amgen where she supported multiple biologic products in clinical development, in registration phase, and in post-marketing phase. Before Amgen, she supported small molecule drug discovery and development for 11 years at Vertex Pharmaceuticals and at Parke-Davis Pharmaceutical Research. She received her PhD degree from The Ohio State University College of Pharmacy with a research focus on Pharmacokinetics and Biopharmaceutics.
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Cambridge Innovation Institute webinar platform hosts KEYNOTE PRESENTATION: The Role of Clinical Pharmacology and Clinical Relevance of Immunogenicity – A Regulatory Perspective
Cambridge Innovation Institute webinars
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