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EVP, Regulatory & Clinical Operations
Karen leads the Clinical and Regulatory Operations team to achieve the highest regulatory and professional standards. With over 30 years of experience in the regulated life science industry and having started her career as a formulation scientist, Karen brings an in-depth understanding of product quality to the Clinical Laboratory team.
Prior to Amprion, Karen was a CMC regulatory expert working for CCS Associates and an independent consultant on a broad range of industry and government clients. A part of a five-member team, Karen helped draft the Drug Master File for the first-ever FDA-approved botanical drug product.
As director of US clinical operations, she leads the first-in-human trials to develop a novel liposome-based cancer imaging agent. Laster, Karen worked as director of manufacturing for a company developing novel targeted delivery cancer therapies.
Karen began her career at Liposome Technology Inc.
A pioneer in the science of detecting misfolded proteins, Amprion advances the diagnosis of brain disorders. Our SAAmplify™-ɑSYN Test aids physicians in diagnosing Parkinson’s, Lewy body dementia, and Alzheimer’s with Lewy body variant. We plan to launch more biomarker tests in the future.
