Karen MacLeod

EVP, Regulatory & Clinical Operations

Karen MacLeod

About Karen MacLeod

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.


Amprion has some important news we need to share with you!

To improve patient access to the SYNTap® biomarker test (CSF), Amprion is reducing the self-pay price for tests with service dates on or after July 1, 2023.

Old self-pay price: $1500.00. New self-pay price: $995.00

Effective July 1, 2023, there is a New ABN (Advanced Beneficiary Notification) form for use when ordering the SYNTap® biomarker test (CSF) for patients on Medicare. Order Process

CPT/PLA – The SYNTap® test has been issued a dedicated PLA code to be used when billing: 0393U
We have applied to be a medicare provider and will soon be able to courtesy bill Medicare for your patients.