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Lauren S. Baker, PhD (she/her/hers)

Shrewsbury, MA, United States

Lauren Baker, PhD is the President and CEO of Insight Medical Consulting which is a strategic advisory group aimed at partnering with clients through the product development life cycle. Insight provides strategic guidance followed by ongoing support with tactical efforts by acting as a Clinical Research Organization. Insight provides support in developing and generaitng regulatory submissions, operational support in all aspects of clinical trials and subsequent generation of all documentation for submissions to support marketing approval. Insight includes tenured individuals that have vast experience in all types of medical products includeing drugs, biologics, devices and combination products.

Baker previously owned and operated Boston Biomedical Associates (BBA) which also focused on the clinical research and regulatory affairs aspects of new medical products. BBA was sold in 2018 and is now operating as Avania LLC, an international CRO. Her tenure in the clinical and regulatory industry began after running the corporate clinical research group for Boston Scientific which supported all clinical trial work worldwide for the organization. She also established a group at BSC that focused on supporting the regulatory, preclinical and engineering aspects of IDE filings. Her vast experience in preclinical and engineering established the foundation for this sector of the BSC organizatoin.

Prior to BSC, she an assistant professor at the University of Massachusetts Medical School in Cardiac Surgery where she ran clinical and preclinical research studies and taught students/residents. She was also a professor in mechanical engineering at Worcester Polytechnic Institute. She remains a leader in clinical research and regulatory affairs in multiple therapeutic areas including cardiovascular, neurovascular, orthopedics, gi/gu as well as various facets of biologics associated with both cell and gene therapy. Baker holds a master’s and PhD in Mechanical Engineering with an emphasis in biomedical engineering and a bachelor’s degree in Chemical Engineering from WPI.

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