Lauren Baker, PhD
Senior Clinical / Regulatory Advisor
Lauren Baker, PhD is a strategic advisor specializing in partnerships with clients through the product development life cycle. Before joining Sunrise, Lauren was CEO of Boston Biomedical Associates (BBA) which she founded to focus on the clinical research and regulatory affairs aspects of new medical products. Her tenure in the clinical and regulatory industry began after running the corporate clinical research group for Boston Scientific which included all clinical trial work worldwide.
She enjoys applying her broad expertise to global regulatory and clinical trial strategies, regulatory submissions, FDA liaison meetings, and working with product development teams to assist in translating business strategies into product development requirements.
Lauren remains a leader in clinical research and regulatory affairs in multiple therapeutic areas including cardiovascular, neurovascular, orthopedics, gi/gu, critical care and breast imaging as well as various facets of biologics associated with both cell and gene therapy. Her product Expertise spans interventional medical devices, combination products, cell and gene therapy, electro-mechanical devices and diagnostics.
A licensed professional engineer, 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 Worcester Polytechnic Institute.