Former FDA Lawyer to Lead TSG Consulting’s Medical Device Practice

TSG Consulting has welcomed Laurie Clarke, JD, MPP, as vice president and principal of the company’s medical device regulatory practice.

“Laurie’s vast experience allows Science Group to play a greater role in supporting clients through both product development and the required FDA approvals in the U.S. TSG is the only company that we are aware of that offers both medical device development and in-house FDA and EPA regulatory expertise,” said Erin Tesch, M.D., of TSG Consulting in North America.

With more than 25 years of experience as a U.S. Food and Drug Administration (FDA) lawyer, Clarke is a known leader in medical device regulation, from premarket submissions to FDA enforcement actions. In this newly created position, she will lead TSG Consulting’s established medical device regulatory team, as well as collaborate with medical device advisory and product development colleagues at sister company Sagentia, to help clients deliver FDA-compliant, innovative medical devices across the patient care continuum. TSG Consulting and Sagentia are both Science Group companies.
 
Rob Morgan, Ph.D., managing partner, Medical, at Sagentia, said: “We work with many companies planning innovation strategies as well as designing and developing breakthrough medical products. With Laurie’s deep understanding of the FDA regulatory processes, clients now have a partner that can provide more support in new product regulation from concept to launch, so expanding the service we offer.”
 
Clarke earned her law degree from Stanford University after obtaining a master’s degree in public policy (MPP) with a concentration in health policy from Harvard University and an AB cum laude from Smith College. She started her career as an FDA lawyer at Patton, Boggs and Blow. While at that firm Clarke obtained public acknowledgement that her client wrote the original Nancy Drew books under the pen name “Carolyn Keene.” As an FDA partner, Laurie helped expand the medical device practices at three law firms: Hogan & Hartson, King & Spalding LLP, and Jones Day. Most recently Clarke was executive vice president, Medical Devices & Combination Products at Greenleaf Health Inc., a boutique FDA consulting company. Throughout her career, Clarke has represented medical device companies ranging from small startups to multi-national corporations on complex regulatory matters involving a wide variety of medical devices.

“Science Group’s thriving and dynamic medical device product development and regulatory practices attracted me to the company. At TSG, I have the rare opportunity to help clients shape their FDA regulatory strategy, including the design of their clinical studies, while their medical devices are in the early stages of development,” Clarke said. “I am excited because at that stage the client has maximum flexibility to align the device’s technology, marketing claims, and regulatory path. In addition, the client benefits from working with an integrated team. This approach promises to be cost effective as it reduces the FDA regulatory risks and thus makes it more likely our clients will obtain FDA clearance or approval to market their devices sooner.”