Drake Kristen
Kristen is the Clinical Director for the study sponsor company, Functional Neuromodulation. She ran the ADvance I study conducted in North America from 2011-2016 and is responsible for the ADvance II study currently running globally in the U.S., Canada and Germany. Kristen is a two-plus-decade veteran of clinical care and medical device development with a BS in Psychology, Masters in Physiology and trained as a Physician’s Assistant. She has worked in global research and regulatory management, with more than 14 years' experience in researching the use of deep brain stimulation (DBS) in a variety of different diseases. She has served on clinical teams at the University of Michigan, the Cleveland Clinic and the Baylor Research Institute as well as in the industry; she has spent time working on projects studying devices acquired by J&J, Medtronic and St. Jude. Kristen has worked for some of the largest medical device manufacturing companies on the planet but prefers the start-up side of the business. She has managed clinical research and regulatory affairs on an international scale for five start-up companies. She provides practical guidance being an integral part of teams developing new medical devices, including an understanding of the international rules governing human research and government regulation compliance, overseeing the clinical trials that result in FDA approval, CE Mark in Europe and other global regulatory agencies.
