Jana Gerken, J.D., Co-Founder and Chief Legal Strategist of Kinetic Compliance Solutions, LLC. She is a seasoned legal leader with a proven track record of developing and executing legal strategies that strike the right balance between risk and reward in order to help her clients gain a competitive edge while remaining compliant. Jana partners with her clients in translating complex legal challenges into pragmatic business solutions in order to free up their time to focus on innovation and growth. Jana has extensive experience with a broad range of commercial contracting and transactional matters, solid healthcare acumen with medical devices and life sciences, and hands-on experience working on the front line with her clients as both in-house counsel and external advisor.
Prior to co-founding Kinetic Compliance Solutions, Jana was the General Counsel for GE Healthcare’s five-billion-dollar diagnostic imaging businesses (Detection & Guidance Solutions (DGS), Molecular Imaging & Computed Tomography (MICT), and Magnetic Resonance (MR)). In that role, Jana was the primary point of contact for all strategic matters on a global scale. Jana recently received an award for “Imagination & Courage” from the Vice President & General Counsel of GE Healthcare. Jana’s near 10-year tenure at GE also includes her role as Senior Legal Counsel of the Life Sciences business.
Prior to joining GE, Jana practiced at the law firms Kaye Scholer LLP and Schnader Harrison LLP in New York City, where she specialized in Mergers & Acquisitions, venture capital deals, and general commercial transactions. Jana has a law degree from Seton Hall University School of Law and is admitted to the bar in New York, New Jersey, and Wisconsin. Jana was born and raised in Berlin, Germany, and is a native German speaker (meaning she can say “Fahrvergnügen” really fast with a smile). Last but not least, Jana is a competitive ballroom dancer (Legal Disclaimer: Watch at your own risk!).
Robin Martin, RAC, Co-Founder and Chief Regulatory Strategist of Kinetic Compliance Solutions, LLC. She is an experienced regulatory affairs professional proficient in strategies leading to successful global medical device approvals. At Kinetic Compliance Solutions, she focuses on gaining efficient regulatory approvals in the U.S., EU, and Canada for her clients. From injectable implants, patient monitoring equipment and accessories to diagnostic imaging equipment and medical device software, her experience with a wide variety of devices give her a solid understanding of what it takes to navigate the dynamic regulatory environment.
Prior to co-founding Kinetic Compliance Solutions, Robin held various roles within regulatory at GE Healthcare. Her six-plus year tenure at GE included roles in clinical regulatory, which involved the development of global clinical strategies for multiple business units, in addition to premarket regulatory roles in patient monitoring and MRI businesses. In 2014 she won a GE Healthcare President’s Award for the successful launch of the company’s first integrated PET/MR system.
Prior to joining GE, Robin worked in both regulatory and engineering for Bioform Medical, Inc. (now Merz Aesthetics), where she supported commercialization of injectable implants and a variety of newly acquired technology.
Robin has an undergraduate degree in Biomedical Engineering and a Masters of Business Administration, both from Marquette University. Robin is an avid year-round hiker and a Master Gardener (though you’d never know it from her yard).
Elle Repie is a senior attorney with a background in intellectual property and her experience spans many industry areas, including healthcare and nanotechnology, and she has navigated many technology-intensive contractual agreements.
During her career, Elle worked as Intellectual Property Counsel at GE Ventures for ten years and supported a wide breadth of technology areas as well as handled a broad range of transactional work with unique considerations and needs. For the last three years, she has worked for research universities assisting with IP program creation as well as supports a number of technology start-up companies and principal level consultants where her work includes assisting healthcare-related initiatives related to product development, consulting, management of clinical information, HIPAA compliance, and BAA related issues.
She graduated from Case Western University School of Law in 2008 with a concurrent masters in accounting from Cleveland State University and received a B.S. in biochemistry and a B.A. in political science from the University of California-Irvine in 2004.
Elle is admitted to the bar in New Jersey but calls Upstate New York home. When she’s not spending time with her kids and dogs, Elle can usually be found cooking happily in her kitchen or enthusiastically learning combat moves in Krav Maga. She also happens to churn a wicked scoop of alcohol-infused ice cream.
Tina Holly is a regulatory affairs professional with a background in pharmaceutical and medical device product development. Her experience spans many business functions including regulatory affairs, quality, design control, good manufacturing practices (cGMP), and research. She has worked for large and small companies helping organizations obtain new and on market product approvals.
During her career Tina facilitated successful PMA submissions for in-vitro diagnostics and 510(k) submissions. She has a clear understanding of quality system regulations and has responded to FDA questions, written post market surveillance reports and worked with product development teams to prepare documentation to support US and international registration requirements.
She has worked as an analytical chemist at Baxter and Hospira and is knowledgeable in Chemistry and Manufacturing Controls (CMC), extractables, sterile injectable products and post approval changes.
Tina has undergraduate degrees in Chemistry and German from the University of Illinois and a Masters in Chemistry from Roosevelt University. She loves traveling, speaking German, bike riding and spending time with her husband, kids and dog Tulip.