Theranos: When High Tech Meets Health Care
Date: February 17th, 2022
Mark Gardner, M.B.A., J.D., Directing Attorney, Gardner Law
Gardner has worked in FDA-regulated industry since 1999. He advises companies on a wide variety of topics including health care compliance, advertising and promotion review, FDA -regulatory, -quality, and -clinical matters, privacy, transparency reporting, and enforcement. He has been “seconded” to manufacturers such as Bayer Healthcare and Johnson & Johnson. Previously he worked in commercial roles, including product management, at ev3 (Medtronic), Celleration, and MedTox Laboratories (Labcorp). Mark is an Adjunct Professor of Law at Mitchell Hamline School of Law where he teaches Drug & Device Law, sits on the Health Law Institute Advisory Board, and serves as a judge and coach for student competitions. He has written and lectured extensively on a variety of topics relating to anti-fraud, FDA, transparency, and enforcement matters. Mark sits on the Section Council for the MSBA Food, Drug and Device Law Section. He previously served as Chair, Vice Chair and Secretary for the Section. Mark also sits on the FDLI Advertising and Promotion of Medical Products Conference Planning Committee. He previously served as Chair for the Medical Alley Regulatory Special Interest Group.
Amanda Johnston, JD, RAC, Managing Attorney, Gardner Law 
Johnston specializes in counseling medical technology and pharmaceutical companies on FDA law, regulatory submissions and strategy, healthcare compliance programs, and fraud and abuse laws. She has worked on 100+ FDA submissions, including PMAs, 510(k)s, HDEs, IDEs, NDAs, Pre-Submissions (Q-Subs), Breakthrough Designations, De Novos, RFDs, EUAs, change control supplements, and annual reports for drugs and devices. Prior to joining Gardner Law, she was the Compliance Officer at Coloplast Corp, in Regulatory Affairs at Medtronic, and in Compliance at UnitedHealth Group. She is an Adjunct Professor of Law at Mitchell Hamline School of Law where she teaches Drug & Device Law. She has written and lectured on a variety of topics related to FDA regulatory and health care compliance. Amanda sits on the Section Council for the Minnesota State Bar Association’s Food, Drug, and Device Law Section and the Board of Directors for Three Rivers Montessori Charter School in Elk River, MN.
Dr. Seth Whitelaw, President & CEO, Whitelaw Compliance Group, LLC. 
Senior Fellow & Adjunct Professor, Life Sciences Compliance, Mitchell Hamline School of Law
Editor, Policy & Medicine Compliance Update
Professor Whitelaw has almost 30 years of industry experience in the life sciences and health care sectors, as an attorney, compliance officer and consultant. His career has focused on food and drug law and corporate governance, as well as designing and running compliance programs within medical devices, pharmaceutical sales, and marketing and pharmaceutical R&D. He is a licensed food and drug attorney, with a doctorate in Health Law. A former Food and Drug Law Institute (FDLI) fellow, he also worked for the FDA’s Office of Chief Counsel and Deloitte. Dr. Whitelaw has served as a compliance officer for several pharmaceutical and medical device companies including as the Chief Compliance Officer (C.R. Bard, Inc. and Misonix, Inc.), head of pharmaceutical commercial compliance (SmithKline Beecham Pharmaceuticals North America), and global compliance officer for R&D (GlaxoSmithKline). In each case, he has designed, built and implemented a compliance program from a “blank sheet of paper.” Currently, he is the President & CEO of Whitelaw Compliance Group as well as Editor for the Policy & Medicine Compliance Update, a monthly publication for life science compliance professionals.
Manny Tzavlakis, Managing Partner, Helio Health Group 
Bachelor of Science, Business Administration, Finance and International Business, Montclair State University, Upper Montclair, NJ
Manny is the founder and Managing Partner at Helio Health Group. Helio Health specializes in providing consulting services across compliance, medical, and patient services areas of life sciences organizations. Prior to founding Helio, Manny was a Managing Director at Huron Consulting Group where he was a Senior Partner in the Life Sciences Practice. Before joining Huron, Manny was a Client Partner in the Life Sciences Practice for Fair Isaac Corporation (FICO), where he was the expert on pharmaceutical data management and multi-channel marketing best practices.
Prior to Fair Isaac Corporation, Manny created and managed the Professional Services Group (PSG) at Dendrite International as Managing Director and was also a senior executive with Accenture’s Pharmaceutical & Medical Products Customer Relationship Management (CRM) division. Manny began his career in sales, sales operations, and business analysis at Novartis Pharmaceuticals. Manny’s focus is on matters related to patient services, off-label detection and business rules management integrated with advanced analytics. He created practice areas for both Compliance Business Insights (CBI) and Aggregate Spend / Disclosure while at Huron.