Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.
Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.
David Teicher, M.Sc., J.D., is an Associate Attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice focuses on regulatory and clinical affairs strategies, preparing domestic and foreign submissions, and creating and implementing quality systems for compliance with FDA's QSR and international regulations and standards. Dave has a thirty year career specializing in FDA regulatory affairs. He started as an investigator biomedical engineer in the FDA's Los Angeles and Minneapolis District Offices where he conducted approximately 300 factory quality assurance audits of medical device manufacturers in the United States and internationally including manufacturers of cardiac pacemakers, mechanical heart valves, angioplasty catheters, dialysis membranes, intraocular lenses, and anesthesia and respiratory care equipment. He then worked in management roles at seven medical device companies including SCIMED and Endocardial Solutions. Dave earned his Juris Doctor from the William Mitchell College of Law, his Master of Science Biomedical Engineering from the University of Southern California, and his Bachelor of Science in Biology with a minor in Chemistry from San Diego State University. Dave is currently an Adjunct Assistant Professor of Regulatory Affairs and Services at St. Cloud State University.
Mark Gardner, M.B.A., J.D., is an attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice focuses on FDA regulation, health care fraud and compliance, design and implementation of regulatory compliance programs, promotional review, and FDA enforcement actions. Prior to his legal career, he worked in product management and sales for three medical device companies over a 10-year span where he focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications. Gardner is an Adjunct Professor at Hamline University School of Law. He currently serves as a Co-Chair for LifeScience Alley's Regulatory Special Interest Group, as Vice Chairman for the Minnesota State Bar Association Food, Drug and Device Law Section and as an Advisory Committee Member for LifeScience Alley. Gardner speaks and writes often on issues that impact FDA regulated products.Gardner earned his Juris Doctor from Hamline University School of Law, his Master of Business Administration from the University of St. Thomas, and his Bachelor of Science, double major, Finance and Economics from the University of Wisconsin-La Crosse.