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.
Amy Fowler, RAC, J.D., is an Associate at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, in vitro diagnostic, pharmaceutical, biotech, food, and nutritional supplement industries. Her practice focuses on regulatory and clinical affairs strategies, preparing domestic and foreign submissions, implementing quality systems, and working on the Unique Device Identifier (UDI) regulation. Amy has a 22 year career specializing in FDA regulatory, clinical and quality systems, working in pharmaceuticals and medical devices, including vitro diagnostics.
Amy obtained her law degree in 2009 from Hamline University. Amy has a Bachelor of Science degree in Chemistry from the University of Minnesota, Institute of Technology, and has held her Regulatory Affairs Certificate (RAC) from the Regulatory Affairs Professional Society (RAPS) in the United States since 1995. Amy’s experience is extensive and includes time as a senior associate in regulatory affairs and quality systems at 3M Pharmaceuticals, 3M ESPE and the Bioanalytical Technologies Project between 1992-2005.
Her varied regulatory, quality and clinical training and experience was a valuable prelude to law school. In her career she has handled a wide variety of medical device regulatory challenges, including 510(k)s, de novos, technical files, combination products, IDEs, global submissions, MDRs, labeling reviews, establishment registrations and device listings. She led a 3M business to regulatory compliance with the European Union Medical Device Directive; acted as Management Representative for a medical device quality system; and managed FDA and Notified Body inspections. She has also worked on pharmaceutical regulatory matters supporting both chemistry and manufacturing controls (CMC) and clinical aspects of New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and Drug Master Files (DMFs), as well as clinical financial disclosure and the Prescription Drug Marketing Act. She obtained approval of a pediatric indication for a drug/device combination product encompassing a complex delivery system.
While at 3M Amy distinguished herself by winning a number of group and individual awards such as the Malcolm Baldrige National Quality Award, 3M Division Circle of Technical Excellence Award, and 3M Corporate Circle of Technical Excellence Award.
Beth Luoma, 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. Her practice focuses on all areas of FDA regulation and related laws such as the Anti-kickback Statute and False Claims Act. She spends much of her time preparing domestic and foreign submissions (510(k)s, de novos, PMAs), and drafting and negotiating research agreements for US and international clinical trials. Prior to her legal career, Beth spent over eight years working at medical device and pharmaceutical CROs where she was involved in all areas of clinical trial conduction, from protocol creation to study close-out. Beth has experience in preparing and negotiating agreements related to clinical trials, including investigator-initiated trials, observational studies, consulting arrangements, confidentiality, informed consent, and other general services related to the conduct of clinical trials. Beth has worked on both US and international trials.
During law school, Beth interned in Corporate Compliance at Medtronic where she worked on risk assessments across various Business Units and performed compliance checks of health care practitioner engagements in preparation for reporting under the Physician Payments Sunshine Act.
Beth earned her Juris Doctor from the University of St. Thomas School of Law, and her Bachelor of Arts in Political Science from the University of Minnesota – Twin Cities.