President, Gardner Law
“Mitchell Hamline’s nationally ranked Health Law Institute is a tremendous asset to the health care sector. The school takes advantage of its surroundings by calling on leaders in the community, which is an internationally recognized health care hub. Minnesota is home to a vibrant medical technology industry, known as ‘Medical Alley,’ and some of the largest insurers and most renowned health care systems in the world. The school trains and helps place many of the health care leaders of tomorrow.”
Mark teaches FDA law as an Adjunct Professor at Mitchell Hamline School of Law. He sits on the Advisory Board for the school’s nationally ranked Health Law Institute. He is also the school Health Law Regulatory Compliance Competition Coach.
In his practice, Mark provides regulatory counsel to medical technology and pharmaceutical companies. Prior to practicing law he worked in product commercialization and development at three companies, MedTox (now LabCorp), Celleration (now Alliqua), and ev3 (now Covidien-Medtronic). Mark has been invited to speak nationally and internationally nearly eighty times on regulatory topics that impact the life sciences industry. His practice focuses on counseling companies on regulations that impact the commercialization of medical technologies and pharmaceuticals.
Mark counsels clients on how to mitigate the risks that the Sales and Marketing functions present. He performs compliance assessments and implements compliance programs, trains companies on how to interact with healthcare professionals, and provides counseling on how to avoid and respond to enforcement actions. Mark performs investigations and negotiates with the FDA and the Department of Justice (DOJ) on behalf of clients. He has convinced the government not to escalate enforcement actions on numerous occasions.
Mark sits on the Section Council for the Minnesota State Bar Association Food, Drug, and Device Law Section. He has chaired the Section. Mark has Co-Chaired the Medical Alley Regulatory Special Interest Group. He is a member of the American Bar Association.