Partner, Holland & Knight
Michael Werner is a partner in Holland & Knight's Washington, DC, office and co-chair of the firm's Healthcare & Life Sciences Industry Team. He has almost three decades of healthcare law, regulatory, reimbursement, and lobbying experience in Washington. He focuses on issues affecting biotechnology and pharmaceutical companies, medical research and research institutions, physicians and patients. His specific areas of knowledge include FDA regulations regarding drug/biological product review, approval, and distribution; regulation of cell therapy, gene therapy, tissue engineering and regenerative medicine products; IRB review, informed consent, and other clinical trial issues; regulation and reimbursement of biosimilars; Medicare reimbursement strategy and issues; and conflicts of interest and other bioethics issues arising from research and uses of new technologies. Mr. Werner is the co-founder and Executive Director of the Alliance for Regenerative Medicine, a Washington, DC-based organization comprised of over 240 member companies, clinical centers, patient advocacy groups and other organizations worldwide whose mission is to advocate for regulatory and reimbursement policies that will advance regenerative medicine research and product development. Before joining Holland & Knight, he was president of The Werner Group, a Washington, DC-based firm that provided lobbying, regulatory, and bioethics consulting services for biotechnology and pharmaceutical companies, physicians, health plans, investors, and patient advocacy groups. Prior to founding The Werner Group, he was chief of policy for the Biotechnology Industry Organization (BIO), representing over 1,000 biotechnology companies in the U.S. and other countries. In that role, he was responsible for virtually all major issues affecting biotech companies including: drug/biologic evaluation and review by FDA; CMS policies and reimbursement, Medicare, intellectual property, stem cell research and bioethics issues. Mr. Werner was senior healthcare advisor to U.S. Senate Majority Leader George Mitchell, a congressional investigator for the U.S. Senate Special Committee on Aging and senior advisor to Maryland Governor William Donald Schaefer. Mr. Werner is a frequent media commentator and has appeared in The Wall Street Journal, Science, Scientific American, and The Washington Post. In 2013 and 2014, he was named one of the Top 50 Global Stem Cell Influencers by Total BioPharma. He was also recently named to the US National Academies of Science, Engineering and Medicine's Forum on Regenerative Medicine. He is a heavily sought-after speaker for meetings and conferences, and the author of over 50 published articles. Michael is co-author of the Bloomberg BNA portfolio series "Life Sciences Compliance: a Pre-market and Post-market Portfolio". His article "Don't Edit the Human Germ Line" appeared in the March 2015 issue of Nature.