Michael Werner is a Partner in Holland & Knight's Washington, D.C., office. Mr. Werner has almost three decades of healthcare law, lobbying, regulatory, reimbursement and policy development experience in Washington. He focuses on issues affecting biotechnology and pharmaceutical companies, medical research and research institutions, and physicians and patients.
Mr. Werner's specific areas of knowledge include legislation and implementing FDA regulations regarding drug/biologic review, approval, and distribution; reimbursement strategy and issues; FDA and NIH oversight of clinical trials including registries and reporting of trial results; approval and marketing of orphan drugs; stem cell research and regulation of cell therapy, gene therapy, tissue engineering and regenerative medicine products; human subject protection issues such as IRB review and informed consent, as well as conflicts of interest and other bioethics issues arising from research and uses of new technologies.
Before joining Holland & Knight, he was president of The Werner Group, a Washington, D.C.-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 1000 biotechnology companies in the U.S. and other countries. Before BIO, he spent six years as counsel for legislation and policy for the American College of Physicians. 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 received his B.A., with distinction, from the University of Michigan and his J.D. from The George Washington University Law School.
He is a co-author of the Bloomberg BNA Health Law & Business Portfolio Series No. 3250, Life Sciences Compliance: A Pre-Market and Post-Market Road Map.
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