Michael Werner has more than 25 years of healthcare law, lobbying, policy development and regulatory experience in Washington. He focuses on issues affecting biotechnology and pharmaceutical companies, researchers and research institutions, physicians and patients. His specific areas of knowledge include FDA drug/biologic regulations; 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 and regenerative medicine products; as well as 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 whose mission is to advocate for federal funding, 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, 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. In that role, he was responsible for virtually all major issues affecting biotech companies including: drug evaluation and review by FDA; CMS policies and reimbursement, Medicare, intellectual property, stem cell research and other sensitive bioethics issues.
Mr. Werner is also a founding member of the Board of Directors of the Coalition for the Advancement of Medical Research (CAMR), an organization of over 100 nationally-recognized patient organizations, universities, scientific societies, foundations, and individuals that advocates for the advancement of breakthrough research and technologies in stem cell research and related fields.
Before BIO, he spent six years as counsel for legislation and policy for the American College of Physicians where he performed legal analysis, and congressional and regulatory advocacy on such issues as Medicare reform; liability reform; integration and delivery system re-structuring; quality improvement; and end of life care.
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.
He is a heavily sought-after speaker for meetings and conferences, and the author of over 40 published articles. Mr. Werner is a frequent media commentator and has appeared in The Wall Street Journal, Science, Scientific American, The Washington Post, BIOWorld, Congressional Quarterly, and The Baltimore Sun, as well as on many TV and radio news programs.