Michael J Werner
advisory board member
Business and management
Holland Knight
Netherlands
Biography
Michael Werner is a partner in Holland & Knight's Washington, D.C. office and a co-leader of the firm's Healthcare & Life Sciences Industry Team. He 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, physicians and patients. His specific areas of knowledge include legislation and FDA regulations regarding drug/biological product, approval, and distribution; biosimilars; Medicare 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; the Physician Sunshine Act; 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.
Research Interest
Accounting & Marketing
