Executive Director, Alliance for Regenerative Medicine; Partner, Holland & Knight LLP
Michael Werner has more than 25 years of healthcare law, lobbying, policy development, and regulatory experience in Washington. In addition to forming the Alliance for Regenerative Medicine and serving as its Executive Director, he is also a Partner at the law firm Holland & Knight, LLP. He focuses on issues affecting biotechnology and pharmaceutical companies, researchers and research institutions, health care investors, physicians, and patients with particular expertise in regenerative medicine. His work with clients include helping them obtain federal funds through the appropriations and grants processes; FDA drug/biologic legislation and regulations including regulation of cell therapy and regenerative medicine products; FDA and NIH oversight of clinical trials including registries and reporting of trial results; approval and marketing of orphan drugs; as well as conflicts of interest and other bioethics issues arising from research and uses of new technologies.
Through presentations and a panel discussion, industry and legal experts examine regulatory frameworks and updates surrounding cell and gene therapy, diagnostics, and digital health, both in the US and Japan.