Holland & Knight's Public Policy and Regulation Group Instrumental In Launch of Alliance for Regenerative Medicine
"Regenerative medicine holds the promise of curing and treating countless diseases and disabilities," said Michael J. Werner, partner in Holland & Knight's PP&R group in the firm's Washington, D.C., office. "The Alliance will educate policy makers, regulators, payors, and Members of Congress about this innovative technology and press for policies that will facilitate the research and development of products that will help millions of patients."
Headquartered in Washington, D.C., the Alliance is dedicated to promoting regulatory, research, and reimbursement policies that will foster innovation in regenerative medicine. Additionally, the Alliance will serve as a source of information about regenerative medicine for policy makers, the media, and the general public.
Holland & Knight helped establish the Alliance through recruitment efforts and is currently the only law firm handling the organization's legal work to include lobbying, regulatory and reimbursement. Initial charter members of the Alliance include: university-based organizations such as the Wake Forest Institute for Regenerative Medicine, Stanford University, the University of Washington, and Georgia Tech University; the Genetics Policy Institute; leading regenerative medicine life sciences companies Geron, Johnson & Johnson, Aldagen, iZumi, Fate Therapeutics, and Maxcyte; and investor organizations Kleiner, Perkins, Caufield and Byers and Proteus Ventures. Alliance organizers expect to announce another group of charter members later this month.
Michael Werner has almost 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; 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.