Michael Werner, Esq.

Michael J. Werner is President of The Werner Group, a Washington DC-based firm that provides legislative, regulatory, and bioethics consulting services for life sciences companies, health care organizations, investors, and broad-based coalitions. Michael has over 22 years of health care law, policy development and legislative/regulatory advocacy experience in Washington and is a leader in the biotechnology industry.

Prior to founding The Werner Group, Michael was Chief of Policy for the Biotechnology Industry Organization (BIO), representing over 1000 biotechnology companies in the US 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 bioethics issues.

Michael is also a founding member of the Board of Directors of the Coalition for the Advancement of Medical Research (CAMR), an organization of more than 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 coming to 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. He is currently a member of the Ethics Committee of the Biomedical Engineering Society, and the Advisory Board of the Pharmaceutical Safety Institute.

Michael was senior advisor to US Senate Majority Leader George Mitchell, a congressional investigator for the US Senate Special Committee on Aging, and senior advisor to Maryland Governor William Donald Schaefer.

Michael is a heavily sought-after speaker for meetings and conferences, and the author of over 40 published articles. His most recent article "California, Here We Come" appears in the October 2007 issue of The Journal of Life Sciences. He is a frequent media commentator and has appeared in The Wall Street Journal, The Washington Post, BIOWorld, Congressional Quarterly, and The Baltimore Sun, as well as on many TV and radio news programs.

Michael is a graduate of The University of Michigan and George Washington University Law School. He is married with two daughters.