NOV 17, 2016 05:00 AM PST

Partnering to advance regenerative medicine and cellular therapies

  • Partner, Holland & Knight
      Michael Werner is a partner in Holland & Knight's Washington, DC, office and co-chair of the firm's Healthcare & Life Sciences Industry Team. He has almost three decades of healthcare law, regulatory, reimbursement, and lobbying 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 FDA regulations regarding drug/biological product review, approval, and distribution; regulation of cell therapy, gene therapy, tissue engineering and regenerative medicine products; IRB review, informed consent, and other clinical trial issues; regulation and reimbursement of biosimilars; Medicare reimbursement strategy and issues; and 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 comprised of over 240 member companies, clinical centers, patient advocacy groups and other organizations worldwide whose mission is to advocate for 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, DC-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 1,000 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/biologic evaluation and review by FDA; CMS policies and reimbursement, Medicare, intellectual property, stem cell research and bioethics issues. 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. Mr. Werner is a frequent media commentator and has appeared in The Wall Street Journal, Science, Scientific American, and The Washington Post. In 2013 and 2014, he was named one of the Top 50 Global Stem Cell Influencers by Total BioPharma. He was also recently named to the US National Academies of Science, Engineering and Medicine's Forum on Regenerative Medicine. He is a heavily sought-after speaker for meetings and conferences, and the author of over 50 published articles. Michael is co-author of the Bloomberg BNA portfolio series "Life Sciences Compliance: a Pre-market and Post-market Portfolio". His article "Don't Edit the Human Germ Line" appeared in the March 2015 issue of Nature.
    • Managing Director, Alliance for Regenerative Medicine
        Morrie Ruffin has more than 20 years of experience in the biotech and healthcare industries. Morrie is the co-founder and managing director of the Alliance for Regenerative Medicine (ARM). He is also the managing partner of Adjuvant Partners, a life sciences advisory practice working with product developers and major medical centers advancing programs in cell and gene therapy. Prior to joining Adjuvant in 2008, he was the Chief Executive Officer of LifeTech Innovations. From 1994-2006, Dr. Ruffin was Executive Vice President of Capital Formation and Business Development at the Biotechnology Industry Organization (BIO), the largest trade organization representing the biotech and drug development industries. Joining BIO in 1994 as one of its original employees, Dr. Ruffin was responsible for building the organization's global business development and investor outreach programs focused on helping companies raise capital and identify strategic partnering and licensing opportunities. This BIO business development franchise is now the largest in the world, with operations in the US, Europe, and Japan. In addition to his business development work at BIO, Dr. Ruffin was responsible for leading the industry's capital formation advocacy efforts with a focus on economic incentives to promote investment in early stage biotech and med-tech businesses. He is also a founder and board member of the Interoperable Informatics Infrastructure Consortium (I3C), an international standards setting body for the bioinformatics industry. Prior to joining BIO, Dr. Ruffin worked for US Senator Arlen Specter for five years as his senior legislative assistant. Prior to that, he spent approximately five years working in varying capacities, including policy analyst at Systems Planning Corporation International and the Center for Strategic and International Studies. Dr. Ruffin received his MA in International Studies & Economics from the Johns Hopkins School for Advanced International Studies (SAIS) and his BA from the University of Virginia.


      The Alliance for Regenerative Medicine (ARM) is the preeminent global advocate for regenerative and advanced therapies. ARM fosters research, development, investment and commercialization of transformational treatments and cures for patients worldwide. By leveraging the expertise of its membership, ARM empowers multiple stakeholders to promote legislative, regulatory and public understanding of, and support for, this expanding field. ARM takes the lead on the sector’s most pressing and significant issues, including advocating for clear, predictable and harmonized regulatory and review pathways; enabling market access and value-based, favorable reimbursement policies; continued access to capital; addressing industrialization and manufacturing hurdles; developing and establishing industry-wide standards; and conducting key stakeholder outreach, communication and education.

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