About the Staff
+ Michael Werner, J.D. | email@example.com
Michael Werner has almost three decades of healthcare law, lobbying, regulatory, reimbursement and policy development experience in Washington. He is the co-founder and executive director of ARM as well as a Partner at Holland & Knight LLP. In these roles, Michael focuses on issues affecting biotechnology and pharmaceutical companies, medical research and research institutions, physicians and patients. His specific areas of knowledge include legislation and implementing FDA regulations regarding drug/biologic review, approval and distribution; 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; 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.
Before joining Holland & Knight and founding ARM, Michael was president of The Werner Group, a Washington, D.C.-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 1000 biotechnology companies in the U.S. and other countries.
Before BIO, he spent six years as counsel for legislation and policy for the American College of Physicians. 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.
+ Morrie Ruffin | firstname.lastname@example.org
Morrie has more than 20 years of experience in the Biotech and Healthcare industries. He is a founder and managing director of the Alliance for Regenerative Medicine (ARM), the global organization representing the interests of the regenerative medicine community. Morrie is also the managing partner of Adjuvant Partners, a boutique regenerative medicine and advanced therapies business consulting firm. Prior to joining Adjuvant Partners, he was the chief executive officer of LifeTech Innovations, LLC a business development consulting firm based in Bethesda, MD. Prior to his position at LTI, Mr. 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, Mr. 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, Mr. 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 was 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, Mr. 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. Mr. Ruffin received his M.A. in International Studies & Economics from the Johns Hopkins School for Advanced International Studies (SAIS) and his B.A. from the University of Virginia.
+ Bethany Kraynack | email@example.com
Vice President, Operations
Bethany Kraynack brings nearly 15 years of experience to ARM, with specific expertise in entrepreneurship, working with emerging technology and life sciences companies, as well as academic institutions. In addition to her role with ARM, Bethany also serves as vice president of operations for Adjuvant Partners.
Prior to the Alliance, Bethany spent seven years with CONNECT, a San Diego-based not-for-profit focused on accelerating the commercialization of new technology and life sciences products. At CONNECT, Bethany oversaw a variety of programs and activities, honing an exceptional skill set in non-profit management, operations, program design, project management, marketing and branding, event planning and budget management. In addition, Bethany has a keen eye for marketing, branding and design, lending her talents to the ARM team to help guide vision and strategy for our programs.
Bethany is a native of Pennsylvania, where she graduated with a B.A. from Gettysburg College. She currently resides in La Jolla, CA with her husband and two young daughters.
+ Laura Parsons | firstname.lastname@example.org
Senior Director, Marketing and Events
Laura comes to the Alliance with extensive experience in marketing and event coordination for multi-stakeholder organizations. Prior to ARM, she was the marketing & event manager at Janssen Labs, a healthcare incubator housed within Janssen Research & Development, the pharmaceutical company of Johnson & Johnson. There, Laura implemented all marketing and press strategies surrounding the newly opened innovation center, as well as managed multiple event programs aimed at increasing awareness of the facility and its residing start-up companies. Previously, Laura spent over three years managing programs and events for CONNECT, a San Diego non-profit organization dedicated to fostering entrepreneurship.
Laura received a B.S. in Hospitality and Tourism Management with an emphasis in Meeting and Event Management from San Diego State University.
+ Lyndsey Scull | email@example.com
Senior Director, Communications
Lyndsey comes to the Alliance following more than 10 years of global communications and public affairs work, the last five years at Hill+Knowlton Strategies where she provided strategic and public affairs communication counsel to a variety of Fortune 500 and non-profit clients. During this time, Lyndsey was based in Dallas, Texas and Washington, D.C., and in 2013, Lyndsey relocated to the firm’s office in Kuala Lumpur, Malaysia as part of a year-long client engagement. Previously, Lyndsey also lived and worked in the Czech Republic. Lyndsey grew up in several countries across Southeast Asia - Singapore, Taipei, Hong Kong, China and Malaysia.
Lyndsey holds a graduate degree in Global Affairs and Management from Thunderbird School of Global Management and a B.A. in Mass Communications from the University of Utah. She lives in Washington, D.C. with her husband.
+ Luke Thorstenson | firstname.lastname@example.org
Director, Membership and Advocacy
Luke Thorstenson brings over seven years of business and legislative experience to his role at the Alliance for Regenerative Medicine (ARM). Prior to ARM, Luke served as an event coordinator for the 2011 Special Olympics World Summer Games in Athens, Greece, and before that spent three years with the Humane Society of the United States. As a member of the team supporting Representative Steny Hoyer in the Office of the Majority Leader, the Office of the Minority Whip and on the campaign trail, Luke gained invaluable legislative and leadership experience that he utilizes daily in his role at ARM. While obtaining his bachelor's degree from the University of Texas at Austin, he simultaneously served as a legislative assistant for the Texas Medical Association.
Luke is currently working toward his Master's of Business Administration at Johns Hopkins University where he is focusing on Health Care Management.
+ Sarah Haecker, Ph.D. | email@example.com
Director, Technology Sections
Sarah is currently the director of technology sections at the Alliance for Regenerative Medicine as well as a chief scientific officer for Adjuvant Partners. She has specific and deep technical expertise in gene transfer technologies based on both extensive post doctoral study for therapeutic gene delivery as well as the commercialization of gene therapy vector technologies for the University of Pennsylvania Human Gene Therapy Program. Her industry expertise is in the commercialization of gene therapeutics and biomaterials for therapeutic indications and research applications. She has worked with a wide range of clients in the regenerative medicine industry, including large cap pharma, emerging growth companies, venture capital and university tech transfer, etc. She has 20 years of senior-level management experience in commercialization, business strategy, business development, licensing, opportunity assessment, market analysis and strategic partnering and has a broad technical knowledge base in gene therapy, regenerative medicine, tissue engineering, stem cell biology and research applications, cell therapy, and has authored numerous articles and chapters in both scientific and business literature. Additionally, she is a member of the medical advisory board for Park BioVentures. She previously held the position of vice president, business development for Orasi Medical, Circle Biologics and BioE.
Sarah holds a doctorate degree in molecular biology and bioethics from the University of Minnesota and a Bachelor of Science degree in biochemistry from the University of Wisconsin. She has continued education in the MBA program at the University of Pennsylvania’s Wharton School.
+ Chelsey Hathaway | firstname.lastname@example.org
Manager, Patient Advocacy and Events
Chelsey brings to the Alliance significant legislative and non-profit event planning experience. Prior to joining ARM, she worked as an event planner for Natalie Shear Associates, a boutique event firm in Washington, D.C. There she worked with dozens of non-profit organizations to plan and manage special events, meetings and conferences around the country. Before that, Chelsey spent several years on Capitol Hill working for Congresswoman Shelley Moore Capito where she coordinated meetings and legislative activities with other Congressional offices and committees, House leadership, constituent groups and campaign staff.
Chelsey holds an M.S. in Integrated Marketing Communications and a B.S. in Public Relations, both from West Virginia University. She currently lives in Washington, D.C. with her husband.
ARM European Staff
+ Annie Hubert | email@example.com
Director, European Public Policy
Annie Hubert brings over 30 years of experience in European regulatory and government affairs, pricing, reimbursement and market access to the ARM Team. She came to ARM via the membership merger with the former Alliance for Advanced Therapies in the fall of 2014, where she had served as Director of Public Affairs since November 2013. In addition to her role at ARM, she is also Managing Director of ESAH (Expert Services and Advice in Healthcare), a consulting company founded in 2012, which provides services in healthcare biotech, with expertise in market access, regulatory and economic policy and government affairs relating to biopharmaceuticals and advanced therapies.
In June 2012, Annie founded and is the director of Co-ACT, an association for small and medium-sized enterprises (SMEs) developing advanced therapies in Belgium. Between 2001 and 2011, Annie worked at Amgen as Corporate Affairs Director for their BeLux affiliate, and then as European Government and Public Affairs Director.
Prior to Amgen, Annie worked as Regulatory Affairs Manager at Warner-Lambert (now Pfizer), Pharmacia (now Pfizer) and Beecham Research Laboratories (now GSK). She has been an active member in various industry associations and led a number of industry initiatives in the areas of Biotechnology and Health Technology Assessment. She periodically lectures on biotechnology topics in different educational courses for healthcare professionals and students in Belgium.
Annie holds a Master in Pharmacy (UCL, Belgium) and has been qualified as an industrial pharmacist since 1983. She is a Belgian national and resides near Brussels.
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