Janet Lambert

Janet Lambert

Chief Executive Officer

jlambert@alliancerm.org

Janet Lynch Lambert joined ARM in 2017 as the organization’s first CEO. With more than 25 years in public and private sector management, Janet is an experienced government relations and business professional with an extensive record of accomplishment. Janet most recently served as the Acting Head of Engagement for the All of Us Research Program at the National Institutes of Health and as head of the Outreach Office in the Office of the NIH Director. Prior to joining NIH, she was Vice President of Government Relations and head of the Washington office of Life Technologies, aiding the company in its growth from $300 million in annual sales to more than $3 billion.

Prior to Life Technologies, Janet held leadership positions in government relations, marketing and business development at large and small life science organizations, including GE and InforMax. Her experience also includes legislative and staff leadership positions in the U.S. Senate and House of Representatives.

Janet received her MBA in International Business from Georgetown University and her B.A. in Political Science from Stanford University. She lives in the Washington, D.C. area with her husband and two daughters.


Michael Werner, J.D.

Michael Werner, J.D.

Co-Founder & Senior Policy Counsel

mwerner@alliancerm.org

Michael Werner has almost three decades of healthcare law, lobbying, regulatory, reimbursement and policy development experience in Washington. He is the co-founder & senior policy counsel 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

Morrie Ruffin

Co-Founder & Senior Advisor 

mruffin@alliancerm.org

Morrie has more than 20 years of experience in the Biotech and Healthcare industries. He is a co-founder and senior advisor at 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

Bethany Kraynack

Vice President, Operations

bkraynack@alliancerm.org

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 daughters.


Lyndsey Scull

Lyndsey Scull

Vice President, Communications

lscull@alliancerm.org

Lyndsey comes to the Alliance following 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 and daughter.


Annie Hubert

Annie Hubert

Senior Director, European Public Policy

ahubert@alliancerm.org

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.


Laura Parsons

Laura Parsons

Senior Director, Marketing and Events

lparsons@alliancerm.org

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 more than three years managing programs and events for CONNECT, a San Diego not-for-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.


Robert Falb

Robert Falb

Director, U.S. Policy and Advocacy

rfalb@alliancerm.org

Robert Falb brings a deep understanding of government affairs and the pharmaceutical industry to ARM, which he joined in the spring of 2018 as its first Director, U.S. Policy and Advocacy. Before coming to ARM, he worked for over a decade at Teva Pharmaceuticals, where he helped to establish and grow the company’s government affairs department. In his last role at Teva, he was the department’s primary contact with the branded commercial units and product launch teams. He was responsible for recommending legislative and regulatory strategies to advance their respective priorities and assessing current and future risks that would impact their business. Robert has also served as a Legislative Director for a Member of Congress and lobbied for a national pharmaceutical related trade association and as well as a medical society.

Robert graduated from Brown University with a B.A. degree in Political Science. He currently lives in the Washington, D.C. area with his wife and twins—a boy and a girl.


Chelsey Hathaway

Chelsey Hathaway

Director, Patient Engagement and Events

chathaway@alliancerm.org

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 coordinating 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, her bulldog George and her cat Rosie.


Michael Lehmicke

Michael Lehmicke

Director, Science and Industry Affairs

mlehmicke@alliancerm.org

Michael joined ARM in 2018 as its first Director of Science and Industry Affairs. Michael has over 20 years of R&D experience in biomaterials, medical devices and regenerative medicine. He has led product development teams for class II devices, human cell and tissue-based products, and drug/device combination products. He is a creator and an inventor with multiple U.S. patents to his name.

Michael has a MSc in /Biomedical Engineering, with a focus on tissue engineering, from Drexel University. Michaels areas of expertise include cell-based tissue engineering, bioceramics, biodegradable polymers, project management, strategic pipeline development, and business development.

He is passionate about regenerative medicine and believes that it represents our best hope for meeting many unmet clinical needs, thereby changing patient’s lives for the better.


Paolo Morgese

Paolo Morgese

Director, EU Market Access & Member Relations

pmorgese@alliancerm.org

Paolo is a healthcare investment and market access professional with more than 15 years of experience in both assessing and supporting access to innovative healthcare technologies. Between 2012 and 2017 he worked at Deerfield Management, a healthcare investment company, where he was Director of EU Research and Market Access. Prior to that, he worked at Merck Serono for five years, Kyphon, which became Medtronic, and also spent several years with the Italian HTA Agency Agenas. Paolo’s interests and expertise are centered around healthcare technology value assessment and maximization, with a particular interest in the early stages of product development. He is an engaged stakeholder in EU and international policy debates around access to cell and gene therapies, health technology assessment convergence, early dialogue activities and value-based pricing/contracting. He is the past chair of the European Biotech Industry Association HTA task force and biotech industry representative at the EUnetHTA Joint Action 2 Stakeholder Forum. In addition to his role at ARM, Paolo is also the Managing Director of Forethought Access, an early-stage market access consultancy based in Geneva, Switzerland.

Paolo holds a BSc in Economics from the University of Siena (Italy) and an MSc in Financial and Business Economics from the University of Essex (UK). He is an Italian national and currently resides in the French Alps with his wife and two children.


Alyce Osborne

Alyce Osborne

Director of Member Engagement

aosborne@alliancerm.org

Alyce has more than a decade of experience in research and advocacy in the public health field. She has acted as a project manager in wide-scale chronic disease studies at the New York City Department of Health and Mental Hygiene, where she co-authored a paper for Public Health Nutrition. She has also led evaluations of nonprofit acute care systems and how they impact low income individuals and families in the Bronx. Prior to joining ARM, Alyce worked as an analyst on a CDC opioid abuse, misuse, and prevention grant at the D.C. Department of Health, with a focus on strategic planning and developing a public-facing data dashboard for the city. Additionally, she has led a private consulting firm, developing training programs and outreach campaigns for many small businesses. Alyce received her Masters in Public Health from New York University.


Kaitlyn Donaldson

Kaitlyn Donaldson

Coordinator, Communications

kdonaldson@alliancerm.org

Kaitlyn comes to ARM with experience in regulatory and legislative research, data visualization and professional writing. Most recently, she interned with the Office of Communications at the Centers for Medicare and Medicaid Services (CMS), where she performed a needs assessment to identify gaps in outreach related to the federally-facilitated marketplace. Her final report combined quantitative and qualitative analysis to produce recommendations to increase the quality and efficiency of future CMS outreach. As a graduate student, Kaitlyn also participated in internships and assistantships focusing on legislative and regulatory research and advocacy on topics including Medicaid reimbursement, women’s health, supplemental nutrition programs, and unemployment insurance.

Kaitlyn received her M.P.P. in Health Policy from the University of Maryland and her B.A. in Political Science from Furman University in her home state of South Carolina. She currently resides in the Washington, D.C. metropolitan area.


Jeanette Lazusky

Jeanette Lazusky

Coordinator, Events

jlazusky@alliancerm.org

Jeanette joined the ARM events team in 2019 in order to support the continued growth of ARM’s core events, as well as ARM workshops, industry events, and stakeholder meetings.

Prior to joining ARM, Jeanette worked with the Washington, DC nonprofit Atlas Performing Arts Center. As their Manager of Special Events, she planned and executed a wide variety of events, including board member events, conferences, and fundraising galas of 450+ attendees. She discovered her passion for event planning while attending Duquesne University in Pittsburg, PA. In addition to her experience with ARM and with the Atlas Performing Arts Center, Jeanette has worked with SRS Events and Pop the Cork Designs, as well as interning with the Pittsburgh Ballet, where she assisted with their annual gala and donor events.

Jeanette is originally from Lancaster, PA. She earned her B.A. in Marketing and Public Relations from Duquesne University and minored in Nursing.


A-P Murphy

A-P Murphy

Coordinator, Executive and Committees

apmurphy@alliancerm.org

A-P Murphy joined ARM in 2019 to provide executive-level support and to coordinate operations for ARM’s thirteen core committees, as well as various subcommittees and task forces.

Before coming to ARM, A-P Murphy worked for VeteransAgainstAlzheimer’s, where she established partnerships with veteran service organizations and promoted awareness and understanding about the risk factors for Alzheimer’s disease. Previously, A-P has managed a DC-based co-working space and has served as an executive assistant to the president of a veterans’ focused mental health non-profit. She has experience working with top-level executives, communicating across stakeholder groups, and managing logistics and operations for large organizations.

A-P received her MSc in War and Psychiatry from King’s College London and her B.S. in Psychology from University of Pittsburgh.


Adam Roose

Adam Roose

Advisor

aroose@alliancerm.org

Adam is a life sciences professional, specializing in cell therapy with experience in both academic and industry settings. He utilizes extensive background in product and process development, as well as operational expertise, to create the best possible solutions for platform specific challenges. Adam has hands-on experience in translating academic discoveries into viable manufacturable products, and has worked with both academic and industrial partners in doing so. During his time in the life sciences profession, Adam spent several years at the Harvard Stem Cell Institute in the lab of Dr. Doug Melton, developing Melton’s proprietary Stem-Cell Derived Beta technology to an industrial standard. Adam was then a first round hire at Semma Therapeutics where he ran the process development group and established the quality and supply chain management platform for the company. Adam received his BA from Bates College in History with a joint focus on Biology.