FEATURED GOVERNMENT SPEAKERS (in order of appearance)

Scott Gottlieb Commissioner, Food & Drug Administration Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 10, 2017. Dr. Gottlieb is a physician, medical policy expert, and public health advocate who previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and before that, as a senior advisor to the FDA Commissioner.

He also worked on implementation of the Medicare drug benefit as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services, where he supported policy work on quality improvement and the agency’s coverage process, particularly as it related to new medical technologies. In 2013 Dr. Gottlieb was appointed by the Senate to serve on the Federal Health Information Technology Policy Committee, which advises the Department of Health and Human Services on healthcare information technology. Dr. Gottlieb was previously a Resident Fellow at the American Enterprise Institute, and a Clinical Assistant Professor at the New York University School of Medicine in Manhattan, where he also practiced medicine as a hospitalist physician. He completed a residency in internal medicine at the Mount Sinai Medical Center in New York, New York and is a graduate of the Mount Sinai School of Medicine and of Wesleyan University, in Middletown, Connecticut, where he studied Economics.

Jeffrey Shuren, M.D. Director CDRH, FDA Jeffrey Shuren, MD is the Director of the Center for Devices and Radiological Health (CDRH) at FDA. He previously served as Acting Center Director. Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including Acting Deputy Commissioner for Policy, Planning, and Budget; Associate Commissioner for

Policy and Planning; and Special Counsel to the Principal Deputy Commissioner. Dr. Shuren is board certified in Neurology and served as an Assistant Professor of Neurology at the University of Cincinnati. In 1998, Dr. Shuren joined FDA as a Medical Officer in the Office of Policy. In 2000, he served as a detailee on the Senate HELP Committee. In 2001, he became the Director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services. From 1998 to 2003, he served as a Staff Volunteer in the National Institutes of Health’s National Institute of Neurological Disorders and Stroke Cognitive Neuroscience Section supervising and designing clinical studies on human reasoning. Dr. Shuren returned to FDA as the Assistant Commissioner for Policy in 2003 and assumed his current position in September 2009.

Adam Boehler Director, Centers for Medicare and Medicaid Innovation Adam Boehler, Deputy Administrator and the Director of the Center for Medicare and Medicaid Innovation, joined CMS in April, 2018. Widely regarded as an innovative leader in the private sector, Adam has designed and implemented new, patient-focused approaches to healthcare delivery. Before coming to CMS, Adam was founder and CEO of Landmark Health, a company that provides home-based medical care. Landmark was founded on the

premise of passionate people transforming how care is delivered to those who need it most - the most chronically ill. Additionally, before joining CMS Adam was an Operating Partner at Francisco Partners, a global private equity firm with a focus on healthcare technology and services. Previously, Adam was Founder and CEO of Accumen. Accumen was incorporated in March, 2011 and is currently the largest provider of comprehensive laboratory management services to health systems. The company manages over 3,000 employees across 25 labs. Accumen has established anchor client relationships with Sharp HealthCare in San Diego, Advocate HealthCare in Illinois, and Aurora HealthCare in Wisconsin. Prior to taking his role as President and CEO of Accumen, Adam was a Principal at Accretive, LLC, where he was responsible for healthcare investments. Prior to joining Accretive, Adam was Executive Vice President and General Manager at MedeFinance, the leading provider of healthcare analytics with over 600 hospital and insurance clients. In this role, Adam was responsible for all hospital sales, product marketing, and business development. He also drove several major product solutions from concept to customer sale, managed MedeFinance’s partnership with The Advisory Board Company, and established MedeFinance’s international business in London. Before MedeFinance, Adam was an associate at Battery Ventures, a leading technology venture capital firm with over $2 billion under management, focusing on investments in software and emerging technologies. Early in his career, Adam spent a summer as an investment banker at Wasserstein Perella in its Media, Telecommunications, and Technology practice. In addition, he spent time as a public finance consultant for the Financial and Fiscal Commission in South Africa where he focused on provincial revenue issues and co-authored a report presented to the South African Parliament that argued for greater provincial revenue responsibility. Adam graduated magna cum laude from the Wharton School of the University of Pennsylvania. He resides in New Orleans, LA with his wife, Shira, and their four children.

Tamara Syrek Jensen Director, Coverage and Analysis Group CMS Tamara has been with the Coverage and Analysis Group since 2004. Tamara became the Director of the Coverage and Analysis Group in the Centers for Clinical Standards and Quality at CMS in March 2014. Before becoming the Director, Tamara was the Deputy Director. CAG develops, interprets, communicates, and updates evidence

based national coverage policies. These policies help provide timely access to services and technologies that improve health outcomes for Medicare beneficiaries. Tamara is one of the principal authors in creating and implementing coverage with evidence development (CED), an initiative that allows for Medicare coverage while developing evidence through clinical trials and registries. Under the CED paradigm, CMS is collaborating with NIH and AHRQ on research topics such as molecular diagnostics, carotid stenting and Alzheimer’s disease. Tamara leads the CMS collaboration with FDA, including the 2010 memorandum of understanding with the FDA and the ongoing CMS-FDA parallel review pilot program. As part of the CAG leadership team, she is part of changing the local coverage decision (LCD) paradigm to create collaborative local decisions and completed several rules updating and creating the screening and preventive benefits within the prescribed statutory or regulatory timeframes. Prior to working at CMS, she worked as a legislative assistant for the U.S. House of Representatives. Tamara is an attorney, licensed in Maryland.

SPEAKER BIOGRAPHIES (in alphabetical order)

Eb Bright President & General Counsel Exploramed Development At the ExploraMed incubator, Eb Bright has many years of technology development, company formation and financing experience. He is a founder of several companies, a patent attorney and has served on the executive management teams of many start-up companies in multiple capacities

(Acclarent, Neotract, Vibrynt, Moximed, Nuelle, Willow). He is a co-founder of and serves on the Alliance for U.S. Startups & Inventors for Jobs (USIJ) Advisory Committee. Previously, Eb was Director of Intellectual Property West Coast Operations at Guidant Corporation where he directed a 9-member team involved in litigation and the strategic development of over 1,300 patent and trademark applications related to the Vascular Intervention, Cardiac Surgery and Endovascular Solutions divisions as well as handling legal issues for Guidant Japan and the Compass Group, the unit responsible for Guidant’s venture capital and merger and acquisition activities. Eb is an inventor on fourteen U.S. issued patents with others currently pending. He holds M.B.A.s from Columbia University and University of California, Berkeley, and Juris Doctorate and B.S. in Mechanical Engineering degrees from the University of Oklahoma.

Carolyn Bruguera Vice President & General Counsel MDMA Carolyn Bruguera is Vice President & General Counsel for the MDMA. She brings extensive experience in the management of legal affairs and compliance for medical device manufacturers. Prior to joining MDMA, Carolyn served as Vice President of Consulting Services for R-Squared Services & Solutions, Inc. (acquired by IMS Health)

where she advised dozens of clients in domestic and foreign antikickback and anticorruption compliance, data privacy, Open Payments and international transparency requirements. She also served as Vice President and General Counsel to Hansen Medical, Inc., a California-based manufacturer of robotics for intravascular procedures, and to Micrus Endovascular Corporation, from its initial public offering through its acquisition by Johnson & Johnson. Before joining the medical device industry, Carolyn was a corporate and securities attorney in private practice. She received her JD from the University of California, Berkeley’s Boalt Hall School of Law, and her AB, magna cum laude, from Harvard University. She speaks French fluently and is a member of the California bar.

Laurence Clark National Government Services Medicare Medical Director, Jurisdiction K Dr. Clark is the Medicare Medical Director for the National Government Services. He develops and updates Medicare local coverage policies for NGS jurisdictions, with particular responsibilitity for Jurisdiction K (New York and England). He also analyzes data related to utilization of services in NGS Jurisdictions.

Dr. Clark serves as co-facilitator of multi-contractor workgroups to harmonize Medicare coverage across mutliple jurisdictions. His function on these workgroups are to promote development of new collaborative Medical local policies.

Rachel Fleurence Executive Director NESTcc, MDIC Rachael L. Fleurence, PhD is the inaugural Executive Director of the newly formed National Evaluation System for health Technology (NEST) Coordinating Center. Under the umbrella of a public-private partnership, NESTcc’s mission is to establish clear pathways within the medical device ecosystem to support the timely, reliable, and

cost-effective development of evidence using Real-World Data sources for key stakeholders, including the medical device industry, regulators, payers, patients, clinicians, and health systems. Dr. Fleurence joins NEST from the Patient-Centered Outcomes Research Institute (PCORI) where she was the Program Director for PCORI’s initiative to build the National Patient-Centered Clinical Research Network, or PCORnet, sine 2012. PCORnet has been a transformational effort to engage patients and leverage electronic health data to improve the speed and efficiency of clinical research in the United-States. A 350-million-dollar investment involving 130 health institutions across the country, 20 patient powered research networks and covering 110 Million patients, PCORnet launched as an independent foundation in March 2017. Dr. Fleurence was also the inaugural director for the PCORI Methods Program in 2012, working closely with the PCORI Methodology Committee on this effort in its initial years. Dr. Fleurence has served on a number of Boards and Steering Committees, including most recently the National Medical Device Evaluation System Planning (NEST) Planning Board, the Medical Device Innovation Consortium (MDIC) Board and the SMART IRB Steering Committee, an effort to streamline IRB reviews across academic research institutions. She chaired the PCORnet Executive Committee from 2015-2017 and served as the vice-chair of the PCORnet Council. A health economist and health services researcher by training, Dr. Fleurence received a BA from Cambridge University (United-Kingdom), a MA in business management from ESSEC-Paris (France), and a MSc and PhD in health economics from the University of York (United-Kingdom).

Sean Flynn Associate General counsel & Chief Compliance Officer ABIOMED, Inc. Sean Flynn currently serves as Associate General Counsel and Chief Compliance Officer for Abiomed, Inc. In that capacity, Sean is responsible for business and legal matters touching every corner of the publicly-traded Massachusetts medical device

company, which specializes in providing products designed to assist the human heart and circulatory system. As Chief Compliance Officer, Sean is responsible for the compliance readiness of the company on a global scale. Prior to joining Abiomed, Sean served for seven years as a federal prosecutor with both the United States Attorney’s Offices for the Eastern District of California and the Eastern District of New York. As an Assistant United States Attorney, Sean was lead investigator and prosecutor on a wide assortment of fraud and corruption-related matters, and held a variety of supervisory positions, to include Health Care Fraud Coordinator. Sean began his legal career as a litigator with Bingham McCutchen LLP, after clerking for the Honorable Ruggero J. Aldisert, Senior Circuit Judge, United States Court of Appeals for the Third Circuit. Prior to beginning his legal career, Sean served as an air defense artillery officer for the United States Army, having graduated from the United States Military Academy at West Point in 1995.”

Josh Holmes President & Founding Partner Cavalry, LLC Josh Holmes is a proven political strategist and communicator who has helped guide Republican policy and politics in Washington, D.C. for nearly two decades. Holmes spent nearly a decade on Capitol Hill where he last served as Chief of Staff to then-Senate Republican Leader Mitch McConnell. In leading McConnell’s re-election

campaign and the return of a Republican Majority in the Senate in 2014, Holmes was nationally recognized as “The Mastermind of Team Mitch,” which earned him praise for the victory from the new Majority Leader for what he called, “a perfect game.” Over the past decade, Holmes has coined some of the most recognizable and durable branding in politics. His bumper sticker concoction of “Repeal and Replace” to short-hand Republican opposition to Obamacare became a rallying cry that has been used by nearly every Republican candidate for federal office since its inception in 2010. The New York Times noted the national significance of Holmes’s branding in the debate over American health care by saying, "The origin story of the 'repeal and replace' mantra is also a reminder of how pivotal strategic messaging has been throughout the health care debate." In 2015 Holmes founded Cavalry with his partners as a next generation public affairs company. By January of 2017, the company was listed by POLITICO as the second most influential player in Washington. In addition to representing a wide variety of corporate and trade association clients, Cavalry maintains a political footprint by contributing to the successful 2016 campaigns of Senators Todd Young, Rob Portman, John McCain, Richard Shelby, and the NRSC.

Holmes is a frequent guest on Fox News and CNN and regularly provides political analysis to national publications. He is a native of Minnetonka, Minnesota, and a graduate of Arizona State University. Holmes currently resides in Arlington, Virginia with his wife Blair Latoff Holmes and son William.

Scott Huennekens President & CEO Verb Surgical, Inc. Scott Huennekens is the President & CEO of Verb Surgical, Google and J&J’s new Surgical Robotics company, starting there in August 2015. Previously, Scott was the President & CEO of Volcano from 2002 to 2015 and lead the company’s growth from a start up to sales over $400 million in revenue and a market cap that approached

$2B prior to its sale to Philips in February 2015. He was the President & CEO of Digirad Corporation, a medical imaging company, Digirad grew from a pre-revenue start up when Scott joined in 1997 to a public company in 2004. Prior to Digirad, Scott progressed through leadership roles in marketing, sales, and general management while at Baxter Healthcare (Edwards Lifesciences) and Birtcher Medical Systems. He has served on the boards of numerous medical device companies and currently serves on the public boards of Viewray and Reva Medical and as the Past Chairman for the Medical Device Manufacturers Association (MDMA). Scott received a B.S. in Business Administration from the University of Southern California and an M.B.A. from Harvard Business School.

Louis Jacques Senior Vice President & Chief Clinical Officer ADVI Louis Jacques, M.D. is Chief Clinical Officer and a Senior Vice President at ADVI, a health care advisory services firm, where he is also a partner. He also serves on several institutional boards and advisory panels. Before joining ADVI in 2014, Dr. Jacques was the Director of the Coverage and Analysis Group (CAG) in the Centers

for Medicare & Medicaid Services (CMS) from 2009 - 2014, where he managed Medicare fee for service coverage policy development on technologies as diverse as molecular diagnostic testing, implanted cardiac devices, advanced imaging, chemotherapeutics, wound care, and screening and preventive services. From 2004 – 2009 he was a division director within CAG, focusing on Part B drugs and diagnostic tests. Before joining CMS in 2003, he served as the Associate Dean for Curriculum at Georgetown University School of Medicine; where he also saw patients at the Lombardi Cancer Center in his practice of hospice and palliative medicine.

Kristina Kaufmann Executive Director Code of Support Foundation Kristina Kaufmann is the Executive Director of Code of Support Foundation and has served as an advocate for military and veteran families for more than 15 years. In her role as the executive director, she combines her first-hand experience as a

wartime Army wife with her knowledge of research, programs and organizational strategies to raise awareness, inform policies and facilitate collective effort necessary to meet the needs of the military/veteran families. Kristy is also subject matter expert regarding the mental health impacts of war on military families. Her publications and media appearances include the Washington Post, New York Times, NPR, CNN, NBC, FOX and ABC. Kristy has briefed congress on several occasions and speaks at conferences across the country. She is a graduate of the University of California Berkeley, and a native of New Rochelle, NY.

Jennifer Kerr President Cook Research, Inc. Jennifer Kerr is the President of Cook Research Inc. In her role, Jennifer has executive oversight of product development, testing, clinical studies, medical/scientific writing, and regulatory submissions for devices, pharmaceuticals and cell-based therapies as requested by Cook. Additionally, Jennifer oversees and

directs the alignment between Cook Research and the needs of the Cook Strategic Business Units (SBUs) and Cook entities. Jennifer provides leadership by identifying and communicating Cook needs and priorities and working to assure customer expectations are met. In her role she is responsible for scientific and clinical leadership in the conduct of global clinical studies on behalf of the Cook organization and for managing resources required to coordinate the overall function of the company to ensure that deadlines are met.

Jennifer received a BSE in Interdisciplinary Engineering and a MS in Veterinary Physiology and Pharmacology from Purdue University.

Joe Kiani Chairman & CEO Masimo Corporation As founder, Chairman and CEO of Masimo, Joe Kiani runs one of the most admired medical technology companies in the world. He co-invented – SET® Measure-through Motion and Low Perfusion pulse oximetry. Studies have shown that this revolutionary technology can reduce false alarms in pulse oximetry by 95%, can help

detect life threatening events, can help reduce blindness in premature babies and can help identify the existence of congenital heart conditions in newborns. In 2012, Kiani founded the non-profit, Patient Safety Movement Foundation (PSMF) with a commitment to eliminate preventable patient deaths in US hospitals and significantly reduce medical errors worldwide by the year 2020 (#0x2020). Over 4,500

hospitals have made a formal and public commitment to zero preventable deaths and over 100 healthcare technology companies have made a public pledge to share their data so that researchers can develop predictive algorithms that notify clinicians of dangerous trends. This worldwide collaboration is hoping to foster a “patient data superhighway” that will catch errors before they cause harm. In February 2018, the hospitals that had joined Patient Safety Movement reported 81,533 lives saved annually.

Walter Koroshetz, MD Director of the National Institute of Neurological Disorders & Stroke National Institutes of Health Walter Koroshetz is the Director of the National Institute of Neurological Disorders and Stroke (NINDS). He works to advance the mission of the Institute, to improve fundamental knowledge about the brain and the nervous system, and to use that

knowledge to reduce the burden of neurological disorders. At NIH Dr. Koroshetz is the co-lead for the NIH Brain Research through Advancing Innovative Neurotechnology (BRAIN) Initiative. The BRAIN Initiative is an ambitious project to develop tools to monitor and modulate brain circuit function. Projects funded by the BRAIN Initiative include devices to stimulate circuits and record from patients with a variety of neuro and psychiatric disorders. Dr. Koroshetz is also a co-lead for the portion of the NIH response to the opioid crisis in the US focused on developing non- addictive means to effectively treat pain. He joined NINDS as the Deputy Director in 2007. Before coming to NIH Dr. Koroshetz was a Harvard Professor of Neurology, Vice Chair of Neurology at the Massachusetts General Hospital, director of Stroke and Neurointensive Care, and a member of the MGH Movement Disorders clinic. His research activities spanned basic neurobiology to clinical trials. He directed Neurology training at MGH for 16 years. A graduate of Georgetown University and University of Chicago Medical School Dr. Koroshetz specialized in Internal Medicine and Neurology.

Paul LaViolette MDMA Board Chairman Executive Chairman, CardioFocus Paul serves as Chairman of the Medical Device Manufacturing Association and as Vice Chairman of the Innovation Advisory Board for the Partners Health System. Paul also served on the board of Advamed for 10 years and is a routine speaker at industry meetings.

Paul La Violette joined SV Health Investors in 2009 as a Venture Partner and in 2011 was made a Partner. Paul was promoted to Managing Partner & COO in 2014 and heads our medical device investments. Paul built and ran medical device businesses for 29 years. Before joining SV, he most recently was Chief Operating Officer at Boston Scientific (BSC), an $8 billion medical device leader. During his 15 years at BSC, Paul served as Chief Operating Officer; Group President, Cardiovascular; President, Cardiology; Group President, Endosurgery; and President, International. During his tenure, the company grew revenue over 20 times. Paul integrated two dozen acquisitions and led extensive product development,

manufacturing and worldwide commercial organizations. Previously, Paul held marketing and general management positions at CR Bard and various marketing roles at Kendall (Medtronic).

Mark Leahey President & CEO MDMA Mark Leahey is the President & CEO for the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents hundreds of research-driven medical technology companies. His responsibilities include advocating on behalf of the entrepreneurial sector of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for

Medicare and Medicaid Services (CMS), and other federal and state agencies. He has lobbied for a more reasonable user fee for smaller companies, worked to open access to the hospital marketplace by challenging the exclusionary and anti-competitive nature of certain large group purchasing organizations (GPOs), as well as ensure that medical device technologies are reimbursed adequately. Mr. Leahey was named one of the medical device industry’s top lobbyists. He is a member of the Massachusetts Bar and a graduate of Georgetown University, the Georgetown Law Center and Georgetown’s McDonough School of Business.

Josh Makower General Partner New Enterprise Associates Josh has worked with NEA since 1995 and recently became a General Partner on their healthcare team leading the medtech/healthtech practice. Josh is the Founder & Executive Chairman of ExploraMed, a medical device incubator creating 8 companies. Transactions from the ExploraMed portfolio include Acclarent,

acquired by J&J, EndoMatrix, acquired by C.R. Bard & TransVascular, acquired by Medtronic. Other ExploraMed/NEA ventures include NeoTract, Moximed, Nuelle and NC7. Josh serves on the faculty of the Stanford University Medical School as a Consulting Professor of Medicine and is Co-Founder of Stanford’s Biodesign Innovation Program. Josh serves on the board of DOTS Devices, Eargo, ExploraMed, Intrinsic Therapeutics, NeoTract, Moximed, Nuelle, NC7 and Coravin. Josh holds over 300 patents and patent applications. He received an MBA from Columbia University, an MD from the NYU School of Medicine, and a bachelor’s degree in Mechanical Engineering from MIT.

Eric Major President & CEO K2M, Inc. Eric Major is the President, CEO and Co-Founder of K2M, Inc., a fast-growing global medical device company focused on developing innovative surgical solutions for the most complex spinal pathologies. Mr. Major previously co-founded and served as the President and Chief Executive Officer of American OsteoMedix Corp., or AOM, a minimally invasive spinal device company that was acquired by Interpore Cross

International in 2001. Following the sale of AOM, Mr. Major served as President of the Minimally Invasive Division for Interpore Cross International (now a Biomet company) until 2002. Prior to co-founding AOM, Mr. Major served in several sales/marketing, strategic and product development capacities with various spinal companies including Acromed Spine Inc. (now a Johnson & Johnson company) and Synthes Spine, Inc. Mr. Major has over 20 years of experience in the spine industry and was the 2010 recipient of the Entrepreneur of the Year Award for Emerging Technologies in the Greater Washington, D.C. region. Mr. Major is a member of the AdvaMed CEO Advisory Council and is active in the local community, serving on the Loudon Small Business Development Center Board of Directors, as well as the Board of Trustees for the Westmoreland Davis Memorial Foundation, Inc., a local historic preservation organization. Mr. Major holds a B.S. from James Madison University.

Juliana Mercer Managing Director MVPVets

Juliana Mercer is a former U.S. Marine in which she honorably served 16

years in active and reserve duty. During her military career she was

deployed to Iraq and Afghanistan providing significant support in Civil

Affairs and Civil Military Operations. Juliana also spent three years serving

wounded, ill, and injured Marines recovering at the Wounded Warrior

Battalion in San Diego.

Since leaving active duty, Juliana has committed her life to developing, connecting, and

successfully assisting veterans in their transition to new careers. It’s in this capacity that she is

the Managing Director of MVPVets, a 501(c) 3 organization whose aim is to assist and prepare

transitioning military veterans for employment in the business and technology of health

innovation. Through this endeavor, she spearheads efforts serving thousands of veterans,

hundreds of mentors and hundreds of life science corporations around the nation.

Juliana also serves on the Board of Directors as Military Adviser and Special Events Chair for

Warrior Foundation - Freedom Station, an organization empowering wounded, ill, and injured

service members and their families, and as a board member for the Veteran Business

Network, a collaboration of “veterans helping veterans.” Through these collaborations, Juliana

works tirelessly with employers, government and military officials to find meaningful

employment for recently separated service members who have given so much in service to

their nation.

Justin Minyard Executive Director Operation Shifting Gears, LLC As an advocate for chronic pain treatment accessibility and reform, Justin regularly travels across the country engaging with thousands of Interventional Pain Management Specialists and patients, seeking to encourage a shift in the

standard paradigm of care. With the understanding that chronic pain care is a national issue that extends beyond the walls of medical practices, Justin has been invited to address committees such as the Social Security Board of Disability Examiners and The Michigan Association of Treatment Court Professionals. Justin has also collaborated with The National Institute of Health, The Department of Defense, members of The United States Congress, and The United States House Committees on Veterans’ Affairs to promote the advancement of cutting edge medical technology, medical device policy, and improved access to patients and providers.

Richard Phillips Director, Healthcare Policy Association of British Healthcare Industries (ABHI) Richard joined the ABHI in June 2015 with over 20 years’ experience in the pharmaceutical and medical devices industries. Richard holds a first degree in Sports Science from Brighton Polytechnic and a

Master's in Health Economics Research and Management from Keele University. He served from 2003 until 2013 as a member of the Technology Appraisal Advisory Committee of the National Institute for Health and Care Excellence and also on the Programme Advisory Group of the Healthcare Quality and Information Authority in Ireland. Richard also serves as a non-Executive Director of the South West Peninsula Academic Health Science Networks, serving as Chair for most of 2015. He is a Board member of the Royal Orthopaedic Hospital, Birmingham and Chairs the Programme Board of the Small Business Research Initiative Healthcare. He is a longstanding member of the Institute of Healthcare Management Richard, his wife Luan, and their daughter Zelah Marie live in North Birmingham and West Cornwall.

Jason Richey President, North America LivaNova, PLC Jason Richey is the President of North America at LivaNova, PLC. With over 20 years of experience in the medical technology industry, Jason most recently served as President of the Neuromodulation Franchise for LivaNova, PLC. Prior to merger, Jason served Cyberonics as Vice President of Global Sales,

Marketing, and Market Access. With a 15-year tenure at Cyberonics starting at the beginning of 2001, Jason began in sales and marketing where he took on roles of increasing responsibility and scope in the United States neuromodulation market. In 2011 he was appointed General Manager & Managing Director of the European commercial business. Shortly thereafter he became the Vice President and General Manager of the Cyberonics international business. Before joining Cyberonics, Mr. Richey worked for B. Braun Medical in sales & sales management. Mr. Richey received a Bachelor of Art in Biology from Indiana University, Bloomington, Indiana.

John Richter Partner King & Spalding John Richter is a trial and investigations partner in the Special Matters and Investigations Practice Group, and represents and defends companies, Boards of Directors, Board committees, and individuals facing a variety of white-collar

criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. The Special Matters group has been twice recognized by Law360 as “White-Collar Group of the Year” and described as “the premier firm in this practice area” by the U.S. News & World Report/Best Lawyers’ “Best Law Firms” survey. John previously served as the Acting Assistant Attorney General in charge of the Criminal Division at the U.S. Department of Justice and as U.S. Attorney for the Western District of Oklahoma, having been nominated by the President and confirmed by unanimous consent by the U.S. Senate.

Beth Roberts Partner Hogan Lovells For the past two decades, Beth Roberts has helped life science companies optimize the value of their innovations. She helps clients navigate the complex coding, coverage, and reimbursement challenges faced by their new technologies.

Beth counsels on medicare and other healthcare issues and lobbies the U.S.Congress and regulatory agencies on her clients’ behalf. Her clients include healthcare providers; pharmaceutical, biotechnology, and medical device manufacturers; investors; and professional and trade associations.

Andy Rosenberg Partner Thorn Run Partners Andy Rosenberg brings 20 years of experience as a lobbyist, Capitol Hill staffer and former congressional candidate to Thorn Run Partners, which he co-founded in 2010. Throughout his career, Mr. Rosenberg has counseled a wide range of corporations,

trade associations and non-profits on strategic matters involving public policy. Prior to entering the private sector, Mr. Rosenberg spent several years working on Capitol Hill. He served on the committee (Senate Health, Education, Labor and Pensions) and personal staffs of Senator Edward M. Kennedy (D–MA). In the years since, Mr. Rosenberg established himself as a highly respected and effective Democratic lobbyist, focusing the majority of his practice in the area of health care and disability policy. Mr. Rosenberg has also counseled clients on tax, labor and clean energy related issues, and has advised numerous individuals who have been called to testify before congressional hearings. Mr. Rosenberg also has significant experience in the political arena. He was a co-founder and Senior Advisor to Draft Obama, the leading national pro-Obama grassroots organization prior to the Senator becoming a presidential candidate. Mr. Rosenberg was also an election law consultant to the Democratic National Committee, a surrogate for the Kerry-Edwards campaign on health care and Middle East policy issues and was a regional coordinator for the DNC's Voter Protection Initiative in the pivotal Philadelphia suburban region during the 2004 presidential campaign. In 2004, Mr. Rosenberg made a spirited but unsuccessful run for Congress in Virginia’s 8th Congressional District.

Ed Rozynski Senior International Advisor MDMA

Ed is an effective advocate and a well-known voice in government affairs, market access and reimbursement policy in the worldwide healthcare community. He maintains direct access to senior foreign health officials who welcome his knowledge of comparative health care (payment) systems. At the same time, able to justify and secure increases in overseas reimbursement for a variety of medical

technologies. Ed served as Intuitive Surgical's first VP for global government affairs and health economics. Prior healthcare organizations and Presidential committees served include: Stryker (as first VP of Govt Affairs), President Obama's Advanced Manufacturing Partnership (AMP), St. Jude Medical, Rozynski and Associates, AdvaMed, PhRMA, USTR and the U.S. Virgin Islands Commerce/Economic Council.

In 2010, Ed was awarded only the 10th Distinguished Alumni award granted by UNC-Greensboro’s School of Business and Economics.

Raja Saliba Partner Sughrue Mion, PLLC Raja N. Saliba is a partner in the firm's Washington D.C. office. Mr. Saliba has over 20 years’ experience in representing domestic and international clients in disputes before federal district courts, the International Trade Commission, the

Federal Circuit, and inter partes matters before the USPTO. Mr. Saliba also regularly engages in patent validity and infringement opinion practice and counseling clients on freedom-to-operate, due diligence, product clearance work, licensing and preparing and prosecuting patent applications. He has lectured extensively in the United States and abroad on intellectual property law and participated in the founding of the PTAB Bar Association where he serves as a member of the PTAB Trials Committee and the PTAB Appeals Committee. In March 2018, Mr. Saliba, along with other Sughrue partners and associates, co-authored a must-have case law reference, "The Essential Case Law Guide to PTAB Trials." The Case Law Guide is the first comprehensive text on decisions of the U.S. Patent Office regarding the newest form of administrative law practice before that agency. Through analysis and summary of the PTAB's decisions, the text identifies boundaries of the PTAB's rules, providing guidance when handling these highly specialized matters before the U.S. Patent Office.

Mr. Saliba’s experience encompasses a broad variety of technologies in the electrical and mechanical fields including fiber optics, agricultural machinery, medical devices, container manufacturing, semiconductors, printers, heating and cooling systems, hydraulic systems, automotive equipment, power generation equipment, sports related technologies, electrical transmission equipment, telecommunications, imaging devices, and business methods. Prior to joining Sughrue, Mr. Saliba worked in industry for over nine years as an engineer on the Seawolf-class submarine program and later as project manager in the design and manufacture of low earth orbit and geosynchronous satellites.

Sandra Sedo Chief Compliance Officer Cardiovascular Systems, Inc. Sandra Sedo has been Chief Compliance Officer at Cardiovascular Systems, Inc. since 2016. She is responsible for managing the company’s ethics and compliance program, including implementation of a Corporate Integrity Agreement. Sandra has over 25 years’ experience as a lawyer and/or

healthcare compliance professional, including experience a partner at Dorsey & Whitney, and as in-house attorney and Deputy Compliance Officer at Medtronic. She has been working exclusively in the medical device industry since 2005.

Robert Shaffer Partner Finnegan Henderson Farabow Garrett & Dunner LLP Rob Shaffer is an attorney in Finnegan, Henderson, Farabow, Garrett & Dunner, LLP’s Washington, D.C. office. He tries cases in a wide spectrum of technologies, including pharmaceutical, medical device, biologics, e-commerce,

and mechanical fields. He has served as lead counsel before district courts (judge and jury), arbitrations, and the U.S. International Trade Commission (ITC). Rob regularly leads litigation teams on significant Hatch-Waxman Paragraph IV disputes, representing leading innovative pharmaceutical companies across the country in dozens of major cases. In addition to his litigation practice, Rob advises clients on a variety of patent matters, including licensing, patent procurement, and pre- and post-litigation strategies. He has written opinions of counsel and has successfully navigated clients through settling complex disputes in private mediation and other alternative dispute resolution proceedings without litigation. Rob holds a JD from George Mason University.

Peter Shearstone Vice President, RA/QA/Clinical and Medical Affairs Sysmex America, Inc. Peter is a twenty-four-year quality professional with exceptional global leadership and medical device industry experience. Prior to joining Sysmex America, Shearstone served as the Senior Director of Regulatory

Communication for Hospira, Inc. Before then, Shearstone was Division Vice President of Global Quality Assurance at Abbott Diagnostics. He also served in senior level positions with Power Medical Interventions and Dade Behring (known now as Siemens Healthcare Diagnostics) as Senior Vice President of Regulatory Affairs and Quality Assurance and Vice President of Global Quality Assurance respectively. Shearstone has spent 22 of his 24 years in the diagnostics industry.