Governing Committee

Naomi Aronson, PhD

Executive Director, Clinical Evaluation, Innovation, and Policy, Blue Cross Blue Shield Association (BCBSA)

 

 

Dr. Naomi Aronson leads BCBSA clinical effectiveness and policy engagement with government, regulatory agencies and policy consortia.  Her areas of leadership include comparative effectiveness, patient centered research, safety surveillance, regulatory science and methodological standards.

Previously, Dr. Aronson led the development of the BCBSA Technology Evaluation Center (TEC), now the Center for Clinical Effectiveness, as a nationally recognized technology assessment program and an Evidence-based Practice Center of the Agency for Healthcare Research and Quality (AHRQ).  She has directed over 300 technology assessments and 20 evidence reports for AHRQ.  Dr. Aronson is a member of the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI).  She also serves on the PCORI Board of Governors Research Transformation Committee and the PCORI Rare Diseases Advisory Panel.

Dr. Aronson is a member of the Health Technology Assessment International Health Policy Forum, Institute of Medicine Genomics Roundtable, the National Business Group on Health Committee on Evidence-Based Benefit Design, and the New Drug Development Paradigms (NEW DIGS) initiative of the MIT Center for Biomedical Innovation, Steering Committee of the Quality Assurance Pilot for Cancer CDx.  Dr. Aronson is a founding member of EXCITE International, Excellence in Clinical and Technology Evaluation.  She serves on the EXCITE International Advisory Board, the Scientific Collaboration and is Chair of the Payer Advisory Committee.

Prior to joining TEC, Dr. Aronson was a member of the Northwestern University faculty, specializing in the sociology of science and medicine.  She was a post-doctoral fellow in the Science, Technology and Society Program at MIT and received research awards from the National Science Foundation and the American Council of Learned Societies.  Dr. Aronson’s academic research focused on how the organization of scientific specialties in biomedical and clinical research affects the process of scientific discovery.

 

 Kathleen Blake, MD, MPH

Vice President of Healthcare Quality at the American Medical Association (AMA)

 

 

Dr. Blake is Vice President, Healthcare Quality at the American Medical Association (AMA) and resides in Washington, DC and Santa Fe, New Mexico. She oversees the AMA’s clinical quality initiatives. She previously served as Executive Director of the AMA-convened Physician Consortium for Performance Improvement and its successor organization, the PCPI Foundation, with executive responsibility for performance measure development, the National Quality Registry Network (NQRN) and PCPI quality improvement initiatives.

Dr. Blake is also Assistant Professor of Medicine at the Johns Hopkins University School of Medicine. She holds her medical degree from the Pritzker School of Medicine at the University of Chicago and her MPH from Johns Hopkins Bloomberg School of Public Health. She is a board-certified clinical cardiac electrophysiologist.

 

Marc Boutin, JD

CEO National Health Council

 

 

Mr. Boutin is the Chief Executive Officer of the National Health Council (NHC), an organization that brings together all segments of the healthcare community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers. In addition to overseeing financial management and operations at NHC, he builds consensus among member patient advocacy organizations enabling them to speak with one voice on systemic health research and healthcare policy initiatives.

Mr. Boutin also provides guidance to patient organizations on various association issues, including corporate structure, government relations, fundraising, and outreach. He has been actively involved in health advocacy, policy, and both federal and state legislation throughout his career. He is a member the International Alliance of Patients’ Organizations Governing Board, Community Health Charities Board of Directors, and the North America Advisory Board to the Drug Information Association.

 

Mark Deem

Managing Partner at The Foundry, LLC and Medical Device Manufacturers Association (MDMA) nominee

 

 

Mr. Deem joined The Foundry at its inception in 1998. Where he leads the research and invention process on new clinical opportunities, as well as the early stage efforts in The Foundry’s new companies until CEO and Senior Staff are hired. Prior to joining The Foundry, Mr. Deem worked in various research and development roles with Ventrica, Micro-Interventional Systems, Devices for Vascular Intervention, Cordis Corporation, and the USCI Division of C.R. Bard.

Mr. Deem has spent over twenty-five years in the design, testing, and manufacture of medical devices and is a co-inventor on over 150 issued and pending U.S. patents. He also serves in a number of leadership roles including as the Director for FIRE1, Holaira, Twelve, as Chairman of Miramar Labs, and as a Venture Partner with Lightstone Ventures.

 

 Rachael L. Fleurence, PhD

NESTcc Governing Committee Chair

 

 

Dr. Fleurence is the newly appointed Executive Director for the NEST Coordinating Center and will chair the NESTcc Governing Committee. She joins NEST and MDIC from the Patient-Centered Outcomes Research Institute (PCORI) where she has led 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 330 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, and was 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).

 

Bill Hanlon, PhD

Chief Development Officer and Head of Global Regulatory Affairs at LabCorp/Covance, and American Clinical Laboratory Association (ACLA) nominee

 

 

Dr. Hanlon has been an active contributor to the development of innovative new medicines for more than 26 years, holding positions of increasing scientific leadership and responsibility. Trained as a biochemist, he spent the first half his career in drug discovery identifying novel small molecules effective in targeting molecular mechanisms regulating inflammatory and immunological disease processes. For the last 12 years, Dr. Hanlon has focused his attention in early and late clinical development as a regulatory affairs expert advising teams of scientists on the many regulatory challenges to develop new medicines for registration globally.

Currently, Dr. Hanlon is Vice President and Head of Global Regulatory Affairs (GRA) at Covance, Inc. where he has led a group of 165 regulatory professionals for the last 2.5 years. GRA provides clients with a broad array of regulatory support for the planning, development, reviewing, publishing, and submission of regulatory documents to Health Authorities in support of clinical trials, agency interactions and marketing applications globally. Dr. Hanlon and his group are also responsible for advising clients on global, regional, or local regulatory strategy.

 

Adrian Hernandez, MD, MHS

Professor of Medicine at Duke School of Medicine, Director of research, quality, and outcomes at Duke Heart, and Director of Health Services and Outcomes Research at the Duke Clinical Research Institute (DCRI)

 

 

Dr. Hernandez is a cardiologist with extensive experience in clinical research ranging from clinical trials to outcomes and health services research. He is the Director of Health Services and Outcomes Research and a Faculty Associate Director of the DCRI. He leads research programs focused on understanding population health, generating real-world evidence, and improving patient-centered outcomes through development of new therapies and better care delivery in our national health system.

He is the Coordinating Center Principal Investigator for multiple networks and clinical trials such as the National Heart, Lung, and Blood Institute’s Heart Failure Clinical Research Network, PCORI’s National Patient-Centered Clinical Research Network (PCORnet) and NIH’s Health System Collaboratory. A central aim of these networks is to transform clinical research by uniting patients, clinicians, health systems, and electronic health data to improve population health and decision making. Dr. Hernandez has over 350 published articles in top peer-reviewed journals including the New England Journal of Medicine, Journal of the American Medical Association, and Lancet.

 

Tamara Syrek Jensen, JD

Director, Coverage and Analysis Group, Center for Clinical Standards and Quality

 

 

Ms. Jensen is the Director of the Coverage and Analysis Group in the Centers for Clinical Standards and Quality at CMS. Before becoming the Director, she 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. She 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.

Ms. Jensen 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 has completed several regulations including updating and creating the screening and preventive benefits within the prescribed statutory or regulatory timeframes.

 

Harlan Krumholz, MD, SM

Harold H. Hines, Jr. Professor of Medicine and Epidemiology & Public Health at Yale University, and Director of the Yale New Haven Hospital Center for Outcomes Research and Evaluation (CORE)

 

 

Dr. Krumholz is a cardiologist and health care researcher at Yale University and Yale-New Haven Hospital. He received a BS from Yale, an MD from Harvard Medical School, and a Masters in Health Policy and Management from the Harvard University School of Public Health. He is the Harold H. Hines, Jr. Professor of Medicine and Director of the Yale Center for Outcomes Research and Evaluation (CORE), one of the nation’s first and most productive research units dedicated to producing innovations to improve patient outcomes and promote better population health. He is also a Director of the Robert Wood Johnson Foundation Clinical Scholars Program, which prepares talented physicians to become future health care leaders.

Dr. Krumholz has been honored by membership in the Institute of Medicine, the Association of American Physicians, the American Society for Clinical Investigation, and was named a Distinguished Scientist of the American Heart Association. He was elected to the Board of Trustees of the American College of Cardiology and the Board of Directors of the American Board of Internal Medicine, and was appointed by the U.S. government to the Board of Governors of the Patient-Centered Outcomes Research Institute.

  

Elizabeth McGlynn, PhD

Vice President of Kaiser Permanente Research, and Executive Director of the Kaiser Permanente Center for Effectiveness & Safety Research

 

 

Dr. McGlynn is vice president for Kaiser Permanente research and executive director of the Kaiser Permanente Center for Effectiveness and Safety Research (CESR). In this capacity, working with the National Research Council, she provides program-wide leadership for research at Kaiser Permanente, coordinates the development and implementation of national research strategy, oversees and supports research administration throughout Kaiser Permanente, represents and communicates about Kaiser Permanente research internally and externally, and works with national and regional leadership to promote Kaiser Permanente research and assure its contribution to improved care for members and improved health in the communities served.

Dr. McGlynn is also responsible for the strategic direction and scientific oversight of CESR, which is designed to improve the health and well-being of Kaiser Permanente’s members and the public by conducting comparative effectiveness and safety research and implementing findings in policy and practice. She is an internationally known expert on methods for evaluating the appropriateness and quality of health care delivery.

 

Michelle McMurry-Heath, MD, PhD

WW Vice President Regulatory and Clinical Affairs at Johnson & Johnson Medical Device Companies, and Advamed nominee

 

 

Dr. McMurry-Heath is a physician and scientist with more than two decades of experience working to bring cutting-edge medical technologies to patients. Prior to joining Johnson & Johnson, she was responsible for providing advisory and advocacy services to clients across the health and life sciences sector at FaegreBD Consulting. As the lead for the firm’s regulatory team, she delivered insights on the current regulatory landscape for medical devices and pharmaceuticals, while also working to shape the future regulatory environment.

Previously, Dr. McMurry-Heath served as Associate Center Director for Science at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the branch of the agency responsible for regulating medical devices. In her role at the FDA, Michelle led the creation of the Medical Device Innovation Consortium (MDIC), a novel public-private partnership between the agency and almost 50 members of the medical technology industry and patient advocacy community. She also led efforts at the agency to stimulate innovation for pediatric and special patient populations, to develop standards, and to measure the impact of FDA-sponsored research.

 

Vance Moore

President of Business Integration at Mercy

 

 

Vance Moore is president of Mercy’s business integration efforts. His career has included operational and sales roles in health care consulting, distribution, manufacturing, third party logistics and provider operations. Since joining Mercy in 2002, Vance has served as senior vice president of operations and president and CEO of Resource Optimization & Innovation (ROi), Mercy’s supply chain division and one of the world’s top health care supply chain operations.

Prior to Mercy, Vance garnered 17 years of experience in health care with Baxter/Allegiance, Cardinal Health and the health care division of the UPS Logistics Group.

Today, Vance is board chair for ROi and has corporate oversight responsibilities of Mercy Virtual, Mercy Technology Services (MTS), Perioperative Services and Mercy Research. Additionally, Vance was recognized as SCM World’s 2015 “visionary of the year.” He is a board member of Omnicell Incorporated (NASDAQ: OMCL) and Ascension Ventures, as well as a former board member of the Strategic Marketplace Initiative (SMI) and The Bellwether League.

Vance has a bachelor’s degree in industrial management from the University of Arkansas.

 

William Murray

President and CEO of the Medical Device Innovation Consortium (MDIC)

 

 

Mr. Murray joined MDIC in August of 2013 as the first President and CEO. He has over 25 years of senior leadership experience spanning the range of privately financed start-up to billion dollar plus global businesses. His small company experience spans 5 years as CEO and executive consultant, including 3 years as CEO of ReShape Medical. His large company experience includes leadership as the Molecular Biology Division President of Applied Biosystems, and at Medtronic where he spent nearly 20 years in various senior leadership positions, including President of the Pacemaker Business.

Mr. Murray has also served as interim President and CEO of MTS Systems (MTSC) a public $500M industrial technology company. He currently serves on the Boards of MDIC, ILT, Sonex Health and Nortech Systems and previously served on the Boards of MTS Systems, LifeSync Holdings, ReShape Medical, and has also served on various industry association and community leadership boards.

 

Jeffrey Shuren, MD, JD

Director of FDA’s Center for Devices and Radiological Health (CDRH)

 

 

Jeffrey Shuren, MD, JD 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.

 

Sharon Terry

President and CEO, Genetic Alliance

 

 

Sharon F. Terry is President and CEO of Genetic Alliance, activating individuals, families and communities to transform health. As ‘just a Mom’ with a master’s degree in Theology, she cofounded PXE International, a research advocacy organization for the genetic condition pseudoxanthoma elasticum (PXE), in response to the diagnosis of PXE in her two children in 1994.  With her husband, she co-discovered the ABCC6 gene, patented it to ensure ethical stewardship in 2000.  She subsequently developed a diagnostic test and conducts clinical trials.  She is the author of 150 peer-reviewed papers, of which 30 are clinical PXE studies. This story is the subject of her 2016 TED talk.

As a citizen scientist animating community engagement, she serves in a leadership role on many of major international and national organizations. She received an honorary doctorate from Iona College for her community engagement work; the Research!America Distinguished Organization Advocacy Award and is an inaugural member of Disruptive Women in Health Care. She is Co-PI of the PCORnet Coordinating Center and Chair of the PCORnet Engagement Committee. She received the Health 2.0 Health Activist award in 2016. She is a student of Gestalt Awareness Practice and is an Ashoka Fellow.

 

Diane Wurzburger, JD

Regulatory Affairs Executive at GE Healthcare, and Medical Imaging & Technology Alliance (MITA) nominee

 

 

Ms. Wurzburger is a Regulatory Affairs Executive with over 25 years of increasing responsibility in global regulatory and policy leadership in the medical device industry, with demonstrated expertise in regulatory compliance, strategic planning, and tactical execution, establishing collaborative cross-functional partnerships, and organizational development.

Ms. Wurzburger is currently responsible for oversight and leadership of regulatory and policy activities at GE Healthcare, inclusive of regulatory strategies, premarket registrations, post-market reporting, and strategic alignment of global influencing opportunities.  She has established and maintained appropriate professional channels of communication and collaborative relationships with regulatory agencies, including FDA, CMS, Health Canada, ANVISA. She is a MITA Board member and Chair of the MITA Technical & Regulatory Committee.  She also served as a MITA representative on the MDUFA IV industry negotiation team.