2017 MDIC Annual Public Forum
Annual Public Forum
2017 MDIC Annual Public Forum
Tuesday, October 3, 2017 | 8:30 a.m. – 4:30 p.m.
Center for Total Health
700 2nd St NE, Washington, DC 20002
Gathering industry, government, and nonprofit partners to advance the regulatory science of medical devices.
Presented by: Bill Murray | President & CEO, MDIC
Presented by: Anna Abram | Deputy Commissioner for Policy, Planning, Legislation, and Analysis, FDA
Moderated by: Mike Minogue | Abiomed, President, CEO, and Chairman; MDIC Board Chairman
- Mark Leahey | President & CEO, MDMA
- Kim McCleary | Acting Executive Director and Managing Director, FasterCures
- Jeff Shuren, MD, JD | Director, CDRH FDA
- Scott Whitaker | President and CEO, AdvaMed
Bill Murray | President & CEO, MDIC
Developments with the National Evaluation System for health Technology Coordinating Center (NESTcc): A Discussion with Members of the NESTcc Governing Committee
Moderated by: Rachael Fleurence, Ph.D. | Executive Director, NESTcc
- Adrian Hernandez, MD | Vice Dean for Clinical Research, Duke University School of Medicine
- Michelle McMurry-Heath, MD, Ph.D. | Worldwide Vice President, Regulatory Affairs and Clinical Research, Johnson & Johnson Medical Devices
- Jeff Shuren, MD, JD | Director, CDRH FDA
Why Patient Input Matters
Moderated by: Barry Liden, JD | Edwards Lifesciences
- Kara Haas, MD | Johnson & Johnson
- Chad Mather, MD | Duke Orthopaedics, DCRI
- Lauren McLaughlin | Michael J. Fox Foundation
- Annie Saha | OCD, CDRH FDA
- Margaret Sheehan, JD | Ashurst LLP
- Sandra Statz | Exact Sciences
- Don St. Pierre | OIR, CDRH FDA
- April Veoukas, JD | Abbott
Moderated by: Danelle Miller, JD | Roche
- Steve Binion, Ph.D. | BD
- Jaime Houghton | Sysmex America, Inc.
- Don St. Pierre | OIR, CDRH FDA
- April Veoukas, JD | Abbott
- Jeff Zinza | Hologic, Inc
- Vicki Anastasi | ICON plc
Innovation and Efficiency in Evidence Generation
Moderated by: Jennifer Kerr | Cook Group
- Randy Schiestl | Boston Scientific
- Jijo James, MD | Johnson & Johnson
- Chip Hance | Regatta Medical
- Owen Faris, Ph.D. | ODE, CDRH FDA
- Mark Carlson, MD | Abbott
- Naomi Aronson, PhD | Blue Cross Blue Shield
Case for Quality
Moderated by: Beth Staub | Stryker
- Luann Pendy, PhD | Medtronic
- Robin Newman, EdD | OC, CDRH FDA
- Cynthia Grossman, PhD | FasterCures
- Merle Goddard | Baxter
- Al Crouse | CVRx
Shahram Ebadollahi, PhD | Vice President, Innovations & Chief Science Officer, IBM Watson Health
Presented by: Bill Murray | President & CEO, MDIC
Kaiser Permanente Center for Total Health
700 Second St. NE
Washington, DC 20002
We encourage guests of the Center for Total Health to consider using public transportation or active forms of transportation in support of your total health.
The Center for Total Health is a short walk from Union Station, accessible by Metro (Red Line), Amtrak, VRE, and MARC trains. There are two ways to get from Union Station to the Center for Total Health.
In Union Station, walk to the end of the Amtrak Gates (Gate L), and turn left to walk through the double glass doors. Follow the tunnel to the end, then turn right and take the elevators down to LL.
Step out of the elevator, and turn left. Follow the hallway to the Kaiser Permanente entrance (it will be on your right). Our security guards will be happy to direct you to the Center for Total Health.
Walk toward the Thurgood Marshall Court Building at the East end of Union Station. Take a left onto Columbus Circle Northeast. You will see a Capitol Bikeshare station and the Securities and Exchange Commission as soon as you turn left.
Follow Columbus Circle as it becomes F Street. At the next intersection (F Street NE and 2nd Street NE), turn left onto 2nd Street NE. Folllow 2nd Street about 2 blocks to the farthest of three entrances to 700 2nd Street, with the Capitol Bikeshare station at the front door.
Bike & Walking
The Center for Total Health is located on the southern end of the Metropolitan Branch Trail, making it a bike and pedestrian friendly spot! There is also a Capitol Bikeshare station at the front door for folks using that system.
There is no parking onsite at the Center for Total Health. There are several nearby public garages, including directly across the street at 701 2nd Street NE. Union Station also has a large parking garage. Metered street parking is available in the neighborhood, though like most urban areas it can be difficult to find an open spot.
Helpful Neighborhood Information
2017 Hotels Nearby
NOTE: MDIC does not have a host hotel for this event. You may contact individual hotels for rates and reservations.
15 E Street NW
Group Reservations: (202) 449-7007
Phoenix Park Hotel
520 North Capitol Street
400 New Jersey Avenue NW
Small Group Reservations:
(202) 719- 8427
Large Group Reservations:
(202) 719- 8424
1325 2nd Street NE
The Liaison Capitol Hill
415 New Jersey Avenue NW
Printable agenda here.
Susan Alpert, PhD, MD | SFA Regulatory, LLC, Fellow of the Medical Device Innovation Consortium
Susan Alpert, PhD, MD, founded and leads a consulting practice to industry, SFA Regulatory, LLC. She specializes in helping companies develop regulatory strategies for entry to the US healthcare market. Prior to SFA Regulatory, Dr. Alpert was the Senior Vice President, Chief Regulatory Officer of Medtronic and was responsible for all Medtronic global regulatory efforts. Before joining Medtronic, Dr. Alpert served as Vice President of Regulatory Sciences for C.R. Bard, Inc. She also previously worked at FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the Director of the Office of Device Evaluation. Dr. Alpert is a microbiologist and a pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials. Dr. Alpert completed her undergraduate degree at Barnard College, Columbia University and holds a Master’s degree and Ph.D. in Biomedical Sciences from New York University. She received her Medical Degree from the University of Miami (Florida) and completed her clinical training at Montefiore Medical Center in the Bronx, New York and at Children’s National
Medical Center in Washington, DC.
Vicki Anastasi is Vice President and Global Head of Medical Device and Diagnostics Research at ICON plc. Ms. Anastasi provides leadership to create and foster priority relationships in the medical device and diagnostic marketplace, developing customized programs to meet medical device client needs. She has over twenty five years of experience in the medical device industry, with over fifteen years specifically focused on global medical device strategic consulting.
Prior to joining the company in 2007, she held senior management roles for medical device companies focused in orthopedics, cardiovascular, general hospital, and general surgical devices. In diagnostics, she held senior positions at companies involved in the development of infectious disease and genetic-based products. She is actively involved in medical device industry groups, including AdvaMed, OCTANe, MassMedic and MDMA, where she regularly speaks and participates in medical device focused panels and discussions.
Naomi Aronson, PhD, is the Executive Director of Clinical Evaluation, Innovation, and Policy, Blue Cross and Blue Shield Association (BCBSA). Dr. 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 (CCE), as a nationally recognized technology assessment program and an Evidence-based Practice Center (EPC) of the Agency for Healthcare Research and Quality (AHRQ). She 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, 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, and the Scientific Oversight Committee of the FDA Medical Device Epidemiology Network (MDEpiNet). She is an Expert Advisor to the Medical Device Innovation Consortium (MDIC) Diagnostics Clinical Evidence Work Group. Dr. Aronson is a founding member of EXCITE International, Excellence in Clinical Evaluation 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 also was a post-doctoral fellow in the Science, Technology and Society Program at the Massachusetts Institute of Technology 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.
With more than 15 years of experience in medical devices, Dawn Bardot, PhD, brings a wealth of experience to her role as Vice President of Technology Innovation at the Medical Device Innovation Consortium (MDIC). She is passionate about the application of data analytics and modeling to improve health care and lower the cost of bringing products to market.
Over the course of her career, Bardot has worked with startup companies, government organizations and academia on data driven design and decision making, including high intensity focused ultrasound, patient specific noninvasive FFR and medical oxygen regeneration for space flight. She has tackled the challenge of big data and data curation; disseminated and promoted the first computational model V&V standard; and recruited, hired and led high performing teams of direct reports and volunteers. At MDIC, her programs have produced and demonstrated a statistical framework for incorporating virtual patients in clinical trials including one mock submission, seven retrospective applications and one prospective application.
Dr. Bardot has a BS and MS in mechanical engineering from Kansas State University, a PhD in mechanical engineering from the University of Washington, was an Innovation Fellow at the University of Minnesota Medical Devices Center, and spent two summers as a Faculty Fellow at NASA Marshal Space Flight Center.
Steve Binion, PhD, MBA, is Director of Regulatory Policy, Technology and Communication at BD. Steve has spent over 25 years in industry, with 20+ years of experience leading regulatory teams in support of biologics, therapeutic and diagnostic devices, drugs, and combination products. His formal regulatory experience began in 1992, as Director, Worldwide Regulatory for Allergan’s Botox biologic. In 1994 he joined Baxter’s Fenwal Division as Vice President, Regulatory Affairs, and for the next 10 years led a global regulatory team with responsibility for 510(k), PMA, and NDA products used in blood component processing and delivery. While at Baxter Steve also gained extensive experience with CE marking of medical device products in the EU, including Class III devices incorporating medicinal products. In 2005 he joined BD as Director of Regulatory Affairs for BD Technologies, BD’s corporate research center in Research Triangle Park, NC. His responsibilities include providing support for early stage technology development efforts in areas including diagnostics, cell and tissue technologies, and advanced diabetes care. In 2011 he also took on responsibility for the Women’s Health and Cancer Regulatory team in BD’s Diagnostics Systems business. In 2013 he took on a new role as Director, Regulatory Policy, Technology and Communication in BD’s Corporate Regulatory group. He is active in a number of medical device and IVD policy issues on behalf of BD, through his involvement in MDIC, various industry coalitions and Advamed. Steve obtained his Ph.D. in immunology from Kansas State University and has an MBA from the University of St. Thomas, St. Paul, Minnesota.
Mark Carlson is Division Vice President and Chief Medical Officer at Abbott. In this capacity, Dr. Carlson leads a medical affairs organization that serves heart failure, cardiac rhythm management, electrophysiology, and neuromodulation devices and businesses. Dr. Carlson joined Abbott in January, 2017 when the company acquired St. Jude Medical. He joined St. Jude Medical in November 2006, serving as Chief Medical Officer and Senior Vice President, Research and Clinical Affairs, in the St. Jude Medical Implantable Electronic Systems Division until September, 2013 and as Vice President, Global Clinical Affairs and Chief Medical Officer thereafter.
Dr. Carlson received his M.D. from the University of Kansas, a Master of Arts degree in public policy from Duke University, and a B.S. from Kansas State University. He trained in internal medicine at University Hospitals of Cleveland and Case Western Reserve University and in cardiology and cardiac electrophysiology at the Massachusetts General Hospital and Harvard University. He joined the faculty of Case Western Reserve University in 1988 and remains on faculty as adjunct professor of medicine. His research on arrhythmias and neural control has resulted in over 150 publications. As a Robert Wood Johnson Fellow on Senator Orrin Hatch’s Senate Judiciary Committee, Dr. Carlson worked on the Medicare Prescription Drug, Improvement and Modernization Act and the Cord Blood Stem Cell Act. Thereafter, he returned to Case as associate vice president, government relations.
Dr. Carlson is a member of the board and past president of the West Los Angeles Council of the Boy Scouts of America.
Al is the Sr. Director of Quality Assurance and Quality Systems at CVRx. CVRx uses Barostim Therapy to treat drug resistant hypertension and heart failure. He developed, implemented, and has continued to improve the quality system at CVRx over the past 10+ years. CVRx has received both European and FDA approvals for their quality system. In addition, Al has participated in the MDIC and AdvaMed Case for Quality efforts over the past 4 years. Throughout this time CVRx has volunteered to pioneer new programs developed in conjunction with FDA to improve the quality of medical devices in general, and the CVRx product line specifically. Prior to CVRx, Al worked for Medtronic for more than 16 years in various divisions and management roles primarily in the area of quality and reliability. He developed and implemented new quality systems at two of these divisions. Key to these systems has been the implementation of appropriate risk management activities and techniques to assure the quality and reliability of the product being produced as well as regulatory compliance. Al has a Bachelor of Science degree in Electrical Engineering from Iowa State University and a Masters of Business Administration degree from the University of Colorado.
Dr. Shahram Ebadollahi is the Vice President of Innovations (R&D) and Chief Science Officer of IBM Watson Health. He is the technical founder of Watson Health, IBM’s first vertical industry business unit in 2015, building on his previous role as the global head and founder of Health Informatics Research for IBM. He oversees all product engineering, innovation incubation, and intellectual property for Watson Health. In his capacity as the Chief Science and Technology Officer, he determines the overall technical and scientific strategy for Watson Health and IBM as a whole in the area of healthcare and life sciences.
Prior to his current role, Dr. Ebadollahi was the global head and founder of Health Informatics Research for IBM, which spanned IBM’s global research labs in Asia, Europe, Africa and the US. He has pioneered novel technologies in the area of health analytics and computational health, has published many scientific publications, and has led scientific projects funded by national agencies.
Dr. Ebadollahi received his masters and doctorate degree in Electrical Engineering from Columbia University, where he worked on the analysis of multi-modal medical documents. He also has a MBA degree from Columbia University. His interests span, healthcare, technology, innovation, and entrepreneurship. He is a frequent speaker and panelist at various healthcare and health analytics related events.
Dr. Owen Faris is the Clinical Trials Director for the Center for Devices and Radiological Health at the FDA, and has been in that position since its creation in February of 2014. Dr. Faris received his B.S. in Mechanical Engineering from Rice University in 1997, and his Ph.D. in Biomedical Engineering from Johns Hopkins University in 2003. Dr. Faris joined the FDA in 2003 as a reviewer in the Pacing, Defibrillator and Leads Branch in the Division of Cardiovascular Devices (DCD) and became a Deputy Director for the Division of Cardiovascular Devices in 2011. Dr. Faris has been very involved in the development of clinical trial policy for several years including developing policy regarding FDA’s decisions and communications for device clinical trials. In his current role, he oversees FDA’s decisions and policies for medical device clinical trials including Early Feasibility studies and also oversees CDRH’s Breakthrough Devices Program.
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).
Merle Goddard is Sr. Quality Director for Baxter Healthcare responsible to implement a globally harmonized Hospital Products Quality Management System that clarifies, simplifies and brings efficiencies in critical product and life-cycle management activities for all product types: active devices (electromechanical), passive devices (disposables), implantables (bio-surgery), therapeutics (drugs and therapies) and application software (class 1 and non-medical devices).
Before her career in Baxter, Merle was Director of the Master of Science program at Northwestern University, and has held progressively more advanced and complex positions at Abbott in Pharma, Device and Nutrition manufacturing businesses. Locations included Canada, EU, Asia and US with global responsibility. Managerial areas included R&D, Manufacturing/Supply Chain/Distribution, Quality Control and Systems Assurance, Engineering Assurance, Commercial, Supplier management and she has worked in the community as a dietician specializing in enteral/parenteral nutrition, geriatric, heart health and diabetes management.
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.
Dr. Cynthia (Cyndi) Grossman is associate director, Science of Patient Input at FasterCures, a center of the Milken Institute. Prior to joining FasterCures, Cyndi was Program Chief in the Division of AIDS Research (DAR) at the National Institute of Mental Health (NIMH). She has spent her career conducting and supporting research to address the unmet patient needs related to mental health, stigma, and other social determinants of health. At FasterCures, Cyndi leads projects to advance the science of integrating patient perspectives from early R&D through care delivery to encourage greater alignment of medical products with patients unmet needs. Cyndi holds a doctoral degree in clinical psychology from the University of Vermont and post-graduate training from Brown University.
Kara Haas is a physician, scientist and educator with more than three decades of experience in healthcare. She currently is the global lead for Regulatory Affairs Policy and Intelligence for Outcomes and Evidence within the medical device companies at Johnson & Johnson. Her role is focused on global issues and topics related to regulatory science and innovation addressing evidence and outcomes including patient centered initiatives, diversity in clinical trial populations, and real world evidence. She has served an executive sponsor and leader for the medical device Regulatory Affairs AcceleRAte leadership development program since 2014.
Dr. Haas is a graduate of Duke University where she earned her BA in Chemistry and graduate of Tulane University School of Medicine and School of Public Health where she earned her MD and MPH degrees. She completed her General Surgery residency at the University of Washington in Seattle and Postdoctoral Fellowships at University of Texas Southwestern Medical Center and Howard Hughes Medical Institute, with a focus on the molecular biology of Tumor Necrosis Factor and G-protein mediated transmembrane signal transduction amplification systems. A former Lieutenant Colonel in the United States Air Force, Dr. Haas practiced general and trauma surgery and critical care medicine in military, academic and civilian settings prior to joining Johnson & Johnson. During her tenure at J&J she has had responsibility for functions in Medical Affairs, Clinical Affairs, Regulatory Affairs, Evidence Based Medicine, Health Economics, Market Access, Quality, Safety and Health Care Compliance functions.
Dr. Haas is a board certified general surgeon, Fellow of the American College of Surgeons, and a member of multiple professional medical and scientific societies.
Robert (Chip) Hance is CEO of Regatta Medical, a company focused on acquiring companies and assets providing either products or services in the medical device industry. As a medical device industry veteran with more than 25 years experience, prior to Regatta Medical, Chip was CEO of Creganna Medical, a leading Ireland based supplier to the minimally invasive medical device industry. After a successful three-year effort to focus the company on higher growth markets and improve operational performance, Creganna Medical was sold in 2016. Preceding Creganna, Chip was an Entrepreneur-in-Residence within the FDA at CDRH, were he co-led the Innovation Pathway team focused on streamlining aspects of medical device clinical trials in the U.S. Prior to his FDA experience, Hance was most recently President of Abbott Vascular, the cardiovascular device division of Abbott. Over a decade in interventional cardiology at Abbott Vascular, Hance led the organization from a small vessel closure business through acquisitions and organic growth and ultimately to global leadership in the drug-eluting stent market with the launch of Xience in the U.S., Japan, and China. Abbott Vascular became a multi-billion dollar division of Abbott.
Hance earned a bachelor’s degree in Chemical Engineering from the Massachusetts Institute of Technology and a master’s degree in Business Administration from Harvard Business School
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.
Jaime Houghton is Sr. Director, Regulatory and Clinical Affairs at Sysmex America, Inc. (SAI) located in Lincolnshire, IL. SAI distributes and supports automated in vitro diagnostic analyzers and reagents as well as information systems for clinical laboratories. Jaime has over 20 years of industry experience having worked in a clinical laboratory setting as a Medical Technologist (ASCP) prior to joining industry. She started with Baxter in the Blood Substitute Division and later the Fenwal (Transfusion Therapies) Division where she was responsible for the clinical studies of 510(k), PMA and NDA products. She has generated and executed global clinical strategies for various products in the blood collection, processing and storage. Jaime earned an MS in Clinical Laboratory Science from the University of Wisconsin-Milwaukee, and a BA in Biology from Drake University, Des Moines, IA.
Dr. Jijo James is the Chief Medical Officer for Johnson & Johnson Medical Devices. In the role, he leads the sector Medical Safety Organization and is responsible for overseeing patient monitoring and safety surveillance practices, and chairs the sector Development Committee and Medical Safety Council. In addition, he drives sector leadership in ensuring the highest medical and ethical standards, approaches to clinical data transparency and scientific integrity. Jijo is a member of the Johnson & Johnson Office of the Chief Medical Officer Senior Leadership team and Medical Devices R&D Leadership team.
Previously, Dr. James was the Chief Medical Officer for The Johnson & Johnson Family of Consumer Companies where he lead the Safety Council for the Consumer sector and was a member of the Consumer R&D Leadership Team.
Prior to joining Johnson & Johnson Dr. James spent six years at Pfizer Inc. where he held roles of increasing responsibility including Therapeutic Area Head in Bangalore, India, and Senior Director of Strategy and Operations for Pfizer Medical in New York. Dr. James previously spent nearly a decade as a consultant providing healthcare solutions to a variety of healthcare and life sciences companies.
Dr. James began his medical career working as a primary care physician in both urban and rural community settings. Having received his medical degree from St. John’s Medical College in India, he later earned a Masters of Public Health degree in Population and Family studies from the Joseph L. Mailman School of Public Health, Columbia University, New York, NY.
Jennifer has been involved in clinical research and regulatory affairs for 20 years. She is currently the President of Cook Research Incorporated which is involved in product development, testing, clinical studies, medical/scientific writing, and regulatory submissions for devices, pharmaceuticals and cell-based medical therapies. Jennifer also serves as the Global Functional Leader for Clinical Affairs for the Cook organization. Jennifer’s professional service in the medical device industry includes serving as the Co-Chair of AAMI/BE/WG 04, Clinical Investigations representing the U.S. industry and as a member of the ISO steering committee for the ISO 14155 clinical standard for medical device clinical studies. Jennifer earned her Bachelors of Science in Engineering and Master’s Degree in Physiology from Purdue University and is a Certified Clinical Research Associate (CCRA) and Regulatory Affairs Professionals Society (RAC).
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. Mr. Leahey’s 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 has been named one of the medical device industry’s top lobbyists and sits on the Editorial Advisory Board of Medical Product Outsourcing. 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.
Barry Liden is Vice President of Patient Engagement for Edwards Lifesciences, the global leader in patient-focused innovations for structural heart disease and critical care monitoring. He is responsible for helping the Irvine, California-based company engage with, learn from and empower patients and their families to improve the healthcare experience. Liden joined Edwards in 2002 as Director of Global Communications, responsible for the company’s external public relations, and has served in a number of public affairs positions, most recently as Vice President of Government Affairs.
Before joining Edwards, Liden served for seven years in leadership positions at two niche public relations and integrated marketing consulting firms in Dallas, Texas and Los Angeles, California. He began his public affairs career in 1990 as the Director of Government Relations for the Los Angeles Area Chamber of Commerce, responsible for transportation and environmental policy development and advocacy for the greater L.A. business community.
For more than 25 years, Liden has integrated public policy, government relations, public relations and crisis management practices to provide strategic solutions to his clients and employers’ challenges. He shared this experience with public relations undergraduate students at the University of Southern California as an adjunct faculty for seven years before moving to the Washington, D.C. area in 2007.
Liden has a bachelor of science in public administration from the University of Southern California, and a juris doctor from Loyola Law School of Los Angeles. He lives in Garrett Park, Maryland with his wife Tracy and three sons.
Kim McCleary is managing director and serves as acting executive director of FasterCures, a center of the Milken Institute. FasterCures is an action tank driven by a singular goal — to save lives by speeding up and improving the medical research system. She leads FasterCures’ Patients Count program to advance the science of patient input and expand patient engagement in FDA’s assessment of benefits and risks for medical products. McCleary also works closely with FasterCures’ network of patient-focused venture philanthropy organizations, The Research Acceleration and Innovation Network (TRAIN). Prior to joining FasterCures’ staff, McCleary was president & CEO of the CFIDS Association of America from 1991 until 2013. McCleary serves on the steering committee for the Medical Device Innovation Consortium’s Science of Patient Input project and is a member of DIA’s Advisory Council for North America. McCleary is a graduate of the University of North Carolina at Chapel Hill.
As Associate Director, Research Partnerships, Lauren focuses on Fox Insight, an online observational study that gathers data about the daily life with Parkinson’s directly from patients, their families and the community at large. This novel new research approach aims to create the world’s largest collection of longitudinal data to give researchers answers to key questions about Parkinson’s that are hard to answer through traditional studies, quality of life metrics and healthcare burden of disease. Lauren joined the Foundation in October 2015.
Previously, Lauren worked at Texas Children’s Hospital for over five years focusing on community engagement and patient support initiatives. With over ten years of nonprofit management experience, she is passionate about involving a variety of stakeholders in fueling systematic changes in the healthcare and research landscape.
Lauren received her MBA from the University of Houston and holds a BA in Metropolitan Studies from New York University.
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.
Richard C. “Chad” Mather III MD, MBA is an assistant professor and vice chairman of practice innovation in the Department of Orthopaedic Surgery at Duke University School of Medicine. He is also a faculty member at the Duke Clinical Research Institute. Dr. Mather is a health services researcher and decision scientist with a focus on economic analysis, health policy, health preference measurement and personalized decision-making. His current work focuses on building tools for healthcare consumerism by facilitating measurement and communication of individual patient preferences in treatment decisions. Additionally, he has great interest in health innovation, particularly in developing new care and payment models to foster different incentives and practice approaches. He was a health policy fellow with the American Academy of Orthopaedic Surgeons and the Arthroscopy Association of North America. Dr. Mather received an undergraduate degree in economics from Miami University and a medical doctorate and masters in business administration from Duke, where he also completed residency training in orthopaedic surgery. He completed a sports medicine fellowship at Rush University Medical Center. His clinical practice focuses on hip arthroscopy including both FAI and extra-articular hip endoscopy. Specifically to the hip in addition to health service research applications he conducts translational research on biomarkers and hip instability.
Danelle Miller is Vice President, Global Regulatory Policy and Intelligence for Roche Diagnostics. In that role, she is responsible for guiding Roche Diagnostics’ global regulatory policy efforts. Ms. Miller joined Roche Diagnostics in 2005, and served as Regulatory Counsel for Roche Diagnostics’ Indianapolis-based affiliates, and later as Global Regulatory Counsel, where she counseled Roche Diagnostics worldwide on quality and regulatory issues. Prior to joining Roche Diagnostics, she worked for the law firm of Baker & Daniels and as Vice President of B&D’s subsidiary, Aventor, where she was responsible for representing food, drug and medical device companies on regulatory and related issues involving the Food and Drug Administration, U.S. Department of Agriculture, Centers for Medicare and Medicaid Services, Federal Trade Commission, and other federal and state agencies. Ms Miller also has served as Regulatory Counsel for a major pharmaceutical firm. Ms. Miller holds a B.S. from the University of Tulsa, M.A from Ball State University, and a J.D. with high honors from the University of North Carolina School of Law.
Mr. Michael R. Minogue is the Chief Executive Officer, President and Chairman of Abiomed Inc. (NASDAQ: ABMD). Since joining in 2004, Mr. Minogue transitioned the company’s mission to heart muscle recovery with the acquisition and development of new technologies such as Impella®, the world’s smallest heart pump. During Mr. Minogue’s tenure, Abiomed has grown by 4,000 percent in market capitalization. The Company is one of the fastest growing, GAAP profitable medtech companies with no debt. Abiomed has earned over 30 global regulatory approvals on new products in the United States, Europe, Japan, China and other countries. Abiomed employs approximately 1,000 people with facilities in Danvers, Massachusetts, Aachen and Berlin, Germany and Tokyo, Japan. In 2017, Abiomed was ranked #4 on Fortune Magazine’s list of the top 100 fastest growing companies in the world.
In addition to his responsibilities at Abiomed, Mr. Minogue currently represents the medical device industry by serving on the executive board of directors for AdvaMed and as Chairman of the Medical Device Innovation Consortium (MDIC), a public-private partnership between industry, government and patient advocacy organizations. He was also recently appointed to Insulet Corporation’s Board of Directors and serves on the Board of Managers for Bioventus LLC.
Mr. Minogue is the Chairman of the Governor’s Advisory Council on Veterans’ Services for the Commonwealth of Massachusetts, and is the Co-Founder and Chairman of the Mentoring Veterans Program (MVP) (www.mvpvets.org), a 501(c)(3) nonprofit organization that helps military veterans network with industry mentors to discover career opportunities in the life sciences industries. Additionally, Mr. Minogue serves on a committee for the Massachusetts Catholic Schools Foundation and recently stepped down as Chairman of the Board of Directors for MassMEDIC after ten years of service. He formerly served on the board for LifeCell (LIFC) before it was acquired in 2008.
Before joining Abiomed, Mr. Minogue spent 11 years with General Electric Healthcare, where he held numerous leadership positions and developed expertise in sales, marketing, product development, information technologies and software/service operations around diagnostic imaging of cancer and cardiovascular disease. He holds three patents.
Mr. Minogue served as an Infantry officer in the U.S. Army, which included multiple distinctions including Airborne, RANGER, Desert Storm Veteran and Bronze Star. He received his Bachelor of Science degree in Engineering Management from the United States Military Academy at West Point and his Master of Business Administration from the University of Chicago.
Mr. Minogue is married with five children and enjoys reading, mentoring, running, coaching, skiing and playing sports.
Gregory F. Molnar, PhD | Associate Professor – Dept of Neurology, Director – Deep Brain Stimulation Research Program, Udall Center of Excellence PI, Chair – MnDRIVE Brain Conditions Industry Partnerships, Neurophysiologic Medical Staff, Industrial Fellow & Member, IEM, University of Minnesota School of Medicine, M Health, Fellow of the Medical Device Innovation Consortium, Medical Device Consultant
Dr. Greg Molnar has 20 years of experience as a medical device innovator and expertise in neuromodulation research. Dr. Molnar is an Associate Professor in the Department of Neurology at the University of Minnesota (UMN) and provides leadership to the clinical and preclinical research across the Deep Brain Stimulation (DBS) Research program. Greg is a Principal Investigator in the newly established UMN NIH Udall Center of Excellence for Parkinson’s Disease and Principal and Co-Investigator on several other NIH and Industry grants. Dr. Molnar trained as a clinical neuroscientist at the University of Toronto, where his research focused on the mechanism of action of DBS and neuromodulation to treat chronic pain and movement disorders. He also used several non-invasive neuromodulation techniques.
After his training, Greg was recruited to Medtronic where he served as the Director of Neuromodulation Research and led his team of scientists to advance our understanding of several therapies including DBS for Parkinson’s disease, Essential Tremor, Dystonia, and Epilepsy; Spinal Cord Stimulation to treat chronic pain; Sacral Nerve Stimulation for urinary incontinence; Gastric Stimulation for gastroparesis; and Intrathecal Drug Infusion to treat chronic pain and spasticity. He was very involved in business development and the commercialization process from concept, market assessment, reimbursement, regulatory science, and product development to voice of customer and sales force.
Dr. Molnar holds several patents and publications in the neuromodulation space and some of his inventions are benefiting patients today. He currently also serves as an Industrial Fellow and Member of the Institute of Engineering in Medicine, the Chair of the MnDRIVE Brain Conditions Industry Partnerships, Fellow of the Medical Device Innovation Consortium, and a consultant for various firms.
Bill 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. Bill’s 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. Bill has also served as interim President and CEO of MTS Systems (MTSC) a public $500M industrial technology company. Bill currently serves on the Boards of MDIC, ILT, Sonex Health and Meso-FLow and previously served on the Boards of MTS Systems, LifeSync Holdings, and ReShape Medical. Bill has also served on various industry association and community leadership boards. He earned a Bachelor of Science Degree in Electrical Engineering from The University of Florida.
Dr. Robin Newman joined FDA as Director, Office of Compliance at CDRH in February 2016. Prior to joining the agency, she engaged in 20+ years of senior level clinical/regulatory and compliance management in new product research and development. Dr. Newman’s experience includes senior level leadership for regulatory strategy, clinical trial design and execution, standards and SOP development, quality system creation and management, clinical affairs, medical writing, and education. Most recently, Dr. Newman served as the Vice President of Quality Management for Siemens Healthcare Diagnostics, managing a global multidisciplinary team of quality, regulatory, and clinical affairs professionals and functioning as the primary company representative to AdvaMedDx and a variety of industry working groups.
She holds a B.S. and M.S. in Nursing from the University of Texas, and an Ed.D. from The George Washington University’s Executive Leadership Program. Dr. Newman also holds certifications as a Pediatric Nurse Practitioner (CPNP – PNCB), in regulatory affairs (RAC -RAPS), and as a clinical research associate (CCRA – ACRP).
Luann Pendy, Ph.D., is the Senior Vice President of Global Quality. In this role, Luann oversees all global quality operations for the company and is a member of the Medtronic Executive Committee. She partners with the business groups and global regions to assure end-to-end quality, reliability and regulatory compliance, from development through manufacturing, distribution and end-customer use. She is responsible for driving the strategic direction for the quality program through the implementation of policy and standards across Medtronic. She joined Medtronic in 2008 as the Vice President of Corporate Quality.
In 2014, Luann received the “Women in Energy” award from the Women’s Leadership Group in Advanced Energy, part of the Medtronic Restorative Therapies Group. In 2015, she was named by the National Diversity Council as one of the Top 50 Most Powerful Women in Technology, which is a definitive list of female executives, influencers and achievers impacting the technology industry.
Prior to Medtronic, Luann served as Corporate Vice President of Global Quality and Regulatory Affairs at Hospira, Inc. In that role, she led worldwide quality and regulatory affairs for the design and manufacturing of medical devices and pharmaceuticals. Previously, Luann spent 17 years at Abbott Laboratories, where she held several leadership roles in technical product development and quality for the diagnostics, devices and pharmaceutical business divisions.
Luann is the Executive Sponsor of the Medtronic Women’s Network Minnesota Hub. She is a member of the Leadership Council on Advancing Women, The Conference Board. She also serves on the Science Museum of Minnesota’s Board of Trustees.
Luann received her Bachelor of Science degree from the University of Michigan and her Doctorate of Philosophy in Immunology from Rush University in Chicago, Illinois.
Anindita (Annie) Saha is the Director of External Expertise and Partnerships (EEP) in the FDA’s Center for Devices and Radiological Health (CDRH). Ms. Saha leads CDRH’s Patient Preference Initiative to incorporate patient perspectives on benefits and risk in regulatory decision-making. She is also helps coordinate CDRH’s larger Strategic Priority to Partner with Patients to incorporate patient engagement and the science of patient input in device design, assessment, and review. EEP also develops and manages CDRH’s external collaborations and partnerships including the Network of Experts program, public-private partnerships including the Medical Device Innovation Consortium (MDIC), fellowship programs including the Medical Device Fellowship and AIMBE Scholars programs, and technology transfer and collaboration efforts for the Center. EEP directs and coordinates CDRH’s Regulatory Science and Critical Path programs to facilitate research to promote the development and assessment of high quality, safe, and effective medical devices. Ms. Saha began her FDA career as a researcher in the CDRH’s Office of Science and Engineering Laboratories in the Division of Imaging and Applied Mathematics in the area of imaging display technologies before moving to EEP to coordinate Critical Path and Regulatory Science activities for the Center. Ms. Saha has a Bachelor of Science in Bioengineering and Minor in History from the University of Pittsburgh. She was a student researcher at the McGowan Institute for Regenerative Medicine working in tissue engineering and wound healing.
Randall (Randy) Schiestl, PMP, is the Vice President of Global Technology at Boston Scientific, where he leads a team to deliver computational analysis, technology roadmapping, product design, packaging & labeling, knowledge management, and lab & test services. Randy’s latest role is building Global Technical Community and Capability across the global corporation. He has BSME, MBA and Executive MBA degrees from the University of Minnesota.
Randy serves on multiple local and national industry advisory boards and consortiums including the Medical Devices Industry Consortium, the Medical Industry Leadership Institute, Heart Advisory Committee, AHA Twin Cities Board, Medical Alley, FIRST Robotics Executive Committee and UMN Biomedical, Medical Device Center, Nanotechnology and Institute for Engineering in Medicine IABs. Randy received the UMAA Alumni Service Award from the College of Science & Engineering in 2011 and the Design of Medical Device Conference Award in 2012.
Margaret Sheehan, a partner at the global law firm Ashurst LLP, is a 25-year veteran of practicing law in the financial services industry, with a specialized focus on investment management and securities. She is the co-author of a book on the regulation of broker-dealers and a frequent speaker on issues facing the securities industry. Diagnosed with Parkinson’s in 2004 at the age of 44, Margaret began participating in clinical trials and educating the broader Parkinson’s community on the trial participant process.
Margaret underwent DBS surgery in 2014. She believes that the key to finding better treatments and a cure lies in gathering and capturing as much information from as many people with Parkinson’s as possible.
Margaret received her undergraduate degree in political science from Duke University and her law degree from Georgetown University. Her interests include gardening, skiing and tennis, and she is an avid baseball and football fan.
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.
Don St.Pierre graduated from Penn State University with a BS in Engineering. He came to CDRH’s Office of Device Evaluation (ODE) in January 1990. At ODE, he worked in various divisions – starting as a reviewer followed by Branch Chief and then Deputy Division Director. In November 2002, he became the Deputy Office Director for New Product Evaluation in the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) that was later reorganized into the Office of In Vitro Diagnostics and Radiological Health (OIR). Beginning October 2017, he assumes the role of Acting OIR Director.
Sandra Statz, MS, is VP of Clinical and Regulatory Affairs at Exact Sciences. Her key responsibilities include developing and executing comprehensive regulatory and clinical strategies, and maintaining regulatory compliance for all commercialized products. Sandra has extensive experience in clinical protocol development and clinical trial management, has supported the development of several IVD products, and led the first industry team through the pilot parallel review process resulting in simultaneous FDA approval and an NCD from CMS. Sandra also has significant experience in phase 1-3 clinical trials for oncology therapeutics and biologicals. Prior to joining Exact Sciences, she worked for Quintiles and Third Wave Technologies (now part of Hologic).
Beth joined Stryker in 1989 as Quality Assurance Manager for the Orthopedics Division, and has held a series of roles in Quality, Regulatory, Clinical and Operations. In 1999, she was promoted to VP of Quality, Regulatory and Clinical Research for the newly formed Howmedica Osteonics Corporation, and in 2007 was appointed VP, RAQA for Stryker Corporation, responsible for the oversight of Stryker’s quality systems, post market surveillance, product registrations, and market access activities. In January 2017, she moved to her current role of Compliance Officer for Stryker’s Global Quality and Operation.
Prior to joining Stryker, Beth was Quality Assurance Manager for MicroScan, an In-Vitro Diagnostic Division of Baxter Healthcare with locations in California and New Jersey. Beth holds a BS in Medical Technology from York College of Pennsylvania, and is a member or ASQ and RAPS.
April Veoukas, JD, is Director, Regulatory Affairs in Abbott Quality & Regulatory. During her more than twenty-five years at Abbott, she has held positions in regulatory affairs, technology acquisitions, and research and development. In her current position, she represents Abbott in industry associations, is responsible for regulatory intelligence, and formulates company responses to proposed regulatory policies.
April earned a juris doctorate from DePaul University College of Law and a bachelor of science in biology magna cum laude from Loyola University of Chicago. She holds a Certificate in Health Law from DePaul University College of Law. April is a member of the Regulatory Affairs Professional Society (RAPS), the industry co-chair of the AdvaMed 510(k) Working Group, a member of the MDIC Clinical Diagnostics Steering Committee, Chair of the MDIC Surrogate Samples Work Group, and a former industry representative on FDA’s Medical Devices Dispute Resolution panel advisory committee.
Scott Whitaker is president and CEO of AdvaMed, the world’s largest medical technology association. AdvaMed members make the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments, to help people live longer, healthier lives. AdvaMed members range from the largest to the smallest medical technology innovators and companies.
As CEO of AdvaMed, Whitaker is the voice of the medical technology industry. He is widely recognized as a top health care advocate and policy expert with experience across multiple health policy sectors, having worked successfully with diverse stakeholder groups – including hospital, patient and physician groups, regulators, public and private payers, and global trade organizations – to advance medical technology innovation and timely patient access to next-generation treatments and cures.
Prior to AdvaMed, Whitaker was chief operating officer of the Biotechnology Innovation Organization (BIO), the world’s largest trade association representing biotechnology companies, and president of the BIO International Convention, the world’s largest biotech conference. Having served as COO of BIO since 2005, Whitaker brings a deep knowledge of the medical technology innovation ecosystem, a wealth of health care advocacy expertise, and strong working relationships with patient groups and other industry stakeholders.
Whitaker also previously served as chief of staff of the U.S. Department of Health & Human Services (HHS) – a cabinet agency with 67,000 employees and a budget of $550 billion – from 2003 to 2005. As HHS chief of staff, Whitaker managed the day-to-day operations of the department; led the department’s activities on all major policy and management issues and initiatives; and served as the top liaison to the White House on policy, management and political matters. He also served as assistant secretary for legislation at HHS from 2001 to 2003. Whitaker began his Washington career on Capitol Hill, where he worked for U.S. Senator Don Nickles (R-Okla.).
Whitaker holds a master’s degree in government from Johns Hopkins University and a degree in political science from Palm Beach Atlantic University.
Jeff Zinza is the Senior Manager of Regulatory Affairs for the Diagnostic Solutions Division of Hologic, Inc. In this role, he leads the team responsible for development and execution of global premarket regulatory strategies for medical devices and IVD products.
Jeff has over 15 years’ experience in the healthcare, molecular diagnostics, veterinary biologics and life sciences industries. Jeff joined Hologic as part of the acquisition of Gen-Probe in 2012. Prior to Hologic, he was the regulatory lead for veterinary and food/environmental diagnostic products, as well as forensic products manufactured by Life Technologies Corporation.
Jeff holds a bachelor’s degree in Cell and Molecular Biology from San Diego State University, and the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.