Dawn Bardot, PhD | Vice President, Technology Innovation, MDIC
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.
Marc Boutin, JD | CEO, National Health Council
Marc Boutin is the chief executive officer of the National Health Council, the only organization that brings together all segments of the health community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers.
Boutin has been a leading voice for greater patient involvement at every stage of the continuum, starting with the development of new drugs, to regulatory oversight of health care delivery, to shared decision-making at the point of care. Under his leadership, the NHC has convened a broad range of stakeholders to create and effectively implement pragmatic strategies and public policy that address diverse issues, such as enhancing patient engagement, advancing the development of new treatments, and developing a better health delivery system to meet the needs of people with chronic conditions.
Robert Califf, MD | Commissioner, FDA
Robert M. Califf, MD, MACC, is the Food and Drug Administration’s commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.
Previously, Dr. Califf served as the FDA’s Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as commissioner in February 2016. In that capacity, he provided executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He also oversaw the Office of Special Medical Programs and provided direction for cross-cutting clinical, scientific, and regulatory initiatives, including precision medicine, combination products, orphan drugs, pediatric therapeutics, and the advisory committee system.
Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.
Dr. Califf has served on the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market, as well as on the IOM Committee on Identifying and Preventing Medication Errors and the IOM Health Sciences Policy Board. He has served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Institutes of Health and the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging.
While at Duke, Dr. Califf led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke’s Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center.
Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke.
Kelly Close | President, Close Concerns, Founder, The diatribe Foundation
Kelly Close founded Close Concerns in 2002, a healthcare information company focused exclusively on diabetes and obesity. At Close Concerns, Kelly and her team write approximately five million words each year on diabetes, obesity, and digital health. Kelly’s passion for the field comes from her extensive professional work as well as from her personal experience, having had diabetes for nearly 30 years. Kelly is the author of over 20 peer-reviewed manuscripts as well as “Targeting A Cure for Type 1 Diabetes: How Long Do We Have to Wait?” a widely-praised book published by the ADA in 2013. Kelly is on the editorial board of Clinical Diabetes, a journal focused on diabetes for primary care physicians published quarterly by the ADA. Close Concerns won the ADA’s “Excellence in Health Communications” Award in 2012 and Kelly and her team write a quarterly column in Journal of Diabetes, a peer-reviewed journal based in Shanghai.
Kelly is founder and Editor-in-Chief of diaTribe, founded in 2006 as an educational resource for people with diabetes. She also chairs The diaTribe Foundation, a nonprofit established in 2012 to improve the lives of people with diabetes and pre-diabetes and to advocate for action. Before starting Close Concerns and the diaTribe Foundation, Kelly’s work focused on life sciences more broadly. Over nearly a dozen years, she worked on Wall Street (investment banking at Goldman Sachs, medical technology equity research at Merrill Lynch and Piper Jaffray) and at McKinsey & Company, where her work centered on pharmaceutical, managed care, and nonprofit organizations.
Kelly has a BA in Economics and English from Amherst College and an MBA from Harvard Business School. She was a founding board member of the Institute for Responsible Nutrition, led by Dr. Robert Lustig, and a previous executive board member of the Diabetes Hands Foundation and the Behavioral Diabetes Institute. She and husband John are co-hosts of the popular discussion series CPS Lectures. They live in San Francisco with their three children.
Owen Faris, PhD | Clinical Trials Director, Office of Device Evaluatio, CDRH FDA
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 new Expedited Access Program.
Lisa Griffin Vincent, MA, PhD | Vice President Corporate Development, Medical Affairs Office of Science, Medicine and Technology, BD
Lisa Griffin Vincent, MA, PhD is Worldwide VP Corporate Clinical Development, Medical Affairs in the Office of Medicine and Technology at BD where she leads the clinical research center of excellence for all products and solutions. Prior to BD, Dr. Vincent served as president of Outcomes Research Solutions and Chief Regulatory Officer for PatientPoint, a healthcare technology firm driving patient engagement, care coordination and population health management for healthcare practices and delivery systems. Vincent spent over eight years at Medtronic in positions of increasing responsibility including, VP Global Clinical and Medical Affairs, Spinal and Biologics Division, and four years at UnitedHealth Group on the leadership team integrating multiple organizations and services crossing clinical research, epidemiology, medical education, and health economics. She developed a foundation of clinical excellence and healthcare proficiency through an early career in nursing and research at the University of Minnesota, Allina Health, and University of Pennsylvania. Vincent holds a doctorate of Health Services Research and Policy, a master of arts in Kinesiology and a bachelor of science in Nursing, all from the University of Minnesota.
Alberto Gutierrez, PhD | Director, Office of In Vitro Diagnostic Device Evaluation and Safety, FDA
Alberto Gutierrez, Ph.D., is the Director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety. Dr. Gutierrez received a bachelor’s degree from Haverford College, and master and doctorate degrees in Chemistry from Princeton University. Dr. Gutierrez has over 10 years of experience in research in the area of structural organic and organometallic chemistry. Dr. Gutierrez joined the FDA in 1992 as researcher and reviewer in FDA’s Center for Biologics Evaluation and Research working on vaccine adjuvants and method development for determination of purity and structure of vaccine components. In 2000, he joined the Office of In Vitro Diagnostic Device Evaluation and Safety as a scientific reviewer, becoming a Team leader for Toxicology in 2003, Director of the Division of Chemistry and Toxicology Devices in 2005 and Deputy Director of the Office of In Vitro Diagnostic Devices in 2007 and Director in 2009.
Tarek Haddad | Sr. Manager, Modeling Integration and Statistics, Medtronic Cardiac Rhythm and Heart Failure
Tarek Haddad is a Technical Fellow and Senior Manager of the Modeling Integration and Statistics groups at Medtronic. Tarek’s area of focus is on developing computational and stochastic models for improving the predictability of product reliability and efficacy, as well as improving the efficiency of clinical trials. He specializes in Bayesian modeling and has numerous publications in these areas. He chairs the MDIC working group on “clinical trials informed by simulation and bench”. He holds a Master’s degree in Biostatistics and a BA in Mathematics both from the University of Minnesota and has a Master Black Belt in Design for Six Sigma & Design for Reliability and Manufacturing.
Chip Hance | Former CEO, Creganna Medical
Chip Hance is the former CEO of Creganna Medical, an Ireland based supplier to the minimally invasive medical device industry. With more than 2,000 employees in six locations (Ireland, Minnesota, Northern California, Portland, Costa Rica and Singapore), Creganna focuses on manufacturing and design of delivery system components and subassemblies for OEM manufacturers in interventional cardiology, structural heart, peripheral vascular, electrophysiology, endoscopy and other minimally invasive fields. Creganna Medical was sold to TE Connectivity, a large industrial manufacturer, in 2016.
In 2012-13, Hance was an Entrepreneur-in-Residence at CDRH within the FDA. 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 to global leadership in the drug-eluting stent market through the launch of Xience in the U.S., Japan and China. Hance also led the development and CE marking of Absorb, a bioabsorbable scaffold for the treatment of coronary disease and the acquisition and international expansion of Mitraclip, a percutaneous mitral valve repair device.
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.
Ross A. Jaffe, MD | Managing Director, Versant Ventures
Ross Jaffe is a venture capitalist who focuses on early-stage investing in medical technology. Ross is a Managing Director of Versant Ventures, a firm he co-founded in 1999 after spending nine years at Brentwood Venture Capital where, as a general partner, he led investments in medical devices, drug delivery, and healthcare information systems companies.
During more than twenty five years in venture capital, Ross has served on the boards of a number of successful life science companies, including Acclarent, St Francis Medical Technologies, Ablation Frontiers, Insulet, Therasense, MicroInterventional Systems, Webster Laboratories, and Novacept. He currently serves on the boards of Alter-G, Cerephex, and Minerva Surgical. Ross has been recognized on Forbes Magazine’s “Midas List” of the top 100 venture capitalists in 2008, 2011, and 2012.
Active in the healthcare venture capital community, Ross has served as a Director of the National Venture Capital Association (NVCA) and of the Western Association of Venture Capitalists (WAVC). He is currently a Director of the Medical Device Innovation Consortium (MDIC), an FDA-industry collaboration to advance regulatory science, where he is the Board Champion for the Patient Centered Benefit-Risk Project. Ross also chairs the Board of Overseers of the Geisel School of Medicine at Dartmouth.
Ross is trained as an internal medicine physician, having completed his residency at the University of California, San Francisco, where he remained a part-time physician until 1995. He earned his BA in Policy Studies from Dartmouth in 1980, his MD from Johns Hopkins in 1985, and his MBA from Stanford in 1990
Rick Kuntz, MD, MSc | Senior Vice President and Chief Scientific, Clinical and Regulatory Officer, Medtronic
Dr. Rick Kuntz is Senior Vice President and Chief Scientific, Clinical and Regulatory Officer of Medtronic, Inc. In this role, which he assumed in August 2009, Kuntz oversees the company’s global regulatory affairs, health policy and reimbursement, clinical research activities, ventures and new therapies, strategy and innovation, corporate development, and acquisitions, integrations and divestitures functions.
Kuntz joined Medtronic in October 2005 as Senior Vice President and President of Medtronic Neuromodulation, which encompasses the company’s products and therapies used in the treatment of chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis. In this role he was responsible for the research, development, operations and product sales and marketing for each of these therapeutic areas worldwide.
Kuntz brings to Medtronic a broad background and expertise in many different areas of healthcare. Prior to Medtronic he was the Founder and Chief Scientific Officer of the Harvard Clinical Research Institute (HCRI), a university-based contract research organization which coordinates National Institutes of Health (NIH) and industry clinical trials with the United States Food and Drug Administration (FDA). Kuntz has directed over 100 multicenter clinical trials and has authored more than 200 original publications. His major interests are traditional and alternative clinical trial design and biostatistics.
Kuntz also served as Associate Professor of Medicine at Harvard Medical School, Chief of the Division of Clinical Biometrics, and an interventional cardiologist in the division of cardiovascular diseases at the Brigham and Women’s Hospital in Boston, MA.
Kuntz graduated from Miami University, and received his medical degree from Case Western Reserve University School of Medicine. He completed his residency in internal medicine at the University of Texas Southwestern Medical School, and then completed fellowships in cardiovascular diseases and interventional cardiology at the Beth Israel Hospital and Harvard Medical School, Boston. Kuntz received his master’s of science in biostatistics from the Harvard School of Public Health.
Mark B. McClellan, MD, PhD | Director, Duke-Robert J. Margolis, MD, Center for Health Policy and Robert J. Margolis, MD Professor of Business, Medicine and Health Policy, Fuqua School of Business, Duke University
Mark McClellan, MD, PhD, is the Robert J. Margolis Professor of Business, Medicine, and Policy, and Director of the DukeMargolis Center for Health Policy at Duke University with offices at Duke and in Washington DC. Dr. McClellan is a doctor and an economist, and his work has addressed a wide range of strategies and policy reforms to improve health care, including payment reforms to promote better outcomes and lower costs, methods for development and use of real-world evidence, and approaches for more effective drug and device innovation. Dr. McClellan is a former administrator of the Centers for Medicare & Medicaid Services (CMS) and former commissioner of the U.S. Food and Drug Administration (FDA), where he developed and implemented major reforms in health policy. He was also a Senior Fellow at the Brookings Institution and a professor of economics and medicine at Stanford University.
Michelle McMurry-Heath, MD, PhD | Vice President & Global Head of Regulatory Affairs, Medical Devices, Johnson & Johnson
Michelle 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, Michelle 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, she 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.
Prior to the FDA, Michelle was founding director of the Health, Biomedical Science and Society Initiative at the Aspen Institute. She has been a MacArthur Fellow at the Council on Foreign Relations and a Robert Wood Johnson Foundation Health and Society Scholar focused on biomedical innovation. Michelle previously served as Senator Joseph Lieberman’s senior health policy legislative assistant from 2001-04 and served on President Obama’s transition team for the National Science Foundation.
Michelle holds a joint M.D./Ph.D. degree from Duke University School of Medicine and completed her undergraduate training at Harvard University in biochemistry.
Mike R. Minogue | President, CEO, and Chairman, Abiomed; Board Chairman, MDIC
Mr. Michael R. Minogue is the Chief Executive Officer, President and Chairman of Abiomed Inc. (NASDAQ: ABMD). Since joining in April 2004, Mr. Minogue changed the corporate strategy and mission to creating breakthrough heart support technologies for patients to enable more complete minimally invasive procedures, heart muscle recovery and cost-effective patient care. To achieve this goal, Abiomed acquired and developed new technology such as the Impella, Symphony, recovery VADs and other heart support concepts. The Impella platform is based on the world’s smallest heart pumps which can be inserted percutaneously through a small hole in the leg.
During Mr. Minogue’s tenure, Abiomed has grown more than five times in revenue and market capitalization and become GAAP profitable with no debt. Pertaining to product development, Abiomed has earned greater than 15 regulatory approvals on new products related to the CE Mark, 510(k), PMA and HDE. Prior to joining Abiomed, Mr. Minogue completed a successful 11 year career at GE Healthcare. He departed GE as the Vice President of Americas Sales and Marketing for the $1B Information Technology business. At GE, Mr. Minogue held various leadership positions in sales, marketing, service, product engineering and software development. The experience includes the diagnostics of diseases from cancer to heart failure and in various technologies such as MRI, CT, PET, X-ray, Cardiology, and Information Technology and Monitoring.
Prior to Abiomed and GE, Mr. Minogue served as an infantry officer in the U.S. Army for four years and eight years Individual Ready Reserve, which included multiple distinctions including Airborne, RANGER, Combat and Expert Infantryman’s badge, 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 MBA from the University of Chicago. Mr. Minogue holds three patents, currently serves on the executive board of directors for AdvaMed, was formerly on the board for LifeCell Corporation (LIFC), and provides personal support for organizations helping military veterans and wounded warriors.
Bill Murray | President & CEO, MDIC
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.
Kyle Myers, PhD | Acting Director, Office of Science and Engineering Laboratories, CDRH FDA
Kyle J. Myers, Ph.D., received bachelor’s degrees in Mathematics and Physics from Occidental College in 1980 and a Ph.D. in Optical Sciences from the University of Arizona in 1985. Following a post-doctoral fellowship at the University of Arizona, she worked in the research labs of Corning Inc. Since 1987 she has worked for the Center for Devices and Radiological Health of the FDA, where she is currently the Acting Director of CDRH’s Office of Science and Engineering Laboratories (OSEL), a position she has held since October of 2015. She was previously the director for OSEL’s Division of Imaging, Diagnostics, and Software Reliability, where she led research programs in medical imaging systems and software tools, including 3D breast imaging systems and CT devices, digital pathology systems, medical display devices, computer-aided diagnostics, biomarkers, and assessment strategies for imaging and other high-dimensional data set medical devices. She holds adjunct faculty positions at the University of Arizona and Georgetown University. She is the FDA Principal Investigator for the Computational Modeling and Simulation Project of the Medical Device Innovation Consortium. She is an associate editor for the Journal of Medical Imaging and Medical Physics. Dr. Myers is a Fellow of the OSA, SPIE, and AIMBE and a member of the National Academy of Engineering.
Richard Naples | Executive Vice President and Chief Regulatory Officer, BD
As Executive Vice President and Chief Regulatory Officer, Rick Naples is responsible for global market access, market development and regulatory compliance functions. This includes regulatory market authorization, postmarket compliance, public policy and reimbursement. Rick has been with BD for a total of ten years.
Overall, Mr. Naples has over 30 years of experience in the medical technology industry. Rick and his team have lead over 300 successful FDA regulatory submissions. He has also driven numerous industry-wide initiatives to shape healthcare policy to ensure more timely patient access to safe and innovative new technologies. He currently serves on the Board for the Medical Device Innovation Consortium (MDIC). MDIC is the first public-private partnership with FDA to advance regulatory science in order to speed time to market for new medical technology. For the last several years, he chaired the AdvaMed Diagnostics Task Force and has been recognized by the trade press as one of the top regulatory professionals in the industry.
Prior to joining BD, Rick was Roche Diagnostics VP of Regulatory and Government Affairs after serving as a Consumer Safety Officer at FDA HQ Center for Biologics, Evaluation and Research (CBER). He has also served on the boards of the New England Healthcare Institute (NEHI) and the Indiana Medical Device Manufacturers Council (IMDMC).
Rick holds a Bachelor of Science degree in Chemistry/Medical Technology from Youngstown State University (Ohio).
Robin Newman, MSN, EdD | Director, Office of Compliance, CDRH FDA
Ms. Newman’s background includes 20+ years of senior level clinical/regulatory and compliance management in new product research and development. She’s served as a senior level consultant for regulatory strategy, clinical trial design and execution, standards and SOP development, quality system management and compliance, clinical & medical writing, customer/public interface and education, and management of Data Safety Monitoring Boards and Clinical Event Adjudication Committees.
Most recently, Ms. Newman served as the Vice President of Quality Management for Siemens Healthcare Diagnostics, where she managed a multidisciplinary quality management team, overseeing GMP and ISO compliance, GCP compliance and clinical trial development, quality engineering and risk management, auditing and compliance, personnel development, and OUS product registrations and regulatory support. She was a member of the Siemens global regulatory affairs team for new regulations/standards, reimbursement and government affairs, and a primary representative for AdvaMedDx and the Diagnostic Tests Working Group.
Ms. Newman holds a B.S. and M.S. in Nursing from the University of Texas and an Ed.D. from George Washington University’s Executive Leadership Program and is a Certified Pediatric Nurse Practitioner, a member of RAPS and ACRP.
Kathryn O’Callaghan | Assistant Director for Strategic Programs (Acting), CDRH FDA
Kathryn O’Callaghan is Assistant Director for Strategic Programs (Acting) at FDA’s Center for Devices and Radiological Health (CDRH). Katie oversees a broad program portfolio at CDRH, with teams supporting a number of strategic partnership and regulatory science programs. Her focus is on directing the Center’s 2016-2017 Strategic Priority of Partnering with Patients. This work aims to promote a culture of meaningful patient engagement between patients and CDRH’s employees, and to increase use and transparency of patient input as evidence in regulatory decision-making. Execution impacts ~1700 employees and dozens of programs and policies across eight organizational departments. Katie is dedicated to building productive partnerships and promoting availability of usable information to reduce healthcare disparities and to drive more patient-centric medical product innovation, evaluation and access. Katie is a biomedical engineer by training and worked in MedTech industry prior to her 11+ years at FDA.
Sally Okun, RN, MMHS | Vice President Advocacy, Policy and Patient Safety, PatientsLikeMe
Sally Okun is the Vice President for Advocacy, Policy and Patient Safety at PatientsLikeMe, an online patient powered research network. She is responsible for bringing patient voice and insight to diverse advocacy and health policy discussions at the national and global level, and is the company’s liaison with government and regulatory agencies. Sally joined the company in 2008 as the manager of Health Data Integrity and Patient Safety overseeing the site’s medical ontology and the development of the PatientsLikeMe Drug Safety and Pharmacovigilance Platform. She is a member of the PCORI Patient Engagement Advisory Panel, the Scientific Advisory Committee for Reagan-Udall Foundation’s IMEDS program and numerous expert panels for the Institute of Medicine, the National Quality Forum, Agency for Health Care Research and Quality, The Commonwealth Fund, and others. Okun, a Registered Nurse and palliative care specialist, received her Master’s degree from The Heller School for Social Policy & Management at Brandeis University, was a 2010 fellow at the National Library of Medicine Program in Biomedical Informatics and a 2014 Salzburg Global Fellow.
Peter Saltonstall | President & CEO, National Organization for Rare Disorders (NORD)
Peter L. Saltonstall is the President and CEO of the National Organization for Rare Disorders (NORD). He joined NORD in 2008 after having served for more than 30 years as a senior official in both for-profit and not-for-profit healthcare environments.
Under his leadership, NORD has forged new relationships between the patient community and the Congress, FDA, NIH and Social Security Administration, as well as with drug/device companies and the medical/academic and investment communities. His efforts to build collaborations stems from his view that advances for the rare disease patient can be achieved best through joint efforts. Peter is also committed to globalization of the rare disease patient community, as diseases do not recognize geographical boundaries and research can be expedited when patients from many countries are involved. He has established collaborative programs with patient communities in Europe and Japan.
Under Peter’s leadership, NORD also has updated and expanded its Patient Assistance Programs, which include assistance to patients in need of medications that they cannot afford; and has recommitted to facilitate research into new therapies and assure access by patients.
Randy Schiestl, PMP | Vice President, Global Technology, Boston Scientific Corporation
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 across the corporation. He has BSME, MBA and Executive MBA degrees from the University of Minnesota. 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.
Suzanne Schrandt, JD | Director of Patient Engagement, Arthritis Foundation
Suz Schrandt recently joined the Arthritis Foundation as their Director of Patient Engagement. In this role she will develop and lead the Foundation’s Patient Engagement strategy, working to infuse the wisdom and lived experience of patients into clinical research, drug and device development, and many other aspects of the healthcare system. Schrandt previously served as the Deputy Director of Patient Engagement for the Patient-Centered Outcomes Research Institute (PCORI). During her tenure with PCORI, she helped to launch several key PCORI efforts including the creation of the Engagement Rubric and the Engagement Officer role, the Advisory Panel on Patient Engagement, the Pipeline to Proposal Awards initiative, the PCORI Ambassadors Program, and the Framework on Compensation (for Patient Partners in Research).
Schrandt’s passion for patient engagement comes in large part from her own diagnosis with a rheumatic disease at age 14. Since that time, she has been involved with myriad patient and clinician education and advocacy initiatives. She serves as a Curriculum Steering Committee Member and Patient Spokesperson for the Rheumatoid Arthritis: Primary care initiative for Improved Diagnosis and outcomes (RAPID) continuing medical education program, and has been a Patient Instructor with the Patient Partners Program at the University of Kansas School of Medicine since 1995.
Schrandt’s prior posts include Health Reform Team Leader for the Kansas Health Institute, Public Health and Public Policy Coordinator for the Arthritis Foundation Western Missouri/Greater Kansas City Chapter, and Research Associate for the Beach Center on Disability, primarily tasked with an ELSI grant through the National Human Genome Research Institute. She received her law degree from the University of Kansas School of Law and is a member of the American Health Lawyers Association, the Kansas Bar Association, and Professional Responsibility in Medicine & Research.
Dan Schwartz | Program Manager, ACTP MDIC
Dan brings award-winning knowledge and experience spanning twelve years implementing strategic healthcare solutions addressing care delivery, research, therapy adherence and process improvements. Specific successes include: leveraging research methods and Health Information Technology (HIT) to identify and implement best practices for clinical research, care communication, therapy adherence and outcomes; automating clinical trial subject adverse event (AE) notifications and therapy adherence; and establishing the North American clinical research division for an international medical product company. Dan previously managed an integrated health economic outcomes research (HEOR) joint venture between a public university, a community hospital, and a private practice, and held voting member roles on (1) a State-wide commission for anatomical tissue donation, and (2) a community hospital’s Institutional Review Board (IRB).
Dan is pursuing a Master of Science in Health Economics at Johns Hopkins University and completed undergraduate degrees in Genetics and Cell Development from the University of Minnesota and Political Science from Saint John’s University. He spent one year interning as a research assistant in the University of Minnesota’s Stem Cell Institute. In addition, Dan holds certifications as a Six Sigma Green Belt through the Project Management Institute (PMI), and as a Certified Scrum Product Owner (CSPO) through the Scrum Alliance.
Suzanne Schwartz, MD | Associate Director for Science and Strategic Partnerships, CDRH FDA
Suzanne Schwartz, MD, MBA is the Associate Director for Science & Strategic Partnerships at FDA’s Center for Devices & Radiological Health (CDRH). In this role, she assists the CDRH Director and Deputy Director for Science in the development, execution and evaluation of the Center’s biomedical science and engineering programs. Suzanne is passionate about cultivating critical dialogue across sectors and across entities towards advancing innovation in the biomedical space and within healthcare, where complex multifaceted problems exist. In this capacity, she is especially delighted to engage with the Medical Device Innovation Consortium (MDIC).
Suzanne joined FDA in October 2010. Initially recruited as a Commissioner’s Fellow, she became a Medical Officer in the Office of Device Evaluation, transitioning in September 2012 to become the Director of CDRH’s Emergency Preparedness/Operations and Medical Countermeasures (EMCM) Program in the Office of the Center Director for the past 4 years. Among other public health concerns, her portfolio has most notably included medical device cybersecurity, for which she chairs CDRH’s Cybersecurity Working Group. She also co-chairs the Government Coordinating Council for Healthcare & Public Health critical infrastructure sector.
Before FDA, Suzanne was a full time surgical faculty member at Weill Cornell Medical College, New York, engaged in clinical outcomes & translational research related to burn trauma & wound repair, particularly the impaired healing state associated with diabetes. Suzanne’s career has spanned the private sector as well, having served as Medical Director & Tissue Bank Director of Ortec International, a development stage medical device company focused on tissue engineering therapeutic approaches to burns and chronic wounds.
Suzanne earned an MD from Albert Einstein College of Medicine, trained in General Surgery & Burn Trauma at the New York Presbyterian Hospital – Weill Cornell Medical Center; an executive MBA from NYU Stern School of Business, and completed the National Preparedness Leadership Initiative – Harvard School of Public Health & Kennedy School of Government.
Jeff Shuren, MD, JD | Director, CDRH FDA
Jeff is a neurologist and attorney, currently serving as the Director of the FDA’s Center for Devices and Radiological Health. He’s been at CDRH since the Fall of 2009. Prior to that he held several policy positions in the agency, including acting Deputy Commissioner for Policy, Planning, and Budget, special counsel to the Principal Deputy Commissioner, and Associate Commissioner for Policy and Planning. Jeff has served as a division director in the Center for Medicare and Medicaid Services’ Coverage and Analysis Group, a staff fellow in the National Institutes of Health’s Cognitive Neuroscience Section, was on detail to Senator Ted Kennedy, and an Assistant Professor in the University of Cincinnati’s Department of Neurology.
Beth Staub | VP Corporate Regulatory Affairs and Quality Assurance, Stryker
Beth Staub is the Corporate Head of Regulatory Affairs and Quality Assurance for Stryker Corporation, which designs and manufactures medical devices used in the Orthopedic, MedSurg, Neurotechnology and Spine sectors. 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. Following Stryker’s acquisition of Howmedica Corporation in 1999, she was promoted to VP of Quality, Regulatory and Clinical Research for the newly formed Howmedica Osteonics Corporation. In 2007, she assumed her current role of VP, Corporate RAQA for Stryker Corporation, where she is responsible for the oversight of Stryker’s quality system, post-market surveillance, and market access activities worldwide. Beth was elected a Stryker Corporate Officer in 2009. She is a member of the Medical Device Innovation Consortium (MDIC) Board of Directors and the Case for Quality Steering Committee.
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.
Roseann White | Director of Pragmatic Clinical Trial Statistics, Duke Clinical Research Institute
With her MA in Statistics from UC Berkeley, Roseann White has been working worked in R&D, preclinical clinical, quality and manufacturing as biostatistician, manager and executive. She has appeared as the Subject Matter Expert for the sponsor for four FDA panels and numerous industry conferences, and has been involved in the use of surrogate endpoints, adaptive designs and Bayesian applications in clinical trials. Currently, she is the Director of Pragmatic Clinical Trial Statistics at Duke Clinical Research Institute in Durham, North Carolina.