With more than 15 years’ experience in computational model validation and uncertainty quantification, Dawn Bardot, PhD, brings a wealth experience to her role as Senior Program Manager, Modeling and Simulation at MDIC. She is passionate about the application of modeling and simulation 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 computer simulations and validation, 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 commandeered associated teams.
Most recently, she served as Director for Verification Validation & Test and Manager for Biomedical Testing with HeartFlow, Inc., in Redwood City, Calif., directing a team of software, mechanical, biomedical engineers, physicians and scientists to test and evaluate a software medical device utilizing high-performance computing as a web-based service for non-invasive evaluation of blood flow in coronary arteries.
Previous professional endeavors include: Assistant Professor in Mechanical & Aerospace Engineering at the University of Alabama/Huntsville; Senior Medical Devices Senior Innovation Fellow at the University of Minnesota/Minneapolis; Bio-Research Engineer with both Acoustx Corp. and Therus Corp.; and Mechanical Engineering Analyst with the Boeing Co.
Bardot holds a number of patents and pending applications, has been published in countless industry and educational journals, and is called upon to regularly address conferences and seminars. She is an active member of the American Society of Mechanical Engineers (ASME); serves as Vice Chair of the Verification and Validation in Computation Fluid Dynamics and Heat Transfer Committee; and is Sub-Group Chair of the Committee on Verification and Validation in Computational Methods for Medical Devices. In addition, she is a member of the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE).
Dr. Bardot earned her PhD in Mechanical Engineering from the University of Washington, and served as an Innovation Fellow at the University of Minnesota Medical Devices Center. She also spent two summers as a Faculty Fellow at NASA Marshal Space Flight Center in Huntsville, Ala. In addition, she achieved an MS and BS in Mechanical Engineering from Kansas State University.
Robert Becker, MD, PhD | Chief Medical Officer, Office of In Vitro Diagnostics and Radiological Health, CDRH FDA
Robert Becker is Chief Medical Officer for the Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices and Radiological Health (CDRH), FDA, with special attention to inter-office coordination on regulation of newly emerging genetic/genomic IVD’s. Dr. Becker previously served as Director, Division of Hematology and Immunology Devices, in OIR (then named OIVD). He is experienced in regulation of IVD’s aimed at cell- and tissue-based specimens (e.g. classical hematology, flow cytometry, cytology, histopathology), plus blood coagulation tests, and immunoserologic tests.
Dr. Becker earned his MD and PhD in Immunology at Duke University, and he is board certified in anatomic and clinical pathology. He served in the United States Air Force as a pathologist at the Armed Forces Institute of Pathology, Washington, DC from 1983 to 2004, specializing in urologic pathology and with research and clinical service applying image analysis and flow cytometry to diagnostic pathology.
Dr. Karim Benali joined Abiomed in 2004 as Vice President of Product Development responsible for planning and directing the full range of Abiomed’s product development policies, objectives and initiatives. In 2006, Dr. Benali was appointed as Abiomed’s Chief Medical Officer. Dr. Benali is responsible of leading the clinical strategy and initiatives to advance the field of acute heart failure for patients that are supported with Abiomed’s products through evidence based medicine, the design and execution of large and complex trials and registries. Dr Benali came to Abiomed with twelve years of international experience in medicine, clinical research, bioengineering and biostatistics, with a strong focus on cardiology.
Prior to Abiomed, Dr. Benali worked for GE HealthCare, where he led the introduction of two of the company’s top products in cardiology. As the Global Clinical Research Leader for the GE cardiovascular business, he led the clinical introduction of the world’s first digital flat panel imaging system that has become a standard in the CathLab. After that, as Global Manager, he pioneered the first cardiac procedures on the newly introduced hybrid imaging platform and positioned GE as market leader in Cardiac PET/CT. Prior to GE, Dr. Benali worked in the academic field at several renowned European medical and research institutions including the Assistance Publique – Hopitaux de Paris, the Cyceron research center and the Inserm Institute. He was part of the French multidisciplinary team that contributed actively to the bourgeoning field of the human brain mapping project using multimodality imaging techniques. In the 90s, he was a key member of the small team that pioneered one of the first real-time neuronavigation procedures in brain surgery using real-time quantitative spatial fusion of 3D MR/CT/PET images with patient’s brain. In parallel, Dr. Benali directed the clinical research program at the High Institute of Technology and Management in Paris, France where he taught biostatistics and Six Sigma methodology.
Dr. Benali earned an MD degree from Institut National de l’Enseignement Superieur des Sciences Medicales in Algiers, an MS in Bio-imaging and Bio-engineering from the University of Val de Marne — Paris XII, and a Pierre & Marie-Curie University Diploma in Biostatistics and Clinical Research from University Paris VI.
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. He is active in a number of medical device and IVD policy issues on behalf of BD, through his involvement in several 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.
Robert M. Califf, MD, MACC, was named Deputy Commissioner for Medical Products and Tobacco for the Food and Drug Administration (FDA) in February of 2015. Dr. Califf provides 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 oversees the Office of Special Medical Programs and provides 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.
Stephanie Christopher, MA, has a background in health communication, public health project management and communication education and training. Stephanie worked for seven years with an academic public health team working on interventions to improve the quality of communication between physicians and parents of newborns with abnormal newborn screening results. In 2012-13, Stephanie went on leave from her academic position to do a special assignment for the Food and Drug Administration Center for Devices and Radiological Health (CDRH), updating and training staff on a new risk communication process. Stephanie also teaches introductory communication courses in the College of Professional Studies at Marquette University.
Stephanie earned her Bachelor of Arts in Communication-Print Journalism from Pacific Lutheran University in Tacoma, Wash. and Master of Arts in Science, Health, and Environmental Communication from Marquette University in Milwaukee, Wis. Stephanie is also a Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals.
Dr. Owen Faris is the acting 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.
Suzanne Fiorino is Senior Director, MD&D Sustainability and Quality Strategy. Her responsibilities have included development and deployment of the sector’s Sustainability Strategy and leadership of the Quality and Regulatory Compliance Strategic Planning process for Johnson & Johnson’s Medical Devices & Diagnostics business and currently serves as the Program Manager for MDIC’s Case for Quality project.
Suzanne has previously held several leadership roles in both the Medical Devices & Diagnostics and Pharmaceuticals businesses at Johnson & Johnson in the areas of Health Care Compliance (HCC), International Regulatory, Quality, and Process Excellence.
Prior to joining Johnson & Johnson, Ms. Fiorino was the owner of Amgis, Ltd., a Quality Improvement and Compliance consulting firm, and she also held positions at QualPro Inc. and Union Carbide Corporation.
Ms. Fiorino holds an MBA in New Ventures Management from the University of Tennessee at Knoxville, a B.S. in Chemistry from Canisius College, and has completed her coursework toward a doctorate in Industrial/Organizational Psychology. She is a Six Sigma Master Black Belt and a Senior Member of ASQ.
Bill Hawkins is a Senior Advisor for TPG Capital and Lead Director of Immucor, Inc., a private company, wholly owned by TPG. Immucor is a market leader in helping secure the world’s blood supply through automation.
Prior to joining Immucor in 2011, Mr. Hawkins served as Chairman and CEO of Medtronic, one of the worlds’ largest and most innovative medical technology companies. Mr. Hawkins assumed the role of CEO in 2007 and became Chairman of the Board in 2008. He joined Medtronic in 2002.
Mr. Hawkins joined Medtronic from Novoste Corp., where he had been President and Chief Executive Officer since 1998. He previously held senior leadership positions at American Home Products, Johnson & Johnson, Guidant Corp., and Eli Lilly & Co. He began his medical technology career with Carolina Medical Electronics in 1977.
Mr. Hawkins received his bachelor’s degree in electrical and biomedical engineering from Duke University in 1976, where he also conducted medical research in pathology. He then went on to earn an MBA from the Darden School of Business, University of Virginia in 1982. Mr. Hawkins became a member of the Duke University Board of Trustees in 2011 and serves on the Business and Finance and the Academic Affairs Committees. In 2012, he was appointed as a member of the Duke University Health System, Inc. and serves on the Audit and Compliance Committee.
Mr. Hawkins is the Chairman of MDIC and was recently elected as the 2013 President of the American Institute of Medical and Biological Engineering (AMIBE). He serves as a Director on the Board of AdvaMedDX, is the Chairman of the Board for KeraNetics, and on the Board of Thoratec Corporation, a NYSE-listed medical device company.
Mr. Hawkins also serves as a Member of the Advisory Boards at nContact Surgical, Arboretum Ventures, Radius Ventures, LLC, Accuitive Medical Ventures, and the A*STAR SERC Cluster Advisory Board in Singapore.
Mr. Hawkins and his wife, Sharon Hawkins, have three children: Elizabeth, Duke University Class of 2009; Julia, Duke University Class of 2012; and Will, Duke University Class of 2014.
Carolyn Hiller joined MDIC in July 2015 as Acting Program Manager for their nascent Clinical Diagnostics initiative. She brings diverse experiences in the health sector; in addition to nearly a decade working in the medical device industry, she brings executive leadership experience with national organizations representing patients, researchers, physicians, and clinical facilities. She guided the organizations she worked with to create successful alliances with both the National Institutes of Health and the American Medical Association. She has an MBA from the University of St. Thomas, St. Paul, Minnesota, as well as a BA in Marketing from Metropolitan State University, and an AAS in Animal Health Technology from the University of Minnesota.
Telba Irony is currently leading the Quantitative Innovation program at the Center for Devices and Radiological Health at the FDA. She received her Ph.D. from the University of California at Berkeley and joined CDRH to help implement the use of Bayesian methods in medical device clinical trials.
Telba is a fellow of the American Statistical Association and an elected member of the International Statistical Institute.
She was instrumental in preparing the CDRH guidance documents for the Use of Bayesian Statistics in medical device clinical trials, on Factors to Consider when Making Benefit – Risk Determinations for medical devices and on the Submission of Patient Preference Information for evaluation of medical devices.
In 2014 she received the FDA Excellence in Analytical Science Achievement Award for spearheading innovative regulatory science studies culminating in the release of novel guidance documents, supporting complex policy decision making and changing the submission review paradigm.