"I see ISCTR as an organization focused on delivering education to drive innovation that has the best chance of yielding genuine clinical benefit. It is an honor for me to have this award named after me."
The ISCTR mission is to expedite scientific discovery by providing education in innovation and translation to bring new concepts into new therapies that improve human health.
Dr. John B. Simpson exemplifies this mission through his creativity and the development of therapies that have improved the lives of patients worldwide. His invention and commercialization of the first over-the-wire balloon catheter used for percutaneous transluminal coronary angioplasty (PTCA) enabled interventional cardiology as it is practiced today.
Dr. Simpson founded ACS and DVI (both acquired by Eli Lilly), CVIS (acquired by Boston Scientific), Perclose (sold to Abbott), Lumend (acquired by Cordis), and Fox Hollow (acquired by ev3 which is now part of Medtronic).
Dr. Simpson received his PhD in Immunology from the University of Texas, his MD from Duke University, and completed his fellowship in interventional cardiology at Stanford University. He is a member of the American College of Physicians, a fellow of the American College of Cardiology, has published on a wide variety of medical subjects, and has lectured extensively throughout the world.
The ISCTR is privileged and proud to name the ISCTR award, “The John B. Simpson Award for Major Contributions to Innovation and Translation in Cardiovascular Devices.” The award will be given to individuals whose contributions have impacted human lives significantly.
Mr. Stanton J. Rowe is CEO of Nidus Biomedical, a medical device incubator in Southern California. Mr. Rowe was previously the CEO of NXT Biomedical, the predecessor of Nidus Biomedical. Mr. Rowe was the Chief Scientific Officer of Edwards Lifesciences Corp. for 15 years and served as its Corporate Vice President of Advanced Technology.
Mr. Rowe was a founder and served as the President and Chief Executive Officer of Percutaneous Valve Technologies Inc. (PVT). This company developed the first TAVR device, sold to Edwards in 2004.
He served as the Corporate Vice President of Business Development and Strategic Planning at Datascope Corp. Prior to this, Mr. Rowe served as a Vice President of Advanced Technology and Business Development at Johnson & Johnson’s Interventional Systems Division (JJIS), responsible for Johnson & Johnson’s coronary stent development efforts. At JJIS and the related Cordis Corporation, he held a variety of positions with increasing levels of responsibility, including heading Johnson & Johnson’s Business Development, Advanced Technology, Worldwide Clinical Research and Marketing groups. Mr. Rowe joined Cordis after having held several positions in product management for various medical device companies.
He serves as a Director of Gradient Denervation, Anuncia Medical, Vivifi Medical, and the Discovery Science Center in Orange County. He served as a Director of NovaSignal, Biomerix Corporation, PQ Bypass, Zift Medical, InSeal Corp, and Remon Medical.
Mr. Rowe has served numerous Biomedical Engineering Advisory Boards at UCI, UC Davis, Texas A&M, Brown University and Georgia Tech. He holds a Bachelor’s Degree and a DSc (honoris) from the University of Alabama.
Antonio Colombo is Senior Consultant at Humanitas Clinical Research Hospital, in Milan, Italy and Director of Cardiac Catheterization Laboratory in Columbus Hospital in Milan, Italy. Prof. Antonio Colombo has been General Coordinator of GVM- Care and Research Group, Cardiac Laboratories in Italy for the past two years and Director of Invasive Cardiology at San Raffaele Scientific Institute and Professor of Cardiology at University Vita e Salute in Milan for the past 20 years.
Prof. Colombo performed landmark work in the field of coronary stenting, intravascular ultrasound and stent thrombosis. He has been one of the early initiators of TAVI procedures in Italy refining some aspect of this procedure. Antonio Colombo is on the Editorial Board of all major Cardiology and Interventional Cardiology Journals. He received several recognitions including the TCT Career Achievement Award and the PCR Ethica Award.
He published over 1000 papers in peer review journals, several books in the field of coronary interventions and contributed with chapters in the most important Interventional Cardiology books
Dr. Bram Zuckerman is a 1981 graduate of the Boston University Medical School. He completed post-graduate training in internal medicine at Baltimore City Hospital and cardiology training at the Johns Hopkins program. Prior to beginning his cardiology training at Johns Hopkins, he received a National Research Service Award from NIH to study pulsatile hemodynamics. This research award provided him the opportunity to work in the laboratory of Frank CP Yin, MD, PhD during his cardiology fellowship where he learned key principles of signal analysis, fluid and solid mechanics, and hemodynamics. His research centered on investigating changes in aortic impedance and compliance in chronic animal models of systemic hypertension and atherosclerosis.
After completing his cardiology training Dr. Zuckerman became an Assistant Professor of Cardiology at the University of Colorado Medical School. His research in Colorado focused on investigating changes in pulmonary impedance and compliance associated with pulmonary hypertension. Prior to joining FDA, he also worked as a cardiologist in Northern Virginia in a private practice setting.
He joined the FDA Division of Cardiovascular Devices (DCD) as a Medical Officer/Reviewer in 1992 and soon became actively involved in development and review of clinical trials for many new cardiovascular devices. His main responsibility was in the FDA Interventional Cardiology Devices Branch and he was the primary clinical reviewer for multiple important interventional cardiovascular devices during the 1990s. In May 2001 he was appointed a Deputy Director in DCD. In September 2002 he became Director of the FDA Division of Cardiovascular Devices and was appointed Director of the newly formed FDA Office of Cardiovascular Devices in September 2017.
Throughout his FDA career he has actively witnessed the challenges associated with design and execution of appropriate medical device trials. While basic principles of drug trial design can be extrapolated to device trials, he has also observed some of the unique features associated with medical device trials. As such he has been quite interested in exploring and optimizing new avenues of clinical trial design and execution during his time at FDA. He has, for example, been an active supporter of the use of Bayesian adaptive trial designs in the regulatory setting, of increased collaboration with Japanese regulators, and has most recently assisted in development of a more efficient early feasibility study device pathway in the United States. Other areas of interest include promotion of pediatric device development and improved use of computational modeling methods in device development.
