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Scientific Advisory Board
Aaron Lottes, PhD, MBA, is an Associate Professor of Engineering Practice and Director of the Online Master’s Program and Professional Education in the Weldon School of Biomedical Engineering at Purdue University. His research and teaching interests focus on the role of regulatory and clinical science to optimize the development, evaluation, and approval of medical devices and drug/device/biologic combination products. Of particular interest is global harmonization of clinical evidence development and regulatory review processes to improve patient access to safe and effective new medical products. Aaron is integrating ISCTR educational materials into the curriculum to improve the training and education of both engineers and medical students in translational processes. Prior to joining the faculty at Purdue, Aaron was Director of Regulatory Science at Cook Medical where he focused on development and approval of drug eluting devices for the treatment of peripheral artery disease and the collection and use of real-world evidence to support product evaluation and clinical decision making. Aaron holds a PhD in Biomedical Engineering from Purdue University.
She has dedicated her career to leading clinical and angiographic evaluations of more than 500 clinical trials in a broad range of ischemic cardiovascular therapeutic areas, including pharmacologic and interventional device trials, many of which are landmark trials in the field and/or leading to FDA approval in the United States. She has served as the principal investigator on numerous national and international imaging studies, device, DES and neuroprotection trials. Dr. Lansky has authored and coauthored over 500 academic peer-reviewed manuscripts in the fields of interventional cardiology, angiography, and women’s cardiovascular health. She chaired the American Heart Association Statement on Interventions in Women and most recently the Academic Research Consortium defining Neurologic Endpoints in clinical cardiovascular trials.
Dr. Lansky has been recognized for her clinical research contributions with several prestigious awards including: Masters of Arts Privatim from Yale University in 2017; Top Doctors in Connecticut in 2017, Thompson Reuter’s 2014 and 2016 “Most influential Scientific Minds for Clinical Medicine”; 2012 Wenger Award of Clinical Excellence in Women’s health, Visiting Professor at Fu Wai Hospital, Bejing, China and Honorary Professor, University College London.
Dr. Lansky is board certified in cardiovascular diseases. A graduate of the Medical College of Virginia in Richmond, VA, she received her residency training in internal medicine, cardiology, and interventional cardiology at Washington Hospital Center, Washington DC. Dr. Lansky is a Fellow of the European Society of Cardiology, the American College of Cardiology, the American Heart Association and the
Andreas M. Zeiher: Professor, Dr. med.
D.O.B. July 3rd, 1955, in Freiburg i. Br., Germany
1965 – 1974: High school Kolleg St. Blasien (Societas Jesu)
1974 – 1981: Medical School, Albert-Ludwigs-University Freiburg
1979 – 1981: Thesis
May 1981: License to practice medicine
1981 – 1983: Resident, Department of Internal Medicine, Division of Cardiology (Head: Prof. Dr. H. Just), University of Freiburg
1983 – 1986: Clinical Fellow, Department of Internal Medicine, Division of Cardiology, University of Freiburg
1986 – 1987: Research Fellowship of the German Research Foundation (DFG) at Cedars- Sinai Medical Centre, School of Medicine, University of California, Los Angeles, CA, USA
1988 – 1990: Clinical Fellow, Department of Internal Medicine, Division of Cardiology, University of Freiburg, Germany
1990: Assoc. Professor of Medicine
1990 – 1995: Director of Interventional Cardiology, Department of Internal Medicine, Division of Cardiology (Head: Prof. Dr. H. Just), University of Freiburg
Since 1995: Chairman, Department of Internal Medicine III, Division of Cardiology / Nephrology / Angiology at J. W. Goethe-University of Frankfurt, Germany
2002 – 2004: Chairman, Working Group Interventional Cardiology, European Society of Cardiology
2001 – 2006: Vice Chairman, Board of Directors at J. W. Goethe – University of Frankfurt
2008 – 2012: Co-Speaker, Cluster of Excellence Cardiopulmonary Systems
2010: Speaker, LOEWE Center for Cell and Gene Therapy (CGT)
2011: Speaker, German Center for Cardiovascular Research (DZHK) Rhine-Main
2019: President German Cardiac Society (DGK)
Awards and Honors
1991: Rudolf-Thauer-Award, German Society of Cardiology and Circulation Research
1995: Franz-Loogen-Preis, Society of Heart and Circulation Research Essen e.V.
2001: Fritz-Acker-Preis, Fritz-Acker-Foundation Bad Homburg v.d.H.
2004: CARIM-Lecture, University of Maastricht, The Netherlands
2005: HJC Swan Professorship, Cedars-Sinai Medical Center, University ofCalifornia, Los Angeles
2006: Princess Lilian Professorship, Belgian Society of Cardiology, University ofBrussels
2007: Ernst-Jung-Award for Medicine
2009: Paul-Morawitz-Award of the German Cardiac Society
2009: Princesses’ Lecture, Victor Chang Cardiac Research Institute, Sydney
2010: ISCTR Award, International Society for Cardiovascular Translational Research
2010: Stanley Davidson Lecture, Royal College of Physicians of Edinburgh, Scotland
2012: Krakoff International Lecture, Brigham and Women’s Hospital, Boston
2016: Silver Medal German Cardiac Society
Andrew O. Brightman, PhD, is the Assistant Head for Academic Affairs and Associate Professor of Engineering Practice in the Weldon School of Biomedical Engineering at Purdue University, West Lafayette, Indiana, U.S.A. Professor Brightman attended North Carolina State University, Raleigh, North Carolina, where he received the B.S. degree in Botany and Plant Physiology. He then attended Purdue University, West Lafayette, Indiana, and received the Ph.D. degree in Cell Biology and Biochemistry. Upon completion of his doctoral studies, Professor Brightman completed two post-doctoral fellowships in Medicinal Chemistry, at Purdue University, and in Cancer Biotechnology, at Eli Lilly & Co, Indianapolis, Indiana. Professor Brightman then joined the Hillenbrand Biomedical Engineering Center as a Senior Research Scientist in Tissue Engineering where he contributed to the research and development of the tissue engineered small intestinal submucosa (SIS) technology. Professor Brightman also has worked as an independent consultant for several medical technology companies. Through these professional experiences, education and research background in analysis of signaling biomolecules and tissue engineering, Professor Brightman has gained knowledge about biomedical technology innovation and translation and built a foundation from which he is able to contribute to engineering design, regulatory affairs, and ethical practice.
Prof. Mathur specialises in the management of patients with cardiovascular disease who fall outside the remit of current recognised therapies. His research interests primarily concern the role of biologics in the treatment of cardiovascular disease, and several of his programmes have gained international recognition, including an adult heart stem cell research programme, and a novel stent development programme. Prof. Mathur is currently the CI for one of the first Phase III trials of cell therapy in acute myocardial infarction. Alongside this, he is a Trustee of the Heart Cells Foundation Charity and heads their pioneering Compassionate Treatment Unit for Heart Failure. This dedicated stem cell programme is the UK’s only centre to treat compassionate heart failure patients with their own stem cells.
Within the Centre for Cardiovascular Medicine and Device Innovation, and as part of an on-going collaboration with Yale University, Prof. Mathur leads the Cardiovascular Devices Hub. The CVDHub supports collaborations between academic, clinical and industrial innovators to develop clinically and commercially viable cardiovascular devices. This novel, cross-specialty unit catalyses innovation and helps SMEs over the hurdles involved in taking new devices to human trials.
Dr. Grancorvitz enjoys mentoring young health care professionals and has been a preceptor with MidWestern University and University of Arizona School of Pharmacy. She is an active board member with TwinEpidemics, a non-profit organization diligently working to quell the epidemic of diabetes and heart disease among ethnic communities. She also helps facilitate local health screenings for pharmacy students and is an active supporter of the ACC Women inCardiology chapter in AZ.
In 2000, he started Cardiac Dimensions. After leading the team to conceptualize and develop a novel cardiac implant for patients with heart failure and mitral regurgitation, he developed and implemented the clinical trial strategy to test the safety and effectiveness of the novel implant. The therapy has received CE Mark regulatory approval and is in use worldwide.
In 2014 Dr. Reuter was appointed Director of Cardiac Innovations at Seattle Children’s Hospital. He is funded by the Gates Foundation to explore how renal venous outflow obstruction causes a renal compartment syndrome leading to both preeclampsia and obesity-related hypertension.
In addition to his clinical practice, Dr. Reuter currently serves as a mentor and strategic advisor for a diverse group of teams innovating solutions for tricuspid regurgitation, decompensated heart failure, and heart failure with preserved ejection fraction.
At Cygnus Regulatory, her international startup clients span a variety of medical disciplines. Prior to staring Cygnus in 2008, Ms. Abruzzo worked at Baxter, Cordis JNJ, CryoLife, Percutaneous Valve Technologies (acquired by Edwards LifeSciences), AtriCure, Sapheon (acquired by Covidien/MDT) and PTS Diagnostics (acquired by Sinocare). She is regulatory affairs certified (RAC) and a Regulatory Affairs Professional Society Fellow (FRAPS).
Previously, she trained at NYU and Bellevue Hospitals as a Pediatric intern, resident, and chief resident and was an NIH K30 awardee as a junior faculty member. She is the past PI of an NIH/NIDDK educational grant to promote training and education in the area of drug discovery/development, a successful program that integrated students from several NYU graduate programs. She is the current PI of an NIH/NIDDK R25 educational grant to promote training in biomedical entrepreneurship and the translation of science. Dr. Gold-von Simson is a section reviewer for NIH/NIDA UE5 grant: Research Education Course in Product Development and Entrepreneurship of Life Science Researchers. She also serves as a director at large and board member for the Association for Clinical and Translational Science (ACTS). She sits on the scientific advisory board for publicly traded companies (Biotechnology and Devices) and serves on the NYUGSOM’s Faculty Council, the NYU C-FSC Senate, the NYU sexual misconduct committee, and the NYU Diversity, Equity, and Inclusion Committee and Workgroup.
Dr. Samady has an actively funded clinical and translational research program (including National Institute of Health, the American Heart Association as well as industry sponsored studies) to investigate 1) hemodynamic mechanisms associated with progression of human coronary atherosclerosis 2) evaluation of pharmaceutical agents for treatment of coronary microvascular disease, endothelial dysfunction, coronary vasospasm and non-obstructive atherosclerosis 3) biomechanics of permanent and bioresorbable coronary vascular devices. These programs involve collaborations with Biomedical Engineering at Georgia Institute of Technology, Emory Vascular Biology and Emory Mathematics and Computer Science.
Dr. Samady is Deputy Editor of JACC Cardiovascular Interventions, is on the editorial board of numerous cardiovascular journals, and is extensively published in the fields of intravascular imaging, coronary physiology, atherosclerosis assessment, and stent biomechanics. His clinical interests include complex coronary disease, high risk percutaneous coronary interventions, chronic total occlusions, and invasive evaluation of coronary microvascular disease.
In 2008, Dr. Stahel founded the start-up company Swiss Cardio Technologies AG and developed a new low-volume single-shot cardioplegic solution (Cardioplexolä). In 2015, they successfully completed the pivotal phase 3 clinical trial and are now in the final stage of the registration process, hoping to get market approval for 10-13 European countries in 2021.
In 2016, Dr. Stahel decided to end his position at the University hospital in Berne, with the motivation to open his future to new horizons. With that in mind, he created TestaLogic GmbH, a consulting company through which he intends to contribute with his broad (clinical, academical, R&D, managerial and entrepreneurial) experience, to the development of innovative companies. In parallel, he created Stahel, simply champagne GmbH, a company importing and distributing grower natural champagnes in Switzerland.
Dr. Piña’s research interests include transition of care in heart failure patients, and the role of natriuretic peptide–guided management for patients hospitalized for heart failure, biomarkers of myocardial stress and fibrosis in chronic heart failure, and heart failure differences by sex. She has been actively involved in gender, racial and ethnic issues in the health care delivery. She is the author/co-author of more than 250 publications. She is currently the Chair of the FIT committee of the AHA and on the Board of Directors National AHA.
Dr. Croce received his medical and Ph.D. degrees from Tufts University School of Medicine. He completed an internal medicine residency, a cardiology fellowship and an interventional cardiology fellowship at BWH. Dr. Croce is board certified in internal medicine, cardiovascular disease and interventional cardiology.
His clinical interests include advanced treatments for obstructive coronary artery disease (CAD), and optimization of antithrombotic and antiplatelet pharmacotherapy. The author of over 100 peer-reviewed publications, Dr. Croce’s research focuses on understanding the molecular pathobiology of atherothrombotic (CAD) and on identifying new targets for CAD treatment. His research has received support from the National Institutes of Health.
MacKenna holds a master’s degree in Medical Law and Ethics from King’s College London. She trained and practiced as a technology dispute resolution litigator at a top London 50 IP practice. She was lead IP advisor to the Centre for the Advancement of Sustainable Medical Innovation (CASMI), a joint venture between Oxford University and University College London focused on accelerating therapies to market in Europe. She continues to advise several academic societies and biotech start-ups, including as legal counsel on the governing board of TERMIS Global (Tissue Engineering Regenerative Medicine International Society). MacKenna is passionate about empowering scientists and physicians with the knowledge and vision they need for their innovations to reach patients successfully.
Dr. Carlson received his M.D. from the University of Kansas, an M.A. in public policy from Duke University, and a B.S. in Biology from Kansas State University. He trained in internal medicine at University Hospitals of Cleveland and CWRU and in cardiology and cardiac electrophysiology at the Massachusetts General Hospital and Harvard University. He joined the faculty of CWRU in 1988 where he was professor of medicine with tenure until he joined St. Jude Medical in 2006. While at CWRU, he held several leadership positions including Vice Chairman, Department of Medicine responsible for Clinical Programs. His research on arrhythmias and cardiac neural control has resulted in over 200 publications. In 2003, 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 CWRU as associate vice president for government relations and led advocacy efforts that established the National Center for Regenerative Medicine. At Abbott, Dr. Carlson led a global team responsible for the strategy and conduct of hundreds of clinical trials on novel medical devices including the world’s first leadless pacemaker, the smallest artificial heart valve for neonates, the first quadripolar pacemaker for heart failure, closure devices to prevent stroke, and left ventricular assist devices, to name a few. He is an inventor of five United States Patents.
Dr. Carlson served on the FDA’s Devices Dispute Resolution Panel, the NCDR ICD registry steering committee, and chaired the Heart Rhythm Society’s (HRS) Health Policy Committee, the American College of Cardiology Electrophysiology Committee, the HRS/FDA Policy Conference on Device Performance, and the HRS task force on device performance policies and guidelines and the Medicare Evidence Development & Coverage Advisory Committee. He served on the board of directors of the Medical Device Innovation Consortium and chaired that organization’s Clinical Science and Medical Officer Steering Committee.
Dr. Carlson is a board member and past president of the West Los Angeles Council of the Boy Scouts of America, a trustee of the Kansas State University Foundation, and a scientific advisory board member of the International Society for Cardiovascular Translational Research. He received Scouting’s Silver Beaver and Distinguished Eagle Scout Awards. In 2020, Dr. Carlson was appointed Alumni Fellow for the Kansas State University College of Arts and Sciences.
He is a frequent international lecturer and an author of numerous publications. Dr. Chronos is a Fellow of the Royal College of Physicians (London), Fellow of the American College of Cardiology, Fellow of the European Society of Cardiology, and Fellow of the American Heart Association. He sits on numerous scientific and medical Advisory Boards and has served as Study Section Chair, SBIR, Cardiovascular Science, for the National Institutes of Health and on the Data Safety Monitoring Boards for numerous clinical trials. In addition, Dr. Chronos has co-founded several successful biotechnology companies.
His main research focus is translational systems physiology, where his research group does a broad range of studies. The Visible Heart® Laboratories are well known for their novel imaging techniques of functional cardiac anatomies and device testing within large mammalian hearts, including human: see the Atlas of Human Cardiac Anatomy (http://www.vhlab.umn.edu/atlas/). Other research areas include: cardiac pacing and ablation, skeletal muscle pathophysiology, thermoregulation, black bear hibernation, wound healing, 3D computational modeling and printing and educational uses of virtual reality. In 2002, he was acknowledged as a “Distinguished University Teaching Professor”. Since 1990, he has trained over 200 graduate students, postdoctoral fellows, and medical students in his laboratories.
Dr. Iaizzo, has authored more than 250 original articles, over 100 book chapters, edited 5 books, and is on numerous patents (both US and European) related to cardiac and thermoregulatory devices. In 2012, he was named to College of Fellows of the American Institute for Medical and Biological Engineering (AIMBE) for “outstanding contributions to research and education in translational systems physiology and cardiovascular engineering”. In 2015 he was named a Fellow of the Heart Rhythm Society and in 2016 was made a Senior member of IEEE.
Dr. Adamson joined Abbott (formerly St. Jude Medical) in 2015. His clinical interests focus on development of more efficient and effective disease management systems for patients with chronic heart failure, specifically focusing on remote monitoring of physiologic signals from implanted devices.
Prior to joining Abbott, Dr. Adamson developed heart failure disease management programs at the University of Oklahoma and the Oklahoma Heart Hospital. He served as the principal investigator or on the steering committees of several large randomized clinical trials. He was the co-principal investigator of the CHAMPION Trial, which demonstrated the efficacy and safety of the CardioMEMS HF System, leading to FDA approval of the system in 2014.
Dr. Adamson received his M.D. and M.Sc. from the University of Oklahoma Health Sciences Center. Upon completion of his Cardiology fellowship he joined the faculty at the University of Oklahoma and received NIH funding to develop a novel model of ischemic heart failure that served to investigate the autonomic mechanisms of sudden cardiac death.
He has extensive scholarly activity and teaching at local and national levels. He coproduced TEE teaching videos for the American College of cardiology / Heart House in 1994. He has published 5 books in cardiology and echocardiography, 200 papers, 58 book chapters and 172 abstracts. He is an editorial board member of multiple cardiology journals.
He is a founding member of Society of Cardiac MR (SCMR) and a Vice President of International College of Angiology. He is also a Fellow of American College of Physicians, Royal College of Physicians (Edinburgh, UK), American College of Cardiology, International College of Angiology and American Society of Echocardiography.
His translational research interest is centered around preclinical modeling, and cardiac regeneration. Together with others, partners (Netherlands Heart Institute, Open Science Platform, Cyrcle and TACTICS) effort is put into improving quality of preclinical translational research by initiating systematic review, meta-analysis and promoting pre-registration. To this end, they initiated the platform www.preclinicatrials.eu. In view of innovation and valorization, his group investigated routes to optimize cell/compound delivery to the myocardium by applying biomaterial techniques (in collaboration with TU Eindhoven), and development of an interventional MRI strategy. Also, he is co-founder of the UMCU spin-off company CART-Tech (www.cart-tech.com) that offers technical solutions to improve cardiac treatment planning (e.g. regenerative medicine and CRT). Furthermore, he is nucleus member for the ESC working Group CARE (Cardiovascular Regenerative and Reparative Medicine).
He is appointed as the head of the department Cardiology at Amsterdam UMC since October 2019.
Sklar’s research focuses on how laws and policies influence the health and well-being of older adults. Her work has appeared in the following peer reviewed journals: New England Journal of Medicine, Journal of Empirical Legal Studies, American Journal of Law & Medicine, and Jurimetrics, among others. She is an Associate Editor for the Global Biosecurity Journal and a regular contributor to The Conversation, PBS, NPR, and Harvard Law School’s Petrie-Flom Center Bill of Health. Sklar has worked for health systems and government entities, including Ascension Health, MD Anderson Cancer Center, and the Food and Drug Administration, on a range of legal, regulatory, and ethical issues. She graduated magna cum laude from Tulane University and has a dual degree Juris Doctor/Master of Public Health from the University of Houston and the University of Texas.
Dr. Tim Laske is currently the Vice President of Research & Business Development for the AF Solutions Business at Medtronic. He is a Medtronic Bakken Fellow and Technical Fellow and a Fellow of the American Institute for Medical and Biological Engineering. His previous roles at Medtronic include VP of Product Development for AF Solutions, Senior Product Development Director for Heart Valves, Senior Program Director for Transcatheter Heart Valves, Technology Director for Cardiac Rhythm Therapy Delivery, and various technology management and design engineering positions. Prior to his 28-year tenure at Medtronic, he worked as a Design Engineer at Ford Motor Company in Crash Safety and Advanced Vehicle Systems Engineering.
He has a B.S. degree in both Biological Sciences and Mechanical Engineering from Michigan Technological University. He received his M.S. in Mechanical Engineering from the University of Michigan, Ann Arbor, and his Ph.D. in Biomedical Engineering from the University of Minnesota where he serves as an Adjunct Associate Professor in the Department of Surgery. His doctoral research was centered on the use of isolated working hearts in the design of medical devices and in parallel co-founded the Visible Heart® Laboratory (www.visibleheart.com). In addition to medical device design and cardiac physiology, his research interests include the study of hibernation physiology in wild black bear and brown bear populations. He has more than 85 U.S. patents and numerous publications in the fields of Biomedical Engineering and Wildlife Biology/Ecology.
Prior to joining PRIA, Tonya held leadership and consultant positions within prominent organizations, including Johnson & Johnson, Quorum Consulting (now Guidehouse) and MCRA, and is recognized as a strategic consultant with an understanding of what it takes to successfully establish market access and adoption for new and innovative medical technologies.
Throughout her career, Tonya has consulted with several new medical technologies including implantable devices, digital health, diagnostics, DME and molecular diagnostics, across multiple disease areas, including cardiovascular, neurology, electrophysiology, urology, gastroenterology, gynecology, otolaryngology, general and bariatric surgery, orthopedics, spine and pain management.
Her leadership and innovative reimbursement solutions has contributed to the establishment of new payment and coding methods, positive coverage and trusted advisor relationships with multiple stakeholders, including MedTech investors, payer partnerships and specialty societies fostering access and the adoption of new technologies within multiple countries. Tonya played a significant role in the broad market adoption of bariatric surgery, pioneering reimbursement pathways and patient access through collaborations with Johnson & Johnson government affairs, specialty societies, health technology assessments and third-party payer organizations.
Tonya is strategic, practical, and opportunistic in her approach to reimbursement and market access. With an expertise and knowledge of global macro healthcare policy trends and direct experience in tactical execution of successful market access and reimbursement strategies, her understanding of how policy is translated into practice sets her apart as a unique and innovative leader in the reimbursement field. Tonya holds an undergraduate degree from the University of Michigan in Health Policy and a Master of Public Health and Global Healthcare from the University of California Los Angeles and is frequently invited as a guest speaker on market access and reimbursement issues. Tonya serves as a judge and value framework coordinator for MedTech Innovator and is an invited guest speaker with multiple organizations.
Biosense Webster pioneered cardiac electrophysiology catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced cardiac diagnostic, therapeutic, and 3-D mapping tools. With its headquarters in southern CA, Biosense Webster employs more than 10,000 people. For more about Biosense Webster see biosensewebster.com.
Prior to joining Biosense Webster in 1996, Uri spent 3 years as a Member of the Technical Staff at the Micro-Physics Research Department of AT&T Bell Laboratories, Murray Hill, NJ.
Uri holds a Ph.D. degree in Physics summa cum laude from the Hebrew University of Jerusalem.
Dr. Youseph Yazdi is an assistant professor of biomedical engineering at the Johns Hopkins University School of Medicine. He holds an additional appointment in the Whiting School of Engineering at Johns Hopkins, through which he serves as Executive Director of the Center for Bioengineering Innovation and Design and Program Director of the Wallace H. Coulter Translational Research Partnership Program.
Dr. Yazdi holds a B.S. in electrical and computer engineering from Rice University, as well as an M.S. in electrical engineering and a Ph.D. in biomedical engineering from the University of Texas at Austin. He also earned an M.B.A. in entrepreneurial management from the University of Pennsylvania’s Wharton School of Business.
Prior to his arrival at Johns Hopkins, Dr. Yazdi was a corporate director in Johnson & Johnson’s Corporate Office of Science and Technology, where he was responsible for the creation and management of external and internal partnerships that funded and guided early-stage health care innovation.