Until March 2010, Tom served as Executive Director of the Medical Technology Learning Institute (MTLI), the education arm of AdvaMed, the world’s largest trade association representing the medical device and diagnostics industries, where he created and ran workshops and conferences on regulatory, reimbursement, and other practical topics important to device, diagnostics, and combination product manufacturers. Prior to joining AdvaMed, Tom was Senior Advisor for Scientific Strategies at Georgetown University Medical Center, Senior Science Writer and Philadelphia Bureau Chief of Red Herring, a technology-oriented national business magazine, the Research and Creative Director for a graphic and industrial design firm specializing in medical products and services, and an independent marketing and educational consultant to pharmaceutical, biotech, and medical device firms. He is the author of five books on topics including literary biography, the law, psychiatry, and the history of the pharmaceutical industry, has co-authored seven humor books, and has written many articles for magazines and newspapers including the Atlantic Monthly, Scientific American, The New York Times, and The Washington Post. He has done exhibition concept design and master plans for several U.S. science museums, and created the internationally traveling exhibit Salt of the Earth. Tom has a degree from Columbia University and did graduate work in developmental neurobiology at the University of Pennsylvania.

Greg Ayers, M.D. joined Philips in June 2106 after working with the HeartStart AED technology for two decades as a consultant. Ayers is both a physician and a biomedical engineer, with an emphasis in cardiac electrophysiology. He received his B.S. and Ph.D. in biomedical engineering from Purdue University, and his M.D. from Indiana University. He is a fellow of the American College of Cardiology, the American Institute of Medical and Biological Engineering and the Heart Rhythm Society.

Through his basic science and clinical research he has contributed to the understanding of the pathophysiology and various treatments for the most common abnormal heart rhythm, atrial fibrillation. Early in his career Ayers was involved in evaluating the use of defibrillation to treat sudden cardiac arrest and has performed research in the area of cardiac ablation for the treatment of abnormal heart rhythms. He holds 21 U.S. patents and has published more than 200 book chapters, scientific abstracts and manuscripts. In addition to his role at Philips Medical, Ayers is also an EMS provider and volunteer firefighter.

Tony Blank is cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Immediately prior to forming Barton & Blank, Blank spent 12 years at Boston Scientific Corp. in both corporate and business regulatory leadership roles. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has likewise been an active representative for Boston Scientific, the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups—including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired). He is very involved in developing and delivering meaningful educational programs in the field of regulatory affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Blank has worked with cardiopulmonary, surgical, ophthalmic, vascular access and critical care medical devices.

Patrick Caines is director, quality & post-market surveillance at Baxter Healthcare where he is responsible for the company’s global post-market surveillance and associated quality systems. Caines has 20 years’ experience in quality systems and compliance for both medical devices and clinical diagnostics and served as director, corporate post-market surveillance at General Electric Healthcare and Boston Scientific, and director of worldwide customer quality at Johnson and Johnson. Caines began his career as a hospital-based clinical laboratory scientist and held faculty appointments at the University of Windsor and Wayne State University. He holds a Ph.D. in clinical biochemistry from the University of Windsor, Ontario, Canada as well as an MBA from St. John Fisher College, Rochester, New York.

As counsel of the life sciences practice at Hogan Lovells International, Fabien Roy advises clients on European Union and national regulatory matters applicable to medical devices, medicinal products and combination products throughout their entire life cycle. Roy focuses particularly on guiding clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. He assists clients in addressing a range of complex issues during clinical investigation procedures (e.g., authorization from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, and handling of personal data), conformity assessment and registration procedures (e.g., preparation and review of technical files, preparation and review of responses to the competent authorities' and Notified Bodies' requests) and post-market activities (e.g., adverse event reporting, field safety corrective actions and promotional and advertising of medical devices). Roy is also a qualified lead auditor for ISO 13485 quality management systems. In addition, he assists life sciences clients in the preparation, drafting and review of numerous agreements including clinical study agreements, sponsor's representative agreements, registry agreements, CRO agreements, European Authorised Representative Agreements and distribution agreements.

Mike Santalucia is the vice president of global regulatory affairs for Terumo Cardiovascular Systems Corp. and has more than 25 years' experience in medical device regulatory affairs and quality assurance systems. Santalucia is responsible for the global management of the RA group to assure the development and execution of global product submissions strategies for the company’s medical devices. He is also responsible for various processes such as removals and corrections, labeling and advertising review, and regulatory due diligence for new business development. Prior to Terumo CVS, Santalucia was the vice president of global regulatory and government affairs for Bausch & Lomb, Inc. In that role, he was responsible for the global management of the RA group for the company’s vision care business and led the company government outreach program with US and non-US government bodies. Prior to joining Bausch & Lomb, Santalucia worked in various regulatory and quality capacities with Deknatel, Inc. and with Valleylab. He was a member of the GHTF SG2 working group and has been an active contributor and presenter on regulatory issues at industry forums.

Weiping Zhong, Ph.D. is the global director of risk management for GE Healthcare, covering a wide range of medical devices from both pre-market and post-market: imaging, patient support and sustaining, maternal & infant care, surgical devices and healthcare IT/digital solutions. Prior to GEHC, Zhong held multiple positions in Bayer Diabetes Care: head of QA/RA for Asia Pacific, clinical/biostatistician and QA engineer. Zhong received his Ph.D. degree from University of Michigan, Ann Arbor in 2002 Mechanical Engineering with a focus on quality and productivity; he held degrees from Industrial and operations & electric engineering.