Will Proposed Cuts at the FDA Slow Down Your Clinical Research Projects?
Join Doctors Leon, Granada, and Ouriel with Dr. Jeff Shuren, former Director of (CDRH) at the FDA, for a discussion on current challenges facing the MedTech industry, clinical investigators, and regulators. Changes at the FDA–current and potential–will require new ways of interacting with the Agency, assisting them to maintain and even improve the efficiencies and timelines of the product development lifecycle.
Key Discussion Points:
- The cost and timeliness of innovation and its dependence on efficiencies, including:
- Preclinical testing protocols
- Investigational device exemptions
- Clinical trial designs
- Review of premarket applications
- Changes at the FDA that may disrupt review workflows and slow product approval
- New ways for clinical researchers and industry members to interact with the FDA to improve the process of market authorization of innovative medical products
Speakers
Dr. Jeff Shuren
Former Director of FDA CDRH
Jeffrey Shuren, MD, JD was the Director of the Center for Devices and Radiological Health (CDRH) at the FDA. He previously held various policy and planning positions within the FDA from 1998 to 2009, including Acting Deputy Commissioner for Policy, Planning, and Budget; Associate Commissioner for Policy and Planning; and Special Counsel to the Principal Deputy Commissioner. Dr. Shuren is board-certified in Neurology and served as an Assistant Professor of Neurology at the University of Cincinnati. In 1998, Dr. Shuren joined the FDA as a Medical Officer in the Office of Policy. In 2000, he served as a detailee on the Senate HELP Committee. In 2001, he became the Director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services. From 1998 to 2003, he served as a Staff Volunteer in the National Institutes of Health’s National Institute of Neurological Disorders and Stroke Cognitive Neuroscience Section supervising and designing clinical studies on human reasoning. Dr. Shuren returned to the FDA as the Assistant Commissioner for Policy in 2003, and became CDRH Director in September 2009. He retired from the FDA in November 2024.
Dr. Martin Leon
Mallah Family Professor of Cardiology at Columbia University | Director of Columbia Care Center for Interventional Care at New York-Presbyterian Hospital
Dr. Martin B. Leon is a leading figure in interventional cardiovascular medicine, serving as the Mallah Family Professor of Cardiology at Columbia University and Director of the Columbia Center for Interventional Care at New York-Presbyterian Hospital. He has been pivotal in over 75 clinical trials, including the influential PARTNER trials, and has authored more than 2,500 scientific publications. Dr. Leon founded the Transcatheter Cardiovascular Therapeutics symposium, the largest interventional cardiology meeting globally, and has received numerous accolades, including the ACC Lifetime Achievement Award. He co-founded the Heart Valve Collaboratory to address gaps in valvular heart disease research. Dr. Leon’s career includes roles at the Washington Hospital Center, Georgetown University, and the National Institutes of Health. He earned his medical degree from Yale School of Medicine and completed his training at Yale-New Haven Hospital.
EVP and KOL Managing Director at NAMSA
Kenneth Ouriel, MD, MBA, is a renowned Vascular Surgeon known for advancing less invasive medical procedures. His career began at the University of Rochester, followed by leadership roles at the Cleveland Clinic and New York Presbyterian Hospital. In 2010, he founded Syntactx, a CRO focused on cardiovascular trials, which was acquired by NAMSA in 2020, where he now serves as Chief Medical Officer. Dr. Ouriel has published over 325 scientific articles and authored five textbooks, contributing significantly to medicine. He holds an MBA from Columbia University and the London Business School, highlighting his interest in the business side of medicine.
Dr. Juan Granada
President and CEO at Cardiovascular Research Foundation
Juan F. Granada, MD, is the President and Chief Executive Officer of the Cardiovascular Research Foundation (CRF). A renowned leader in cardiology, he joined CRF in 2007 and served as Executive Director and Chief Innovation Officer at the CRF Skirball Center for Innovation, the preclinical division of CRF. He is also an Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons. Granada is one of the world’s foremost investigators in the translational validation of novel cardiovascular therapies and has helped develop and successfully validate several endovascular imaging and device technologies. He received his medical degree from the Institute of Health Sciences in Medellin, Colombia, and finished his cardiovascular disease and interventional cardiology fellowships at Baylor College of Medicine in Houston, Texas.
Moderator
Chief Medical Officer at NAMSA
As a Board-Certified Cardiothoracic Surgeon, Dr. Saltman has more than 25 years’ experience in the management of complex patients with multiple comorbidities. He also worked for 12 years as a Medical Officer at the U.S. FDA Center for Devices and Radiological Health, where he gained a deep understanding of the requirements for successful medical device introductions, as well as quality systems, compliance, and benefit-risk evaluations. Before joining NAMSA, Dr. Saltman earned industry experience as the first Chief Medical and Regulatory Officer for two medical device organizations, during which he successfully brought three AI-powered devices through R&D, clinical validation, regulatory approval, and market introduction.
*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com.
NAMSA uses a third-party provider, GoToWebinar, to host NAMSA webinars. For information related to GoToWebinar’s privacy policy and utilization of information, please contact GoToWebinar directly.
This is a free educational webinar.
