Duke University Medical Center and Duke Clinical Research Institute, Durham, NC
Stakeholder Council Member, MDEpiNet
Dr. Krucoff is the director of the MDEpiNet Coordinating Center, and has spent 30 years as an interventional cardiologist and clinical trialist, with 25 years at Duke Medical Center where he is Professor of Medicine with tenure, having published more than 200 peer review papers and book chapters on ischemic heart disease, medical device evaluation, national and international regulatory and clinical research constructs. Dr. Krucoff is the Principal Investigator for the FDA-Duke Memo of Understanding founding the critical path Cardiac Safety Research Consortium (CSRC) PPP program. The CSRC has conducted more than 30 broadly based stakeholder think tank-incubator meetings, developing and tracking over two dozen peer review white papers and research projects related to pre- and post-market cardiac safety concerns for drugs, devices and biologics. Many lessons learned and successes within the CSRC’s pre-competitive, collaborative PPP environment are leveraged in this proposal with modifications suited to the specific needs of medical devices as well as to the already established elements and effort of the MDEpiNet program.