BIOE Seminar: Kyle Myers

Friday, April 5, 2019
9:00 a.m.-10:00 a.m.
A. James Clark Hall, Room 2132
Dr. Giuliano Scarcelli

Dr. Kyle Myers
Food and Drug Administration

Innovations in Evidence Generation and Incorporation in Medical Device Regulatory Decision-making

The FDA has called for alternative sources of evidence of device safety and effectiveness beyond clinical trials, specifically noting the potential for computational modeling to reduce the size and cost of clinical trials. In some cases computational modeling is arguably mature enough to serve as the primary source of evidence for regulatory decision-making; in other cases, novel approaches to combining actual clinical trial data with data from virtual patients might be utilized. New methods drawn from decision science are being developed to allow for quantitative incorporation of data from multiple sources including animal studies, bench measurements, clinical data, reported patient reported outcomes and preferences, and computer simulations. This talk will describe recent efforts led by research scientists in FDA’s Center for Devices and Radiological Health to demonstrate the maturity of computational modeling tools for the evaluation of novel x-ray imaging systems for breast cancer screening as well as other examples of approaches to bringing down the cost of evidence for novel medical devices.

About the Speaker

Kyle J. Myers received a Ph.D. in Optical Sciences from the University of Arizona in 1985.  She is the Director of the Division of Imaging, Diagnostics, and Software Reliability in the FDA’s Center for Devices and Radiological Health. Along with Harrison H. Barrett, she is the coauthor of Foundations of Image Science, published in 2004 and winner of the First Biennial J.W. Goodman Book Writing Award from OSA and SPIE.  Dr. Myers is a Fellow of AIMBE, OSA, SPIE, and a member of the National Academy of Engineering.

Audience: Public 


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