How Simulation Can Transform Regulatory Pathways
Thursday, August 9, 2018
12:00 p.m. - 1:00 p.m. EST
Tina Morrison, PhD
Division of Applied Mechanics
FDA’s Center for Devices and Radiological Health (CDRH)
About the Presentation
FDA recognizes the public health benefits offered by modeling and simulation, including those in the area of in silico clinical trials (using individualized computer simulation in development and or regulatory evaluation of medical products, medical device, or medical interventions).
FDA advocates for their use as one of many research and product development tools because modeling and simulation play a critical role in, among other areas, organizing diverse data sets, exploring alternate study design strategies, and predicting performance, so that safe and effective new therapeutics can advance more efficiently, from preclinical studies through clinical trials to market.
FDA routinely advises industry on using modeling and simulation to, for example : 1) predict clinical outcomes, 2) inform clinical trial designs, 3) support evidence of effectiveness, 4) identify the most relevant patients to study, and 5) predict product safety. In some cases, in silico clinical trials are used to replace human clinical trials, especially those that are intended to evaluate the risk of drug interactions. FDA will continue to advance these methodologies and techniques to ensure the benefits of product innovation and more rapid introduction of life-saving technology to our nation’s patients.
This presentation will provide an overview of those methodologies, highlight success stories with simulation, and discuss the potential for in silico clinical trials for advancing medical products.
About the Presenter
Dr. Tina Morrison is the Chair of FDA’s Agency-wide Modeling and Simulation working group and Regulatory Advisor of Computational Modeling for FDA’s Office of Device Evaluation. In that capacity, she leads the Regulatory Review of Computational Modeling working group at CDRH, which has developed guidance documents on using modeling and simulation in the regulatory evaluation of medical devices.
As a mechanical engineer who studied Cardiovascular Biomechanics as a post-doctoral fellow at Stanford University, Dr. Morrison investigated the in vivo biomechanics of the aorta, using gated CT imaging. Those data are now used as boundary condition inputs for computational modeling and bench-testing of endovascular devices in premarket submissions. She earned her PhD in Theoretical and Applied Mechanics from Cornell University in 2006.
Dr. Morrison dedicates much of her energy to advancing regulatory science through modeling and simulation, believing that the future of medical product design and evaluation, and thus enhanced patient care, lies with computation and enhanced visualization.