Science & Research

FDA Grand Rounds

Image of scientist holding test tube

 


The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.  #FDAGrandRounds.

Thursday, August 9, 2018
12:00 p.m. - 
1:00 p.m. EST

Register here for Webcast (Public attendees and FDA staff)
CE credit is available

For technical assistance please contact Jeffery Rexrode at: Jeffery.Rexrode@fda.hhs.gov
Remote Access Instructions are found at bottom of web page*

Presented by

Tina Morrison, PhD
Deputy Director
Division of Applied Mechanics
FDA’s Center for Devices and Radiological Health (CDRH)

Webcast Lecture

          How Simulation Can Transform Regulatory Pathways

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.

Remote Access Instructions/Webcast Registration (pre-registration is required):
To register for the webcasts, please click the registration link and then follow the instructions on the registration pages. After you register you will receive links via e-mail as outlook calendar invitations with information on how to access the live webinars. You must log in with your username and password which you create when you register. You must pre-register at least one day before the event to ensure that the access link e-mails and outlook invitations are received for each day.

HHS/LMS Registration Link for FDA employees for in-person attendance is here(FDA employees must also register in the LMS if registered for the webcast to ensure that the training will be listed on their official LMS transcripts after completing it)

Past Grand Rounds

2018

2017

2016

     

Page Last Updated: 07/09/2018
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