Our long-term collaborator and in silico advocate at FDA, Tina Morrison, has been promoted to Director of Regulatory Science and Innovation
In this new position, Tina Morrison has the opportunity to provide strategic leadership, coordination, infrastructure and support for excellence and innovation in science at the FDA. She is working to advance the Agency's ability to protect and promote the health of the public, through engagement with stakeholders, support of on-going activities, like the Centers for Excellence in Regulatory Science and Innovation (CERSIs), and the development of new programs and initiatives.
Tina has advanced the role of computer modeling and simulation in medical device design and product evaluation during her tenure at FDA. Lauding her work ethic, in 2016 the FDA Office of the Chief Scientist entrusted her with forming and leading an agency-wide working group on modeling and simulation, whose workshops attracted hundreds of FDA participants. She also headed the drafting of FDA’s breakthrough guidance for modeling: Reporting of Computational Modeling studies in Medical Device Submissions, attracting international recognition. Outside the Agency, Tina has led the development of pathways for enhancing modeling credibility and acceptance. For instance, she was selected by her peers to lead a 3-year effort in developing a verification and validation standard for ASME, which culminated in 2018 with the first-ever set of evaluating procedures for computational modeling of medical devices. The FDA recognized this standard for support medical device evaluation. Because of these efforts, Tina was selected as the 2019 Federal Engineer of the Year for FDA.
Tina also serves as Chair of the ASME Committee on Verification and Validation (V&V) of Computational Modeling, where she is leading the development of a method to assess the credibility of computational models. She helped lead the ASME V&V 40 standard published in Nov-2018, culminating 6 years of work with 40+ industry partners. She is working with a team at CDRH to implement this strategy into the review of premarket submissions that leverage computational modeling.
Tina has been a much appreciated speaker at many VPHi and Avicenna Alliance events, conferences and summer schools (link: https://www.vph-institute.org/webinar/towards-credible-modeling-and-simulation-at-the-fda-virtual-patients-for-regulatory-decision-making.html). In this VPHi video, you can hear her explain why organisations like VPHi are important (https://youtu.be/cse_GBcHcsc ,1’53”).
Tina is a mechanical engineer who studied Cardiovascular Biomechanics as a post-doctoral fellow at Stanford University. During that time, she investigated the in vivo biomechanics of the aorta using gated CT imaging; those data are now used as boundary conditions for modeling and bench-testing of devices in medical device submissions. She received her PhD in Theoretical and Applied Mechanics from Cornell University in 2006.
We congratulate Tina on this wonderful opportunity and look forward to continuing working with her and her colleagues at FDA to strengthen in silico medicine to the benefit of the patients world-wide.
