On 12 January, FDA Commissioner Dr. Scott Gottlieb presented the Agency’s 2018 Strategic Roadmap, providing an overview of some of the key priorities.
Among these priorities presented in the Agency’s 2018 Strategic Roadmap, the FDA intends to develop and advance the use of in silico tools and models to evaluate device performance and patient outcomes as part of the Medical Device Innovation Consortium.
In addition, the FDA will be making investments in the Agency’s high-performance, scientific computing to develop novel methods for creating models of virtual patient outcomes and modernising FDA’s evaluation of patient benefit and risk. A similar initiative has been announced at EU level (please see our article “European Commission to invest €1 billion in world-class European supercomputers”) showing a growing interest in computational modelling from public authorities.
Other relevant priorities include:
The FDA’s 2018 Roadmap revolves around 4 priority areas:
The use of in silico techniques to develop novel methods for creating models of virtual patient outcomes falls under the second priority whereas the last priority includes a focus on expanding the use of high performance computing.
For more information, the full Roadmap can be found here.