FDA Strategic Roadmap for 2018 and beyond: a focus on computer modelling and simulation

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:

• Development of updated statistical and computational methodologies as part of the medical product review process to evaluate clinical trial data using improved methodologies;
• Organisation of workshops, publication of guidance documents and development of policies and procedures for leveraging modelling approaches.

Background

The FDA’s 2018 Roadmap revolves around 4 priority areas:

1. Reduce the burden of addiction crises that are threatening American families;
2. Leverage innovation and competition to improve healthcare, broaden access, and advance public health goals;
3. Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease;
4. Strengthen FDA’s scientific workforce and its tools for efficient risk management.

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.