Resources

Evidence and Impact

What is the UK and international evidence and impact behind in-silico technologies based?

InSilicoUK Network, MHRA and Royal Academy of Engineering

Journeys, experiences and best practices on computer modelled and simulated regulatory evidenc— Cross-Regulator Workshop Report

Evidence generated by computer modelling and simulation methods (CM&S) have the potential to reduce, refine or even replace late-stage human testing, benefiting patient safety, the economy and sustainability. However, an identified barrier to their further scaling is uncertainty about regulator’s expectations and requirements for CM&S evidence.

This report reflects on the best practices, experiences and journeys of different regulators to explore what barriers remain and what next steps are needed to improve their regulatory acceptability.

Guidance for Industry and Food and Drug Administration Staff

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

This guidance document provides the FDA’s recommendations on a risk-informed framework for credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. This guidance applies to physics-based, mechanistic, or other first principles-based models. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions, to increase confidence in the use of CM&S in regulatory submissions, and to facilitate improved interpretation of CM&S credibility evidence submitted in regulatory submissions.

InSilicoUK Pro-Innovation Regulations Network

Unlocking the power of computational modelling and simulation across the product lifecycle in life sciences

A UK Landscape Report

This report

Outlines the public health and economic benefits of using in silico technologies (ISTs) to refine, reduce, and even replace the need for conventional human clinical trials and animal and physical testing in the development of new medical products,
Describes current barriers to the expanded use of ISTs,
Identifies opportunities for the UK to spearhead the global effort to develop ISTs, making the UK a leader in the field and, therefore, friendly to inward investors,
Details the significant commercial and economic benefits in the development of the UK life sciences sector and broader societal benefits to the NHS, UK, and the world in general,
Makes recommendations on how the UK government can support this initiative.

InSilicoUK Pro-Innovation Regulations Network

The Economic Impact of In-Silico Technology on the UK and its Lifesciences Sector

By 2025 at least £2.6 billion worth of Pharma and Med Devices underpinned by in-silico methods will be made in the UK, even at our current share of the global manufacturing.

In-silico technologies will be critical to the future of the 111,200 directly employed in 2010 UK manufacturing sites in the Pharmaceutical and Med-Tech sectors.

InSilicoUK In collaboration with Beauhurst and InnovateKTN

Researching next-generation life sciences innovations in the UK

On the UK’s Public and Private Equity investment in the UK over the past 10 years on in silico medicine technologies

https://www.beauhurst.com/research/in-silico-medicine/

Medical Device Innovation Consortium

Use of Computational Modeling & Simulation in Medical Device Development

Computational modeling and simulation (CM&S) has numerous applications throughout the medical device life cycle, from product development and testing to clinical evaluation, premarket submissions, and postmarket performance assessment and failure analysis. CM&S has the potential to reduce or eliminate the need for physical prototyping and testing, and to rapidly and cost-effectively evaluate more design and clinical use variations than are feasible using traditional methods.cuments

Modelling & Simulation WG, FDA’s Office of the Chief Scientist,

Successes & Opportunities in Modeling & Simulation for FDA

Elucidates how and where M&S is used across FDA, and the type and purpose of M&S used
Presents a selection of M&S case studies from across nearly all FDA centers, which demonstrate how M&S is playing a tangible role in FDA fulfilling its mission
Identifies opportunities for FDA to better harness M&S in upcoming years by embracing computational advances and new (and big) data streams to develop improved public health solutions

Government Office for Science

Council for Science and Technology

Computational Modelling: Technological Futures

This report, also known as Blackett Review, sets out the findings of a review looking at the rapid evolution of UK computational modelling capability, and how it could be better used in both the public and private sectors.

UK HM Treasury

Quality Assurance of Government Analytical Models: Review

Following the ‘Review of quality assurance of government analytical models’, a cross-departmental working group on analytical quality assurance was established. The Aqua Book is one of their products and is a good practice guide those working with analysis and analytical models. It establishes the principles and fundamental best practices that apply to scientific evidence and policy development.

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