Evidence and Impact
What is the UK and international evidence and impact behind in-silico technologies based?
KPMG Life Sciences Regulatory Solutions
In Silico Regulatory Evidence Utilisation within the Life Sciences Sector
In an age where technology and artificial intelligence are reshaping industries, KPMG Life Sciences Regulatory Solutions dives deep into the game-changing potential of Computational Modelling and Simulation (CM&S) and In Silico Evidence (ISE).
Why This Matters:
Accelerate R&D: Expedite product development and bring life-saving treatments to market faster.
Innovate Safely: Reduce reliance on animal testing with in silico clinical trials, ensuring treatments are effective across diverse populations.
Cost-Efficient: Slash R&D costs and risks, and navigate global regulatory landscapes with confidence.
Reagan-Udall Foundation for the FDA
In Silico Technologies
A strategic imperative for accelerating breakthroughs and market leadership for FDA-regulated products.
Key points supporting the business case for ISTs include:
• ISTs accelerate innovation—providing an environment for rapidly exploring promising ideas; • ISTs are cost-effective—knowledge capture and transfer are streamlined; • ISTs are a ‘new normal’ in product development life cycles in traditional engineering product development; • ISTs are being accepted by the FDA in support of regulatory submissions; • Global regulatory landscapes are also shifting to accept evidence generated from ISTs; • ISTs strengthen the product safety profile of devices and drugs, and build a competitive advantage over the status-quo; • ISTs enable progressive tangible next steps and structural changes for maximal transformation (leap in trust)
InSilicoWorld & Avicenna Alliance
Toward Good Simulation Practice
This book is open access, you have free and unlimited access
Offers readers a unique guide to In Silico Trials
Documents consensus process run by the most authoritative organisations worldwide in the field
Represents the first attempt to produce a consensus position on the best practice for In Silico Trials
Reagan-Udall Foundation for the FD
In Silico Alternative Methods
The FDA’s Office of the Chief Scientist’s Office of Regulatory Science and Innovation (ORSI), in collaboration with the Reagan-Udall Foundation, established the Regulatory Science Accelerator (RSA) to support emerging technologies. The RSA facilitates information sharing about upcoming technologies for FDA centers. This report details the discussions of the RSA's in silico alternative methods workgroup, where experts proposed In Silico methods to replace animal models in FDA-regulated product development. Proposals were ranked by impact and effort, with summaries provided. The FDA’s Modeling & Simulation and Alternative Methods Working Groups, comprising over 200 scientists, reviewed these discussions and offered regulatory science insights.
InSilicoUK Network, MHRA and Royal Academy of Engineering
Journeys, experiences and best practices on computer modelled and simulated regulatory evidence— 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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