Making the UK the best milieu for delivering medical innovations using in silico evidence and regulatory science.

InSilicoUK - A pro-innovation regulatory science and innovation network funded by InnovateUK

We're bringing together a dynamic, pro-innovation community focused on shaping a national strategy that's all about fast-tracking the adoption of in silico trials.

Our goal? To deliver medical breakthroughs that benefit patients, spur economic growth, and place the UK at the forefront of healthcare innovation. Get ready for a healthier, brighter future!

“The InSilicoUK Landscape Report is the grassroots response to therecent review of the pro-innovation regulation of life sciences technologies byprofessionals from industry, academia, NHS and beyond. Without trivialising the challenges and obstacles to overcome, it highlights the evidence, benefits, and investment opportunities to take advantage of existing UK talent and infrastructures.”

Unlocking the power of computational modelling and simulation across the product lifecycle in life sciences: A UK Landscape Report.

Professor Alejandro Frangi, RAEng and Bicentennial Turing Chair in Computational Medicine, University of Manchester

“This is a much-needed report that sets out the rationale, opportunities and economics of adopting regulatory evidence based upon computational modelling and simulation. It sets actionable recommendations that, if adopted, will put the UK in a world-leading role as a science, innovation, and regulation powerhouse.”

Professor Rebecca Shipley OBE, Professor of Healthcare Engineering, University College London

“Healthcare is at a critical turning point: this decade sees life-saving medical products and technologies emerging at unprecedented speed; yet their regulation still relies on lengthy and arguably imperfect safety and efficacy assessments. CMS can be a game changer by expanding the range of evaluation options available for device designers. However, its adoption needs derisking and accelerating through close public-private partnerships demonstrating the promise. If Britain successfully mobilises industry, academics, andregulators with this common goal, it will enjoy first-mover's gains."

Professor Tim Denison, Royal Academy of Engineering Chair in Neurotechnologies, University of Oxford

In silico trials

refers to the development of patient-specific models and simulations to form virtual cohorts for assessing the safety and/or efficacy of new drugs and new medical devices.

In silico, in vitro, in vivo, in situ…

Complementary sources of scientific evidence and drive confidence in patient benefit, safety, and effectiveness

In silico medicine

Transforming the UK into the premier hub for pioneering medical innovations, where in silico evidence and cutting-edge regulatory science converge to create a thriving environment for healthcare breakthroughs!

Transforming the UK into the premier hub for pioneering medical innovations,

Where in silico evidence and cutting-edge regulatory science converge to create a thriving environment for healthcare breakthroughs!

The Mission

To widely adopt in silico evidence in regulatory practice, our community is tackling the following challenges  

  1. Validation and Verification: Ensuring the accuracy and reliability of in silico models is crucial. Regulators need robust methods to verify and validate these models to ensure they accurately predict clinical outcomes. This involves establishing the credibility of the model for the intended context of use.

  2. Standardisation: There is a need for standardised methodologies in the development and use of in silico models. This includes standardising how data is collected, analyzed, and reported. Without standardisation, it can be challenging to compare and assess the results of different in silico trials.

  3. Data Quality and Availability: High-quality data is essential for building and validating in silico models. There are challenges in accessing sufficient, high-quality clinical data due to privacy concerns, data sharing restrictions, and variability in data collection methods.

  4. Regulatory Framework: Existing regulatory frameworks were primarily designed for traditional clinical trials. Adapting these frameworks to accommodate in silico trials, including new types of evidence and methodologies, poses a significant challenge.

  5. Interdisciplinary Expertise: In silico trials require expertise in computational modeling, clinical science, and regulatory affairs. There is a need for professionals who can understand and bridge these disciplines to effectively develop and evaluate in silico models.

  6. Ethical and Legal Considerations: The use of patient data in developing and validating in silico models raises ethical and legal questions. Issues around consent, data privacy, and the potential biases in model development need to be addressed.

  7. Transparency and Public Trust: Ensuring transparency in how in silico models are developed and used is vital for building public trust. Regulators must ensure that these models are not "black boxes" and that their decision-making processes are explainable and understandable.

  8. Global Harmonisation: Different countries may have varying standards and regulations regarding in silico trials. Harmonizing these regulations internationally can be challenging but is important for the global development and approval of medical products.

Addressing these challenges requires collaborative efforts among regulatory agencies, industry, academia, and other stakeholders. Ongoing dialogue and the development of guidelines and best practices are essential for the successful integration of in silico trials into the regulatory landscape.

Driving UK innovation, policy, and regulation in life sciences for patient benefit

A community driving innovation and growth for patient safety and benefit using in silico evidence and regulatory science

"The TIGRR Report recommends the Prime Minister how the UK can reshape its approach to regulation and seize new opportunities from Brexit with its newfound regulatory freedoms."

Rt Hon Sir Iain Duncan Smith MP, the Rt Hon Theresa Villiers MP, and George Freeman MP, The Taskforce on Innovation, Growth and Regulatory Reform

“We will use the provisions of the Medicines and Medical Devices Act 2021 to overhaul our clinical trial frameworks, giving a major boost to the UK’s world-class R&D sector and get patients access to new lifesaving medicines more quickly.”

A community effort

Coordinated by InnovateUK KTN and the Royal Academy of Engineering, in collaboration with Avicenna Alliance and the Virtual Human Physiological Institute, we work with trade organisations, regulators, standardisation bodies and UK government.

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