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

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!

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

The Mission

To integrate in silico evidence into regulatory practice, we face several challenges:

Validation and Verification: We need reliable ways to ensure these models predict clinical outcomes accurately.
Standardisation: Consistent methods for data collection, analysis, and reporting are essential for comparing results.
Data Quality and Availability: Access to high-quality clinical data is crucial but often limited by privacy and sharing issues.
Regulatory Framework: Current regulations are designed for traditional trials and need adaptation for in silico methods.
Interdisciplinary Expertise: Experts in modeling, clinical science, and regulation must collaborate effectively.
Ethical and Legal Considerations: Using patient data requires careful handling of consent and privacy issues.
Transparency and Public Trust: Clear, understandable models are key to gaining public trust.
Global Harmonisation: Aligning international standards is challenging but necessary for global product development.

Collaboration among all stakeholders and ongoing dialogue are vital for success.

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.”

Lord Frost statement to the House of Lords on Brexit opportunities, Sep 16th 2021.

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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