InSilicoUK Launch outcomes – March 2022
On 22nd March 2022, Innovate UK KTN hosted a launch event to gain engagement and cement support for InSilicoUK – an open network representing all the stakeholders in the field of In Silico Clinical Trials, including academics, industry, government, regulators, standards developing organisations.
InSilicoUK was established in 2022 by Dr Alex Frangi, facilitated by Innovate UK KTN, and already has over 650 members. Membership is free and open to everyone.
The event was held in partnership with Royal Academy of Engineering, the British Standards Institute, the Association of British HealthTech Industries, the Association of the British Pharmaceutical Industry, techUK and Avicenna Alliance.
Watch the full event here.
The term ‘in silico’ describes the use of computational modelling and simulation in clinical trials, echoing the ‘in vitro’ and ‘in vivo’ labels appended to conventional clinical trial methodologies.
The event brought together policy-makers and funders to learn about the transformational prospects of In Silico Trials and framed the current window of opportunity for the UK to claim a global leadership role in computational modelling and simulation in the development of new medical products and therapies (i.e., drugs, devices, software, and their hybrids). These in silico methods have numerous benefits for industry and the public good.
As well as key-note talks from George Freeman MP, Minister for Science, Research and Innovation, and Indro Mukerjee, CEO of Innovate UK, over 200 attendees of the online event heard presentations from Professor Alex Frangi and Dr Tina Morrison, Director of the Office of Regulatory Science and Innovation at the FDA.
They also heard two panel discussions, one from industry representatives, the other from the point of view of regulators and standard-developing organizations.
The event ended with concluding remarks from Rob Turpin, and two of the event’s sponsors, Dr Jennifer Harris, Director of Research Policy at the Association of the British Pharmaceutical Industry, and Sue Daley, Director of Technology and Innovation at Tech UK.
The launch considered the urgent need to find robust ways of validating that evidence produced by in silico trials (IST) is safe, effective and reliable. This is so that it can be accepted by medical regulators and, critically, that the medical products and therapies it supports will be adopted by practitioners and trusted by patients. As Johan Ordish, Deputy Director of Devices, Software and Digital Health at MHRA, put it, “The objective is, as far as possible, to reduce, refine and replace conventional clinical trials with the opportunistic reuse of data.”
The ambition is aligned to the UK Government’s policy for innovation as set out in the recent independent report from the Taskforce on Innovation, Growth and Regulatory Reform (TIGRR), which identifies, amongst other things, the UK’s strengths in digital health and the regulation of medical trials as significant opportunities for the nation.
As the keynote speaker at the event, George Freeman MP, Parliamentary Under-Secretary of State for Science, Research and Innovation, enthusiastically supported the ambition and warmly welcomed the InSilicoUK initiative. He said:
“In the healthcare sector, digitalisation and the genomics revolution are coming together to create the most profoundly disruptive but exciting opportunity to transform the way we develop medicines and diagnostics and therapeutics. We will take a ton of time and money and cost out of the system. We can reimburse properly. And get people healthier Earlier. That’s the dream. To do that we’ve got to both keep investing in deep science and in digital but, crucially, the UK has got to make a play to be the global regulatory testbed for digitalisation of healthcare.”
As one of the authors of the TIGRR proposals and now charged by the Prime Minister with implementing them, the endorsement shows that the InSilicoUK is backed by political good will, and set the tone for a lively, informative and positive meeting.
Without underestimating the challenges ahead, speakers and panellists not only confirmed the critical importance of the ambition but were optimistic that it could be achieved.
Some of the key takeaways from the event included:
- To encourage adoption of in silico techniques in the regulatory process, regulators should prepare the ground and clarify their needs to industry by helping to develop standards at the Earliest possible opportunity and providing guidance to developers.
- IST techniques need input from all the stakeholders, from study design teams, sponsors, funders, study delivery teams, regulators, standards bodies, patients and the public.
- With appropriate mechanisms and technological solutions for safeguarding privacy, extending consent for the use of health data in ISTs should be encouraged on the grounds that it maximizes patient benefit and public health.
- International collaboration between all stakeholders is critical in all aspects of the initiative and at all stages of R&D.
- InSilicoUK should learn from best practice and the experience of the successful introduction of modelling and simulation methods in other sectors, notably the aerospace and automotive sectors.
- The ecosystem of IST is multi-disciplinary, with the digital technology sector in particular able to play an important role in enabling ISTs by addressing issues of interoperability, cybersecurity and privacy.
- Establishing the credibility of and trust in ISTs will require innovative approaches to testing and information sharing to overcome commercial sensitivities and uncertainty.
In his concluding comments, Prof Alex Frangi, founder and lead coordinator of InSilicoUK, broached the topic of cost-benefit. Verifying and validating IST in all its use cases will of course incur present costs, which is predicted to be amply paid back later in financial savings, economic benefits, and better health outcomes. To understand the potential worth of the ISNUK objectives, it is important to quantify those costs and potential gains, both for private industry and public good, and to work together for change.
In the meantime, Indro Mukerjee, CEO of Innovate UK, confirmed that his agency stood ready not just to facilitate the initiative but to serve as a catalyst for its realisation by inspiring, involving and investing.
InSilicoUK is producing a roadmap report to map the expertise, activities, benefits, challenges and recommendations for driving forward the development and adoption of ISTs in UK as part of an international landscape. Join the community on Slack here and get in touch wtih Karen Wilkinson if you want to be involved.