Public Funding for Health Innovation Research Alliance

The Northern Ireland (NI) Health and Life Sciences (HLS) sector presents an emerging cluster combining expertise, infrastructure, academia and industry across a DBT designated area of High Potential Opportunity: in Precision Medicine, Biomarkers and Diagnostics. Historically, there has been a disjointed local approach with a lack of industrial capacity in specific areas due to a decade of under-investment. To address this the NI region has been awarded a HLS launchpad in recognition of the emerging cluster of \>250 R&D intensive, high-growth potential life sciences SMEs (Life Sciences superclusters for global Britain 2021). Levelling up NI HLS GVA with the rest of the UK represents a percentage uplift of 93% and a ~200-fold return on investment against the total Innovate UK Launchpad fund. The Health Innovation Research Alliance (HIRANI) is a pan-Northern Ireland not-for profit alliance of industry, Health (H&SC), NI's 2 universities (Queen's University Belfast, Ulster University), and government stakeholders working to unlock growth for health and prosperity. HIRANI is already deeply embedded across the NI cluster and acts as a single voice, promoting capabilities and priorities. Recognition of this meant HIRANI successfully led the original NI £7.5M Launchpad consortium bid with Invest-Northern Ireland (I-NI) and 5 NI councils covering 99% of HLS businesses. We are now making an application to leverage our resources developed over the last 3 years, including significant connections, assets, and cluster insights to apply for the management organisation for HLS Launchpad. This represents excellent value for money and creates significant additionality and sustainability potential, as it builds on significant assets. To enhance the productivity and growth of this sector, we propose to design a Launchpad programme that incorporates existing business-led programmes and the sector-specific needs of the cluster: skills, collaboration and external networking. Key deliverables to strengthen the cluster innovation pipeline over the Launchpad (and several sustainable beyond 2 years) include:- 1. Recruitment of our first innovation manager to align and develop bespoke wrap-around HLS business support to promote R&D from spin-outs to SMEs and engage large industry 2. A regional mentoring network (60+hours) 3. 10 skills development workshops, clinics with RTOs, KTN-Catapults, Life-Science/business leaders 4. An online sector platform to map and measure longitudinal cluster growth and impacts 5. Promotional activities to showcase success, impacts, including celebrating diversity to encourage underrepresented groups/communities 6. Kick-off and annual events with another Launchpad/cluster This proposal has full support from HIRANI founding organisations and local civic leadership, including Belfast-region, Armagh-Banbridge-Craigavon, Newry-Mourne-&-Down and Derry-Strabane Councils.

A UK Centre of Excellence in in-silico Regulatory Science and Innovation (UK CEiRSI) will scale up activities of the InSilicoUK Pro-Innovation Regulations Network, in pioneering advanced computational modelling and simulation methods (CM&S), aka in-silico methods, to develop and regulate Life and Health Sciences products. Traditional testing for medical and veterinary products is exhaustive and costly to meet stringent safety regulations for both human and animal applications. This usually entails progression from bench testing or cell cultures to animal testing, and human clinical trials. In contrast, sectors like aircraft engineering derive substantial safety and efficacy data from sophisticated computer simulations. Translating this in-silico paradigm to healthcare could revolutionise medical product development by accelerating timelines, curbing expenses, and reducing reliance on animal and human testing. In-silico testing harnesses computational models to simulate the behaviour and efficacy of life/health sciences products throughout their lifecycle. This approach employs digital twins---virtual replicas of medical products, biological systems, or manufacturing processes---and virtual patients (populations) for in-silico testing/trials. These models enable researchers to predict optimal designs and clinical outcomes, enhancing product safety and effectiveness. Digital twins in life/health sciences represent complex simulations of individual patient anatomy and physiology, allowing for personalised medicine and treatment optimisation. Virtual animals, patients, and populations are simulated constructs used in in-silico trials to evaluate the performance of medical interventions without the constraints of traditional clinical trials, offering insights into efficacy and safety across diverse patient groups. Established in March 2022, InSilicoUK (www.insilicouk.org) is a community of over 2,000 stakeholders from academia, industry, and regulatory bodies. The network is dedicated to integrating in-silico evidence into regulatory science, thus improving patient safety, and speeding up the development of medical products. By advocating for computational modelling and simulation, we will advance public health, enhance the healthcare system, stimulate the life/health sciences sector growth, and contribute to the UK's economic prosperity. The UK is set to lead the global shift towards in-silico science and its regulatory acceptance. UK CEiRSI seeks to cultivate a community that supports innovative regulation and establishes a national framework for widely adopting in-silico methods, reinforcing the UK's global influence in life/health sciences. Adopting in-silico testing places the UK at the vanguard of medical product evaluation, solidifying its status as a beacon in life and health sciences innovation. This forward-thinking approach is set to overhaul the evaluation of medical products by streamlining processes, cutting costs, enhancing precision, and upholding patient safety.