The Campbell Report: a roadmap to investment for health innovation life sciences and healthtech

Recommendations: Innovation and commercialisation

For supporting innovation and commercialisation

We recommend that universities

11. Work together, with support from the public sector, to create and maintain a digital online platform for life sciences and health tech/medtech intellectual property (IP) (similar to successful Singapore model) to make IP available digitally and visible globally. The opportunity to include NHS IP on the platform should be considered.

We recommend that the Scottish Government and Enterprise Agencies

12. Test and develop an approach for providing support for Scottish SMEs to access advisors on standards and regulations. This should support access from the initial stages of innovation throughout the commercialisation pathway, up until regulatory approval (for local and key global markets).

13. Develop increased regulatory knowledge within the Scottish public sector in order to better develop policy and support industry.

14. Conduct a review of the life sciences innovation and commercialisation environment in Scotland to explore opportunities for simplifying the process for companies to access domestic and international markets, including the regulatory landscape.

15. Develop and test an approach for greater risk-sharing with investors to drive innovation (eg. innovation vouchers).

We recommend that our health and care services

16. Set out our national priorities for the attention of industrial collaborators. This should include a clear single point of contact through which to initiate discussions on future collaborations, as part of an innovation pathway that extends to procurement as part of a connected national approach.

17. Develop a framework to incentivise and create the conditions to mobilise and adopt innovation across health and care services at all levels. This should maximise the huge potential to our innovation ecosystem and health and care services from making secure data available nationally for the purposes of collaborative research.

We recommend that trade bodies

18. Develop a playbook for key sectors / subsectors to act as a knowledge base on when and how to access Notified Bodies and regulators, and ensure right standards are in place at the right time.

Early stage companies and Intellectual Property (IP)

Scotland performs well in start-up activity but less well in terms of companies successfully scaling here. The recommendations in the previous section will lead to actions to provide an important first step in improving the scale-up ecosystem for health innovation life sciences. The Working Group has also looked at the earlier stages in the company life cycle from the perspective of innovation so that start-ups have the right conditions to become scale-ups. Spin-outs often emerge too early, and with too little IP, providing a weak foundation for accelerated and continued growth. Encouraging universities to collaborate more in innovation and development of high quality spin-outs with more IP, following the successful model in Singapore, should be prioritised for testing in the Scottish context to help address this issue. The approach should build on the important role of Interface in bringing together research teams with industry, and provide a platform to make Scottish IP from across sectors available digitally and visible globally. This will encourage greater collaboration across research teams in a range of settings.

Partnership with health and care services

The challenges faced by our health and care services, especially in light of Covid-19, create a requirement to better harness innovation. There is a clear benefit to health and care services in being able to adopt local innovation, where there is alignment with local and national priorities. From a company – and investor – perspective, our domestic market is small compared with larger and emerging health and care systems internationally. Furthermore, there is added risk attached to the Scottish market from selling to one main customer. The evidence gathered in developing this roadmap highlighted that some investors are making decisions that would preclude investing in companies only seeking to access the domestic market. This is due to perceived barriers, including those around innovation adoption. Change is needed so that innovative companies can maintain the option to access the domestic market (in addition to others internationally), and benefits to health and care services can be realised.

Scottish health and care services already play an important role in supporting innovation and commercialisation pathways through test beds and clinician-led activity. However, innovation is often localised and there is scope to scale innovation adoption more quickly to deliver wider improvement. A culture of innovation across health and social care services, supported by the required infrastructure, is needed to manage change and to continue to improve patient care. Health and care services offer an attractive partnership opportunity for companies seeking to innovate and commercialise products and services. There must be capacity, pump-priming and capability throughout the health and social care system to harness and adopt innovation that aligns with priorities. For example, Scotland's health data offers significant opportunity for innovation to improve health and care delivery as well as supporting investment and company growth. However, to realise this opportunity, improvements are required in the level of data that is gathered, its consistency in quality and format, and collation and management. The creation of one national health and care data platform with appropriate access for research and industry would be pivotal for supporting innovation. An inclusive culture of innovation could position health and care services at the centre of a national health innovation cluster in Scotland. This would enable a greater ability to signal to the market and shape the innovation agenda based on national public health priorities.

As set out elsewhere in this report, the first step in developing a national cluster must be about clearly articulating the component parts of our ecosystem and, in a practical sense, how to make connections. For both a local and international audience, our public services need to more clearly communicate our systems, particularly where they are separate to other parts of the UK. Building on work programmes underway, there is also greater need to signpost access points for opportunities for partnership, collaboration, innovation and investment.

Innovation responsive to public health priorities: Novabiotics

NovaBiotics is a clinical-stage biotechnology company revolutionising the treatment of medically unmet, life-threatening and life-limiting diseases with novel, immune-based therapies. A leading innovator with the ambition to transform treatment paradigms in inflammatory, infectious and respiratory disease, the Company's robust technology and business model has been validated through successful development from concept through to phase 3 clinical development of its most advanced product candidates. In addition, Novabiotics has generated a robust pipeline of earlier stage, high- value drug candidates including life-threatening and drug-resistant invasive and respiratory fungal disease and for multi-drug resistant bacterial infections. Key to NovaBiotics, a pre-revenue SME, being able to advance its programmes to late-stage clinical have been partnerships with the NHS, both in conducting investigator-led, real-world clinical studies for our drug candidates and in providing invaluable clinical expertise across all of our programmes which has helped shape our drug development pathways and added immense value to our pipeline.

Access to market

The Working Group identified access to markets as a priority area for discussion. The recommendations aim to create a seamless route to both national and international markets. Regulatory pathways must be clear and easy to navigate, both for experienced industry players and new innovators. EU Exit has made this more difficult, as well as creating additional barriers to accessing EU-based regulatory advisors. This creates increased importance to accelerate development of the regulatory elements of the Scottish ecosystem, including governance. Different types of advice and guidance are needed, including practical interpretation, sub-sectoral guides, and one-to-one support as required, particularly for first time innovators.

Health and care services may also support this by partnering with companies at an early stage to provide support, regulatory advice, access to clinical testing and an understanding of the clinical pathway to adoption and successful commercialisation. Health and care services stand to benefit from innovation partnerships and so do scaling Scottish health innovation companies. For companies, commercialising through partnership with the NHS provides the credibility to succeed in other markets. Scotland also has an international profile based on the credibility of our ethics and regulatory systems, offering companies a first market opportunity, from which products and services could be readily exported. Directed support at the right time could enable SMEs to consider targeting international markets much earlier in the lifecycle. By taking up opportunities for partnership with health and care services, scaling companies could be better able to access international markets while remaining rooted in Scotland. This would mean that the economic benefits stay in, or return to, Scotland and the health innovation ecosystem will continue to flourish through a positive feedback loop of global capital investment, inward company investment, talent and innovation.

Local innovation with global ambition: TauRx

Aberdeen's TauRx is a global leader in tau protein research. Their mission is to develop and commercialise products to treat and diagnose neurodegenerative diseases caused by misfolding and aggregation of tau, with current focus on developing a treatment to slow the rate of decline in Alzheimer's Disease, one of the world's greatest unmet medical needs. Results of their phase three clinical trial will be announced in 2022, with potential market launch by end 2023.

TauRx is an active member of Scotland's growing life sciences cluster. The company believes the commercialisation of breakthrough products will anchor Scotland's research capability while trailblazing alternative marketing and distribution routes.