Professor Cathy Tralau-Stewart PhD, Executive Director, Milner Therapeutics Institute, University of Cambridge, UK, asks why a new approach is needed in the UK for getting therapies to the market.

Evolution of the translational path

Academic institutions contribute a substantial share of the therapeutic approaches that ultimately reach patients (1), but the path to translating such innovation to clinical use is difficult and haphazard. Therapeutics discovery is challenging and has a very high likelihood of failure from idea to clinical validation, making it expensive ($2-4BN) and increasingly difficult to fund. As this high-risk process continues to evolve, it is now widely accepted that monogenic genetic linked diseases have a considerably greater success rate in delivering impactful marketable medicines. This is due to there being known disease mechanisms, severity of disease, identification of the right patients for the right medicine and clear clinical trial approaches. 

In times past (pre-2000), academic research was largely focused on understanding biology and disease mechanisms, and universities therefore focused on ‘research and teaching’ activities. The research was mainly funded by government and charity grants with industry investing in areas of basic research where they saw future potential – often significant investments into research groups for extended time periods. Pharma was primarily focusing on disease mechanisms, new potential drug targets, and novel small molecule and modality approaches, and interesting approaches were licenced by academic institutes to pharma companies for further progression. At this point institutes filed patents on many basic inventions including potential targets and disease mechanisms. 

These investments into early research were high-risk and only a few would result in successful therapeutic products for industry to achieve an acceptable return on their investment. To increase the likelihood of success, pharma companies investigated many models and designed collaborations which shared the risk and cost of this research. The Structural Genomics Consortium was founded in 2003 and was one of the first multi- pharma public – private consortia based upon creating crystal structures of proteins and potential drug targets. Many other therapeutic and technology focused public-private consortia were also developed globally i.e. The Bespoke Gene Therapy Consortium, Childrens Cancer Therapeutics Consortium. 

Growth of the start-up culture

Within a similar timeframe, the start-up culture to develop ideas into companies was growing. One of the most successful early start-ups of that time was Genentech, founded by Robert Swanson and Herb Boyer California in 1976. Genentech was formed following Boyer and Stanley Cohen’s discovery of recombinant-DNA technology, which led the way to successfully expressing a human gene in bacteria when they produced the hormone somatostatin in 1977 and insulin in 1978. This led to a massively successful start-up, which is now part of the Roche organisation. Many universities have since been taking too much equity in their spin-outs, which did not support fundraising. 

The translational eco-system has been evolving since then, driven by a need to reduce company investment risks, improve focus and efficiency of the process, and ultimately improve the likelihood of delivering new therapeutic products to the clinic.

Who is funding therapeutic asset development in the UK in 2025?

Universities increasingly avoid filing patents on targets and biological mechanisms, which are considered unprotectable and poor investments. Pharma and investors are now moving their interest to IP protected assets, which are closer in the development pathway to the clinic. More of these approaches are to be found in start-ups as few universities have the required capabilities, skills and funding access to effectively support these phases. Access to funding is limited and highly competitive for these stages and there are accepted ‘valleys of death’ where funding is particularly limited in product creation and scale-up stages (2). Many universities are now taking less equity in start-ups which helps with their fundraising. In 2025, investors and pharma companies continue to invest to a greater extent in later stage projects and assets which are closer to delivering to their pipelines (3). In the UK, limited investment goes into the earlier pre-clinical stages where academia usually works. 

In 2014, charities and non-profit organisations such as The Wellcome Trust Seed funding initiative were the highest funders (~40%) of drug discovery in academia, with Research councils (mainly MRC ~20%) and EU funding (~10%) contributing about 30% (4). In 2014, US Research Institutes (NIH mainly) funded ~40% of academic drug discovery research. In, 2025, the Wellcome Trust initiative has halted, and EU funds declined significantly (currently UK eligible Horizon grants are very competitive and limited).

Figure: funding sources for academic drug discovery (5)

The need for greater funding to develop assets and product is well recognised. The recent DSIT report (6) highlighted the value of public investment in R&D: ‘Based on a comprehensive analysis of the evidence, DSIT’s assessment is that, on average, £1 of civil public R&D investment generates £8 in net economic benefits for the UK over the long term”. Public investment is also strongly linked to UK productivity. Universities are increasingly developing linked mechanisms to raise funding to support early-stage company development ie Oxford Science Enterprises and Cambridge Enterprises Technology Investment Fund. 

The importance of intellectual property capture for return on investment

Universities need to find ways to re-coup some ownership and return on investment for supporting translational activities. To do this, they need to capture asset- based IP and/or start-up equity.  

There are excellent examples of institutions in the USA and Canada that are creating the required facilities and support to develop therapeutic assets: Stanford, UBC, Florida, UCSF, Vanderbilt (Jeff Conn), UNC (Stephen Frye), Johns Hopkins (Barb Slusher). A longer list of these can be found at Academic Drug Discovery Consortium. 

The need for UK universities to develop approaches to asset creation was recognised as early as 2009 (4,5), and the development of academic drug discovery approaches was led in the UK by MRCT/ LifeArc, Cancer Research UK and Dundee University (Drug Discovery Unit. Other universities such as Sussex, Cardiff and Imperial also house limited initiatives. In Europe, good examples include EU- Max Plank LDC  and CD3 KU Leuven Belgium. 

For therapeutics translation, although the breadth of skills learning and development in higher education is increasing considerably, there are still many areas of skills and expertise required for academic researchers to directly support and develop asset generation and progression.  There is a need to develop more supportive well-funded eco-systems linked to universities to support therapeutics translation. 

Growing a supportive eco system

The UK requires an ecosystem that effectively supports therapeutics-related innovators and start-ups to develop novel assets, partner with pharma, and to return investment to investors and contributors.  

There has been significant growth in commercial incubators, but these are often costly for start-ups with limited funding. Universities UK reports that the number of student and staff start-ups increased by 70% from 2014-15 to 2022-23. 

Academic incubators often support early-business activities using HEIF funding allocated by its university. The Centre for Entrepreneurs suggests that there are 269 university-affiliated incubators and accelerators across the UK, and it is understood that start-ups are more likely to survive with university support: 60% of Start-ups fail within three years, yet there were over 10,000 university start-ups that have been active over three years in 2022-23. For positive growth in start-ups, the government needs to expand HEIF funding for incubators. 

Many universities have initiated the development of incubator infrastructure to support start-up creation and development. These represent a significant investment in the growth and development of technology-based start-ups in the UK and an opportunity to return investment into UK higher education institutes. 

New funding opportunities for therapeutics?

For UK growth and university value-creation it is important for the UK government to invest in the university therapeutic asset development space through the research councils, Innovate UK, the British Business Bank (BBB), and the National Wealth Fund (NWF). The development of NIH SBIR- like approaches would support this further, and universities also need to invest in opportunities to build therapeutics companies and capture return on investment. 

A further potential for investment in this sector is from UK pension funds. The recent Science and Technology Committee report 2025 highlighted the importance of the Mansion House reforms to move forward for UK pension funds to invest in UK-based technology. Active investment of pension funds into therapeutics start-ups and biotechs will provide significant opportunities for company growth and new therapeutics development. 

The Milner Therapeutics, University of Cambridge

The Milner Therapeutics Institute (MTI), University of Cambridge was founded in 2015 by Professor Sir Tony Kouzarides and Dr Jonathan Milner, who are also co-founders of Abcam. The Milner Institute was created to drive interactions between academics and industry to support therapeutics discovery. Initially, this involved three pharma companies and three academic institutions and was focused on providing academics with access to pharmacological tools for their research. The model has since developed into a unique institute focused on developing partnerships between academia and industry to discover new therapeutics, improving how we discover new molecular drug targets, developing entrepreneurial talent and developing and supporting new start-up companies.  

The Milner Therapeutics Consortium currently has 10 major pharma companies, and its affiliated companies include 80+ life sciences companies that interact with the MTI to develop partnerships with the Cambridge academic and industrial eco-system. 

The Milner Bio-incubator supports early-stage therapeutics related start-ups to validate their hypotheses and develop their proposition for next-stage pre-seed or Series A funding. Currently, the Milner Bio-incubator houses and supports 10 early companies, providing access to shared expertise, laboratory space and equipment. Milner Incubator companies have successfully raised more than £100M and created over 160 jobs. Recent examples of successful fundraising include Epitopia & TrimTech. There is a significant need for this type of infrastructure in universities across the UK to grow strong, scalable life sciences companies. 

The Milner Therapeutics Institute is a unique model that supports academic drug discovery translation by working with all parts of the life sciences eco-system to build collaborations, create and support development of new innovative therapeutics and support company growth. 

Summary

The translation pathway from early disease-related innovation through to patients has changed significantly in the last 20 years. It is essential that innovators and entrepreneurs are supported in these endeavours to develop a strong UK therapeutic asset creation and development pathway and deliver UK life sciences sector growth. In the therapeutics space we need to support: 

• Therapeutic asset creation activities in the university sector, with access to funding and industry-related development expertise 

• Development of supportive ecosystems to create and aid start-ups and progress asset development into the clinic, or to partner with industry to the clinic. These include access to incubators, laboratories, the required equipment and expert technical mentoring. 

• Entrepreneurial training, mentoring and support.  

This represents a major opportunity for UK growth, which builds on the strong established therapeutic sciences base within universities. It is urgent that we develop the effective support to grasp the opportunity and build and scale our therapeutics sector.

About the author 

Dr Cathy Tralau-Stewart is a pharmacologist with experience of academic and industry drug discovery in the UK and USA, ranging from target discovery to early clinical assessment in many therapeutic areas. Her track record includes material involvement in numerous marketed products and candidate compounds. 

References

1: Takebe T, Imai R, Ono S, Clin Transl Sci (2018) 11, 597-606 

2: House of Lords, Science and Technology Committee report 2025 ‘Bleeding to death: the science and technology emergency: https://committees.parliament.uk/committee/193/science-and-technology-committee-lords/ publications/  

3: J.P. Morgan Q2 2025 Biopharma Licensing  and Venture Report July 2025 

4: Tralau-Stewart CJ et al 2009, Drug Discovery Today Volume 14, Numbers 1/2 January 2009 

5: Tralau-Stewart C et al, UK academic drug discovery, Nature Reviews drug discovery Vol 13, January 2014 

6: DSIT Research and analysis ‘The value of public R&D’ Published 30 October 2025 https://www.gov.uk/government/publications/the-value-of-public-rd/the-value-of-public-rd 

From DDW Volume 27 – Issue 1, Winter 2025/2026 – Read the digital issue here