The UK’s departure from the European Union looks likely to dent many sectors at least in the short to medium term, but the biopharmaceutical industry is one that might just continue to shine, however damaging the exit from the trade bloc proves to be.
The quality of innovation coming out of labs, with 25 of the world’s top-selling 100 drugs discovered – albeit not always commercialized – in the UK, is a major factor, along with a healthy flow of investment from the USA and elsewhere, strong research charities and academic heritage.
Having the National Health Service (NHS) too, which is generally willing to adopt innovation and therefore joins up the drugmaking ecosystem, is helpful, but it is something that is spoken about less that really makes the UK stand out.
This is the ability to ‘bridge the gap’ in those parts of the ecosystem that need it, from discovery to manufacturing, even when the therapies in development are so advanced that the gaps have not existed before and need to be foreseen before they become an obstacle.
They are being bridged with the help of specialist agencies, in particular The Cell and Gene Therapy (CGT) Catapult and the Medicines Discovery Catapult (MDC).
The catapult programs are part of a network of government-backed centers designed to transform the UK’s capability for innovation.
In terms of the CGT Catapult, this was set up in 2012 to bridge the gap between academic research and commercialization of cell and gene therapies, with chief executive Keith Thompson explaining that the plan for the agency was based “around what’s getting in the way of the development of the industry, which was characterized as not understood and too risky to attract major investment from either big pharma or venture capitalists.”
The CGT Catapult has sought to lower the barriers to investment in the scientific, technical, clinical, regulatory and business-related areas, represent significant challenges for researches in cell and gene therapy.
Trials on the rise
There is evidence that this work is helping, with the CGT Catapult saying earlier in 2019 that there were 85 clinical trials and 875 pre-clinical research projects in cell and gene therapies ongoing in the UK, representing a 37% and 20% increase year-on-year, respectively.
Only last year, the UK’s advanced therapy ecosystem was strengthened in 2018 by two major developments. One was the opening of CGT Catapult’s cell and gene therapy manufacturing center to create the infrastructure needed to produce advanced therapies at scale. The other was the formation of a network of Advanced Therapies Treatment Centers designed to help ensure the benefits of the innovation taking place in the UK reaches NHS patients.
Mr Thompson said: “The UK is fast becoming the premier hub for advanced therapy R&D. We are building the world’s most complete advanced therapies ecosystem.
“As the number of clinical trials has accelerated, the UK has made a determined effort to scale-up its research and manufacturing infrastructure to ensure this rich pipeline can continue to advance and grow.”
The MDC is a newer agency, having been around since 2017. Its chief executive Chris Molloy said that its role is to industrialize and drive the adoption of emerging technologies in drug discovery and development to help overcome certain challenges, and he highlighted one area where promising assets were frequently hitting a wall.
“The community now is facing an issue of predictability in Phase II,” he said. “That leads to a cross-community issue with return on investment in R&D. From big pharma, that cascades down into biotech.
“In order to become more predictable and more productive, the industry has got to start adopting more predictive and productive technologies. The MDC is here to industrialize those out of the academic milieu into industry, trying, testing proving doing those things that no one person in the community can do or would wish to do on behalf of the community. So we are always answering the ‘somebody really needs to’ question for this sector.”
Facilitating access to national infrastructure
Examples cited by Mr Molloy include organ-on-a-chip, acoustic mass spectrometry and other informatics technologies that are emerging, with the MDC then helping them to become usable in the industrial environment.
“Then we expect the industry to adopt them and then we will move on to the next thing, so what we are there for is to bridge the gap between all the great stuff that is being generated in the academic environment and the requirement to use that in an industry that has a great tradition of doing things in a particular way,” Mr Molloy explained.
In this way, drugmakers can perhaps adopt more complex pre-clinical models that reflect disease better, or use more innovative early stage clinical trials methods, to get over barriers such as the high Phase II failure rates.
It has quickly become clear to Mr Molloy that there is a major need for the MDC in order for start-up biotech companies to grow and prosper.
He said: “We’re providing smoother access for biotech companies to parts of the national infrastructure that they find very hard to get hold of. Around 40% of biotech companies have fewer than five people in them, so access to national infrastructures, national capabilities, is really hard for these guys, so one of the things that we’re doing is lowering the barrier for them.”
Investment defying Brexit uncertainty
Mr Molloy said that the most accurate way of describing the agency is perhaps as a national workshop where emerging tools, technologies and methods are put on the wall for industry to use. But it is not just industry wanting to maximize the potential of these tools.
Mr Thompson said: “What impresses me is the NHS leadership wanting to get ahead of the curve. They even seconded some key people into the CGT Catapult. They understand that they are at the heart of an economic ecosystem as well as a health ecosystem.”
With such willingness to embrace new technologies throughout the health and economic ecosystems, it is not surprising that the UK has become known as an epicenter for developing advanced therapies.
Indeed, more than 70 advanced therapy medicinal product (ATMP) developers are active in the UK, including 56 headquartered in the country, and there are 93 clinical trials going on involving these therapies, with 27 of these sponsored by British companies.
Even with the uncertainty over Brexit, financings for ATMP companies grew 66% from £473 million ($580 million) to £785 million between 2017 and 2018.
As long as the commitment to science and making it deliver for companies and patients remains – helped by the key work of agencies such as the catapults – then the UK can be confident of remaining an ATMP powerhouse.