Paul Denny Gouldson, vice president strategic solutions, IDBS talks about pharmaceutical research and development and how the sector is evolving
Paul Denny Gouldson, vice president strategic solutions, IDBS
Change is afoot for Europe’s research and development (R&D) ecosystem. Key factors that shape this sector in the region are evolving, from regulation changes and funding issues to competitive pressures and altered research practices.
These changes have been particularly prevalent in pharmaceutical R&D, in which the shift from a ‘big pharma’ model to increasingly distributed, collaborative research networks has started to turn the industry thinking on its head.
Ten years ago, if someone suggested that two large pharma companies would collaborate jointly on a new drug or exchange intellectual property, they would have been summarily dismissed. Today, however, it is happening more and more.
Patents: Quality over quantity
Patents have long been a key cog in the wheels of the pharma sector. They have also been cited as proof that the US is racing ahead of Europe, with European firms and researchers taking a more conservative approach to patent logging. Anne Glover, who recently stood down as the EU’s chief scientific advisor, suggests this risk-averse approach is holding the region back.
However, we must also factor in quality alongside quantity, taking into account the quality and rate of commercially successful patent progression rather than just volume – i.e. how many of these ideas go on to become viable commercial entities in a market? A long-awaited unitary European patent system could also redress the balance, by lowering the cost of filing, renewing and defending patents.
Skilled researchers: In demand
Europe is also battling a skills crisis. Research from the European Commission highlighted the looming threat of a misalignment between need and availability of skilled researchers, scientists and engineers.
The demand for human capital is rising sharply and the region could require an additional 16 million highly qualified people between now and 2020. Just as industry increasingly partners with academia on research projects, perhaps the answer to the region’s R&D skills issue also lies here.
We may also see a change in how some academic institutes are funded and structured, to take advantage of the more collaborative driven R&D model being adopted by pharma and biotech players.
Funding: Europe under pressure
Pharma, biotech and chemistry-related firms, already under significant pressure, suffered another blow when £1.7bn of funding was cut from Horizon 2020 – the European Commission’s flagship science research programme.
Meanwhile, UK researchers were relieved when the recent government spending review spared R&D from drastic funding cuts as initially feared. In contrast, the US aims to ramp up its National Institutes of Health budget by an additional £1.1bn annually, and infrastructure investment over the past 20 years has nurtured Boston and San Francisco to become thriving, globally recognised research and development hubs.
China is pushing further ahead still, increasing public investment and surpassing even the US in attracting foreign investment in R&D. When we consider these facts, Europe is falling behind.
Taking the lead: Global R&D
Clearly, the UK and Europe are unlikely to lead the charge in volume of research, and will never win in a ‘race to the bottom’ for lowered regulation and low-cost clinical trials. But as British scientist Ben Goldacre recently highlighted, they could realistically establish a leadership position in producing high quality research, underpinned by high quality and robust data.
Data integrity and quality should always be viewed as more important than just volume, all along the drug development value chain – from discovery through to manufacturing and beyond. Decisions made on low quality, untrustworthy data are risky decisions.
A more intelligent technology approach will help Europe remain at the top table of global R&D.
A recent Barclays report, for example, suggests that additional investment in automation and robotics could boost the UK’s pharma output by 10%. As technology for the lab becomes more intelligent and more predictive, European players would be wise to embrace solutions that enable them to automate processes, collect and manage good quality data more efficiently and collaborate with other stakeholders more effectively.
If they can succeed on that level, the future for Europe’s R&D sector could be very bright indeed.