The measurement underpinning government goals for UK life sciences
pharmafile | January 22, 2018 | Feature | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | Life Sciences Industrial Strategy, brexit, john bell, life sciences, pharma
Michael Adeogun, Head of Life Sciences and Health at National Physical Laboratory, discusses the importance of effective measurement for the life sciences industry in achieving the key goals outlined in Sir John Bell’s Life Sciences Industrial Strategy, the UK Government’s accompanying Sector Deal and beyond.
The Life Sciences Industrial Strategy white paper was published in November and seeks to accelerate UK R&D in order to boost productivity and benefit our economy and society. Hot on its heels was the announcement of the Life Sciences Sector Deal, which sets out an agreed strategic vision, built on co-investment, for the government and UK life sciences that will drive the industry forward.
Good measurement is critical to realising the collective vision of both of these documents. The National Physical Laboratory (NPL), the UK’s National Measurement Institute, is one of the organisations responsible for delivering the National Measurement System (NMS) that provides the framework, facilities and expertise to enable measurements to be reproduced with confidence and with quantified uncertainty in the UK. This helps to ensure confidence in new innovation and treatments, gives assurance of consistency of care, and helps to turn health data into decisions.
Many of the goals identified by the Strategy and the accompanying Sector Deal are priority areas for the NMS too. In this article I will outline how measurement can help government and industry to achieve its goals for the UK life sciences sector. In particular, through accelerating patient access to innovative new treatments and technologies, encouraging growth of UK industry and improving the collection of health data and streamlining access, the government will be aligned with NMS’ priority areas too.
Better collaboration between the NHS and industry to speed the adoption of innovative treatments is a key part of the Life Sciences Industrial Strategy and is adopted from the government’s Accelerated Access Review. The Sector Deal seeks to implement this through establishing an Accelerated Access Collaborative, which will develop a faster pathway for bringing new products to market and to patients. For this to be successful, two stages need to be addressed: firstly, how innovative treatments are developed, and secondly, ensuring they are rapidly adopted.
1. Developing new treatments
The pharmaceutical industry needs 10-15 years and more than $1 billion to develop a drug to clinical trial stage, and even more to get the product to patients. A recent report from Deloitte shows that the average price of bringing a drug to market has now hit $2 billion, up from $1.5 billion in 2016 and $1.2 billion in 2010. At the same time, the amount of money a drug is expected to deliver annually — the forecast peak sales — is $465 million, which is well below the $816 million value in 2010, but an increase from $394 million in 2016. So it is costing more to develop new drugs, and they are not delivering the returns they once did.
Phase 2 clinical programmes have the lowest success rate of the four development phases, with only 30% of developmental candidates advancing to Phase 3. Failure at Phase 2 is very expensive and is most often due to drugs being ineffective, having safety problems or intolerable side effects, and this is despite all of the work to develop the product up to this stage. If we can establish an improved measurement infrastructure, we can help ensure that many drugs that would go on to fail are eliminated earlier in the development process.
The Industrial Strategy Challenge Fund has funded NPL to strengthen its UK high-resolution mass spectrometry imaging facility. A world-leading imaging facility with new medical imaging technologies was identified by industry as a pivotal route to understanding drug delivery, uptake and metabolism. The facility is the first of its kind in the UK. It underpins drug development by providing an understanding of where unlabelled drugs go in tissues and the changes induced by these treatments as well as helping to better characterising disease tissue for example for personalised therapies.
2. Ensuring they’re adopted
Effective device and drug development is only part of the process, ensuring their uptake presents further obstacles. This includes understanding how new treatments can be adopted into patient pathways and the NHS infrastructure, along with demonstrating cost-effectiveness or cost benefit. A recent briefing from the Nuffield Trust commissioned by ABHI identifies that the NHS need to be more problem-driven in its approach to innovation and that much depends on clinicians being able to think about innovation within NHS organisations.
NPL, and other partner organisations from the UK NMS, previously identified that we could partner with NHS staff to help them be at the forefront of making scientific innovation an intrinsic part of delivering a world-class NHS through better collaboration and building strategic networks. This year, together with NHS England, we launched the inaugural Chief Scientific Officer’s Knowledge Transfer Partnership Programme for Leaders in Healthcare Science and, because of the success of that programme, a second round will be launched next year.
Another aspect is reproducibility of research. This helps to achieve scientific consensus earlier and accelerates the uptake of discoveries. Across all this work is a drive to make life sciences and biomedical research more reproducible. Standards provide certainty in the consistency of the product performance that is crucial in addressing these challenges and deciding which products are adopted and commercialised by industry. NPL, working with SynbiCITE at Imperial College London, LGC and NIBSC, is establishing a new £7 million virtual lab to help the UK synthetic biology industry improve the manufacturing and adoption of new products through standardisation.
The new lab, which will underpin a joint Centre of Engineering Biology, Metrology and Standards, will develop and provide relevant reference materials and methods, in the form of a toolbox, which will aim to improve the reproducibility of research results, and help to convert innovation in synthetic biology into valuable products and services.
Ensuring the fiscal environment in the UK supports growth, provides access to finance and attracts manufacturing investment is another key theme within the Life Sciences Industrial Strategy. With the launch of the strategy, the government announced £146 million to help fund new manufacturing centres for vaccines, cell and gene therapy and medicines manufacturing, in addition to announcing increasing R&D investment to 2.4% of GDP to ease cooperation between academia and industry in this area.
Thanks to a grant from Innovate UK, NPL is working with Ingenza, a world leader in the application of industrial biotechnology and synthetic biology, and the University of Plymouth to tackle antimicrobial resistance (AMR), a problem that could cause up to 10 million deaths each year by 2050. The project uses a class of antimicrobials called epidermicins, which naturally target superbugs like MRSA, to enhance the range of bacteria they can kill as well as the potency at which they can do this. The project will also look to scale up production of these antimicrobials for further testing and clinical trials, helping to accelerate their development and eventually validate a new class of antimicrobials.
Making better use of data
Lastly, the Strategy outlines the need to make the best use of data and how we collect and access it, including the digital tools to support research and better patient care. The Sector Deal goes further, setting out a range of activities to improve our data infrastructure, including establishing clear and consistent standards and approaches for data and the establishment of digital innovation hubs to support using data for research purposes.
The long history of the NHS provides a wealth of data sets that can and should be used to improve our healthcare. This unique trove of information can help to identify trends, co-morbidities and assess the effectiveness of new drugs and other treatments.
NPL is working with the Royal College of General Practitioners’ Research and Surveillance Centre network to provide more accurate surveillance of diseases and epidemics in the UK. The network has been running for 50 years and uses patient records to identify and measure incident rates. However, medical records are not always accurate.
NPL will be addressing this by using its data mining expertise to correct miscoded data and help optimise retrospective data in identifying trends, and by assessing the efficacy of treatments. NPL is also developing data standards to ensure the integrity of data accelerates its use in critical applications, like healthcare and drug development, and eases the integration of non-medical datasets, such as those from wearables, into a clinical setting.
The Life Sciences Industrial Strategy white paper and Sector Deal provide bold visions for the UK to work towards. Government and industry have already signalled their collective commitment to this cause, progress is now required across the research, technology, manufacturing and regulatory landscapes, and measurement will be essential to achieving this. It is critical that NPL works collectively, to create and deliver the measurement infrastructure to underpin new therapies, accelerate medical innovation and improve patient outcomes. Only then will we be able to realise our collective goal of establishing a world-class life sciences sector for the UK.
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