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MARCH 2018 BUSINESSANDINDUSTRY.CO.UK PROF. SIR JOHN BELL The UK as a global leader in life sciences P02
GREG CLARK MP Investing in an ‘already-successful’ industry P04
STEVE BATES UK’s biotech pipeline attracts worldwide investment P14
Life Sciences
Dr Liam Fox International Trade Secretary “Life sciences is a sector that will lead the future – I want to make sure the UK stays ahead.” P8
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IN THIS ISSUE
Access to treatments Brexit Health Alliance on keeping patients at the heart of Brexit negotiations. P12
Brexit’s impact on MedTech Phil Brown, the ABHI on regulation and trade.
How to export in life sciences Mike Josypenko, Institute of Exports, on regulatory changes.
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Growth in life sciences benefits patients and UK
Investing more in UK life sciences will mean benefits for patients, industry and the UK, says Professor Sir John Bell, author of the Life Sciences Industrial Strategy Report.
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By Linda Whitney
he UK is already one of the leaders in the global life science race. The £64bn turnover sector employs over 223,000 scientists and staff. Its current high growth rate is forecast to exceed that of the economy as a whole in the next 50 years. We already do life sciences well, but the UK also has a unique advantage – the NHS. The Department of Health, the NHS and the life sciences sector, working together, can achieve major changes. We are already seeing moves towards this, and if we continue to develop this mindset in the future, with more collaboration and the adoption of innovation we can deliver better health services, make Follow us
the UK health care system more effective and save money. On the way, however, there are opportunities and challenges. The NHS, being a single system, provides life scientists with access to huge amounts of data that can deliver unique insights. No other country has this advantage. Meanwhile, the NHS’s robust approach to assessing the economic value of drugs and medical devices, delivered by The National Institute for Health and Care Excellence (NICE), reveals what works and what doesn’t. In this respect the UK is a world-beater. However, lack of investment in the healthcare system means advances are often adopted slowly and in a patchy fashion. For academia, the challenges include finding ways to collaborate with industry while maintaining facebook.com/MediaplanetUK
Professor Sir John Bell Regius Professor of Medicine, University of Oxford, and Life Sciences Champion
“Lack of investment in the healthcare system means advances are often adopted slowly.” @MediaplanetUK
its mission to discover new products, pathways and targets. Most collaborations between academic researchers and industry work without perverting the academic mission. The challenge is to further these initiatives while maintaining that integrity. The UK’s expertise in life sciences also contributes to global health. We are ahead of the global game in academic discovery, and we have some of the world’s best research programmes and institutions. Commercially, the UK is particularly strong in vaccines and antiretrovirals. Our expertise leads to innovations that result in better health outcomes, and our global sales success means the industry contributes substantially to the UK economy through taxes and employment. For patients, most of the uplift in @MediaplanetUK
outcomes is a result of innovations in the last 50 years. New antibiotics, surgical procedures, the discovery of drugs such as statins and new cancer medicines bring huge benefits for patients and have undoubtedly contributed to the UK increase in life expectancy of eight to nine years. Currently, the UK is a front runner in the global life science race – but how do we remain competitive in a sector where the world’s biggest economies, and some of the emerging nations too, are all fighting for a place in the race? To meet this challenge, the UK life science’s ability to run fast is not enough. To win in the future, we must run faster.
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UK life sciences: powering into the future
This is a critical time for UK life sciences, but in order to be a world-leader, several challenges and concerns must be addressed. SPONSORED
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By Linda Whitney
lobally, we are facing significant healthcare challenges in key disease areas such as cancer, antibiotic resistance and dementia. As a global healthcare company, we are committed to finding solutions to many of these devastating diseases through the focus on cutting edge research and development (R&D) and ground-breaking scientific interventions. At MSD we’re pushing the boundaries of science with the hope and expectation that the medicines and vaccines we invent will lead to better health for people worldwide. With this front of mind, we were delighted to announce our pledge to invest in a new state of the art Discovery Centre facility for R&D in London. The life sciences sector is a major component of the current economic base of the UK, generating £64 billion of turnover and employing more than 233,000 scientists and staff. It is from this position of strength that the Life Sciences Industrial Strategy (LSIS), launched in August 2017 by Sir John Bell, aims to consolidate and extend the UK’s lead with a bold vision for the future of the sector. By taking a lead in this hugely global competitive sector, the UK has the opportunity to not only increase its economic growth but to also support patients treated in the NHS. As
a member of the LSIS task board and a partner of the Life Sciences Sector Deal, we believe there are three strategic priorities the UK should focus upon to support growth: NHS collaboration and partnerships, investment in innovative medicines and technologies and utilising data and digital tools.
Why the UK? The last few years have witnessed a change in the way drug discovery is conducted. As scientific progress has been made, the quest to identify cures for apparently more complex conditions has become ever harder. The UK brings together a unique collection of factors, which make it fertile ground for developing into a world-leading nation in the life sciences sector that are able to advance these healthcare challenges. The UK is already acknowledged as a world-leader in developing science, underpinned by a strong research and development infrastructure, scientific skills base and clinical trial network. We are already taking advantage of this, as a committed partner to the NHS, universities and research bodies, as well as commercial and non-profit organisations. Each year we spend over £40 million on research partnerships with the NHS and UK academic centres and, at any one time, we conduct approximately 100 clinical studies in the UK with over 3,000 patients participating each year. The UK’s London, Cambridge, Oxford scientific triangle is well recognised as a leader in scientific expertise and innovation worldwide and we recently announced plans to maximise on this, announcing plans to establish a state of the art R&D centre and head office in London in the next few years. The UK life science industry also benefits from the interna-
ent. By collaborating, the NHS and industry are enabling better access to new innovation and treatments for patients.
Louise Houson MD, MSD, UK and Ireland
tionally-recognised National Institute for Health and Care Excellence (NICE), which offers evidence-based guidance to the NHS on effective, good-value healthcare, including medicines, health technology and devices. The existence of NICE means life sciences companies can engage with the medicines evaluation process in a positive way. Maintaining research and development centres in the UK enable access to skills, innovation, invention, new products, trials, and accelerated access for patients. Early UK clinical experience with new innovations can aid adoption and early patient access.
The UK is an important landscape for collaboration The quest to identify cures for ever more complex conditions has become ever harder, but the growing convergence of biology, genetics, and informatics, new computational tools and access to data sets means there is no shortage of insights, capabilities or therapeutic candidates. However, we cannot do it alone. Collaboration is more important than ever in today’s ecosystem, so it is important to locate in places such as London, which are rich in biomedical expertise and tal-
Real-time data can support government healthcare plans Technology is revolutionising the management of healthcare and we are proud to continue to push the boundaries of invention to go ‘beyond the pill’, investing in harnessing innovative solutions and technology to help address the challenges in the NHS now and in the future. For example there is a huge opportunity with data because we have single payer and patient records in the UK that go from the time somebody is born until they die. That is unique. Projects such as the NHS Test Bed programme, where GPs, an NHS clinical commissioning group, a commercial technology partner, our organisation and a university are working together to develop predictive tools and techniques to help assess and manage patients at risk of developing long-term conditions. Maintaining the UK as top early launch market post-Brexit At this critical time for the future of the UK life sciences industry, it is essential to address concerns relating to the potential impact of the UK’s exit from the EU for the industry’s supply chain, regulatory environment and ability to attract talent to the UK. Addressing these issues is fundamental to creating a stable environment for economic growth and to continuing to make a positive difference for patients. The LSIS is an important mechanism to providing greater certainty and reassurance in light of the UK’s exit from the EU and its effective implementation across
the next five years or more is critical.
Challenges: Patient access to medicines While the UK has a world class science base, which attracts companies such as ours, there also remain many challenges in relation to patient’s access to medicines and within the wider commercial environment in which we operate. This hinders the creation of a more competitive environment in which to drive investment, jobs and growth for the future. The Industrial Strategy offers the opportunity to deliver a stable and holistic approach to life sciences that recognises the full value of innovative medicines from early stage research all the way to adoption. We believe in the power of partnership and recognise no single organisation has everything it takes to deliver on complete healthcare. The ability of industry, government and the NHS to work in partnership to deliver these ambitious aims will send a positive message of the UK’s vision and desire to be a world-leading environment for life sciences.
As part of the Life Sciences Sector Deal, announced in December 2017, MSD plans to invest in a new Discovery Centre in London, a life sciences discovery research facility and headquarters, focussed on early bioscience discovery and entrepreneurial innovation. It will support 950 jobs, 800 existing roles together with 150 new high-skilled and high-value research roles.
Read more and follow us on msd-uk.com @MSDintheUK CORP-1251250-0000
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Industrial Strategy Life Sciences Sector Deal
Raise total research and development
2.4% of GDP by 2027 – this will increase to 3% over the investment to
longer term.
Investing in life sciences pays off for everyone UK life sciences is getting a huge boost from government. Greg Clark, Secretary of State for Business, Energy and Industrial Strategy, explains why this benefits us all.
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By Linda Whitney
Increase the rate of R&D tax credit to 12%.
Invest £725m in new Industrial
Strategy Challenge Fund programmes to capture the value of innovation.
In the government’s Industrial Strategy white paper, it announced a
further
increase in R&D investment of £2.3bn in 2021/22, raising total public investment in R&D from £9.5billion in 2016/17 to £12.5billion in 2021/22.
Source: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/665452/life-sciences-sector-deal-web-ready-version.pdf
he government is to invest up to £210 million in the UK’s life sciences sector through its Industrial Strategy Challenges Fund. But why choose to boost an already-successful industry? The answer is that it is not just life sciences that will benefit – so will patients, the NHS, and the whole economy. Greg Clark, Secretary of State for Business, Energy, and Industrial Strategy, was involved in the Life Sciences Sector Deal, and says: “The life sciences industry transforms lives. New treatments and technologies, being developed daily, provide better care and treatment, but also contribute significantly to our economy.” In 2016, pharmaceutical manufacturing added £12.8 billion to the UK economy (7.3 per cent of total manufacturing gross value added (GVA)). Total life sciences manufacturing is estimated to account for 9.4 per cent of total UK manufacturing GVA. The UK’s 5,000+ life sciences companies, along with their associated services and supply chain, turn over £64 billion each year and employ over 230,000 people. Clark says: “Progress in this industry grows our economy and provides skilled jobs for the future.”
Why the UK? The government is aiming to attract more life sciences industry investment. The UK has the most productive and highest-impact science base of the G7 countries, offers the lowest corporation tax of the G20 and G7 countries and enhanced R&D tax credits. Life sciences already accounts for around 20 per cent of all business spending on R&D and public investment in R&D will be raised to around £12.5 billion
for research infrastructure in the NHS, providing the expertise needed by the life sciences industry and other funders to undertake vital studies.”
RT Hon Greg Clark MP Secretary of State for Business, Energy and Industrial Strategy
“Progress in this industry grows our economy and provides skilled jobs for the future.”
in 2021/22 – an increase of £7 billion over five years. Meanwhile, with 60 million patients, the NHS offers a deep source of learning. Clark points to the NHS England and Government Test Bed programme, which created seven NHS-innovator partnerships to test how innovative health technologies can work in combination to improve patient outcomes at the same or lower cost than current practice, while supporting economic growth. Britain’s clinical trial environment is also being boosted. Clark says: “In the Life Sciences Sector Deal, the government announced £950 million of investment through the National Institute of Health Research (NIHR)
Collaboration is vital for foreign investment Clark says: “The government’s Industrial Strategy and the Life Sciences Sector Deal bring together universities, charities and over 25 companies to invest across the UK, and the sector deal is attracting substantial foreign investment.” The NIHR enables collaboration between the life sciences industry, companies, charities, academia and the NHS. The NIHR’s clinical research network, for instance, uses adaptive trial designs to increase the speed and efficiency of testing new cancer treatments, and is making it easier for life sciences companies to undertake studies of inflammatory diseases and dementia.” What about Brexit? Continued cooperation between the EU and the UK is in the best interests of patients, and will ensure quality, safety and efficacy of medicines. The UK has a history of co-operation with the EU, plus a close regulatory alignment built on strong trust in one another’s institutions and a spirit of collaboration stretching back decades. As the Prime Minister recently said, “We will want to make sure our regulators continue to work together… This will be essential for everything from getting new drugs to patients quickly to maintaining financial stability.” Across the life sciences sector, Clarke says: “The government aims to ensure that patients in the UK and Europe continue to access the best and most innovative medicines.” Read more on businessandindustry.co.uk
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The MedTech sector in the UK employs over 93,600 people across 2,500 companies. The MedTech industry is worth over £17 billion to the UK economy.
UK MedTech supports a service & supply sector of 986 companies.
Employing an estimated 28,500 people, generating £4.9bn in annual turnover.
In 2016, UK Digital Health companies generated over £1bn.
MedTech can be familiar, everyday objects, like syringes, through to pacemakers and hip replacements.
Source: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/635714/ strength-and-opportunity-2016-bioscience-technology-accessible-revised.pdf
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Regulation and trade: Brexit’s impact on MedTech
The MedTech sector is incredibly diverse. It encompasses single-use products like wound care dressings, as well as multi-use pacemakers, MRI scanners and even robotic-assisted technology. The likelihood is, we will all need MedTech at some stage during our life. It’s a sector driven by innovation and underpinned, crucially, by strict regulation.
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or a product to be placed on the European market, it must meet the requirements in the relevant regulation and be affixed with a CE Mark. The current EU regulation for MedTech products is undergoing change, with the existing Medical Device Directive (MDD) being replaced by the new Medical Device Regulation (MDR), first published in 2017. The culmination of eight years’ work, the MDR will ensure that European regulation for devices is considered the ‘gold standard’ globally. For our industry, this new regulation modernises the original MDD rules, bringing together best practices from existing commission guidance while covering newer technologies such as nano-materials and human tissue derivatives.
Post-Brexit, EU and UK medtech regulations may differ Owing to its complexity, a three-year transitionary period is necessary to allow companies to move from the old regulation to the new. As a result, all new products must be fully compliant with the MDR by May 2020. However, ‘day one’ of Brexit is March 2019, which is mid way through this compliance period. The moment we leave the EU, our sector’s regulation could potentially diverge from the rest of Europe. If we are to ensure a healthy and thriving MedTech sector after March 2019, there should–at least initially–be continued recognition of the MDR and the continued validity of CE marked products
Phil Brown Director, Technical and Regulatory, Association of British Healthcare Industries (ABHI)
“The MDR will ensure that European regulation for devices is considered the ‘gold standard’ globally.” currently on the market. This is a view supported by 97 per cent of ABHI’s membership who, in a recent survey, stated they were in favour of regulatory convergence with Europe.
Varying from EU regulations risks UK patients’ early access to new products For MedTech companies, the CE marking process is not just the seal
of approval needed for access across Europe, but it is a mark used by other jurisdictions outside the EU as a basis for market entry. If the UK is to remain competitive, it is critical we remain part of this system. Furthermore, the high international esteem of UK regulators, and the English-speaking environment (which has utility throughout Europe) makes the UK very attractive. As such, the UK often enjoys first sight of many innovative MedTech products. The benefit of this to patients is obvious and we must protect this advantage.
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UK-made, internationally sourced It is vital that we have sensible trading agreements in place from day one. “Complex, inter-t he m national supply chains meanapproac that products manufactured ininnovati the UK cross the UK/EU borderin the g many times during their lifecycleIndustria before reaching patients. Currently, that border is frictionless; weWhat a must protect this in order to keepcluster developing and delivering MedTech“The c innovations. The industry is callingscientifi for all products used in healthcarecreates a to be exempt from any new cus-is rapid toms, tariffs or VAT arrangements,successfu and afforded pre-shipping clear-high-tec ance and fast track access acrossDr Barb any new EU/UK borders. Business While Brexit remains highlyScience political, one thing that cannot“Harwel be debated is the need for UK patientsinvestme to be able access innovative MedTechnational and we are hopeful policy makers30 univ will recognise this. at any people ac academi huge com collabora Read more on businessandindustry.co.uk Camp
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PHOTO: HARWELL SCIENCE AND INNOVATION CAMPUS, OXFORDSHIRE
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Cluster collaboration boosts R&D and life science innovation
internators, and ronment t Europe) . As such, t of manyBy Linda Whitney ucts. The wo heads are better s obvious than one - and many antage. brilliant minds ally across multiple disciplines are e sensibetter still. That’s in place the theory behind x, inter-the multi-disciplinary cluster s meanapproach to R&D, commercial ured ininnovation and scale-up as laid out U borderin the government’s Life Sciences lifecycleIndustrial Strategy. Currentless; weWhat are the benefits of the r to keepcluster approach? ng Med-“The cluster model catapults ndustryscientific innovation forward. It used increates an ecosystem where research rom anyis rapidly accelerated through arrange-successful commercial outputs into shippinghigh-tech manufacturing,” says k accessDr Barbara Ghinelli, Director of Business Development at Harwell ders. highlyScience and Innovation Campus. cannot“Harwell includes several billion of K patientsinvestment in the UK’s open-access MedTechnational physical laboratories; over y makers30 universities work on campus at any one time alongside 6,000 people across 250 private, public and academic organisations. All see the huge commercial benefits of working collaboratively.” ry.co.uk Campus collaboration spans
How the cluster model generates innovation in life science, turning ideas into commercial innovation faster.
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bio-imaging, bio-sensor and tissue engineering is also being researched.
Dr Barbara Ghinelli Director, Business Development, Harwell Science and Innovation Campus
Gordon Duncan Director, Harwell Oxford Partners
everything from oncology, infectious and neurodegenerative diseases, vaccine and drug resistance through to biomaterial and drug design, imaging, radiation, and health and telemedicine apps. “AI, supercomputing and big data expertise bring even greater knowledge and capabilities,” says Ghinelli.
“In clusters, everyday contacts between scientists, engineers, entrepreneurs and industrialists working in different fields, stimulate new ideas and innovative approaches to long-standing problems,”. Multidisciplinary campus-wide events bring people together. “We are a science and innovation community and we must nurture that,” says Ghinelli. Collaboration has led, among other things, to the world’s first portable hand-held DNA sequencer and 3D printing of a new disease model for obesity and diabetes. The applications of nanodiamonds in life sciences industries, including drug delivery,
Scientific benefits: “Clustering makes it easier to build a clinical network and attract R&D personnel. With critical mass, companies offering regulatory affairs, clinical trials, and contract research move in.”
Business benefits: “Clusters accelerate the emergence of new companies commercializing cutting edge research. New technologies in space and health are leading to innovation in digital health, remote monitoring and data analysis,” says Gordon Duncan, Director of Harwell Oxford Partners. “A critical mass of businesses also means supply-chain benefits, risksharing of new developments, shared knowledge on building businesses, job creation and concentration of capital and investment. All attract foreign direct investment and external funding from large local investment institutions.” Clusters need space to grow for commercial and residential development. The Harwell cluster is going to be further bolstered by the addition of 1,000 new homes creating an ideal work/life ecosystem. Life Sciences Industrial Strategy: The campus is home to a HealthTec cluster of 40 public, academic and commercial organisations working alongside the life sciences community
in Oxfordshire and throughout the UK. With strong industry and government links, and a close relationship with Oxford University (a world leader in Life Sciences & clinical medicine), it feeds into regional and local development plans and contributes to the UK’s Life Sciences Industrial Strategy. Duncan concludes “The evidence that clusters work is seen in the government’s £100 million investment in the new Rosalind Franklin Institute, to be located at Harwell, bringing together life sciences, physical sciences and engineering and linking ten universities with over 240 scientists” As the UK places itself at the forefront of innovation the cluster model is a guaranteed template for future success. Read more on harwellcampus.com/ healthtec-cluster SPONSORED
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233,400 employees in the life science sector
5,142 companies
£64bn annual turnover
1,640
current apprentices
£24
Estimated m in annual apprenticeship levy payments from the life science sector Apprenticeship Standards now in development include: Science Research Professional at Level 8 (PhD) Research Scientist at Level 7 (Masters) Bioinformatician at Level 7 (Masters)
SOURCE: Science Industry Partnership
UK life sciences are leading the way, showcasing worldclass innovation Fast forward to 2050, and the way we live will be completely shaped by the inventions and breakthroughs made today.
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or many decades, technology has changed in a way, which, until only recently, would have been unimaginable. Put simply, we live in a time of unparalleled technological advances. Spearheading this technological charge is the life sciences sector, utilising the best of British innovation to tackle some of the biggest healthcare challenges of our time – aging populations, lifestyle diseases, cancer and antimicrobial resistance. As an international economic department, we are busy forging a vision of the UK as a world-leader in innovation and technology. It’s a role Britain is made for. Across the UK, scientists are pioneering treatments, progressing advanced therapies and genomics using digital technology and artificial intelligence. With a combination of top universities, research institutions, global life sciences companies and increasing government support, the UK is a fantastic place for the sector to invest, which is why we are now in the top three life sciences hubs globally. Companies that have the potential to change global health dynamics are thriving here. The UK offers a strong base for world-class research and manufacturing, while connecting business with bio-science clusters featuring the best science minds, the best universities and the best research institutions. Yet, while the sector flourishes, we must do everything possible to ensure the UK remains on top in a fast-changing industry whose success rests on its ability to quickly adapt and change.
Dr Liam Fox International Trade Secretary, Department for International Trade
The Department for International Trade is forging ahead with our strategy for promoting British trade across the globe. Life science businesses are playing a key part, with exports of more than £30 billion a year also attracting significant investment. Just last month, Trinity College Cambridge, and Tsinghua University in Beijing, agreed a £200 million joint venture, which will include a stateof-the-art biohub for Cambridge Science Park. This extraordinary collaboration will provide labs and offices for early-stage companies and inventors working on tomorrow’s game-changing healthcare products and technologies. UK regions are also attracting investment from life sciences inward investors working on flu vaccines and the development of new medicines. Just recently, several companies have expanded manufacturing sites in both Liverpool and Wales. I am determined that my department will play its part in
supporting this growth. We are doing everything possible to connect investors with the right partners for their needs, make them aware of our generous tax incentives and grants, and help them find the right plants and premises - many adjacent to the UK’s increasingly-renowned science parks. Using our network of global trade experts in over 100 countries, in our offices, embassies and consulates around the world and in the English regions, we will support and match the ambitions of our leading life sciences companies. We also will continue to support regular trade delegations from China and other fast-growing countries as part of an ongoing roadshow to encourage delegations to visit key UK cities, promoting our life science companies. For example, this week, I led a group of over 200 companies to Hong Kong as part of the Great Festival of Innovation, with several life sciences companies showcasing the best of British to a global audience. The event, organised by my department, brought together business leaders of the future, government ministers from China and the UK alongside the latest technologies form both our countries and across Asia. As we move forward into a world full of technological change, I’m confident that UK life sciences companies will be at the heart of the cutting-edge innovation that will be sought after on an international level. It is a sector that will lead the future – I want to make sure the UK stays ahead. Read more on businessandindustry.co.uk
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How Scotland is leading in precision medicine
The precision medicine revolution is happening now, and Scotland’s triple-helix approach could help usher it in. Here’s how.
By Linda Whitney
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recision medicine is capable of spurring a revolution in healthcare, bringing the prospects of earlier diagnosis, more effective treatment, cost savings and better patient outcomes. The University of Glasgow is leading the way in this medical revolution, with collaboration at the heart of its success says Professor Dame Anna Dominiczak, Head of the University’s College of Medical, Veterinary and Life Sciences.
What is precision medicine? “Precision medicine, also called stratified or personalised medicine, involves combining the usual patient examinations and data, with information derived from techniques such as genomics, proteomics, metabolomics and new imaging modalities, so a patient’s condition can be ‘stratified’,” says Dominiczak, who is a University of Glasgow Vice Principal and the Regius Professor of Medicine. The new techniques mean that diseases that were previously thought to be just one blanket condition – such as breast and pancreatic cancers, high blood pressure, diabetes, or rheumatoid arthritis – can be stratified into various sub-types, all slightly different and requiring different treatments. “This ability to sub-stratify the patient’s condition allows for a more try.co.uk accurate and earlier diagnosis, and
Professor Dame Anna Dominiczak Vice Principal and Head of the College of Medical, Veterinary and Life Sciences, University Of Glasgow
“Scotland is in a particularly strong position because of its size, the wealth of its NHS data and the high level of willingness among Scots to participate in clinical trials.” enables clinicians to select the most effective treatment. The goal is to deliver the right treatment for the right patient at the right time,” says Dominiczak.
Why is collaboration vital? While precision medicine can enable better, earlier diagnosis and treatment, a large measure of collaboration is required for it to be successfully implemented.
“We are using a ‘triple-helix’ approach to precision medicine, which involves close collaboration among academic researchers, the NHS and industry here in Glasgow,” says Dominiczak, explaining that the three parties are essential to making precision medicine work. “First, it requires the molecular technologies developed by academic researchers. Then this is combined with the high levels of strong patient data held electronically by the NHS, safely managed and anonymised where necessary,” she says. Here, the NHS Scotland Community Health Index (CHI) database is very valuable, she says, as it offers access to patient demographics and clinical information on aspects of healthcare screening and surveillance. It is a key plank of the introduction of electronic health records and other information and communication technologies in Scotland. “This puts Scotland in a prime place to utilise the data and get the most out of research and development,” she says. The third part of the triple-helix is industry. “We need industry in the form of large and small companies, to transfer new discoveries into treatments that benefit patients. In the process this will also bring benefits to the economy and increase the number of jobs,” says Dominiczak. “This is a medical revolution that will happen – in fact, it is happening now. Scotland and the UK have the opportunity to lead it, but it will require collaboration with industry.”
What is happening now? Glasgow is home to a biomedical innovation cluster called the Clinical Innovation Zone, funded by the Scottish and UK governments, within the new Queen Elizabeth University Hospital (QEUH) campus– the largest acute medical facility in Western Europe.
“The university works in collaboration with industry partners who have co-located here, including companies that have moved in from overseas. They are attracted by the possibility of developing precision medicine where they are close to researchers, can interact with clinicians, and implement their products in the NHS,” says Dominiczak. The zone also includes companies that are spin-outs from the university, and also an informatics company that links Scottish health data. “The University of Glasgow, working with NHS and industry, has created a research and development cluster, as advocated in the government’s recently-announced Life Sciences Industrial Strategy.” The zone also encompasses the university’s Imaging Centre of Excellence (ICE), which includes an ultra-high resolution 7 Tesla MRI scanner – the first of its kind to be fully-integrated within a clinical site in the UK. “The MRI scanner, coupled with our on-site clinical expertise, means we can scan patients with conditions such as stroke and cardiovascular disease, and carry out brain imaging at a much higher resolution. This enables us to add precision imaging to stratification,” Dominiczak says.
Ahead of the game Scotland is ahead of the game when it comes to creating life sciences innovation clusters, says Dominiczak. “We have been creating a multidisciplinary ecosystem for precision medicine here for the last four years – well ahead of the publication of the government’s Life Sciences Industrial Strategy paper. We hope our experience will enable us to offer help in developing that strategy, so the whole UK benefits.” In April, the university will deliver the results of the first UK
government-commissioned Science and Innovation Audit on precision medicine innovation in Scotland. The audit will map Scotland’s research, innovation and infrastructure strengths in precision medicine to help identify the opportunities for inward investment and regional growth. “We think Scotland is in a particularly strong position because of its size, the wealth of its NHS data and the high level of willingness among Scots to participate in clinical trials. A high percentage of Scots are also happy to donate surplus tissue and blood samples for research,” Dominiczak says.
Financial savings and more accurate diagnosis in the future Modelling reveals that the introduction of precision medicine will deliver benefits not just to patients but to the NHS as a whole, explains Dominiczak. “The ability to stratify patients will bring significant savings to the NHS drugs bill as more accurate diagnosis allows the selection of more efficacious drugs,” she says. Moreover, better drug choice would cut the number of adverse patient reactions, which in serious cases can require hospital admission, leading to suffering for the patient and extra cost to the NHS. Dominiczak adds: “Introducing precision medicine into the NHS will enable us to provide better services to patients, improve health and outcomes – and save money too.”
Read more on gla.ac.uk/research/beacons/precisionmedicine/
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Between 2011 and 2015, exports of medical technology products in the UK grew from $3.7 billion to $4.1 billion Source: UNCTAD STAT Data Centre
How to export in the life sciences
The life sciences is one of the UK’s top sectors but businesses face a number of regulatory challenges selling overseas. How can exporters in the sector overcome these barriers?
Between 2011 and 2015, exports of pharmaceutical products in the UK grew from $36.7 billion to $36.9 billion, a compound annual growth rate of approximately 0.6% Source: UNCTAD STAT Data Centre
UK pharmaceutical employment increased from aproximately 37,000 to 39,000 between 2014 and 2015 Source: Eurostat – Data Explorer, Annual Detailed Enterprise Statistics for Industry
Exports from the US, UK, Ireland and India all grew between 2014 and 2015 Source: UNCTAD STAT Data Centre
T
he life sciences sector is one of the UK’s best international performers, contributing 5.2 per cent of the UK’s exports in 2016. This diverse sector includes drugs and medicines, laboratory and diagnostic instruments, as well as a wide range of surgical supplies and equipment, from dressings, prosthetics, to furniture and equipment.
Strict regulations can create barriers within this sector The sector is highly regulated and the extent and variation in regulatory and documentary requirements for different export markets can be a major barrier and compliance cost for exporters. Any UK business exporting medicines to countries outside the EU will require a manufacturer or wholesaler licence. Exports of narcotics or controlled drug products are even more strictly overseen. In addition, exports of medicines to different countries may require a range of documents, such as export certificates. Controls around exporting also apply Export controls also apply for exports of diagnostic and medical instruments including complex technologies, which fall into the category of “dual use” that could pose a strategic risk to the UK in the wrong hands. Exporters may have to obtain strategic export licences for all sales to non-EU clients. How difficult is it to export then? The real problems begin when goods arrive in the destination market. Each country can impose their own regulatory requirements for products to be sold in that country. Many countries impose more stringent regulations for consumer protection
Mike Josypenko Senior Director of Special Projects, Institute of Export and International Trade
purposes, but the true motive can be to create trade barriers to protect domestic manufacturers. Nonetheless, these regulations must be overcome before goods can be imported.
How can these barriers be overcome? Understandably, drugs and medicines are highly-regulated and must be registered and approved by that country’s regulatory body. This typically requires the exporter and manufacturing sites to be registered with a body such as the US Food and Drug Administration (FDA). Manufacturers may have to provide certification of Good Manufacturing Practice, issued by the exporting country’s government, as well as Certificates of Analysis, and Free Sale, demonstrating that goods are approved for sale in the exporter’s home market. Pharmaceutical companies will usually need to appoint a local representative - either a subsidiary of the exporter or a locally based distributor - to act as the point of contact for regulatory purposes or litigation. Importers may also need to apply for marketing authorisation
to act as a local distributor. In Saudi Arabia it can even be required that the local importer provide price lists for the products in other international markets. Other healthcare products are similarly controlled. Many countries impose technical standards for electronic products, such as diagnostic equipment, so that they require compulsory testing for conformity. Similarly, manufacturers of medical devices and equipment must be registered in many countries, such as China, before goods can be sold. These regulations may apply even for relatively non-specialist products, such as medical or surgical appliances, furniture or dressings.
And there are regulations for moving the goods, too Even when goods are approved for sale, exporters must adhere to strict conditions to transport products to their destination. Pharmaceutical products are controlled by “Good Distribution Practice” regulations to ensure that they are carried safely and securely, avoiding damage or contamination. Many products must be transported under temperature-controlled conditions, using electronic devices to record temperature and highlight any failures, known as “excursions”. The consequences of any lapse can be catastrophic. Unsurprisingly, specialist logistics providers have sprung up to support this major sector. The UK is a global leader in life sciences Despite all of the challenges they face, the UK’s life sciences sector remains one of the UK’s success stories, establishing a significant reputation globally. Read more on businessandindustry.co.uk
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Patients should come first in Brexit negotiations
P
atients across Europe currently benefit from the close collaboration between medical researchers who investigate, develop and test new treatments on an EU-wide basis. We are exceptionally good as a nation at failing to recognise our strengths. As a result, too often we fail to capitalise on them. The UK’s pioneering role in life sciences, and especially in medical research, is a classic example. The danger of this false modesty is that we fail to protect the strong contribution we play, not only for the benefit of patients here, but also for patients across Europe. Whether you look at clinical trials, where the UK has the highest number in the EU testing a new drug or treatment for the
1848 Chloroform used during surgery
first time, leadership of scientific committees and panels, (a quarter of clinical reference networks are UK-led) or scientific training, (home to eight of Europe’s top universities), we are at the forefront throughout the sector. Just take transactional research, where the UK’s record of discovery of treatments and devices has included a new generation of genetically targeted personalised medicines to tackle leukaemia, skin, colon, brain and breast cancers. If there were one area where pragmatism should drive the Brexit negotiations, it must surely be here. The benefits to both sides are unarguable. A recent statement from the Royal Society concluded: “Whatever Brexit modalities are agreed... full and continued engagement with the UK within the research and innovation programme re-
1922 Insulin used for treating diabetes
mains an obvious win-win for the UK and the EU.”
A team game And while the UK does make a real difference, the reality is that research has increasingly become a transnational activity. Big strides are made within individual great minds and in individual laboratories, but today, most discoveries rely on team effort and are the result of multi-site collaboration The interdependency of research endeavour today is much greater than in the past, and is hard to overstate. Over the last 30 years then, clinical research has increasingly benefited from UK and EU research collaborations, and nowhere more so than for rarer and paediatric diseases, where the UK has the highest number of clinical trials. As the number of pa-
1944 Penicillin becomes available
tients with rarer conditions in each country is low, it is only possible to recruit enough patients by carrying out trials across countries. These conditions have also benefitted from EU research funding, which has filled gaps that are often left by national programmes. The European Reference Networks have been vital here – these virtual networks bring together researchers and practitioners in rare and complex diseases and conditions from across Europe. They enable the development of highly specialised treatments, and they concentrate knowledge and resources. UK clinicians, such as Chris Chapple, who coordinates the urogenital disease network has no doubt about their value. Professor Chapple, a consultant urological surgeon from Sheffield is adamant that the network fosters
1956 First antidepressant (Iproniazid)
innovation and allows better diagnosis, new treatments and surgical techniques to be tested and made available more quickly. The health service in the UK is currently involved in 23 of the 24 networks (involving 40 NHS hospitals). Importantly the networks have a legal basis under EU law, so the UK exiting the EU will have an impact on UK involvement, unless we devise an alternative arrangement in the negotiations.
Regulatory alignment We also need to tackle the more complex issue of regulating medical research, medicines and medical devices. As with research co-operation, leaving the EU means that the UK will be outside the EU’s regulatory systems as of March 2019, unless an alternative solution can be found.
1960 First contraceptive pill becomes available
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This is by no means insoluble with goodwill on both sides but, as industry has made clear across Europe, the consequences of not resolving it are significant. From a UK point of view there is one stark fact - the EU represents 25 per cent of the global pharmaceutical sales market - the UK accounts for just three per cent. That is almost certainly going to affect decisions about where to launch new products, resulting in slower access for UK patients to new therapies. Countries such as Canada and Australia with smaller markets routinely see drugs introduced later, with companies devoting the time and effort to launch in the larger markets of the US and Europe. The challenge then is not just about copying EU legislation; the UK needs to secure a deal on how
1987 First medicine to tackle HIV / AIDS
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it will continue to engage with EU regulatory bodies (such as the European Medicines Agency) and how it will continue to share infrastructures such as the database and portal used to assess clinical trials.
Ending uncertainty These are unsettling times, and much if not all the anxiety is the uncertainty of what lies ahead, a factor already affecting UK research. Our universities, NHS hospitals and the pharmaceutical industry all say that talented researchers are turning down opportunities to work in the UK because of the lack of clarity around the impact of Brexit. Last year, the government did make it clear that its preferred position was maximum alignment with EU regulation of medicines and medical devices. This was
1993 First medicine released to slow Multiple Sclerosis
Niall Dickson Co-Chair, Brexit Health Alliance
2006 First shot to prevent ovarian cancer
“The UK needs to secure a deal on how it will continue to engage with EU regulatory bodies.”
2007 First medicine against liver cancer
underlined in the UK Future Partnership Paper on science and innovation which gave a strong positive signal of the government’s intentions. These aspirations, along with the commitment to pay to continue to access relevant research programmes were highlighted again in the recent Mansion House speech by Theresa May on 2nd March. But the hard truth is that, as yet, nothing is agreed. The message the negotiators on both sides need to understand is that this is a crucial public health issue – developing and accessing new types of treatments matters to patients across Europe and their interests need to at the heart of these negotiations.
2012 First gene therapy to tackle pancreatic inflammation in developed countries for patients born with lipoprotein lipase deficiency (LPLD)
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The UK’s Global Bioscience Cluster in 2017
01 02
The UK has the strongest pipeline
in Europe across all preclinical and clinical stages, with 351 preclinical products, 43 phase I, 70 phase II and 15 phase III
UK biotech company IPOs
raised more than twice as much money in 2017 (£234m) than in 2016 (£105m)
UK biotech raised more
03
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on the public markets than in venture capital as UK companies matured and progressed through the funding lifecycle with £515m raised in venture capital, £234m raised in IPOs and £452m raised in follow on funding
The 2017 IPO listings on Nasdaq
show that there is global demand for UK biotech companies
Source: BIA/Informa Pharma Intelligence Source: Pipeline Progressing
UK biotech pipeline progressing and sector maturing at pace
P
ipeline Progressing: the UK’s global bioscience cluster in 2017 is the BIA’s annual state of the nation report on sector financing, produced with our data partner Informa Pharma Intelligence. This year’s report revealed the UK’s impressive preclinical and clinical pipeline, showing the strength and capability of the UK biotech ecosystem to produce fantastic science that attracts talent and funding from across the globe. There is money to be made as this pipeline develops and investors saw strong returns on biotech investments in 2017. In addition to this, the sector has seen support for the life sciences with the first of the government’s sectors deals and the government’s response to the Patient Capital Review, which reflected many of the calls that the BIA made in its submission, including opening up pension funds which could make a substantial difference to investment into the sector. The Pensions Regulator will provide clarity around the ability of pension fund managers to invest in venture capital and innovative companies and the government will address barriers holding back Defined Contribution pension savers from investing in illiquid assets, such as private companies.
Steve Bates CEO, BioIndustry Association (BIA)
“The variety of funding options open to them means we can build the third global cluster in bioscience in the UK.” We work with a wide range of stakeholders to identify new sources of finance for the sector. A key source of funding in 2018 will be the new funds available through the British Business Bank, whose funding was increased by £2.5bn, with much of this going towards a ‘British
Patient Capital’ entity, launching in 2018. This entity will incubate an expanded VC Catalyst programme that will invest on a commercial basis into UK venture and growth capital, alongside private investors. Importantly, fund managers operating in the UK can apply to the existing VC Catalyst programme today. The UK is the most profitable/ reliable VC Industry in Europe and will remain an attractive destination for global money. It is very encouraging to see that UK biotech companies are scaling and maturing at pace, and the variety of funding options open to them means we can build the third global cluster in bioscience in the UK. Our entrepreneurial and dynamic sector is accustomed to working around changes in the external environment. The UK government have also shown their support to UK biotech through their response to the Patient Capital Review and in making the Life Sciences Sector Deal the first for any industry in the UK. The UK remains one of the most business-friendly locations for life science companies in the world. We boast great science, the ability to hire great talent, a world-class, vibrant ecosystem of scale with a tax position that is better than post Trump reforms in the USA. Read more on businessandindustry.co.uk
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ABHI Seminar: are you ready for Brexit?
BY ASSOCIATION OF BRITISH HEALTHCARE INDUSTRIES (ABHI)
As we get a far better sense of what the details of the transitionary period will look like, join a panel of legal and business experts to assess your company’s readiness for Brexit. This event will give a unique opportunity to take stock of the implications for the MedTech sector.
Alison Dennis
Partner -Life Sciences FieldFisher LLP
Jennifer Revis
Partner Baker & McKenzie LLP
Gary Slack
Senior Vice President Global Medical Devices BSI Group
Alex Stojanovic
Researcher Institute for Government
Thu 26 April 2018 10:30 – 14:00 BST Baker & McKenzie LLP 100 New Bridge Street London EC4V 6JA 10.30 11.00 13.00 14.00
Registration & Coffee Panel of Experts Networking Lunch Event Close
£100 +VAT pp for ABHI Members £150 +VAT pp for Non-Members For further information please Email: ukevents@abhi.org.uk or Telephone: +44 (0)20 7960 4366