The first appointments to the Board of Health Data Research UK (HDR UK), the new data science and health research institute, have been made.
Harnessing the power of health data, HDR UK will develop and apply cutting-edge data science tools and techniques to address the most pressing health research challenges facing patients and the public.
The members of the HDR UK non-executive Board are:
- Dr Graham Spittle CBE (Chair) was until recently IBM's Chief Technology Officer, Europe, and Vice President, Software Group. Dr Spittle took on the role of Interim Chair HDR UK in July 2016.
- Professor Sir Alex Markham is Director of the Leeds MRC Medical Bioinformatics Centre, Chairman of the Lister Institute of Preventive Medicine and Chair of the OSCHR Health Informatics Group.
- Professor Jonathan Montgomery is Chair of the Nuffield Council on Bioethics and Chair of the Health Research Authority.
- Professor Sir Jim Smith was Deputy CEO and Chief of Strategy at the MRC and Director of Research at the Francis Crick Institute prior to joining Wellcome as Director of Science.
- Professor Dame Janet Thornton was Director of EMBL-EBI until 2015 and played a key role in ELIXIR, the pan-European infrastructure for biological data.
- David Zahn is Head of European Fixed Income at Franklin Templeton Investments, a Board member at The Health Foundation and a Trustee of the Medical Research Foundation.
The Board will convene for the first time on 9 November. The appointment of the non-executive Board follows the announcement in March of Professor Andrew Morris as Director of HDR UK and confirmation of Dr Graham Spittle’s appointment as Chair of the Board.
Dr Spittle commented:
“The emerging HDR UK Board brings together a wealth of knowledge and expertise. In tandem with the executive team, the Board will bring passion and vigour to the goal of maximising health benefits from data science.”
Members of the non-executive Board share collective responsibility for the effective governance and development of HDR UK, setting its major policies and agreeing the strategic direction with the Institute Director. A small number of additional appointments to the Board will be made over the coming months.
HDR UK is an independent, not-for-profit company established through a joint investment led by the MRC, together with the National Institute for Health Research (England), the Chief Scientist Office (Scotland), Health and Care Research Wales, Health and Social Care Research and Development Division (Public Health Agency, Northern Ireland), the Engineering and Physical Sciences Research Council, the Economic and Social Research Council, the British Heart Foundation and Wellcome.
Researchers studying neurodegenerative disease can now look up cohort studies and make connections through a new online database.
The JPND Global Cohort Portal, created by the EU Joint Programme in Neurodegenerative Disease Research (JPND) for which the MRC is a founder member, is a searchable online database of neurodegenerative disease cohort studies.
Long-term studies which follow large groups of people over time – known as longitudinal cohort studies – are a rich, but currently under-used, resource. Finding and contacting relevant cohorts can be a difficult and time-consuming task for researchers.
The portal aims to overcome this challenge by allowing users to search for cohorts around the world that could be relevant for their neurodegeneration research. A summary of the cohort study, the data collected and the contact details are available on the portal, giving researchers the opportunity to make new connections.
Currently including 110 cohorts, the tool will continue to grow as new cohorts are discovered and added. The aim of the portal is to encourage information exchange and new collaborations within the neurodegenerative disease community, to support scientific progress.
After exploring the database, Dag Aarsland, Professor of Old Age Psychiatry at King’s College London, said: “I was pleased to see that the JPND Global Cohort Portal offers a broad and overarching view of cohorts that have been funded in countries across Europe and beyond. In fact, after just a few minutes of exploring the JPND Portal, I identified a number of cohorts that I hadn't heard of before, which may be useful in my research.” Read the full interview with Professor Aarsland on the Portal.
Neurodegenerative disease-specific and general population cohorts, related to neurodegenerative disease research, are both included. To be considered relevant, they must be cohorts that were set up to follow a range of health or social factors as a population ages, or cohorts looking at other chronic diseases but using measures of risk relevant to neurodegenerative disease, for example metabolic or cardiovascular factors.
To be included, neurodegenerative disease-specific cohorts must have more than 200 participants, unless they are classed as rare conditions. General population cohorts must include over 1,000 participants.
To allow the database to grow and evolve, an online entry form is available for principal investigators to submit their cohort for inclusion after checks. Cohorts can also be updated to reflect changes, such as when new waves of data are available or upon the introduction of a new test.
UK Research and Innovationopens in new window is a new organisation that, from 1 April 2018, will bring together the seven research councils, Innovate UK and Research England. Each will be led by an Executive Chair who will be supported by a Council of up to 12 members.
The Councils will have a pivotal role in ensuring the success of UK Research and Innovation, helping it achieve its strategic objectives to be the single, strong voice of UK research and innovation, and building on our world-leading reputation.
Council members will have a range of expertise and experience in research and innovation across higher education, industry and commerce, policy and/or civil society, reflecting different characteristics and professional backgrounds.
The PHG Foundation are pleased to announce Dr Mark Kroese as the new Director of the PHG Foundation. Mark will be taking over from Dr Hilary Burton, who stepped down as Director at the end of September.
Mark has an intimate understanding of the work of the PHG Foundation, first joining in 2002 as a Specialist Registrar in Public Health Medicine. In 2005, Mark was appointed consultant in public health medicine and associate director of public health at Peterborough Primary Care Trust, but retained close links with PHG Foundation. He returned in 2012 to take up his current post of Deputy Director, where he has been leading the development and delivery of the work programme and contributing to the strategic development of the organisation including the establishment of its consultancy services.
Commenting on his new role, Mark said:
I am delighted to become the next Director of the PHG Foundation and to have the opportunity to lead such an expert and successful team. We look forward to addressing the future health and innovation policy challenges. I would like to personally thank Hilary for her leadership, guidance and support. I feel very fortunate to be her successor and to be able to build on her achievements.
Mark graduated in medicine from the University of Edinburgh and trained in general practice before entering public health medicine. A fellow of the Faculty of Public Health and the Royal College of Physicians of Edinburgh, Mark is also a member of the Diagnostics Advisory Committee of the National Institute for Health and Care Excellence (NICE) and the Royal College of General Practitioners. His special interests include the evaluation and regulation of genetic tests and biomarkers and the commissioning of clinical genetics services. In addition to his work at the Foundation, Mark is the public health advisor to the UK Genetic Testing Network since 2006.
Dr Hilary Burton, founder member and Director since 2010, will continue to contribute her extensive knowledge and experience to the PHG Foundation work programme, particularly, but not exclusively, with My Healthy Future, PHG Foundation’s major new project.
Two exciting new guides to support healthcare professionals to develop clinical academic careers have been launched.
The guides have been developed with Health Education England (HEE) to provide information on the various awards available through our two organisations, how to apply for awards, and how the awards work in practice should applicants be successful.
The guides also include case studies from award holders who talk about their experiences and the impact holding an NIHR or HEE award has had on their career.
There are two guides available:
- The NIHR Integrated Academic Training programme for doctors and dentists
- The HEE/NIHR Integrated Clinical Academic (ICA) programme for non-medical healthcare professionals, including nurses, midwives, allied health professionals and healthcare scientists
The Department of Health has confirmed the appointment of Professor Jonathan Van-Tam as the new Deputy Chief Medical Officer for England.
Professor Van-Tam will take up the position on 2 October 2017. He replaces Professor John Watson who is retiring after 4 years in the role.
The Deputy Chief Medical Officers are senior public health leaders who support the Chief Medical Officer – the most senior adviser on health and medicine to the UK government.
Professor Van-Tam is an internationally recognised flu, vaccine and respiratory expert. During his 25-year career, he has advised the World Health Organization, the UK Government and The European Centre for Disease Prevention and Control on influenza and other respiratory virus infections.
He graduated in medicine from the University of Nottingham in 1987, trained in public health medicine from 1991, and became a Senior Lecturer at the University of Nottingham in 1997.
In addition to publishing 150 scientific papers, Professor Van Tam has also held the following posts:
- 2004 to 2007: Head of the Pandemic Influenza Office at the UK Health Protection Agency
- 2005 to 2009: part of the UK national Scientific Pandemic Influenza Committee (SPI)
- 2007 to 2017: consultant to the World Health Organization on influenza
- 2007 to date: Professor of Health Protection at the University of Nottingham
- 2009 to 2010: part of the UK Scientific Advisory Group for Emergencies (SAGE) during the influenza pandemic
- 2010 to 2017: leader of the WHO Collaborating Centre for Pandemic Influenza and Research
- 2013 to 2017: Editor-in-Chief of Influenza and Other Respiratory Viruses
- 2014 to date: Chair of the UK Government’s New and Emerging Respiratory Virus Threat Advisory Group (NERVTAG).
Professor Van-Tam said:
It is a great honour to be given the opportunity to serve as the Deputy Chief Medical Officer for England. I am looking forward to the work ahead with enormous enthusiasm.
Professor Dame Sally Davies, Chief Medical Officer said:
I would like to congratulate Professor Van-Tam on his appointment. His track record speaks for itself; he will bring a wealth of experience and expertise to the role and I look forward to working closely with him.
Professor John Watson has been a fantastic Deputy Chief Medical Officer. I would like to thank him for his huge contribution to public health and for his expert support.
The UK Pharmacogenetics & Stratified Medicine Network is made up of academics, clinicians, industry partners, regulators and patient groups.
Our new node map allows website visitors to see which individuals and institutions belong to the network.
To use the node map to find a potential research partner, begin by selecting the relevant research interest, e.g. Adverse Drug Reactions.
Next, select from which sector you wish to find a research partner, e.g. Academic.
Now you can see the educational institutions that have network members researching in the area you previously selected. Now, choose an institution to see a list of network members, e.g. University of Liverpool.
Choosing one of the names will provide you with more information about that individual, e.g. Munir Pirmohamed.
To coincide with the publication of the Life Science Industrial Strategy, Health Secretary Jeremy Hunt, announces £14.25 million funding to support 11 NIHR Medtech and In vitro diagnostic Co-operatives (MICs).
The NIHR MICs will build expertise and capacity in the NHS to develop new medical technologies and provide evidence on commercially-supplied in vitro diagnostic (IVD) tests. Funding will be provided over five years for leading NHS organisations to act as centres of expertise; bringing together patients, clinicians, researchers, commissioners and industry.
Dr Louise Wood, Director of Science, Research and Evidence at the Department of Health said:
“The funding received by the 11 NIHR Medtech and In vitro diagnostic Co-operatives will make a real difference to patient’s lives and provide a focal point for the medtech and in vitro diagnostic industries to develop new technologies and generate the evidence needed by the NHS to support the uptake of new tests”
The NIHR MICs with launch 1 January 2018 replacing the NIHR Healthcare Technology Co-operatives and NIHR Diagnostic Evidence Co-operatives, incorporating and retaining the remits of both.
Over one million people in primary care have actively participated in research studies looking at healthier lifestyle, disease diagnosis and prevention, and management of long term illnesses such as diabetes, as reported by the National Institute for Health Research (NIHR).
Clinical research is the way clinicians in primary care (including GPs, dentists and pharmacists) gather evidence about new treatments, in order to improve patient care in the NHS.
Simon Denegri is the NIHR National Director for Patients and the Public in Research, he said:
“This is fantastic news. The nature of the health challenges facing the UK means that GPs, in partnership with patients and carers, have a crucial role to play in developing treatments of patient benefit. That over one million people have volunteered to participate in clinical studies is a mark of how successful this partnership has become. The NIHR hopes that many more people and their families will be encouraged by this to also come forward and help us do more life-saving work. Research cannot happen without them.”
The NIHR Clinical Research Network provides clinicians with the practical support they need to make research studies happen, so that more research takes place across England, and more patients can take part.
In April 2006, the NIHR Clinical Research Network created the Primary Care Specialty to bring research opportunities for patients closer to home, where the majority of common illnesses and conditions are treated.
Of the 7,840 general practices in England, 42 per cent are now active in research. The Network works with key stakeholders to promote the successful delivery of research studies in the NHS and to help plan new studies that will address the needs of patients. Collaboration with the Royal College of General Practitioners (RCGP) has meant that over 1,000 practices are now Research Ready® accredited. See the below Q&A with the RCGP to find out more.
Professor Paul Wallace has been in the Network since the Primary Care Specialty began. Currently Co Specialty Cluster Lead for Primary Care, he looks back over the last ten years:
"This is very exciting news, and it is really wonderful that we are reaching such a large proportion of the population. People all over the country now have the opportunity to take part in research in their local community as well as at their hospital. We have come a long way thanks to the Network, which has enabled us to give so many practices the mechanisms to help their patients get involved with research.
“To see the proportion of research active practices grow over the years has been phenomenal and reaching this milestone is a tribute to Network staff, primary care staff but above all, patients and the public who have given their time freely to make a difference in the NHS.”
In 2015/16 there were 249 open studies on the NIHR Clinical Research Network Primary Care Portfolio. The Primary Care Specialty also supports or is involved in research relating to the other 29 Network specialties such as Diabetes, Respiratory and Mental Health. This means that last year the Primary Care Specialty supported over one quarter of the recruitment to the NIHR Clinical Research Network Portfolio (total recruitment over 605,000).
NIHR DEC Leeds has been successful in its bid to become one of the Government’s newly-funded MedTech & In Vitro Diagnostic Co-operatives.
The new organisation, called NIHR Leeds In Vitro Diagnostics Co-operative (NIHR Leeds IVD Co-operative), will launch on 1 January 2018, and will be led by Professor Gordon Cook, who is taking over as Clinical Director from Professor Peter Selby.
"Leeds hosting this very important infrastructure programme is a fantastic opportunity to bring together several talented researchers in Leeds to interface with industry and academia to impact diagnosis and ultimately benefit patients,” says Professor Cook.” We will build on the excellent work of NIHR DEC (Leeds) moving forward to generating more successful interactions and outcomes"
NIHR Leeds IVD Co-operative is one of 11 MICs established nationwide to build expertise and capacity in the NHS to develop new medical technologies and provide evidence on commercially-supplied in vitro diagnostic (IVD) tests. In particular, NIHR Leeds IVD Co-operative will continue to focus on catalysing the generation of high quality evidence on commercially-supplied IVDs that is required by the NHS, industry and other organisations.
Funding will continue for five years, enabling the MICS to act as centres of expertise, bringing together patients, clinicians, researchers, health commissioners and industry.
Dr Louise Wood, Director of Science, Research and Evidence at the Department of Health, said: “The funding received by the 11 NIHR Medtech and In Vitro Diagnostic Co-operatives will make a real difference to patients’ lives and provide a focal point for the medtech and in vitro diagnostic industries to develop new technologies and generate the evidence needed by the NHS to support the uptake of new tests.”
In response to a report by Sir John Bell to the UK government, Sir John Chisholm, Executive Chair of Genomics England said:
“Genomics England welcomes Sir John Bell’s report to government from the life sciences sector – recognising as it does the critical role that genomics will play in the future health, well-being and economic prosperity of this country.
The UK has been quick to act on the opportunities of genomics, with significant investment in the 100,000 Genomes Project – harnessing the world’s biggest integrated healthcare system to deliver the world’s largest national sequencing project. Today’s report gives us the blueprint to build on our global lead in genomic science to drive NHS transformation, improve health outcomes and realise material economic benefits for UK plc.”
Industry proposals to help the UK’s life sciences sector become an international benchmark for success were unveiled by Professor Sir John Bell during a speech at the University of Birmingham’s Institute of Translational Medicine on 30 August 2017.
Attended by Business Secretary Greg Clark and Health Secretary Jeremy Hunt, Sir John Bell outlined the industry’s vision for how government can work alongside the sector to boost businesses large and small across the £64 billion life sciences sector.
In the government’s Industrial Strategy green paper, launched in January, life sciences was one of five of the UK’s leading sectors tasked with working with stakeholders across the industry to identify opportunities for how government can support the industry.
The industry-led Life Sciences Industrial Strategy follows Sir John Bell’s comprehensive cross-sector review into the long-term future of the industry and brings together input and recommendations from a broad range of stakeholders, including global companies such as AstraZeneca, Johnson and Johnson, MSD, GSK and healthcare groups, SMEs and charities.
The report’s recommendations will be considered carefully by the government and used to work towards a sector deal between government and the global life sciences sector.
Sir John Bell said:
The vision for the Life Sciences Industrial Strategy is an ambitious one and sets out proposals for how the UK can continue to capitalise on its strengths in the sector, both to encourage economic growth and to improve health outcomes for patients.
We have created a strategy which capitalises on our strong science base to further build the industry into a globally-unique and internationally competitive life sciences eco-system, supported by collaboration across industry, government, the NHS, academia, and research funders to deliver health and wealth.
I look forward to working with government to consider the strategy’s recommendations, including those that can be taken forward as part of an ambitious sector deal.
From a cross-section of industry and trade association members of the Life Sciences Industrial Strategy Board:
We welcome the publication of the Life Sciences Industrial Strategy, led by Sir John Bell. The Strategy and Board demonstrate the breadth and vibrancy of the life sciences ecosystem in the UK, the importance of collaboration across the sector, the critical role of the NHS in delivering the development and use of new medical technologies, and the contribution of our sector to the UK economy.
The Strategy provides a holistic and collaborative framework to realise the many exciting opportunities in the future of life sciences in the UK and is a positive first step to cementing the success of our sector.
This should provide the springboard for any sector deal for the life sciences sector, including the NHS and other stakeholders; this will be vital to ensuring that the recommendations set out in this Strategy are fully implemented.
As the UK leaves the EU, collaboration with, and support from government is more important than ever to maintaining the UK’s position as a global life sciences ecosystem.
The Life Sciences Industrial Strategy, a report to the government from the life sciences sector, is organised under 5 key themes – science, growth, NHS, data, and skills – with proposals to build on the UK’s strengths in each area. These include:
- Science – Reinforcing the UK science offer by sustaining and increasing funding for basic science to match our international competition and by further improving UK clinical trial capabilities
- Growth – Improving growth and infrastructure across the country, through a tax environment that supports growth and by attracting substantial investment to manufacture and export high value life science products of the future
- NHS – Encouraging NHS collaboration by recommending the Accelerated Access Review be adopted with national routes to market streamlined and clarified, including for digital products
- Data – Making better use of data and other evidence by establishing 2 to 5 regional innovation hubs that would provide data across regions of 3 to 5 million people.
- Skills – Ensuring the UK has the talent and skills to underpin future life sciences success by delivering a reinforced skills action plan across the NHS, commercial and third sectors
The Strategy also recommends the establishment of the Healthcare Advanced Research Program (HARP), a programme through which industries, charities and the NHS can collaborate on ambitious and long-term UK-based projects to transform healthcare and take advantage of the medical trends of the next 20 years.
Health Secretary Jeremy Hunt said:
The UK has always been at the forefront of scientific excellence. From the discovery of antibiotics to our world-leading 100,000 Genomes project, we have a proud history of medical breakthrough and innovation.
I want patients to continue to be at the front of the queue for the best treatments available, whether that means early access to trials, giving staff brand new innovations and technology to work with, or being at the heart of research to share best practice quickly across the health and social care system. A strong and growing life sciences sector ensures this, particularly as we negotiate our exit from the EU.
In welcoming the Life Sciences Industrial Strategy, the Health Secretary is also announcing £14 million funding to support 11 medical technology research centres to encourage collaboration between the NHS and industry in developing and bringing new technologies to patients through the National Institute for Health Research (NIHR). This will mean patients will continue to benefit from new technologies which will help to improve diagnosis and get them the treatment they need quickly.
Business Secretary Greg Clark said:
The life sciences sector is of critical importance to the UK economy and UK health – with over 5,000 companies, nearly 235,000 employees and a turnover of £64 billion in 2016 – and the government is committed to continuing to help this sector go from strength to strength.
The Life Sciences Industrial Strategy demonstrates the world-class expertise the UK already has in this sector and represents the industry’s vision for how we can build on our world-leading reputation in this field.
We will be engaging with Sir John Bell in the coming months in an effort to work towards a sector deal that helps us seize the opportunities in this area.
Chief Executive of Innovate UK, Dr Ruth McKernan, added:
I know from my own experience that the UK is a world leader in life sciences. These new proposals underline our strength and will keep the nation at the cutting edge. At Innovate UK, we look forward to playing a key role in its delivery.
Working with the research community and exciting companies, with equally exciting ideas, we will drive innovation to create new jobs and deliver greater productivity.
At the launch of the Life Sciences Industrial Strategy, the Business Secretary reiterated government’s commitment to the sector, announcing the first phase of the government’s investment in life sciences through the Industrial Strategy, with £146 million for leading-edge healthcare, which is expected to leverage more than £250 million of private funding from industry.
This investment, part of the government’s flagship Industrial Strategy Challenge Fund, will be spread over 4 years and covers 5 major projects supporting advanced therapies, advanced medicines and vaccines development and manufacturing. These projects are:
- Medicines Manufacturing Innovation Centre: A £13 million competition to establish a new centre, in partnership with industry, that will accelerate the adoption of emerging and novel manufacturing technologies
- Vaccines Development and Manufacturing Centre: To develop and manufacture vaccines for clinical trials and prepare for emergency epidemic threats, government is investing £66 million in a new centre of excellence
- Advanced Therapies Treatment Centre £30 million investment in 3 new sites will help establish a network of centres, based in hospitals, that will transform the UK’s ability to develop and deliver cell and gene therapies to a large number of patients
- Expanding the Cell and Gene Therapy Manufacturing Centre: Enhancing the UK’s offer in the fast-moving field of cell and gene therapy by investing £12 million in doubling the capacity of the Cell and Gene Therapy Centre in Stevenage
- Research and Development to support innovation at the manufacturing centres: Through a new collaborative scheme, the government is investing £25 million to support SMEs working in this sector and boost innovation
Government has increased investment in research and development over the next 4 years by £4.7 billion to create jobs and raise living standards through the Industrial Strategy Challenge Fund. The Business Secretary has announced that the first £1 billion of investment is being made in 6 key areas in 2017 to 2018, driving progress and innovation that will create opportunities for businesses and sectors across the UK.
There is no common definition of personalised medicine, but in the context of this guidance the term refers to the targeted use of a treatment in a patient on the basis of the individual’s characteristics and genetic makeup and the understanding of how the treatment works.
The choice of a personalised medicine relies on the use of a companion diagnostic, a diagnostic medical device which allows identifying patients who are most likely to benefit from a specific medicine. The device can also identify patients who are likely to be at increased risk of serious adverse reactions as a result of treatment with the associated medicine. It is very important to clarify how evidence to support the validation of a companion diagnostic can be generated during the development of a medicine.
While EMA does not issue recommendations on companion diagnostics, the recently revised European Union (EU) legislation on in vitro diagnostic medical devices1foresees cooperation between medicines regulators and EU notified bodies, which conduct the conformity assessment of medical devices in the EU, in the evaluation of new companion diagnostics to obtain the CE label2.
The future guideline will replace the existing reflection paper on co-development of pharmacogenomics markers and assays in the context of drug development.
The deals will help speed translation of discovery research into potential therapies by giving academic researchers the chance to use industry infrastructure and expertise to further their discovery science research.
One of the partnerships gives researchers the chance to apply for unprecedented access to AstraZeneca’s high-throughput screening drug discovery capabilities at the MRC/AstraZeneca Centre for Lead Discovery.
High-throughput screening is a tool that has been used by industry for decades to search for small molecules with potential for use as future therapies. Developments in robotics and technology mean that facilities can now screen more than 300,000 compounds per day, helping to make the process of drug discovery smarter, faster and cheaper.
Successful applicants will have access to AstraZeneca’s drug discovery robotics platform (NiCoLA-B) and a high-quality, chemically-diverse compound collection of over two million compounds.
The other opportunity is the UCB Antibody Discovery Initiative.Scientists can apply for access to their cutting-edge technologies to discover therapeutic antibodies. Several early steps in the process are now automated to expand the capacity, increase the speed and improve the consistency of the antibody discovery process.
Biologics, including therapeutic antibodies, are becoming increasingly important in the treatment of disease. 30 years on from commercial development of the first therapeutic monoclonal antibody, by Sir Greg Winter at the MRC Laboratory of Molecular Biology, monoclonal antibodies are used to treat a wide range of diseases, including cancer and autoimmune conditions.
These new opportunities complement many existing ground-breaking MRC-industry partnerships. The world-leading MRC-Industry Asset Sharing Initiative involves access to deprioritised molecules of six global pharmaceutical companies. The pioneering Stratified Medicine Initiative has funded 13 consortia to date, leading to exciting and successful collaborations between 34 UK universities and more than 40 biopharmaceutical companies, ranging from small biotechs to pharma giants.
Neil Weir, Head of Discovery Research at UCB, said: “UCB is committed to increasing our collaborative networks to accelerate scientific discovery. We want to facilitate industry-academic interaction to generate potential therapeutics to benefit patients suffering with severe diseases. This joint initiative with the MRC is a world-leading collaboration between academia and industry with the aim of enhancing the pace of new drug discovery and improving patient outcomes”.
Mark Wigglesworth, Director of High Throughput Screening at AstraZeneca, said: “AstraZeneca is committed to creating a truly innovative and collaborative research environment and this first-of-its-kind initiative will enable our teams to work side by side with world-leading MRC scientists. AstraZeneca and the MRC share the same passion to push the boundaries of science to accelerate drug discovery and the development of new medicines here in the UK.”
Chris Watkins, Director of Innovation at the MRC, said: “We are really excited to have negotiated these industry-led collaborations that bring together the best UK-based scientists with the best technology in UK-based industry. Through access to AstraZeneca and UCB’s state-of-the-art technology we are hoping that these collaborations will enable scientists to deepen their understanding of disease, identify new therapeutic targets and kick-start the search for new medicines. We also hope they will strengthen links between academics and industry. The MRC continues to explore innovative new ways of working with industry to achieve our mission of improving human health through world-class medical research.”
The Research Environment
The government has announced new funding of up to £86 million for UK firms to develop medical breakthroughs.
The package will allow small and medium sized enterprises (SMEs) to develop and test new technologies in the NHS. This could include innovations such as digital technologies to help patients manage their conditions from home instead of a hospital, or to develop new medicines.
Access to this funding will also speed up the time it takes to get new technologies from the lab to patients in the NHS.
The announcement is the first step in taking forward the Accelerated Access Review (AAR) – an independently chaired review, which made recommendations to government on speeding up patient access to new technologies.
Technologies that have previously received support are already bringing benefits to patients. For example, MyCOPD is an online system that helps people with chronic obstructive pulmonary disease (COPD) better manage their condition. It has helped over 32,000 patients by helping them improve their breathing, manage flare-ups and track medicine use. This reduces reliance on GP and hospital appointments.
Health Minister Lord O’Shaughnessy said: "The government’s ambition is that NHS patients get world-leading, life-changing treatments as fast as possible. That can’t happen unless we support medical innovation and tear down the barriers – like speed to market and access to funding – that can get in the way, especially for SMEs. Our investment in innovation shows how much we value the UK life sciences sector."
The funding is split into 4 packages. These include:
- £39 million of funding to the Academic Health Science Networks (ASHNs), enabling them to assess the benefits of new technologies and support NHS uptake of those that deliver real benefits to patients according to the local need
- £35 million Digital Health Technology Catalyst for innovators – this will match-fund the development of digital technologies for use by patients and the NHS
- up to £6 million over the next 3 years to help SMEs with innovative medicines and devices get the evidence they need by testing in the real world, building on existing opportunities such as the Early Access to Medicine Scheme (EAMS)
- £6 million Pathway Transformation Fund, which will help NHS organisations integrate new technologies into everyday practices - this will help overcome more practical obstacles such as training staff on how to use new equipment
Business Minister Lord Prior said: "The government has an important role to play in driving innovation that will increase economic growth and support businesses across the country. Through this funding we will quicken the pace of scientific discovery and innovation in the UK. Our Industrial Strategy will boost our status a global hub for life sciences."
Association of British Healthcare Industries (ABHI) CEO Peter Ellingworth said: "ABHI welcomes the announcement as a further commitment to supporting the UK medical technology sector. These additional funding initiatives will complement work already in place on Innovation Tariff, NICE processes and horizon scanning as part of the overall Accelerated Access Review. The measures could significantly enhance the UK as a destination of choice for MedTech companies, in turn, benefiting patients, the health system and the wider economy."
Ben Moody, Head of Health and Social Care at techUK, said: "The UK is a world leader in health tech but we must not be complacent. The Digital Health Technology Catalyst will be a great boost for innovators in the sector. The announcement also recognises that the resources needed to generate evidence to show that a technology is worth reimbursing can be prohibitively difficult for SMEs - so the fund to support evidence generation for innovative devices is particularly welcome."
BIA CEO, Steve Bates, said: "These new building blocks for the UK life science innovation ecosystem will help UK small companies get their innovations into the NHS more quickly to benefit patients - something the BIA has long campaigned for. It will make the UK a more attractive location for starting and scaling life science businesses. Enabling smaller companies to access the Early Access to Medicines Scheme will be particularly helpful for small UK biotech companies."
British In Vitro Diagnostics Association (BIVDA) Chief Executive, Doris-Ann Williams MBE, said: "BIVDA very much welcomes the government’s announcement about funding towards practical support for the introduction of new medical technologies into the NHS. It is a constant source of frustration that implementation of new tests takes years to achieve. It means that not only are people not benefiting from improved diagnosis and disease management but also that the NHS is losing the chance to gain cost efficiencies along clinical pathways. We would like to congratulate the Department of Health and the Department for Business, Energy and Industrial Strategy on pulling together these funding streams ahead of the Industrial Strategy to show practical support of their intent to foster healthy and vibrant Life Sciences industries in the UK."
The chances of survival increase significantly if cancer is detected and treated at an early stage. Expanding research in the early detection field offers the potential for transformational improvements in patient outcomes and is essential in making progress towards our vision of 3 in 4 people surviving cancer by 2034.
Cancer Research UK are convening a new Early Detection Research Committee that will award funding for research into the early detection of cancer. They say: "We’re challenging the research community to focus efforts, drawing together disparate activity across many areas of cancer research and across disciplines – including biomedical sciences, physical sciences, engineering, mathematics and industry – to bring in new thinking and build novel early detection research projects.
"The Early Detection Research Committee will consider early detection research as investigations that enable the detection of cancer, or pre-cancerous states, at the earliest possible time point at which an intervention might be made. Our ambition is to build to an annual investment of £20 million in this area by 2021."
Initially, the committee’s remit will include:
- Catalytic awards to stimulate and support new lines of early detection research
- Up to £500,000
- Up to 3 years
- High-level support for ambitious research programmes to enable significant progress in early detection research
- Flexible funding to be responsive in an evolving field
- Up to £2.5m
- Up to 5 years
CRUK will fund discovery and translational research which is mindful of the clinical/population context, including, but not limited to:
- Biological research underpinning early detection and biomarker discovery/validation
- Human-based early detection discovery research
- Population risk-stratification for early detection
- Biomedical and health informatics, and systems biology for early detection
- Development and utilization of preclinical early detection model systems
- Novel early detection technology development
- Translational/clinical early detection research
A new video has been released to explain who the NIHR is and what it does. The video, which is less than one minute long, describes the NIHR ‘in a nutshell’ and features people from across the NIHR who are working towards improving the health and wealth of the nation through research.
The NIHR is asking all those funded by, supported by, working for and working with the NIHR to watch and share the video, which is available to view on NIHR’s YouTube channel NIHR TV and across the NIHR’s social media channels.
Three years after the launch of the Global Alliance for Genomics and Health (GA4GH) and six months after the first GA4GH-hosted convention of national genomics initiatives, Kathryn North (Australian Genomics) and Genomics England’s Chief Scientist, Professor Mark Caulfield recently convened representatives from 13 National Initiatives in genomic data collection to discuss areas of potential collaboration at the Wellcome Trust in London.
The goal of the meeting was to identify potential areas of collaboration, resource and expertise sharing, as well as common needs across National Initiatives that GA4GH can incorporate into its “toolbox” of data sharing standards and tools.
The meeting was attended by representatives of major population-sequencing endeavours, from: Australia, Brazil, Canada, Finland, GenomeAsia100k, Global Gene Corp (India), the Netherlands, Qatar, South Africa, Switzerland, Turkey, the USA and the UK.
The three more established projects – Genomics England, Australia and the USA gave detailed talks about progress to date and challenges they have faced. This was followed by presentations from all of the emerging projects – covering their aims, funding models, disease focus, and resources they’ve developed. There were also workshops on Data & Sharing, Regulation, and Clinical & Education, as well as a round-table discussion.
Sir John Chisholm, Executive Chair of the Genomics England Board, spoke on his vision for genomic research:
"This change is possible because we will soon be able to understand the genome, and to use it to predict outcomes.
“It’s a fantastic vision, but it’s very hard and it will take most of rest of the century to get there,” said Chisholm. He cited two challenges in particular:
1. Genomic medicine involves “colossal” amounts—millions, tens of millions, or even 100s of millions—of data points. This scale is necessary because of the low probability of making connections between the genome and human health.
Additionally, because very few associations are monogenic, combinatorial problems make unpacking the genome a very difficult and complex pursuit. In the past, scientific programs have built individual research cohorts for each study. This will not work with clinical genomic research, because no organization has enough money to fund research cohorts at this scale.
The only way to achieve cohorts of the size needed is by aligning fully consented patient data from the healthcare system with genomic data. No one country will be able to do this alone so national programs must collaborate.
Given that no one country can do it alone, nations must agree on rigorous standards and protocols, as artefacts of non-harmonized data collection processes will make it impossible to understand outcomes across a combined data set.
2. Implementing standards and protocols in routine healthcare will be difficult, Chisholm said, “but it’s something where the prize is so great, it’s worth doing.” In the four years since it was launched, Genomics England has spent considerable effort and made progress on the development of standards and protocols for data collection and getting them implemented across the UK’s National Health Service.
Now, he said, that needs to be taken to the international stage. He invited meeting attendees to “form a club” to work together to agree on standards and protocols for clinical genomic data sharing. This will allow for federated data sharing that is protective of participant confidentiality and privacy and enables “this transformation of the human experience in the 21st century.”
In closing remarks, Professor Mark Caulfieldsaid that the groups present must showcase their achievements to patients and the publicin order to promote further involvement from those communities. Doing so, he said will result in “more ‘Denmarks’ and less places where we lock data away.”
He also summarised a number of high level themes emerging from the meeting:
- In three years, the discussion has moved from a focus on future goals to examples of established infrastructure and large-scale genomic data collection in health care systems around the world
- The next step is to position healthcare against research in order to achieve the needed scale, and to move from cohorts of 1 million individuals to 5 or 10 million thanks to shared data across the globe
- This will require an ethical framework and robust guidelines for follow up
- Initiatives must engage with patient advocacy and support groups since those populations are willing to take on challenges that researchers shirk from
- Industry is vital to this endeavor, as it requires millions (or billions) of dollars
- There is a need for robust IP that allows for freedom to operate, and the ability to account for situations where the responsible act is not to protect IP but to give it away
On Friday 30th June, Genomics England published the following update:
This week, we are very happy to announce that we have begun the GeCIP early onboarding phase of the 100,000 Genomes Project. Throughout the first half of 2017 we have been concentrating our efforts on developing and improving the Genomics England Research Environment - a datacentre that is aimed to facilitate collaborative research within a secure environment whilst protecting the privacy of participants enrolled in the Project. Advancement of this datacentre, effectively designed to be a ‘lending library’, alongside the need to develop and deliver an automated pipeline that handles clinical and genomic data for use by the clinical community continues to be one of the key priorities for Genomics England. In addition to ensuring that the 100,000 Genomes Project data is supported by our systems, we have been working with the Genomics England Clinical Interpretation Partnership (GeCIP) research community and the academic institutions to make sure that GeCIP members fulfil the necessary requirements for access to the Project’s dataset. These consist of a two-step process: (1) approval by the Access Review Committee (ARC) given for each of the inaugurated GeCIP domains; (2) signed Participation Agreement by the academic institutions housing the respective GeCIP members. To date we have successfully approved and verified over 40% of our membership base totalling over 2600 researchers worldwide. Detailed numbers are presented in the infographic below.
We have invited a total of 34 researchers from three GeCIP domains (Neurology, Colorectal Cancer and Quantitative Methods, Machine Learning and Functional Genomics - the first to have gained ARC approval for data access) to conduct research within the Genomics England Research Environment. The early onboarding dataset consists of a small subset of the Main Programme data from Cancer and Rare Disease. These GeCIP members will be working with the Genomics England’s team in testing the research environment by conducting research within the datacentre. Over the course of roughly two months, the early onboarders will be feeding back their user experience and informing us of any necessary improvements to the system.
The ultimate goal of this activity is to assure that the environment is fit to sustain research at scale in preparation for next stages of GeCIP onboarding. This process will be dictated by order of domain ARC-approval and the availability of relevant data within the research environment. The data set will include genomic and primary clinical data alongside a wealth of secondary longitudinal datasets such as Hospital Episode Statistics, and we hope GeCIP researchers’ work on this data will further drive clinical interpretation. Moreover, we hope that it will also incentivise the GeCIP community to help drive recruitment, ensuring that the 100,000 Genomes Project supports representation of a broad range of disorders across rare diseases and cancers and provides equitable access to whole genome sequencing for all. We will keep you informed of developments as we progress through this new and exciting phase of the Project. As always, we would like to express our gratitude for your continued support of the 100,000 Genomes project. We look forward to working with the GeCIP community in the months to come as we onboard more researchers to the Genomics England Research Environment.
NICE Scientific Advice has launched a competition for small or medium sized companies, charities and academic research groups, who are developing transformative products that have the potential to change patients’ lives and/or save the NHS money.
The NICE AdviSeME Prize is open to products (pharmaceuticals, devices, diagnostic test/tools, cell/gene therapies, healthcare apps) in the early clinical stages of development. To be considered the technologies should demonstrate clinical credibility and target a population with a high unmet clinical need. In addition they need to have a potential beneficial impact on either:
- survival and/or health-related quality of life,
- costs to the NHS,
- the use of healthcare resources and/or access to healthcare.
Organisations are invited to submit an application detailing their product development plans which will be assessed by the expert selection panel comprising Professor Sir Michael Rawlins (MHRA), Professor Carole Longson (NICE), Dr Ian Campbell (Innovate UK) and Professor Sue Hill (NHS England).
The winner will receive a free Light Scientific Advice Service from NICE, usually costing £15,000. The award will support discussions between the company and payers and commissioners to enable market access for their product. NICE will work with clinical and health economics experts to provide a comprehensive commentary on proposed evidence generation plans to help the organisation demonstrate the value of their product.
Leeza Osipenko, Head of NICE Scientific Advice, said: “The NICE AdviSeME Prize is a realisation of our commitment to supporting smaller organisations in the life sciences landscape and increasing the profile of their products by helping shape their development efforts to meet patient and healthcare system needs.”
NICE Scientific Advice provides a fee-based consultancy service to developers of pharmaceuticals, biopharmaceuticals, medical devices and diagnostics. It works with companies in the early stages of product development. Its aim is to help companies ensure that their clinical programmes collect data relevant for reimbursement decisions when assessing the clinical and cost effectiveness of new healthcare interventions.
The NICE AdviSeME prize will run from 27 June and the closing date for applications is 13 October 2017. Further information about the competition, including terms and conditions, is available on the NICE website.
Cancer Research UK have developed a new, online, free, Research Involvement Toolkit.
About the Toolkit:
- This is a resource for researchers who want to involve people affected by cancer in their research (at any stage). It is not a resource to support researchers with engagement activities, or with recruiting to clinical trials.
- It aims to support researchers to plan, deliver and evaluate Public and Patient Involvement (PPI)
- It’s designed to be easy to use and to meet the researcher needs surfaced in researcher surveys conducted by CRUK and also the Shared Learning Group for Involvement in Research
- The Toolkit has been developed to be open access – a single Username and Password has been created so that any researcher (or member of the public/staff) can access the Toolkit
- The Toolkit will be reviewed and refined on an ongoing basis in order to respond to researcher needs and feedback.
How to access the Toolkit:
2) Log in with the following username and password Username: CRUK\InvolvementToolkit Password: CRUKInvolvement
The Academy, Cancer Research UK and the Wellcome Trust have published the report of the joint FORUM workshop on the regulation and governance of health research, held five years on from the Academy’s report on ‘A new pathway for the regulation and governance of health research’.
This workshop brought together participants from across the life sciences sector to explore developments in the regulatory and governance landscape over the past five years, and any new challenges arising, in three particular areas: Health Research Authority (HRA) Approval; regulation of clinical trials; and data privacy and governance. Key points of discussion at the meeting included:
The overall improvements in simplification and coordination of NHS research governance, and the importance of striving to embed a research culture in the NHS.
Difficulties of over-interpretation of guidance and the need for more proportionality such as in application of ICH Good Clinical Practice (GCP).
Anticipated improvements to regulation of clinical trials through the EU Clinical Trials Regulation, and the need to address remaining burdensome or ineffective aspects of trials regulation
Importance of a whole systems approach to regulation supported by end-to-end metrics across the research pathway.
Access to health data remains a critical barrier.
NICE’s Scientific Advice service is launching an online tool to help developers of medical devices and diagnostics understand and generate the evidence needed to show their products are clinically and cost effective. This will help companies prepare for a dialogue with health technology assessment organisations and payers and potentially speed up time to market.
The Medtech Early Technical Assessment (META) tool has been developed in partnership with Greater Manchester Academic Health Science Network. The tool helps companies identify what evidence they have and what gaps need to be filled to satisfy payer requirements. It is a paid for service aimed at, but not limited to, small and medium sized companies.
Leeza Osipenko, head of NICE Scientific Advice said: “Medical devices and diagnostics is a fast growing and highly competitive field. Healthcare systems are facing financial pressures and are keen to adopt transformative and cost saving technologies.
“We want to help healthcare systems get access to more products that meet such criteria and help companies develop these technologies and relevant evidence to demonstrate their value to patients and payers.
“NICE Scientific Advice is committed to supporting small and medium sized enterprises, charities and academic groups so we’ve designed META to ensure it’s both affordable and flexible. However, we hope that larger enterprises also find the META tool of interest and value for their medtech pipelines.”
The META tool can be licensed for use by partner organisations working with medtech companies. These could include Academic Health Science Networks, Healthcare Technology Consortiums and consultancies who may have their own bespoke approaches to using META and assisting product developers prepare their products for adoption into a healthcare setting. This accessibility will allow NICE to maximise META’s potential and make it available to companies not just in the UK but and internationally as well.
The tool will be launched on 3 July at the Royal Society of Obstetricians and Gynaecologists, 27 Sussex Place, London NW1 4RG by NICE chief executive Sir Andrew Dillon. Further information about the launch event, including how to attend and how to become a META partner, is available on the NICE website at https://medicinesevents.nice.org.uk/meta
NICE Scientific Advice provides a fee-based consultancy service to developers of pharmaceuticals, biopharmaceuticals, medical devices and diagnostics. It works with companies in the early stages of product development and its aim is to encourage companies to consider the relative clinical and cost effectiveness of their products which can then inform the overall product development strategy.
PIF is delighted to publish a Summary Report of Phase 1 of our Perfect Patient Information Journey project.
A key plank of PIF’s mission is to campaign for high quality healthcare information and support to be an integral part of the patient journey.
In light of the growing move towards supporting people with long-term conditions to self-manage and share in decision-making about their care, PIF has launched a project aimed at creating a model pathway to support the ‘perfect patient information journey’ for people with long-term conditions.
The project aims to:
- Identify good practice principles to ensure the provision of high quality information for people with long-term conditions.
- Develop resources aimed at supporting patients, healthcare professionals and commissioners to better access, provide and commission high quality information.
- Pilot and evaluate these resources in a clinical setting.
The first phase of the project involved conducting research on previous efforts to embed information into patient pathways, as well as talking to patients, healthcare professionals and commissioners, to identify key themes related to the provision of high quality information.
Ten key points were identified:
- Information on first diagnosis is essential.
- Information on first diagnosis can also be overwhelming.
- Information needs change as people move along the pathway.
- Every patient pathway is different, but there are certain points along each pathway where information is essential.
- It’s obvious, but information must be tailored to the needs of the individual.
- Being supported to ask questions is vital.
- ‘Dr Google’ can be a problem, but patients generally know how to filter online information.
- Local leadership and information champions are needed.
- Healthcare professionals want to do more, but time is a barrier.
- Commissioners want to do more, but need the evidence
Launching the report PIF’s Chair, Sue Farrington, said:
“This report brings together the experiences of people with long-term conditions, healthcare professionals and commissioners, to begin to create a map for how we can support health services to embed the provision of good information into their care pathways and improve the patient experience. We are looking forward to testing our findings over the next six months, to evidence the impact of providing better information and develop tools that support health services to deliver this.”
The next steps in the project for PIF are:
- Develop a Patient Information Commissioning Toolkit to raise awareness of the evidence and policy drivers that support the commissioning of high quality information.
- Develop a series of resources to support health services measure and improve how they provide information to service users, informed by the principles outlined in this report.
- Deliver a pilot of the resources, and evaluate the impact to service users, and the service, in improving the provision of health information.
The pilot stage of the project will begin next month and we look forward to sharing the results towards the end of 2017. Based on the experiences to emerge from the pilot, the findings from good practice research and subsequent recommendations, PIF will aim to campaign at local and national level for a greater policy focus on ensuring effective access to healthcare information.
The Medical Research Council’s neuroscience and mental health board has launched a completely updated mental health strategy (PDF, 736KB) to drive forward discovery science in the field.
Mental health issues, such as anxiety and depression, are estimated to affect approximately one in six people at any time in the UK and have a significant and long-term impact on the lives of individuals and their families. Mental disorders cost the UK economy an estimated £70-100 billion annually.
The MRC will work with other Research Councils; Departments of Health across the four nations of the UK; charities; industry and people with experience of mental illness.
While continuing to support mental health research through the MRC’s open competitions for research grants and fellowships, the new strategy aims to accelerate understanding of mental illness and the development of new treatments by focusing research in a number of key areas. These will include:
- A lifelong perspective on mental health and illness with special emphasis on youth and adolescence because of the impact of early life on lifelong mental health. (Work on the MRC-funded Dunedin cohort showed that 50% of mental illness started before the age of 15 and 75% by age 18.)
- Harnessing data from patients, cohorts and the NHS and employing cutting edge informatics technology and expertise supporting cohort and patient group studies. This will include working with health services and other funders to link research programmes and informatics on a larger scale, allowing better use of information about mental health in existing UK population studies, and new studies with patients, people at risk, and healthy volunteers, powered with new technology. We will provide extra support for researchers to engage with the new Health Data Research UK. This national institute will have a priority topic in lifelong mental health and will be vital in the development of capacity and methods to use new data science.
- Develop a major new investment in global mental health (up to £20m over five years in the first instance) in order to progress understanding of the interactions between biology, environment, culture, cognition and experiences during childhood and adolescence that contribute to mental health disorders and directly address the growing global burden of mental illness.
- Accelerate research and development of better pharmaceutical and non-pharmaceutical therapies (including psychological, behavioural, cognitive and digital) and early, preventative interventions for mental illness. One barrier to therapy development is that validated targets are not being developed quickly from discovery science effort. This could be accelerated by the development of validated cellular, animal, cognitive and behavioural models.
Dr Rob Buckle, Chief Science Officer at the MRC, said: “In research terms, five years may not seem a long time, but since the MRC launched its strategy for mental health research in 2012 there have been a number of advances in understanding the biological, environmental and psychological factors that influence the development and impact of mental illness.
“Mental health has been and continues to be a priority for the MRC, from funding our researchers to explore the role our genes play in mental health, through understanding brain function and cognitive processes, to developing new digital technologies to help people to live with conditions as challenging as schizophrenia.
“With a significant financial commitment to ensure the UK is at the forefront of new discovery science in mental health, this rebooted strategy sets out how we will further accelerate our understanding of mental illness with the long-term aim of developing new treatments for the prevention of, and early interventions for, mental disorders."
On 5 October 2016, the Academy of Medical Sciences and the Pharmacogenetics and Stratified Medicine Network held a FORUM workshop on ‘Health economics for stratified medicine’.
The workshop aimed to explore the ‘value’ of stratified medicines and diagnostics and the evidence base underlying new approaches to economic evaluation.
The discussions at the meeting broadly focused on three main challenges:
(a) consideration of new elements of value;
(b) a new reimbursement model which reflects this value and the needs across different stakeholders; and
(c) different standards of evidence.
Key points of discussion from the workshop included:
Building a broader definition of value for stratified medicines that incorporates aspects beyond direct health improvements such as reduced switching between treatments, patient ‘trust’ in clinical decisions and ability to work. There should be a drive to better accommodate different stakeholder needs and perceptions of value such as patient preferences.
Establishing a robust model for separating the value of a diagnostic and treatment.
Acceptability of alternative forms of evidence and methodologies used to generate such evidence as there are specific challenges in evidence collection for stratified medicines. It was agreed that there is an important role for academia in working with regulators and policy-makers to explore such methodologies. Better alignment is needed on evidence requirements from regulators, health technology assessment bodies, payers and other key stakeholders to drive patient access and provide clear signals for development programmes.
Limited evidence generation around diagnostics which complicates assessment of these technologies. It was agreed that alternative forms of evidence should be accepted where required and in general, evidence generation on diagnostics must be better encouraged and incentivised to ensure that there is a robust evidence base underlying their use.
Ensuring patient access through driving uptake and adoption of stratified innovations in the NHS and establishing flexible pricing and reimbursement models. These models must both reflect the value of an intervention, and the The Academy of Medical Sciences 5 potential evolution in value over time, as well as creating a mechanism by which innovations such as companion and complementary diagnostics, and combination products, can be appropriately evaluated.
The overarching need for a general culture change in the healthcare system, particularly amongst commissioners and clinicians, moving from a short-term focus on cost-savings to a longer-term view of the benefits of moving towards a stratified approach.
Achieving a balance between value to individuals and populations when assessing medicines, and the benefits of mechanisms such as shared decision-making in supporting choices at a personal level whilst enabling wider evaluation at a population level. It was agreed that to be feasibly incorporated into evaluation, personal utility and patient preferences must be considered at the population level, which will require societal evaluation similar to the quality-adjusted life year (QALY) measure.
The Problem Solving in Oncology series is published with the Association of Cancer Physicians, and the latest title is called Problem Solving through Precision Oncology.
Problem Solving Through Precision Oncology is:
- Authoritative: the latest book in the series from the Association of Cancer Physicians, written by 76 contributors including the editors Ellen Copson, Peter Hall, Ruth Board, Gordon Cook and Peter Selby
- Comprehensive: providing a succinct overview of the latest progress in the field with 15 clear teaching chapters to refresh knowledge.
- Practical: gives a hands-on guide for the cancer physician including 21 ground-breaking real-life case studies showing how to apply precision in practice.
- Educational: a valuable learning tool for everyone in the team, including graduate medical trainees and anyone wanting to expand their knowledge.
- To see the contents and view a sample chapter, click here
While precision oncology has huge potential to improve the well-being and outcomes of treatment for cancer patients, the challenges of application can be daunting. This book is a highly practical resource, helping clinicians and their teams make good decisions and gain a common understanding of this important new treatment area.
The Pharmacogenomics Research Network has entered into a working relationship with the UK Pharmacogenetics and Stratified Medicine Network to advance basic and clinical research in pharmacogenomics and its clinical translation.
We will work together to cooperate and collaborate on programs of mutual interest, including joint meetings/workshops in Europe and the US, and foster collaborative research worldwide.
Professor Joanne Hackett joins Genomics England on 18 April 2017 as its new Commercial Director and lead member of the company’s new Commercial Business Committee.
As Commercial Director, Joanne will develop the next phase of Genomics England’s industry engagement strategy by developing, managing and accelerating relationships with commercial organisations − creating opportunities for collaboration both nationally and globally.
Joanne brings a formidable track record of clinical, academic and entrepreneurial success. Training initially in regenerative medicine, she has gone on to create and sell two companies to major multinationals; hold a professorship at the University of Cambridge; and has worked for organisations such as UCLPartners and Cambridge University Health Partners to translate academic research into medical and commercial returns.
Professor Joanne Hackett said: “The relentless pursuit of better health for the patient population is at the heart of Genomics England. I look forward to being part of the journey and plan to work closely with our stakeholders to realise the potential of genomic medicine.”
Sir John Chisholm, Executive Chair at Genomics England said: “We are delighted that Joanne Hackett is joining Genomics England as our new Commercial Director. She will play a pivotal role in accelerating industry engagement to further our goal of developing new diagnostics and treatments, applied in an NHS that is well prepared for a future of genomic medicine. Joanne’s expertise, drive and ambition will help Genomics England to deliver better care and improved outcomes for patients – not just in the UK, but across the world.”
Following our recent Open Meeting, feedback is in from our delegates.
The venue, 30 Euston Square, was described as "perfect, excellent, fantastic, lovely, superb, outstanding”. Delegates loved the location, the lecture theatre, the delicious food and the welcoming venue staff.
The event was described as "friendly, informative, visionary, thought-provoking, stimulating, well organised, very impressive.” Delegates felt that the speakers were “top-notch”, “high calibre” and enjoyed the broad scope of diverse topics presented. Many commented on the excellent networking opportunities. Comments included:
“I found it to be very well organised and extremely fruitful: many inspiring presentations and plenty of interesting people to network with. The conference covered some of the hottest topics related to stratified medicine and each talk gave me a take home message.”
“A great event with a broad range of fascinating topics delivered by a great bunch of speakers.”
“Great value for money.”
Of course, there is always room for improvement. Genomic talks were focussed on Mendelian disorders and single variants, but the polygenic underpinnings of common disorders and treatment response will be where the real gains in healthcare come from. While the evidence for implementation is still weak, it is important to prepare clinicians, scientists and patients for this change in perspective.
Despite there being female chairs we need more female speakers.
More practical information of how the genome project data is going to be used in practice is needed and there are many questions to be answered. For example: Are there pilots planned to try use in discrete clinical areas? How will guidelines for practice adapt? How will HTA review adapt?
The Network holds focused workshops to address the challenges of adoption of stratified medicine into the clinic and will look to incorporate answers to these comments in future workshops. Click to view the presentations and findings from our workshops.
Whole Genome Sequencing to diagnose TB
Public Health England has announced that Whole Genome Sequencing (WGS) is now being used to identify different strains of tuberculosis (TB).
This is the first time that WGS has been used as a diagnostic solution for managing a disease on this scale anywhere in the world. The technique, developed in conjunction with the University of Oxford, allows faster and more accurate diagnoses, meaning patients can be treated with precisely the right medication more quickly. Where previously it could take up to a month to confirm a diagnosis of TB, confirm the treatment choices and to detect spread between cases, this can now be done in just over a week by Public Health England’s Birmingham laboratory. This slows the spread of the disease and boosts the fight against anti-microbial resistance.
This world first service has been developed in partnership with Genomics England, National Institute for Health Research (NIHR) and Wellcome Trust. The implementation of this technology will contribute to achieving the aims of the 100,000 Genomes Project.
Health Secretary, Jeremy Hunt, said:
“The UK has a proud history of leading the world in science and innovation – this is another global first for our country. These pioneering techniques will change patients’ lives in the NHS as well as being used across the globe to slow the spread of a terrible disease and take the fight to drug resistant infection.”
Professor Mark Caulfield, Chief Scientist at Genomics England, said:
“Genomics England are delighted to fulfil the transformative ambition of the 100,000 Genomes Project infectious disease programme for the NHS by finding a faster, better diagnostic approach for a tuberculosis which is a major infectious disease causing many deaths world-wide.”
Professor Derrick Crook, Director of National Infection Service, Public Health England, said:
“The use of whole genome sequencing to diagnose, detect drug resistance and very accurately type TB is a world first for any disease on this scale. By working closely with our partners, we are now able to use cutting edge science to effectively treat these patients with the right medicines quickly. We are immensely proud of the contribution this makes to the prospects of better treatment of TB globally. This approach will also increasingly be used for many other infectious diseases. Our ambition is to achieve this as quickly as possible so many infections can be better diagnosed and treated.”
The work has been supported by the NIHR Oxford Biomedical Research Centre, a partnership between Oxford University Hospitals NHS Foundation Trust and the University of Oxford to enable clinical research for patient benefit and foster innovation to improve healthcare.
Whole genome analyses for cancer returned to the NHS within three weeks
One key aim of the 100,000 Genomes Project is to improve cancer care for NHS patients. Whole genome sequencing in cancer can enable clinicians to choose better treatments and improve outcomes for patients through personalised medicine.
While the Project continues to recruit patients and develop the infrastructure for interpreting genomic data at scale, we are delighted that the first four cancer whole genome analyses from our ‘fast track’ project have been returned to the NHS in 18 working days of patient samples being dispatched to our whole genome sequencing pipeline.
Our ‘fast track’ project aims to provide cancer analyses within a timeframe that will help in clinical decision-making and care. It is a major part of our plans to build a sustainable legacy for cancer whole genome sequencing.
Further work is needed so the pathways for sample processing and data analysis in whole genome sequencing can be fully accredited for diagnostic use. NHS laboratories will now confirm our reported findings with a standard accredited test, before using the information to guide clinical management.
Chief Scientist, Professor Mark Caulfield says:
“During the early stages of our cancer programme, most patients will not see a personal benefit as we develop the tools, processes and systems to analyse genomes at scale. But this first set of fast-track results is very promising and confirms that we can return whole genome analyses in time to provide better outcomes for NHS patients.”
Throughout 2017 and 2018, we will return results for patients in both rare disease and cancer at pace.
The following new funding opportunities are available:
Efficacy and Mechanism Evaluation Programme
An NIHR and MRC Partnership
17/35 Mechanisms of action of health interventions
17/37 Interventions to slow the progression of chronic kidney disease
17/38 Chronic obstructive pulmonary disease
17/39 Intraoperative imaging for oncological surgery
Health Technology Assessment Programme
17/12 Coenzyme Q10 and chronic heart failure
17/13 Cytoreductive surgery with hyperthermic intraoperative peritoneal chemotherapy
17/14 Zoledronic acid to reduce fractures in patients with alcoholic liver disease
17/15 Thrombolysis in submassive pulmonary embolism
17/16 A national pre-hospital major trauma triage tool/process
17/17 Management strategies for pilonidal disease
17/18 Treatment of children with medial epicondyle fractures
17/19 First trimester detailed ultrasound scan for the earlier detection of fetal anomalies
17/20 Improving continence in children and young people with neurodisability
17/21 Early mobilisation/ rehabilitation in paediatric critical care
17/22 Mode of delivery for preterm infants
17/23 Treatment of torus fractures
17/24 Topiramate for posttraumatic stress disorder
17/25 Cognitive behavioural therapy-based treatment for adults with intellectual disability and harmful sexual behaviours
17/27 Surveillance of arteriovenous fistulae in haemodialysis
17/28 Benzodiazepines for treatment resistant panic disorder
17/29 Effectiveness of group arts therapy for diagnostically heterogeneous patients in mental health services
17/30 Urinary catheter washout
17/31 A refined prognostic tool to better identify individuals at high risk of developing psychosis
17/32 Variceal bleeding in people with small oesophageal varices
17/33 Management of diarrhoea in patients with stable ulcerative colitis
17/34 Opioids for the treatment of breathlessness in palliative care
Research for Patient Benefit Programme
For more information and a list of all current funding opportunities, please visit the NIHR website.
The UK is at the forefront internationally in the area of genomics and personalised medicine. This presents a great opportunity for the UK to capitalise on this position and achieve commercial gain through international commercial partnerships, as well as enjoy the many other benefits of international collaboration. Healthcare UK is a small team within the UK Government which helps organisations win international commercial contracts.
Clinical Lead for Healthcare, Rory Shaw, as well as his team, are actively looking for commercial opportunities in many countries in particular China, which is currently the most rapidly growing healthcare market. They are taking a very broad definition and looking in all areas including education and training, clinical services, pharmacogenomics, laboratory services, data handling, analytics, data interpretation, big data, research, med tech, e- and m-health applications and new therapies, as well as looking in areas such as cancer and diseases where the new –omics era has a potential impact.
Healthcare UK are looking for organisations in both the commercial and public sectors which meet the following criteria -
A] Working in any aspect of genomics, pharmacogenomics, precision medicine, and other -omics linked clinical areas such as cancer, or inherited disease
B] U.K. Registered company or part of the UK public sector
C] With a clear offer of a product or service
D] A desire and corporate commitment to winning a commercial deal overseas, in particular in China, within a year
E] Being “market ready” with a sufficient understanding of what it would take to work overseas in terms of scale of the market and culture
F] Having the ability to follow up an introduction including visiting the customer in their own country eg China
If your organisation meets these criteria, it would be helpful also to know your view on which countries you are, or are not interested in, and also your idea of the type of customer in the target country likely to be interested in your product or service.
To make contact with Healthcare UK regarding this, organisations would need to prepare one Power Point slide indicating -
1] your product or service, described in about four lines and written in a way that a lay person in an embassy overseas can understand
2] a couple of lines about your company and the website details
3] any evidence of existing or previous overseas commercial activity (this gives confidence to the customer)
4] the email address of the contact person
Professor Andrew Morris has been appointed Director of the new UK health and biomedical informatics research institute, which is to be named Health Data Research UK (HDR UK). The new institute will, for the first time in the world, incorporate on a national scale the whole breadth of data science research aimed at improving human health.
HDR UK is a joint investment led by the MRC, together with the health research departments of England, Scotland and Wales; the Engineering and Physical Sciences Research Council (EPSRC); the Economic and Social Research Council (ESRC); British Heart Foundation; and Wellcome. Harnessing the power of the NHS and associated health and biomedical data in the UK, HDR UK will develop and apply the cutting edge informatics approaches needed to address the most pressing health research challenges facing patients and the public.
Professor Morris was chosen by expert and lay panels following an open international search led by the MRC. He is a world leader in the field whose research has advanced the use of health informatics in the UK and beyond.
The new director currently works at the University of Edinburgh, directs the Farr Institute’s centre in Scotland and is Chief Scientist at the Scottish Government Health Directorates.
Professor Morris said: “The UK has world renowned data resources and research capabilities. As the volume and complexity of health data increases, there is an extraordinary opportunity to harness advances in mathematics, statistics and computer science to develop the medical science of tomorrow. HDR UK will enable us to remain at the forefront of this new field of health research by, for the first time anywhere in the world, incorporating the whole breadth of data science research from the laboratory to the clinic to the population, on a national scale.
“The Farr Institute and other informatics programmes have laid superb foundations in this area. The opportunity now is to find innovative ways of linking detailed epidemiological data with biological data at scale. This ‘molecule to man approach’ is imperative if we are to fully realise the UK’s huge potential to solve the health challenges we face, to make new medicines, and to transform lives locally and globally.”
HDR UK will build on the partners’ long term investments in informatics skills, science and infrastructure. Over recent years, these have led to advances in many areas such as stratified and precision medicine, using genomic medicine to improve patient healthcare delivery, and in understanding how the environment affects public health. HDR UK will now bring together, into a single independent organisation harmonised under a single director’s vision, the breadth of interdisciplinary skills, expertise and national and international partnerships needed to accelerate progress, analysing complex and diverse health related data at an unprecedented depth and scale.
HDR UK will also work closely with charities and the public as part of its commitment to public communication and engagement around the use of health related data. Developing NHS and industry partnerships that can work within trusted frameworks will be important in realising the opportunities to transform health and healthcare.
The Chair of HDR UK will be Dr Graham Spittle CBE, Vice-President IBM. Dr Spittle has been Interim Chair for the institute since July 2016.
Dr Spittle said: “I’m delighted that Professor Morris has accepted the position of Director following an open international search for an outstanding and visionary leader. The new institute will bring together leading edge health scientists and advanced analytics to revolutionise health research and delivery.”
The MRC, together with the other partners, has made an initial commitment of £50m over five years. Additional funding is expected to be provided by new partners investing in specific projects.
Innovate UK have started recruitment for a series of roles in Health & Life Sciences.
Two roles are currently open, Innovation Lead in Precision & Discovery Medicine, and Innovation Lead in Advanced Therapies.
Click here for more information, or read on for a brief description of each role.
Innovate UK: Innovation Lead - Precision and Discovery Medicine
Closing Date 24th March 2017
Innovate UK is the UK's innovation agency. We work with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy.
We are recruiting an Innovation Lead Precision and Discovery Medicine to be responsible for developing and implementing the innovation strategy for UK wealth creation in precision medicine and medicines discovery. We are looking for an individual with strong business and commercial experience and sound up to date knowledge of the sector in the UK and globally.
For more information click here to view the full job specification.
Innovate UK: Innovation Lead – Advanced Therapies
Closing Date 24th March 2017
Innovate UK is the UK's innovation agency. We work with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy.
We are recruiting an Innovation Lead Advanced Therapies to be responsible for developing and implementing the innovation strategy for UK wealth creation in advanced therapies. We are looking for an individual with strong business and commercial experience and sound up to date knowledge of the sector in the UK and globally.
For more information click here to view the full job specification.
A new agreement between the UK and Japan aims to promote international medical research collaboration, by combining world-class scientific expertise to help advance human health.
On 1 February, the MRC and the Japan Agency for Medical Research and Developmentopens in new window (AMED) signed a Memorandum of Cooperation to advance a UK-Japan partnership in medical research and development.
The aim of the partnership is to promote research collaboration in areas of medical science that build on the strengths of both countries. The research fields identified as initial priorities for collaboration include regenerative medicine, dementia, antimicrobial resistance and infectious disease.
The Japan AMED supports integrated medical research and development, from basic research to practical applications, with the aim of achieving the world's highest level of medical care and services, and to form a society in which people live long, healthy lives.
Professor Sir John Savill, Chief Executive of the MRC, and Professor Makoto Suematsu, President of AMED, signed the agreement at the Japanese Embassy in London, as part of an opening ceremony for a new AMED European office, based in London.
Professor Sir John Savill said: “The opening of a Japan AMED office in London is an exciting development that will open up new opportunities for UK researchers to work with world-class scientists in Japan’s medical research community, with an initial focus on neuroscience, regenerative medicine, antimicrobial resistance and infectious disease. Our agreement with the Japan agency represents our strong commitment to international research collaboration, aiming to speed up the development of new treatments for diseases, leading to better health for all.”
Professor Makoto Suematsu said: "We are delighted to announce the establishment of the AMED London office, which will serve as a European base from which to build new, and further strengthen, links the Japanese medical and healthcare research communities have with partners in the region. Furthermore, it is our sincere hope that our Memorandum of Cooperation with the MRC – a welcome opportunity to work more closely with world-leading research expertise in the UK – will lead to rapid, real-world benefits in terms of new medical treatments, extended healthy lifespans and improved quality of life."
Genomics England has selected QIAGEN’s HGMD® Human Gene Mutation Database for the 100,000 Genomes Project. HGMD is the leading content knowledgebase for interpretation of genomic data in hereditary and rare diseases, providing a deep resource of expertly curated data from the world’s scientific and clinical literature.
The 100,000 Genomes Project will use QIAGEN’s HGMD Online Professional solution, which is part of the QIAGEN Clinical Insight (QCI) portfolio of solutions for the interpretation of complex genomic data, to support scientists, clinicians and researchers in 13 NHS Genomic Medicine Centres for clinical reporting and interpretation.
“Rare and hereditary diseases can lock patients, families and healthcare providers in a long, difficult diagnostic odyssey, and 100,000 Genomes is a cutting-edge NHS program to gather and analyze whole genomes from a large cohort of patients in search of causes and future treatments,” said Dr. Laura Furmanski, Senior Vice President and Head of QIAGEN’s Bioinformatics Business Area. “We are honored to deepen our collaboration with Genomics England. QIAGEN’s industry-leading bioinformatics solutions, including cloud-based HGMD content, will help 100,000 Genomes derive actionable insights from a massive pool of next-generation sequencing data. We are pleased to be selected.”
“We are delighted to work with QIAGEN’s bioinformatics solutions as a comprehensive resource for manually-curated analysis and interpretation content. High-quality interpretation of genomic data in the 100,000 Genomes Project will provide deeper insights into rare inherited diseases, and ultimately lead to more diagnoses and tailored treatments for patients”, said Dr. Augusto Rendon, Director of Bioinformatics for Genomics England.
QIAGEN Bioinformatics offers a portfolio of industry-leading solutions for the analysis, interpretation and reporting of biological data. Products include Ingenuity, CLC bio and OmicSoft software and databases. As part of the QIAGEN Knowledge Base, HGMD is the gold standard for expertly curated content from peer-reviewed publications on human inherited disease mutations. HGMD has been cited in more than 5,000 scientific publications.
The NIHR Clinical Research Network (CRN) has introduced the CRN Study Support Service to give greater consistency in the guidance and procedures the CRN provides to support both commercial and non-commercial research delivery in the NHS. As long as a clinical study is eligible for CRN support, the national Study Support Service will provide uniform help for clinical investigators across England regardless of whom the investigators are, or where they are based.
The introduction of the Study Support Service complements the implementation of the Health Research Authority in relation to research governance. The Early Contact and Engagement element of the Study Support Service is the first step in the process and includes advice on how the grant application is optimised for successful delivery in the NHS, as well as providing advice for Chief Investigators and study Sponsors on how the CRN can support delivery of their study on time and to the recruitment target.
The UK Pharmacogenetics & Stratified Medicine Network Open Meeting attracts delegates from a range of sectors: academics, clinicians, industry partners, regulators, charities, patient groups and others.
Feedback from our 2016 Open Meeting told us that our delegates enjoyed the opportunities to meet and build relationships with colleagues from these various sectors; some delegates asked if we could provide even more networking opportunities in the future.
As a result of this feedback we have extended the lunch period at this year's Open Meeting and also included a drinks reception at the end of the day.
At NICE’s January Board meeting, the Board agreed a position statement setting out in detail the important relationship NICE has with the life sciences industry.
Sir Andrew Dillon, chief executive of NICE, said: “As the independent body issuing guidance to the NHS, NICE has a complex relationship with the life sciences industry.
“This is a good moment for us to reflect on our relationship with the industry and to set out what we can do contribute to its long term prospects, whilst maintaining our focus on primary role in helping patients and the NHS get the best outcomes from the resources available. This position paper sets out how we can do that.”
“We want it to provide the basis for our engagement with the Government’s emerging life sciences strategy, as an agenda for our work with the industry, and as a public statement of our role and our commitment to supporting the growth of a thriving life sciences sector.”
NICE continues to work with the industry and Government to develop innovative approaches to evaluate new technologies such as the Early Access to Medicines Scheme and the reformed Cancer Drugs Fund. And NICE’s dedicated Scientific Advice programme and Office of Market Access have also created new opportunities to engage with the industry.
Estonia and Finland once again show what good cooperation between neighboring countries can lead to, as both countries prepare to share patient data with one another.
On 10 May 2016, Estonian and Finnish Prime Ministers digitally signed a joint declaration on an initial roadmap for launching data exchange and e-services between Estonia and Finland. It was also agreed that, by the end of 2016, specific action plans would be completed for launching automatic data exchange in the field of commercial registers, population registers, social benefit data, e-prescriptions and maritime affairs.
According to the plan, both countries will make their databases mutually available, which will allow for cross-border access to digital prescriptions by 2017-2018 and full patient medical history by 2018-2019. This step should increase the quality of healthcare in both countries, as doctors and patients will have access to all the data needed, on the spot.
This all ties in with the bigger picture: connected health systems are becoming increasingly popular every day; as such, people should always have access to their data. “People move around more and more therefore data about their health should always be with them. This way they’re able to use the best services from different countries, or live where they desire, without the loss of important healthcare services,” said the Deputy Secretary General on E-services Development and Innovation Ain Aaviksoo.
Aaviksoo went on to explain that doctors could use e-health solutions to offer their services to patients from all over the world. He added that co-operation needs to expand but that it also needs to happen step-by-step. “The United States and several Asian countries are also interested in the e-health system and its support services developed in Estonia. At the same time, our ICT-infrastructure and our citizens’ mentality towards an information society, including the healthcare sector, is most similar to the Nordic countries,” he explained.
When it comes to sharing data, the first question in everyone’s mind is privacy. Aaviksoo explains: “Ensuring privacy and security starts with giving people real control over their healthcare data. Actually, this could be made to suit any country’s combination of law, information technology, and information management applications. The only real technological challenge is the lack of standards to connect all of the necessary data in a suiting way, but in my opinion, this is a question of political will.”
A recent RAND study found that people are becoming more and more open to connected health solutions. It also discovered that most respondents are in favour of health devices and systems that store identification data along with information on lifelong health conditions as well as basic health data. The study also found that most respondents prefer that data can be accessed not just in their home country but across the EU; however, most respondents are averse to worldwide access compared to home country access only.
So, to say that the world around us is becoming more interconnected each day is an understatement. Estonia has always been at the forefront of digital innovation and now it’s time for the healthcare sector to get its part of the innovation as well.
Not only does sharing data make the lives of doctors and patients easier, it also makes them healthier. No more guessing which doctor you visited when you were 12; no more trying to figure out which doctor wrote which prescription. It’s all there, even when you are hundreds of miles away from your home.
Intellia Therapeutics has joined the Genomics England Genomics Expert Network for Enterprises (GENE) Consortium, as the first dedicated genome editing company to participate in the 100,000 Genomes Project.
The GENE Consortium, established in March 2015, is the 100,000 Genomes Project’s industry partnership. Intellia will join 12 other companies who are working together in a pre-competitive trial. The collaboration aims to identify the most effective and secure way of bringing industry expertise into the 100,000 Genomes Project to realise future potential benefits for patients affected by rare diseases or cancers. Members of the consortium are granted controlled access to aggregated, de-identified genome and health data of participants. They work alongside experts that specialise in data analysis, so that the project can benefit from cutting edge advances in handling Big Data.
Genomics can greatly improve our understanding of health and disease, unlocking new treatments or repurposing existing treatments based an individual’s genomic makeup; so-called personlised medicine.
Sir John Chisholm, Executive Chairman, Genomics England, said: “The potential for genomics to transform healthcare, from better diagnoses to new drugs and treatments, is extraordinary. We are delighted to welcome Intellia Therapeutics to our GENE Consortium. The UK is a global leader in population sequencing and it’s important for the future of medicine that we continue to attract and collaborate with the most innovative emerging technologies in this space.”
“Access to genomics information is critical as Intellia looks to better understand the basis of disease and to develop potential genome-editing treatments,” said Intellia’s Chief Executive Officer and Founder, Nessan Bermingham, Ph.D., “We look forward to actively participating in the GENE Consortium, as Genomics England is enabling scientific exploration and key medical insights that ultimately will benefit patients.”
A new document has been produced, which sets out principles and obligations of all UK institutions and clinical trainees in receipt of nationally competitive funding for clinical academic research training.
Research-active clinicians have an overwhelmingly positive impact on patient care. But there are still many challenges facing clinicians who juggle clinical work and research.
Academic training must be acknowledged, recognised and integrated with clinical training and work, and clinical academics should feel valued for their important contribution.
The funding community has worked together to develop principles and obligations (PDF, 475KB) which set out what is expected from those responsible for clinical training, trainees and funders across the UK. This is the first time that all the key players in this community have come together to outline best practice.
A key issue the principles address is employment rights. The principles state that the rights of clinical academics with continuous employment must be protected, even when they change their employer from a NHS trust or board to an academic institution, and vice versa. These rights include all family and care-related leave and pay, as well as sick leave and pay.
The principles and obligations have been developed in partnership with the following organisations:
- Academy of Medical Sciences
- British Heart Foundation
- Cancer Research UK
- Conference of Postgraduate Medical Deans of the United Kingdom (COPMeD)
- Health Education England
- Integrated Academic Training Advisory Committee (InterACt)
- Medical Research Council
- Medical Schools Council
- National Institute of Health Research
The British Medical Association and the British Dental Association were also consulted on, and support, the principles.
Job Title: Scientific Director of the Leicester Precision Medicine Institute (LPMI)
Salary Grade: 10 - Competitive
Job reference: MBP01756
Post Responsible To: Director of the LPMI, Professor Martin Tobin
The Scientific Director of the Leicester Precision Medicine Institute will work closely with the Director and Commercial Director, supported by the Operations Manager, to implement the strategy for the Institute and to strategically develop specific areas and projects of the institute together with our partners. Together the Director, Scientific Director, Commercial Director and Operations Manager will form an Executive Team that will provide smooth and effective running of the Institute and deliver ambitious growth in the discovery, evaluation and implementation of precision medicine in Leicester.
The Scientific Director will attend Executive Team and Scientific Board meetings that will oversee the implementation of the strategy across the core strands of Discovery, Evaluation and Implementation and will deputise for the Director when required. The Scientific Director will play a key strategic role on the Governance Board alongside senior representation from the University, UHL and representatives of patients and the public.
The Scientific Director will show leadership in ensuring the effective operation and development of the Institute. This role will deliver a consistently high level of quality in excellent research and knowledge output, successful generation of income to support research and knowledge activity, together with facilitating activities across the core strands. The Scientific Director will work with affiliated members of the Institute, staff of the Research and Enterprise Division, and with external stakeholders and funders to ensure a collaborative and effective approach to deliver the strategic vision.
NICE is taking part in a European project to speed up the development of new drugs to treat Alzheimer’s disease.
The ROADMAP initiative aims to establish a sustainable platform for real world evidence generation on Alzheimer’s disease.
The new project provides a unique and game-changing opportunity to gather evidence from other sources, such as electronic health records, and discover what outcomes are important to patients and carers.
Alzheimer’s disease, and the different ways it presents and progresses in different people, poses a difficulty for traditional clinical trials which do not always provide answers decision makers such as NICE would be looking for when assessing new drugs to treat the disease.
Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said: “The ROADMAP initiative is an exciting new project that we are delighted to contribute to. Alzheimer’s disease represents a real challenge for both drug companies and organisations such as NICE.”
NICE’s Science, Policy & Research Programme will be involved in identifying the regulatory, health technology assessment (HTA) and payer challenges and opportunities in making better use of big data sources such as electronic health records.
NICE will also coordinate the input of policy partners across the EU to ensure their requirements are taken into account.
Professor John Gallacher, University of Oxford and one of the projects leaders, said: “Roadmap creates a pan-European collaboration of unprecedented depth and breadth. This is an unusually exciting opportunity to identify cost-effective treatments for Alzheimer’s disease.”
Dr Matthew Norton, Director of Policy and Strategy at Alzheimer’s Research UK, said: “There is still hope for a number of treatments for Alzheimer’s disease that are making their way through clinical trials, and it will be essential to have the best information available to help assess the impact of any treatments that may prove effective.
“We hope this important project will lead to a better understanding of the outcomes that matter most to people with Alzheimer’s, and help guide health authorities and industry in their efforts to assess the potential long-term effects of new treatments. This is a welcome collaboration, and it’s encouraging to see UK partners, including NICE, taking a lead in this partnership.”
The IMI (Innovative Medicines Initiative) is Europe’s largest public-private partnership, aiming to speed up the development of better and safer medicines for patients. ROADMAP is the first in a suite of projects that are part of the IMI’s Big Data for Better Outcomes Programme. ROADMAP has a budget of €7.7 million, distributed among 22 partners from the private, academic, and public sectors.
Professor David Lomas has been appointed as the MRC’s new Deputy Chief Executive. He takes up a fixed term position which began on 1 January 2017 and will run to 31 March 2018.
Professor Lomas will sit on the MRC’s management board and his role will focus primarily on supporting John Savill, CEO of the Medical Research Council, in driving forward the MRC Delivery Plan and ensuring that the organisation remains a world leader in medical science in preparation for the creation of UK Research and Innovation (UKRI).
Professor Lomas joins us from University College London where he is the Vice-Provost Health, responsible for overseeing the largest group of medical researchers in the UK.
Sir John Savill, Chief Executive of the MRC, said: “I am delighted that David Lomas is returning to MRC as Deputy CEO. He is an exceptional clinician scientist and leader, currently overseeing the largest concentration of biomedical scientists in the UK in his role at UCL, which will continue. He will make an important contribution towards guiding MRC into the successful partnership we anticipate within UKRI”.
Commenting on his new appointment, Professor Lomas said: “I am delighted to be appointed to this role at the MRC. This is an exciting time for the organisation as we work towards creating UKRI and deal with the challenges raised by Brexit.”
Professor Lomas, as the Vice-Provost Health at UCL, serves as Academic Director for UCL Partners Academic Health Science Centre, facilitating and guiding the development of its six academic medical centres. In this role, he promotes close partnership working across UCL Partners to ensure that research expertise and outputs are combined across the whole translational pathway for the overall benefits of patients and the population. Professor Lomas is also responsible for facilitating health initiatives across UCL and building on key relationships with NHS partners, local universities and NHS England. He helped shape UCL’s participation in the establishment of the Francis Crick Institute and serves on the Board of Directors.
NICE and the United States’ Food and Drug Administration (FDA) are working closely to help developers of medical devices, diagnostics, and similar technologies gather the best evidence to demonstrate clinical effectiveness of their products. The aim is to speed up patients’ access to the best new technologies.
Once they get approval from safety regulators, medical technology companies need to demonstrate the value of their product to the organisations who pay for healthcare – in the UK that is usually the NHS, whereas insurers mostly pay for technologies in the United States.
The products could be diagnostic tests or medical devices.
“In their efforts to get a product to market, companies can get caught out,” explains Leeza Osipenko, who leads the NICE Scientific Advice programme. “To win regulatory approval in the US, companies give the FDA data on the safety and efficacy of their devices. But although they often do enough to win FDA approval, they need additional evidence to prove to the organisations who would actually pay for those devices that they are cost-effective and clinically-effective.
“To help companies overcome this hurdle, NICE’s Scientific Advice programme has joined forces with the FDA in the Payer Communication Taskforce. Early engagement should help medical technology makers to design their development programmes better to produce the data needed both to obtain regulatory approval and to persuade the payers of the value of their product.”
NICE Scientific Advice is a fee-for-service programme aimed at supporting the life sciences industry. It provides advice on the company’s proposals for evidence generation on economic and clinical effectiveness. NICE’s involvement in this joint initiative may consist of reviewing the evidence a company is gathering; providing advice in a pre-submission meeting with the other advisory bodies and commenting on the resulting company’s minutes; or producing formal written advice as a follow-up to the pre-submission meeting.
The funding will be given to 23 NHS organisations and will pay for specialist research nurses and technical staff, as well as providing cutting-edge facilities to support clinical research and trials.
The money, awarded by the National Institute for Health Research (NIHR) following a competitive application and assessment process, will be provided over the next 5 years.
Minister for Public Health and Innovation, Nicola Blackwood, said:
UK researchers lead the world and our investment in this area so far has led to a variety of breakthroughs, including the first new asthma treatment in a decade, and a promising treatment for peanut allergies in children, to name just two.We know that such ground breaking research simply would not happen without the support of these clinical research facilities.I’m delighted to announce this £112 million of extra funding to support the skilled personnel and cutting-edge facilities we need to keep the UK at the forefront of clinical research.
Previous funding for clinical research facilities has led to medical breakthroughs, including:
- identifying an effective treatment for peanut allergies in children
- trialling of the ‘bionic eye’ in retinitis pigmentosa (RP) – the first ever study to combine artificial and natural vision in humans
- establishing an innovative and standardised approach to test treatment for cystic fibrosis
- developing the first new therapeutic asthma treatment for a decade, reducing the severity and duration of life-threatening asthma attacks
Clinical research facilities and funding
|NHS organisation||Funding for 5 years from 1 April 2017|
|Alder Hey Children’s NHS Foundation Trust||£2,000,000|
|Cambridge University Hospitals NHS Foundation Trust||£11,485,445|
|Central Manchester University Hospitals NHS Foundation Trust||£12,500,000|
|Great Ormond Street Hospital for Children NHS Foundation Trust||£3,038,927|
|Guy’s and St Thomas’ NHS Foundation Trust||£7,256,216|
|Imperial College Healthcare NHS Trust||£10,885,958|
|Lancashire Teaching Hospitals NHS Foundation Trust||£750,000|
|Leeds Teaching Hospitals Trust||£750,000|
|Moorfields Eye Hospital NHS Foundation Trust||£5,315,730|
|Newcastle upon Tyne NHS Foundation Trust||£4,000,000|
|Nottingham University Hospitals NHS Trust||£2,407,641|
|Oxford University Hospitals NHS Foundation Trust||£3,738,298|
|Royal Brompton and Harefield NHS Foundation Trust||£750,000|
|Royal Devon and Exeter NHS Foundation Trust||£5,738,298|
|Royal Liverpool and Broadgreen University Hospitals NHS Trust||£1,392,550|
|Sheffield Teaching Hospitals NHS Foundation Trust||£3,111,845|
|South London and Maudsley NHS Foundation Trust||£3,964,705|
|The Royal Marsden NHS Foundation Trust||£2,483,179|
|University College London Hospitals NHS Foundation Trust||£6,500,000|
|University Hospitals Birmingham NHS Foundation Trust||£12,812,957|
|University Hospitals Coventry and Warwickshire NHS Trust||£750,000|
|University Hospitals of Leicester NHS Trust||£1,430,641|
|University Hospital Southampton NHS Foundation Trust||£9,244,166|
NIHR is funded through the Department of Health and works to improve the health and wealth of the nation through research.