The UK Biobank is a research resource following the health of its 500,000 participants who joined the study between 2006-2010. These volunteers have undergone tests and provided blood, urine and saliva samples, and detailed information about themselves. Information provided by participants is made available to approved health scientists in a way that does not identify the individuals concerned. More than 10,000 researchers have registered to use UK Biobank from 68 countries, and 1,000 projects are under way. Around three-quarters of registrations are now from overseas. Academic and industry researchers can use Biobank data to understand why some people develop particular diseases and others do not, with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. If you are a health scientist from anywhere in the world, academia or industry, and wish to use the resource, you can begin your application process here. The Biobank has set out to make the system as easy as possible for you to access data, while protecting the anonymity of its participants. (UK Biobank)

Stephen Hawking endorses new £50 million centre Gifts totaling more than £32 million, together with government funds of over £17 million, have enabled the launch of a highly innovative Centre in Cambridge (UK) that is pioneering new approaches to understand and treat neurodegenerative disorders such as Alzheimer’s and Parkinson’s diseases, motor neurone disease and frontotemporal dementia. The Centre for Misfolding Diseases has been established to tackle some of the world’s most devastating diseases. Many of the neurodegenerative diseases are currently incurable and represent a huge burden for an ageing society, potentially crippling healthcare systems with costs that already exceed those associated with cancer and heart conditions combined. … In addition to fundamental science, the new building will house a Chemistry of Health Incubator that will respond to the need for closer integration between the University and industry and aim to increase the rate at which scientific breakthroughs are translated into new therapies. (University of Cambridge – October 27, 2017)

PHE launches campaign to rein in use of antibiotics  Public Health England has launched a major new campaign designed to further rein in inappropriate use of antibiotics, as estimates show that around 5,000 people in England alone die every year because of antimicrobial resistance. As part of the Keep Antibiotics Working campaign, TV adverts featuring antibiotic pills singing “Every time you feel a bit under the weather, don’t always think that we can make you better”, are being broadcast to urge people to stop asking healthcare professionals for antibiotics because taking them when they are not necessary increases the risk of a more severe or longer infection. It will also support pharmacists by providing evidence and resources to support their conversations with patients about the use of antibiotics.  (PharmaTimes – October 23, 2017)

PharmaTimes Clinical Researcher of the Year 2018 – The Americas: Enter now! Designed to recognise and reward the talent and passion of industry and academic researchers, PharmaTimes Clinical Researcher of the Year – The Americas is open to clinical researchers in pharma, CROs and investigator sites who currently work in the USA, North, South and Central America. (PharmaTimes – October 23, 2017)

First-ever UK-US Science and Technology Agreement paves the way for closer research collaborations  Signed by Science Minister Jo Johnson, the treaty outlines a commitment to collaborate on world-class science and innovation, building on existing successful research co-operation in recognition of the value of open data to further scientific research and strengthen our economies. The first project under the agreement includes £65 million UK investment to increase our knowledge on the origin and structure of the universe.  (  September 20, 2017)

Capital Cell, Europe’s First Dedicated Life Sciences Crowdfunding Platform, Opens to UK investors  Investing in the UK’s innovative life sciences and biotech sector just became more accessible to a wide spectrum of investors, with Capital Cell, Europe’s first dedicated Life Sciences crowdfunding platform. Capital Cell has formally ‘opened to investors’ with the first four investment opportunities now live on the platform. These opportunities include a company developing alternatives to antibiotics and an equine health company. Capital Cell’s model is to support early stage companies, with seed stage investment up to £1 million sought through the platform.  (BusinessWire  September 20, 2017)

Increased research in the NHS for 2016/17  More people than ever before are being given access to new and better treatments through participation in clinical research. Participants recruited into clinical research studies in 2016-17 exceeded 665,000, the highest number of clinical research participants in any given year and 10% more than last year. In 2016-17, 99% of NHS trusts and 48% of general practices recruited participants into clinical research. 2,055 new studies were added to the NIHR Clinical Research Network Portfolio, representing a 50% increase. 65% of trusts increased their research activity in 2016-17, demonstrating the growing appetite for research within the NHS. The proportion of non-commercial studies delivering to time and target has doubled since 2012 from 41% to 83% while the proportion of commercial contract studies delivering to time and target has increased from 45% to 73%. (NIHR  August 2017)

Life-saving medical breakthroughs don’t happen in Britain by accident  (Jeremy Hunt/Health Minister & Greg Clark/ Business Minister) One of the abiding strengths of the UK is its extraordinary capacity for innovation and creativity, and perhaps nowhere more so than in the field of medical science. Few countries can match our roll call of achievement, from the discovery of antibiotics in the 1940s, to life-saving vaccination programmes in the 1950s and 60s, through to pioneering hip and knee replacement surgeries and IVF treatments in the 1970s and 80s. More recently, Britain again is laying the foundations for the new age of personalised medicine, with world-leading programmes like the 100,000 Genome project, helping us to understand the genetic basis of cancers and rare disease – a fitting legacy for a nation that first discovered DNA. …These achievements are not a matter of chance, nor are they solely the product of isolated genius. Rather they reflect the outstanding environment we have built, over many decades, to enable and translate cutting edge research, from conceptual design into clinical practice. Whether it’s through our world-class higher education institutions, or the outstanding infrastructure and scale provided by clinical research teams within our NHS and NIHR, this country is one of the best places in the world to develop and deliver innovative ideas in healthcare and medical technology. And we want to keep it that way. …As a sign of the government’s commitment to the sector, we are announcing the first phase of investment in life sciences with £160m providing investment in projects supporting advanced therapies, medicines and vaccines development, manufacturing and research.  (The Times August 30, 2017)

Early Access to Medicines

Making a reality of the Accelerated Access Review: improving patient access to breakthrough treatments   The Accelerated Access Review made a series of recommendations to enable the NHS to: improve patient outcomes, use the UK’s strong biosciences research and life sciences industrial base, enhance the international competitiveness of our life sciences industry. The response to this review sets out how government will work with industry and the health system to create an approvals system so that cost-effective breakthrough products can get to NHS patients as fast as possible. Key elements of this response include: an Accelerated Access Collaborative that will develop an accelerated access pathway to bring breakthrough products to market and then to patients as quickly as possible; £86 million government funding to support innovators and the NHS in overcoming barriers to getting new, innovative technologies to patients quickly; and improved NHS England commercial capacity and capability to deliver deals that achieve better value for the NHS and innovators.  ( /Depts of Health and BEIS   November 2017)
NOTE: Former GSK CEO Sir Andrew Witty is to lead the Accelerated Access Collaborative charged with selecting and progressing access to five new drugs and devices each year.

Recognising that the process to authorize medicines is very long, expensive and challenging, especially for smaller companies with greatly limited funding, the Early Access to Medicines Scheme was introduced in March 2015. The programme aims to give patients with a life threatening or seriously debilitating condition when there is no other treatment available to them access to promising new drugs that have yet to go through the full licensing process.  The Medicines and Healthcare Products Regulatory Agency (MHRA) makes decisions about these medicines using its Promising Innovative Medicine designation which can bestow an early signal that the medicine may be a possible choice for the EAMS scheme. After further investigation, if the MHRA decides that doctors can prescribe the drug, the positive scientific opinion lasts for one year, with the potential to be renewed.

U-turn over prostate cancer drug after price change   Patients with prostate cancer in England will now have early access to a drug that can delay the need for chemotherapy.  The National Institute for Health and Care Excellence now agrees that abiraterone is affordable. It had previously said the treatment was not cost-effective for the NHS until cancers were more advanced. The drug costs £3,000 a month, but a lower price has been agreed with the manufacturer Janssen. Abiraterone, also known as Zytiga, is a hormone therapy, and unlike chemotherapy which kills the cancerous cells, it stops more testosterone from reaching the prostate gland to stifle the tumour.
BBC News   March 21, 2016

UK kidney cancer patients get early access to BMS’ Opdivo   UK patients with advanced kidney cancer are being given the opportunity to be treated with Bristol-Myers Squibb’s investigational immunotherapy Opdivo ahead of a licensing decision in Europe. Opdivo (nivolumab) has been accepted by the Medicines and Healthcare Regulatory Products Agency onto the country’s Early Access to Medicines Scheme for patients with renal cell carcinoma, giving them the chance to access the drug before it is officially approved by regulators
PharmaTimes   February 12, 2016

Pfizer’s Ibrance on track for UK early access scheme   Pfizer UK’s Ibrance has cleared the first hurdle to joining the UK’s Early Access to Medicines Scheme after being awarded ‘Promising Innovative Medicine’ status by the Medicines and Healthcare Regulatory Agency. Ibrance (palbociclib) is being developed as a treatment for hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced/metastatic breast cancer.
PharmaTimes   January 22, 2016

EAMS gave 500 UK melanoma patients early access to Keytruda   UK patients with advanced melanoma were among the first in the world to access MSD’s Keytruda last year because of the country’s early access to medicines scheme.  Keytruda (pembrolizumab) was the first medicine to be awarded a positive scientific opinion and thus accepted onto the EAMS scheme back in March, offering patients with limited options a new treatment alternative ahead of a licensing decision in Europe.
PharmaTimes   January 4, 2016

Genomics England— 100,000 Genomes Project

Genomics England is a wholly owned company of the Department of Health set up to deliver the 100,000 Genomes Project.  The project will sequence 100,000 genomes from around 70,000 NHS patients and their families focusing on rare diseases and common cancers. The aim is to transform patient care with more precise diagnosis and treatments. The project will study how to best use and interpret genomics in healthcare and kick-start a UK genomics industry. This is currently the largest national sequencing project of its kind in the world.

Genomics England, Inivata, Thermo Fisher to Assess Liquid Biopsy for Cancer Patient Management  Genomics England is collaborating with Inivata (Cambridge UK) and Thermo Fisher Scientific to assess the potential of liquid biopsy testing to improve disease management and outcomes for cancer patients. In the first phase of a larger pilot study, Inivata will use its InVision circulating tumor DNA test and Thermo Fisher will use its own liquid biopsy technology to analyze the quality of about 500 blood plasma samples donated by participants in Genomics England’s 100,000 Genomes Project. The partners are also planning to assess the utility of liquid biopsy for the discovery of mutations that can lead to or indicate the presence of cancer. These results, and those from the two subsequent phases of the study, will be shared with researchers around the world.  (GenomeWeb – October 13, 2017)

Scottish investment in genomic medicine   Minister for Sport, Health Improvement and Mental Health, Jamie Hepburn has announced a £6 million investment in the Scottish Genomes Partnership (SGP), ahead of a parliamentary reception to mark Rare Disease Day. The SGP is a collaboration of Scottish Universities and the NHS capitalising on £15 million investment in whole genome sequencing technology by the Universities of Edinburgh and Glasgow.
Genomics England   March 1, 2016

Illumina, Icon land data deals with UK mass genome sequencing program   … Genomics England has revealed more details of what it is trying to achieve in collaboration with Illumina. The plan is to create a platform that automates the interpretation of genomes, making it simpler for clinicians and researchers to draw conclusions from the data. Genomics England wants the tools to have open application programming interfaces so its other bioinformatics partners can continue to provide services. …  Icon has landed itself the role of data management partner. In this capacity, Icon will apply its capabilities to the validation of clinical data from participants in the 100,000 Genomes Project.
FierceBiotechIT   February 12, 2016

First children receive diagnoses through 100,000 Genomes Project   Both Georgia Walburn-Green and Jessica Wright had rare, undiagnosed, genetic conditions when they joined the Project. Whole genome sequencing pinpointed the underlying genetic changes responsible for their conditions. As well as removing a large amount of uncertainty for the families, the results stand to have a major impact on many areas of their lives including future treatment options, social support and family planning. They also have the potential to help many more children with undiagnosed conditions who may be tested for these genetic mutations early on and be offered a diagnosis to help manage their condition most effectively.
Genomics England   January 11, 2016

Northern Ireland joins the 100,000 Genomes Project   Health Minister in the Northern Ireland Executive, Simon Hamilton, today announced £3.3m investment to create a Northern Ireland Genomic Medicine Centre that will provide rare disease patients with a much earlier and more accurate diagnosis.
Genomics England   October 29, 2015

Innovate UK

Innovate UK (formerly the Technology Strategy Board) is the UK’s innovation agency. An executive non-departmental public body sponsored by the Department for Business, Innovation & Skills.  Works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. Work with companies to de-risk, enable and support innovation. Fund the strongest opportunities, connect innovators with the right partners they need to success, help innovators launch, build and grow successful businesses. Innovate UK has established four sector groups, including health and life sciences.

Innovate UK’s Delivery Plan for the year 2016 to 2017 shows how it will invest £561 million, with a more focused approach to innovation support.

Innovate UK has long played a pioneering role in connecting businesses with ‘lead customers’ for their new ventures – for example in the public sector through the Small Business Research Initiative (SBRI) programme – and this will continue.

Innovate UK’s network of Catapult centres has been established to support and encourage innovation and growth across the UK by transforming its capability for innovation in specific areas and helping to drive future economic growth. The three Catapult Centres focused on the life sciences are:

Cell and Gene Therapy Catapult    works to drive the growth of the cell and gene therapy industry by helping cell and gene therapy organisations translate early stage research into commercially viable and investable therapies.

Medicines Discovery Catapult    will operate at the earliest stages of medicines development, developing and validating new technologies for testing of potential medicines before human trials and supporting the key UK strength in pharmaceutical, biotechnology and contract research organisations.

Precision Medicine Catapult     is focused on making the UK the most compelling location in the world for the development and delivery of this new targeted approach with priority given to capturing value in the UK in therapeutic, diagnostics, algorithm and data companies and demonstrators with the NHS.

NHS Innovation Acceleration (NIA)

The aim of the NIA is to deliver on the commitment detailed within the Five Year Forward View – creating the conditions and cultural change necessary for proven innovations to be adopted faster and more systematically through the NHS, and to deliver examples into practice for demonstrable patient and population benefit.  In its first year, the 17 fellows who joined the programme received support to take their high impact innovations to more than 60 NHS organisations, benefited more than three million patients, and helped attract funding of over £8m.  After this successful first year, NIA 2016 will be open for applications from healthcare innovators on Friday 17 June 2016, closing on 1 August 2016. This round of applications will focus on three challenges based on population health needs: prevention, early intervention and long-term condition management, with successful applicants announced in October.

NHS announces new funding route for medtech innovations   The programme is designed to cut the hassle experienced by clinicians to get uptake across the NHS by removing the need for multiple local price negotiations. Instead, the new Innovation and Technology tariff category will guarantee automatic reimbursement when an approved innovation is used, while also allowing NHS England to negotiate ‘bulk buy’ prices for medtech devices and apps which can help patients with conditions such as diabetes, heart conditions, asthma, sleep disorders and other chronic health conditions.
Health Business UK   June 17, 2016

Three million using health innovations under NHS scheme   …tapping into new apps, safety devices, on-line networks, and a stream of other new technologies and services during the first nine months of a pioneering programme designed to introduce new innovations to the NHS.  The NHS Innovation Accelerator programme was launched in July 2015 with the over-riding goal of creating the conditions and culture changes necessary to accelerate adoption of cutting-edge solutions and thus boost patient care.
PharmaTimes   April 20, 2016

The Clinical Research Network (CRN)

The Clinical Research Network (CRN) is part of the National Institute of Health Research, the research arm of the NHS, and is wholly funded by the Department of Health in the UK.  This unique initiative provides the infrastructure that allows high-quality clinical research to take place in the NHS, so that patients can benefit from new and better treatments. The organisation helps researchers to set up clinical studies quickly and effectively; supports the life sciences industry to deliver their research programmes; provides health professionals with research training; and works with patients to ensure their needs are at the very centre of all research activity.

Record-Breaking Trial Recruitment Now a Reality   A unique, wholly government-funded initiative has made the UK the hot ticket in clinical trial recruitment.  The National Institute of Health Research’s Clinical Research Network, wholly funded by the Department of Health in the UK, is a unique initiative aiming to aid researchers to set up trials quickly and easily, by working closely with pharma, healthcare professionals, and of course, patients.
Eye for Pharma   April 14, 2016

The Avon Longitudinal Study of Parents and Children (ALSPAC)

Based at the University of Bristol, the Avon Longitudinal Study of Parents and Children, also known as Children of the 90s, is a world-leading birth cohort study that has been charting the health of 14,500 families in the Bristol area in order to improve the health of future generations. Between April 1991 and December 1992 we recruited more than 14,000 pregnant women into the study and these women (some of whom had two pregnancies or multiple births during the recruitment period), the children arising from the pregnancy, and their partners have been followed up intensively over two decades.  ALSPAC is the most detailed study of its kind in the world, providing the international research community with a rich resource for the study of the environmental and genetic factors that affect a person’s health and development. ALSPAC aims to inform policy and practices that will provide a better life for future generations.

UK Biobank

UK Biobank is a major national health resource with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses – including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. UK Biobank recruited 500,000 people 40-69 years of age in 2006-2010 from across the UK to take part in this project. The recruits have undergone measures, provided blood, urine and saliva samples for future analysis, detailed information about themselves and agreed to have their health followed, including their lifestyle, weight, height, diet, physical activity and cognitive function, as well as genetic data from blood samples. Linkage to a wide range of health records is also under way, including data from general practices. Over many years this will build into a powerful resource to help scientists discover why some people develop particular diseases and others do not.

UK Biobank launches world’s largest imaging project to shed new light on major diseases   It will create the biggest collection of scans of internal organs, and transform the way scientists study a wide range of diseases, including dementia, arthritis, cancer, heart attacks and strokes. The £43m study will involve imaging the brain, heart, bones, carotid arteries and abdominal fat of 100,000 current participants of UK Biobank, a visionary project set up in 2006 by the MRC & Wellcome Trust to create a research resource of half a million people across the UK to improve health.
Medical Research Council    April 14, 2016