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    FORUM Workshop Report

    Cancer Research UK held a FORUM Workshop with the Academy of Medical Sciences in February 2018. Over 60 participants were welcomed to this multidisciplinary event, including representation from academia, industry, patients, regulators, funders, commissioners and healthcare professionals.

    The outcomes from the workshop include:

    • To improve the evidence generation of early detection and diagnosis research:
      • We need a national repository of longitudinal samples linked to clinical data, to be made available for the discovery and validation of novel diagnostic assays.   
      • Researchers should develop ‘target product profiles’ for emerging technologies to ensure there is a clear clinical need, defined performance and health economic characteristics.
    • To support the planning and delivery of clinical trials for diagnostics, we need infrastructure for the clinical evaluation of diagnostic tests to provide a stable platform of expertise to accelerate progression to the clinic, equivalent to a Clinical Trials Unit (CTU).
    • To improve the outcomes of screening trials, researchers should risk-stratify populations to increase surveillance of those that benefit from it and decrease surveillance of those that do not.
    • We need health service planners to recognise the real cost-saving benefits of early detection and diagnostic technologies, which are often only evident over a long term, when assessing the economic rationale for adoption of new diagnostics.
    • We need a system change in the NHS to focus more on early detection and diagnosis, rather than treatment, in order to fully capitalise on the disruptive potential of novel cancer diagnostic technologies.
    • We need a roadmap for the translation of early detection and diagnosis tests, as a resource to support researchers through the various stages, and guidelines for evidence generation, diagnostic development, clinical evaluation, and economic viability.

    To read more, and download the published workshop report, click here to visit the CRUK website.

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    £37.5m Digital Innovation Hubs

    Faster development of new treatments for diseases like cancer, heart disease and asthma are set to emerge following a £37.5 million investment in new Digital Innovation Hubs across the UK.

    The new hubs will help connect regional health and care data with biomedical data in secure environments. This will pave the way for NHS, academic researchers and industry innovators to harness scientific knowledge and emerging technologies to develop new drugs and devices and improve health services.

    Funded through the Industrial Strategy Challenge Fund, the Digital Innovation Hubs will be led by Health Data Research UK (HDR UK), the national institute for data science in health, delivering on behalf of UK Research and Innovation.

    Between three and five hubs will be created across the UK over the next three years to enable innovation that will have a long-lasting impact on improving the health of the public. The hubs will provide safe, secure and controlled environments for data and enable NHS clinicians to work together with health researchers, data scientists, computer scientists, ethicists, social scientists and the public.

    The Digital Innovation Hubs will securely and safely connect data across regions of 3-5 million people and create an accessible layer of data from GP practices, hospitals, social and community care providers, alongside genetic and biomedical information and other datasets for research and innovation. Combined with the unique research expertise across UK universities and industry, this initiative offers an unprecedented opportunity to use data to improve the long-term health of the public. It will also create new jobs in the UK’s life sciences economy, drive medical innovation and ensure that NHS patients benefit from new treatments first.

    HDR UK will work in partnership to establish the hubs and ensure data is used responsibly and ethically to benefit society. The hubs will follow the strict safeguards underpinning health data security and access as set by UK regulatory bodies and will be transparent in how and why data is used, stored and shared.

    Safe, secure and trusted use of health data has a long track record of enhancing public health and facilitating innovative research. High profile examples include:

    • revealing the indisputable link between the effects of air pollution and smoking on developing lung cancer and heart disease;

    • discovering new genetic causes of disease that allows tailored treatments in cancer, arthritis and asthma;

    • reducing life-threatening complications of diabetes such as amputation and blindness, whilst shedding light on the genetic causes of disease.

    The UK has some of the richest health data of anywhere in the world. However, these datasets across health, care, genomics and biomedicine are fragmented making it difficult, sometimes impossible, to access and use for research purposes. This causes delays and, in some cases, prevents accredited researchers and industry innovators from analysing data to help deliver better care and improve health for patients, society and for future generations.

    The Digital Innovation Hubs programme will launch this Autumn with HDR UK seeking, and learning from, local examples of research partnerships that are already working in practice. These ‘demonstrator projects’ will test approaches that will inform the design and delivery of the Digital Innovation Hubs. Following this, in Spring 2019, HDR UK will invite regional partnerships of NHS, academia and industry to bid to establish a Digital Innovation Hub.

    The hubs will complement other initiatives across the UK, including the NHS’ Local Health and Care Record Exemplar programme, which is joining up local health and care data for individual care and planning purposes, and the work of NHS Digital to create a Data Services Platform.

    The Digital Innovation Hubs programme is part of the Industrial Strategy Challenge Fund Wave 2 £210 million ‘Data to Early Diagnosis and Precision Medicine’ theme. Closely related investments within this theme include:

    • Genome sequencing using UK Biobank volunteers, and

    • A network of up to six Centres of Excellence in digital pathology and imaging, including radiology.

    Click here to learn more at the HDRUK website.

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    Genomics England 70,000 Milestone

    As the NHS celebrates its 70th birthday, Genomics England announces that it has now passed the 70,000 genomes mark. This milestone comes just five months after the 100,000 Genomes Project reached its halfway point – signalling that it is well on track to reach its goal of 100,000 genomes by the end of this year.

    Genomics England has worked with the NHS to create the biggest national genome sequencing project of its kind in the world. It has provided the evidence NHS England needs to embed genome sequencing in routine care through the new Genomic Medicine Service (GMS). Rolling out in October 2018, the GMS will help to ensure that the NHS stays at the forefront of healthcare delivery – now and in the future.

    The groundbreaking 100,000 Genomes Project focuses on patients with rare diseases, their families, and patients with cancer. Working with sequencing partner, Illumina, Genomics England has now sequenced a total of 71,095 genomes.

    Beyond 2018, Genomics England will continue to support the NHS GMS, acting as a testbed for new applications, encouraging discoveries and their translation into novel medicines and treatments, as well as working to support a thriving genomic medicine industry in the UK.

    Health Minister Lord O’Shaughnessy said: “Genetic sequencing can revolutionise healthcare by offering truly personalised care to patients and their families.

    “This project is a shining example of a partnership between the public sector, the life sciences industry and the research community – with NHS patients reaping the benefits.

    “Genomic medicine is no longer a thing of the future, it’s here now and helping to save lives.”

    Genomics England’s CEO, Professor John Mattick, said: “Genomics England’s mission is to realise the enormous potential of genomic information to enable precision medicine.  As the technology and our understanding continue to grow over the coming years, we will provide genome analyses to inform personalised treatments and preventative actions tailored to individual circumstances, to ensure the best healthcare for our patients and generations to come.”

    Professor Dame Sue Hill, Chief Scientific Officer for England, who is leading the NHS Genomics programme, said: “I’m delighted the Project has reached the 70,000 sequence mark in the week of the 70th Birthday of the National Health Service. The NHS has harnessed cutting-edge science and technology through the Project to deliver real benefits for patients with rare diseases and cancer and in the growing field of genomics and health we are, once more, building a world-leading service that is admired and respected across the globe.

    “Reaching the 70,000 mark has been possible because of the contribution and support of all the patients and families involved and driven by the tremendous work done by the dedicated teams across the NHS in our Genomic Medicine Centres in providing the highest quality samples and data as part of routine care.”

    Professor Mark Caulfield, Chief Scientist at Genomics England, said: “Genomics England was set up five years ago during the 65th celebrations of the NHS. The 100,000 Genomes Project is ground-breaking and on the 70th anniversary of the NHS it is amazing that we have now sequenced over 70,000 genomes from participants with rare disease and cancer – and we are grateful to everyone who has generously taken part in the Project. It has already changed the lives of many patients with cancer or a rare disease in the UK, and now this programme will expand to further transform genomic health in the NHS with improved outcomes for many more.”

    Click to read more at the Genomics England website.

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    Genedrive Receives NHS Grant

    The UK NHS National Institute for Health Research in June 2018 have offered Professor Bill Newman an Invention for Innovation programme grant to work with Genedrive plc to develop and implement a point-of-care test in the NHS to avoid antibiotic-related hearing loss in newborn children.

    Due to an identified genetic predisposition, certain individuals develop irreversible hearing loss when exposed to gentamicin, an antibiotic used to treat several types of bacterial infections. In the UK, approximately 90,000 babies per year are treated with gentamicin on intensive care units. Antibiotic treatment should start within the first hour after admission, but current lab-based genetic tests are not able to return actionable results within that timeframe. A Genedrive® test is targeted to allow genetic results to be available within an hour, allowing alternative antibiotics to be used and thus avoiding the potential life changing adverse reaction to gentamicin. The project is expected to commence immediately, with an expected development phase of one year followed by a trial implementation phase in selected NHS hospitals in year two. The Company will then target the release of a Genedrive® test within the NHS and more broadly. The consortium will be led by William Newman, Professor of Translational Genomic Medicine at the University of Manchester and Consultant at Manchester University NHS Foundation Trust. The team includes partners from Liverpool and Manchester Neonatal Intensive Care Units and is working closely with parents of children previously treated on intensive care units. Professor William Newman said: "We look forward to working with genedrive and our colleagues in Manchester and Liverpool to assess the impact of rapid genetic testing as a method of avoiding irreversible hearing loss in babies treated with antibiotics. Successful implementation would be a first in the integration of a rapid decision making, genetic-based diagnostic in the UK NHS." David Budd, Chief Executive Officer of genedrive plc, said: "The application of Genedrive® in an urgent healthcare setting is an excellent example of how a rapid, affordable, point-of-care test could impact patients' treatment and quality of life. The NHS is a huge market place and, if adopted, this would be the first placement of Genedrive® in a developed world healthcare setting.

    Click here to learn more.

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