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For stroke patients and any patient undergoing surgery the time period from diagnosis to treatment is a major factor in clinical outcomes. Research carried out at the University of Warwick has led to the development of sensors that can be used to measure, in whole unprocessed blood, diagnostically useful analytes that can be used to select the best therapeutic treatments. Point-of- care diagnosis and prompt referral to an appropriate care pathway, facilitated by the use of biosensors, will result in efficiency savings for healthcare professionals and the NHS in the long- term, and will also improve patient outcomes. To commercialize these biosensors, Sarissa Biomedical Ltd was founded in 2002, as a UK-based spinout from the University of Warwick. Sarissa sells, around the world, microelectrode biosensors fabricated by a unique enzyme deposition technology protected by patents filed in 2004 and 2008 by the University of Warwick. The diagnostic sensors are based on technology that incorporates Ruthenium Purple and use a sol-gel coating to entrap enzymes on a microelectrode. Sarissa is pursuing human trials of its biosensors as diagnostic tools in two main areas: stroke, and trauma with associated sepsis.
Psynova Neurotech is a prize-winning spin-out company founded by Professors Sabine Bahn and Chris Lowe from the University of Cambridge. It focuses on the commercialization of novel blood-based biomarker tests for conditions like schizophrenia, depression and bipolar disorder. Psynova and its partner company Rules Based Medicine (now Myriad RBM Inc.) launched the first commercially available Aid for the Diagnosis of Schizophrenia (VeriPsychTM) in 2010. In June 2011, Psynova and Rules Based Medicine were acquired by Myriad Genetics Inc. for £50 million. In February 2011 Psynova Neurotech and Professor Bahn were announced winner of the ACES best European Life Science spin-out award.
Novel methods of measurement developed by Marek Czosnyka, Peter Hutchinson, David Menon and John Pickard have provided new insights into the pathophysiology of brain injury, led to commercial applications, and influenced patient care in terms of improved outcome for clinical trials. Multimodality brain monitoring of intracranial pressure (ICP), brain oxygen and microdialysis; PET/MRI imaging of critically ill patients; and computerised CSF infusion tests for shunt function in hydrocephalus have each impacted on the clinical practice and the ability to evaluate novel treatments and interventions in brain injury. This work has led directly to the establishment of a National Institute for Health Research (NIHR) Health Technology Cooperative for Brain Injury.
The capacity for cognitive function may be missed by clinical examination in severely disabled survivors of acquired brain injuries, resulting in individuals being mislabelled as being in the vegetative state (VS). Work from David Menon and John Pickard has shown that functional brain imaging provides a more consistent and less observer-dependent means of detecting and quantifying such cognitive capacity. As a result of this work, the use of functional imaging has been integrated into clinical protocols as the basis for: identifying patients with such covert cognition; prognosticating on outcome; defining a rational framework for patient selection in clinical trials; and exploring the use of brain-machine interfaces to improve communication with such patients.
Temozolomide is a major UK anti-cancer drug development success story. Following chemical synthesis at Aston University, early clinical evaluation of temozolomide carried out at Imperial College optimised how temozolomide was scheduled and delivered to patients to ensure maximum efficacy balanced acceptable side effects. Imperial's early trials demonstrated how the drug could be used effectively to treat patients with a type of brain cancer, glioma, and was pivotal to its subsequent market licensing. ESMO and NICE guidelines recommend temozolomide for use in patients with recurrent glioma and for patients with newly diagnosed Grade IV glioma. Glioma is a relatively rare cancer yet annual sales of temozolomide have been in excess of £900 million per year since 2009. Temozolomide given during and following radiotherapy is now standard of care for glioma and has improved survival compared to previous treatments or radiotherapy alone.
VisensiaTM is a bedside `early warning' system, deployed in many hospitals in the UK and US, which automatically analyses hospital patients' vital signs, produces simple-to-read scores, and alerts healthcare staff to any deterioration in a patient's condition. It resulted from research in this Department, commercialised by Oxford BioSignals Ltd (£1.5m sales to date, and 137 licences sold since 2010). VisensiaTM reduces the number of patients already in hospital who suffer an unexpected cardiac arrest or need an unplanned transfer to intensive care. The US Food and Drug Administration (FDA) approved the system's use after a 1000-patient clinical trial. There were no unexpected fatal cardiac arrests on the wards where the clinical trial took place in the three years after VisensiaTM. was deployed.
Treating stroke consumes 5% of the NHS budget. Government objectives for improving stroke rehabilitation have driven our important advances in aiding recovery of movement and independence. We have developed and evaluated innovative technologies and directly ensured translation into clinical practice and home use. Over 2,500 therapists have received training in functional electrical stimulation (FES) in the UK and abroad. Our research into FES and upper-limb robot therapy has attracted great media attention, as well as international clinical and commercial success. FES is now incorporated into National Institute of Health and Care Excellence (NICE) and Royal College of Physicians (RCP) Stroke Guidelines. We have demonstrated successful adoption of technologies in practice (the main UK commercial provider reports 16,000 sales of FES devices), and we have published evidence for their continued use.
University of Bristol researchers at the Bristol Heart Institute (BHI) have pioneered the development and clinical take-up of the novel technique of off-pump coronary artery bypass (OPCAB) surgery. Over ten clinical trials and several large cohort analyses have assessed the impact of this technique on elective and high-risk patients. The results have shown that it is as safe as the conventional coronary artery bypass grafting (CABG) technique that uses a cardiopulmonary bypass pump and cardioplegic arrest. Most importantly, however, OPCAB significantly reduces the risk of post-operative complications, and reduces morbidity and mortality. It also uses less hospital resources, reducing time in intensive care and length of hospital stay. In 2011 (the last year for which data are available), 20% of CABG operations in the UK were carried out with the OPCAB technique and it has had significant take-up overseas (for example, 18% of CABG operations in the US and 21% in the EU in 2010). NICE has recommended the safety and efficacy of OPCAB surgery.
Impact: Health and welfare; public health studies in Sri Lanka and clinical trials in a cohort of 35,000 pesticide self-poisoning patients have led to the withdrawal of high-dose pralidoxime as a WHO-recommended treatment and bans of three toxic pesticides in Sri Lanka.
Significance: Resultant changes in clinical practice and pesticide regulation have saved 3000 lives in the last four years in Sri Lanka alone; in the rest of Asia many times this as local guidelines and practice have changed.
Beneficiaries: Patients and communities, healthcare providers, policy-makers.
Attribution: Studies designed and led, with international collaborators, by Michael Eddleston, UoE.
Reach: International, particularly Asia, changes in WHO and international guidelines on pesticide use.
A low-cost, efficient, blood cell salvage technology (HemoSep) has resulted from research carried out at Strathclyde between 2008 and 2013. The novel technology has been patented and licensed to Brightwake Ltd., who manufacture the device in the UK and market it through a global distribution network. HemoSep has now been used in clinical centres across Europe, North America, and South Africa since its commercial launch in late 2012. The use of the device has been shown to reduce the need for donor blood transfusions in open-heart surgical patients by at least 1 unit (450 ml) with an associated reduction in transfusion related complications such as heightened inflammatory response and bleeding. The reduction in blood transfusions associated with the use of HemoSep has a considerable cost benefit to healthcare providers (in North America blood costs up to $1600 per unit). In addition, commercialisation of HemoSep has led to the creation of new manufacturing, marketing and sales jobs in the UK and overseas.