Industry Case Studies

Enabling proton beam therapy research

Proton beam therapy (PBT) is an advanced form of radiotherapy (RT) that uses a high-energy beam of protons, rather than X-rays to deliver radiation to treat cancer.

The INSPIRE (Infrastructure in proton international research) study is working to enable and integrate proton beam therapy research across Europe, funded by the EU’s Horizon2020 fund for research and innovation.

It forms part of our Cancer Advanced Radiotherapy theme, and is led by Professor Karen Kirkby, BRC New Indications and Combinations with Protons Lead, and Professor of Proton Therapy Physics at The University of Manchester.

The evidence

PBT offers greater precision and targeting of radiotherapy to the tumour, and avoids surrounding healthy tissue. It also has the potential to lead to faster recovery and better outcomes for patients, and reduces the risks of long-term side effects from the radiation, which is especially beneficial to children and young adults.

The Christie NHS Foundation Trust is now home to the first high-energy NHS PBT centre in the UK, allowing further research and development, and industry investment, into this relatively new and innovative treatment.

How we are helping

INSPIRE brings together research activities in clinical PBT centres, academia and industry from across Europe, to enable researchers to access infrastructure and conduct their own research. It provides training to the next generation of researchers, facilitates best practice and aims to develop an innovation pipeline translating research into the clinic and industrial products.

Research is undertaken by the PRECISE group, also led by Professor Kirkby. The group has a dedicated research facility known as the ‘research room’, located within The Christie’s clinical Proton Beam Centre. The group has a dedicated research facility know as ‘the research room’, which is a unique resource. It is available to other UK and EU researchers through the EPSRC Network grant and EU grant INSPIRE.

The research in PRECISE takes a multidisciplinary approach, from basic research, to applied and translational research leading in to clinical trials. The research is designed to improve the outcomes for patients both in terms of survival and quality of life.

“INSPIRE brings together 14 institutions from across Europe, including industry partners Varian and IBA investing €5m over four years. We’re now looking at additional projects to test new software for treatment and planning of Proton Beam Therapy.”

Professor Karen Kirkby, BRC New Indications and Combinations with Protons Lead

Improving outcomes in lung cancer

Led by Dr Phil Crosbie and Professor Caroline Dive, the Manchester Early Detection of Lung Disease (MEDLD) project aims to develop a pioneering new screening programme to improve the early identification and prevention of lung cancer.

Spanning both our Cancer Prevention and Early Detection, and Cancer Precision Medicine themes, our researchers also aim to work with industry partners on the development of a new biomarker for disease prediction.

The evidence

Manchester has the poorest premature death rate in under-75s in the country. Lung cancer is the main cause of this, with the population having some of the highest levels of deprivation and smoking in the UK.

Lung cancer is often diagnosed too late for treatment to be effective, with around three quarters of our population diagnosed at a late stage. The Government is making a concerted national effort to back initiatives to prevent and detect lung cancer early so that treatment can be appropriately targeted.

Progress and next steps

STAGE 1 – Piloting a CT lung cancer screening service

Supported by Cobalt Health and Siemens, providers of mobile scanning units, community-based ‘Lung Health Checks’ (LHC) were delivered in supermarket car parks, focusing on high-risk individuals in deprived areas of Manchester. With demand far exceeding expectation, more than half of participants qualified for a CT scan, with one in every 33 scans detecting lung cancer. Early detection meant potentially curative treatment could be offered to nine out of every ten people with the disease.

STAGE 2 – Biomarkers

Individuals attending the second round of the MEDLD pilot will be eligible to participate in the Community Lung Health Study (funded by Cancer Research UK), which will test the feasibility of biological sample collection in community pharmacies.

Alongside this, the team will develop a liquid biopsy study to identify biomarkers for lung cancer, with discussions now taking place with a number of biomarker companies on how to provide access to data, imaging, diagnostics and patients to support this research.

STAGE 3 – Wider deployment

In November 2018, Dr Phil Crosbie launched the Yorkshire Lung Screening Trial (YLST), securing a £5.9M in funding from Yorkshire Cancer Research, as well as further funding of YLST Biomarker Sub-Study (£1.05M) which is based on the success of the Community Lung Health Study.

In February 2019, NHS England announced a £70m investment in Lung Health Checks across ten sites in England. Based on the Manchester model, this could form the start of a national lung cancer screening programme.

“Cobalt is very excited to be part of the first commissioned lung screening service in the UK. As a medical charity, we have been supporting oncology services with the NHS for over 50 years using the latest technologies.

“The partnership with Manchester University NHS Foundation Trust and Siemens will enable us to deliver the very best service to the people of Manchester using the latest Siemens equipment.”

Peter Sharpe, CEO, Cobalt Health

Attracting industry to translational hearing research

Hearing devices are the main treatment for hearing loss, and the NHS buys more of them than any other entity in the world, currently spending £1.2m each year.

The NIHR Manchester BRC’s Hearing Health theme has established the UK’s only Hearing Device Research Centre (HDRC), to drive innovation in treatments for hearing loss and accelerate translation into the NHS.

Our research

The centre focuses on four main areas of research:

• measuring the efficacy and effectiveness of devices or individual device features, including both technical measurements, and behavioural investigations of the impact of the devices on hearing capabilities and quality of life
• developing effectiveness with which devices rehabilitate hearing
• establishing methods to determine candidature for hearing
  devices or features
• developing new algorithms and features for hearing devices.

Impact

Since it was established, the HDRC has become an important service for the NHS and a ‘go to’ centre of excellence, allowing evaluation of all NHS hearing devices. We have also improved study recruitment, by employing dedicated research audiologists and developing a volunteer database, whilst our bespoke ‘listening room’ allows us to simulate real-world scenarios, including non-auditory responses such as movement.

Following selection of the HDRC as its preferred research centre, Sonova secured their first commercial study, whilst its Vice President for Research and Innovation, Dr Stefan Launer, was also awarded a position as honorary chair at The University of Manchester.

This collaboration with Sonova led to a successful joint application to the Hearing Industry Research Consortium (HIRC) to study stigma around use of hearing devices.

In partnership with our Informatics and Data Sciences cross-cutting theme, we are now establishing an information governance framework for research with digital NHS hearing aids. In addition, the HDRC will benefit from our recent ISO 27001 certification, the the international standard for an information security management system.

“The HDRC is a unique facility and acts as a single point of contact for industry partners looking to test the latest developments in hearing devices. Working closely with industry adds great value to the NHS and means patients get faster access to the latest devices, and we hope more partners will use it as their preferred research centre.”

Professor Kevin Munro, BRC Hearing Health Theme Lead

Preventing hearing loss in newborns

The Pharmacogenetics to Avoid Loss Of Hearing (PALOH) study aims to prevent hearing loss in newborns who carry a genetic predisposition to certain antibiotics used to treat serious infection.

This forms a major part of our Hearing Health theme, and is led by Professor Bill Newman, BRC Developing Genetic and Genomic Solutions Associate Lead, and his team at Saint Mary’s Hospital, part of Manchester University NHS Foundation Trust.

The evidence

Each year in the UK around 90,000 newborn babies in intensive care are given the antibiotic Gentamicin to treat sepsis and other serious infections. It is vital they are given the drug within the first hour of admission to intensive care if they are to stand the best chance of fighting the infection.

However, a small percentage of babies have a genetic predisposition to the antibiotic, which can cause irreversible hearing loss. Until now there have been no suitable tests to identify those at risk of hearing loss.

How we are helping

Building on Professor Newman’s work through the NIHR Manchester BRC, and with funding from Action for Hearing Loss, we are working with Genedrive to develop a rapid genetic test to run on their point-of-care platform that could be used at the bedside.

The project has now leveraged £900K through NIHR Invention for Innovation (i4i) funding for a North West-based consortium (Genedrive plc; Neonatal Intensive Care Units in Manchester and Liverpool) to carry this research forward in a wider study.

Impact

• the first successful implementation and integration of a rapid decision making genetic based test in the UK NHS.
• demonstrates how a rapid, affordable, point-of-need test could impact patients’ treatment and quality of life.

“The application of the Genedrive® test in an emergency healthcare setting is an excellent example of how a rapid, affordable, point-of-need test could impact patients’ treatment and quality of life.”

David Budd, Chief Executive Officer of Genedrive

“We’re working with 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.”

Professor Bill Newman, BRC Developing Genetic and Genomic Solutions Associate Lead

Rapid access diagnostics for asthma (RADicA)

Asthma is an extremely common condition but diagnosis can be challenging. This is because it relies on a combination of clinical judgement and a range of pulmonary tests. Currently there is no single test to diagnose asthma.

Our Respiratory theme is working alongside global diagnostics company Owlstone Medical, to test a novel breathalyser device which looks for breath-based biomarkers to diagnose the condition quickly and guide patients to treatments.

The evidence

• analysis of a person’s breath is emerging as a highly promising way to directly measure small molecules (metabolites) reflecting underlying disease activity
• current guidelines recommend asthma is diagnosed based on clinical judgement, combining the presence of symptoms suggestive of asthma with results in the most commonly used pulmonary tests (spirometry, peak flow variability, bronchodilator reversibility) and the Fraction of exhaled Nitric Oxide (FeNO), which focus primarily on the large airways
• small airways are now recognised as just as important to establish a clear diagnosis, with this non-invasive approach offering a ‘window’ into individuals’ overall lung health.

How we are helping

This research is jointly funded by Asthma UK and Innovate UK and the project will be embedded within the NIHR Manchester BRC RADicA study, which sits under our Respiratory theme. Aims of the study include:

• using breath-based biomarkers and measures of small airway function to enable the rapid, accurate and low-cost diagnosis and monitoring of asthma
• better classify different forms of asthma, their progression, and effect on airway inflammation
• predict early if someone is likely to respond to inhaled corticosteroid (ICS) treatment.

By using the data collected in the study, the project will compare the performance and clinical use of these approaches to the existing large airway tests.

“The emergence of new devices that enable biomarkers to be detected in breath has the potential to revolutionise asthma diagnosis, and we are very pleased to be working with Owlstone Medical on this important project.”

Dr Clare Murray, NIHR Manchester BRC Asthma Programme Associate Lead

“Many of us either are or know asthma sufferers, so are only too aware of the pressing need for better diagnosis and improved, personalised treatments. This new funding will allow innovative businesses to work hand-in-hand with the very best researchers, to bring forward these much-needed breakthroughs.”

Dr Kath Mackay, Interim Director – Ageing Society, Health & Nutrition at Innovate UK