Author: Louise Stanley

Focused life science professional pipetting human serum media containing HIV infected cells from petri dish to microtiter plate. High protection degree work.

New gene therapy innovation centre to turn scientific discoveries into life-changing treatments

Written by Louise Stanley on 18/03/2021. Posted in Experimental medicine.

BHP founder-member the University of Birmingham is set to play a key role in a pioneering new gene therapy innovation centre which will advance scientific discoveries into promising treatment options for millions of patients with life-threatening diseases.

The Gene Therapy Innovation and Manufacturing Centre (GTIMC) will be led by the University of Sheffield in collaboration with the University of Birmingham, Cell & Gene Therapy Catapult, Centre of Process Innovation, University of Liverpool, and BHP’s Midlands-Wales Advanced Therapies Treatment Centre.

It is one of three pioneering hubs announced today in a new £18 million network funded by LifeArc and the Medical Research Council (MRC), with support from the Biotechnology and Biological Sciences Research Council.

Gene therapy is a promising treatment option for more than 7,000 rare diseases that currently have no cure. It aims to treat these conditions, by engineering another gene to replace, silence or manipulate the faulty one.

The UK has a world-class genetics research base – however, to date, academics have found it difficult to get access to the clinical materials, facilities and expertise required to progress gene therapy research into clinical trials.

Professor Mimoun Azzouz, Director of the GTIMC and Chair of Translational Neuroscience at the University of Sheffield, said: “The Gene Therapy Innovation and Manufacturing Centre will tackle major challenges in gene therapy development for some of the most devastating diseases.

“Gene therapies are pioneering medical advances that have the potential to offer much needed, novel, effective treatments for many rare and incurable diseases that cannot be treated by conventional drug compounds.

“Sheffield has emerged as one of the leading players in the cell and gene therapy and this national network of partners, facilities and training programmes will allow us to keep pace with translational discoveries for new and potentially life changing treatments. This is a momentous milestone for revolutionary medical advances.”

Professor Dame Pam Shaw, Director of the NIHR Sheffield Biomedical Research Centre and co-applicant on the GTIMC application said: “This exciting development and partnership will speed up the pull through of new gene therapies into early phase clinical trials and offer hope to patients with neurological and other rare diseases that can be addressed in this way.

“The support given to this initiative will greatly accelerate the translational potential of genetic therapies in the UK and bring benefits in key areas of unmet medical need.”

Professor Philip Newsome, Director of Research and Knowledge Transfer at the University of Birmingham’s College of Medical and Dental Sciences, said: “We are delighted to be part of this pioneering new gene therapy innovation centre, providing our leading expertise to play a pivotal role in its potentially life-changing work.

“By smoothing the transition between small-scale supply for early clinical trials through to larger-scale manufacture for patient trials, and beyond, the centre will be able to advance scientific discoveries into promising treatment options for millions of patients with life-threatening diseases.”

The state-of-the-art centre will bring together academic institutions, NHS trusts, non-profit and industry partners across the north of England, Midlands and Wales enabling academic-led clinical trials of novel gene therapies.

The GTIMC will deliver essential translational and regulatory support alongside extensive training and skills programmes to enable upskilling and address shortage of skills in Good Manufacturing Practice manufacturing.

The facility will utilise highly efficient processes to manufacture clinical grade adeno-associated viruses and provide all the necessary quality assurance, regulatory certification and governance for human trials at Advanced Therapies Treatment Centres and NHS trusts within the GTIMC and the national network.

The three national hubs, located at the University of Sheffield, Kings College London, and NHS Blood and Transplant in Bristol will operate as a coordinated network, sharing technical skills and resources to enable innovative gene therapy research.

Dr Melanie Lee, CEO of LifeArc, said: “Recent innovations in gene therapies hold enormous potential for treating conditions such as rare diseases, but often promising ideas – particularly in academia – are not making it through to patients. Through our collaboration, we aim to meet the need for researchers to have access to the essential facilities and translational advice to progress promising research.”

The GTIMC will manufacture commonly used vectors including both lentivirus and adeno-associated virus that are needed for genetic therapy trials, while positioning the UK for significant bioprocessing innovation work with the potential to radically increase yields and reduce productivity barriers in future years. The hub network will also design and share commercially ready platforms, using common cell-lines, plasmids and reagents to reduce costs, facilitate simplified licensing agreements and streamline regulatory reviews.

Professor Fiona Watt, MRC’s Executive Chair, said: “The new network of Innovation Hubs for gene therapies will build on the UK’s great strengths in this area, providing targeted investment in vital infrastructure to accelerate academic research programmes down the path to patient benefit, supporting the delivery of a new wave of genetic medicines.”

£1.1m funding to improve uptake of at-home dialysis

Written by Louise Stanley on 18/03/2021. Posted in Inflammation and chronic disease.

A new study being carried out in collaboration with BHP founder-member the University of Birmingham could save the NHS up to £45m over three years by increasing the number of dialysis patients whose treatment takes place at home.

Funded by the National Institute for Health Research (NIHR), the study will focus on the reasons why home therapies are not used more equally and fairly by kidney centres across the country, as well as designing and testing possible solutions to improve the uptake of home therapies.

Called Inter-CEPt (“Intervening to eliminate the centre-effect variation in home dialysis use”), the research builds on previous collaborations and is a multi-disciplinary project integrating ethnographic and statistical expertise from Keele University, health policy researchers from the University of Birmingham and health economists from the University of Sheffield.

Around 30,000 kidney failure patients in the UK currently manage their condition with dialysis, either at home or by travelling to their local dialysis unit as an out-patient, where it is provided by healthcare staff.

Although national guidelines encourage the use of home dialysis, the uptake is limited and varies greatly by treatment centre. Some centres offer home treatments more than others, with provision varying between 2-28% of patients requiring kidney replacement therapy.

Having dialysis at home is associated with improved clinical outcomes, treatment satisfaction and patient autonomy. It has also been safer for patients during the Covid-19 pandemic.

Recent research by the Renal Registry has also found that certain groups in society were less likely to have home therapy, with patients from Black, Asian and Minority Ethnic (BAME) groups, and those from poorer or more disadvantaged backgrounds being particularly affected.

This research aims to change the uptake and availability of home dialysis treatments, by using a five-stage approach to assess the main factors affecting home dialysis availability, which will allow the researchers to develop a practical and feasible approach for dialysis centres to make these treatments more accessible.

The research team includes BHP’s Dr Iestyn Williams and Dr Kerry Allen, of the University of Birmingham’s College of Social Sciences, and Dr Sarah Damery, Institute of Applied Health Research, University of Birmingham.

Dr Williams, Reader in Health Policy and Management at the University of Birmingham, said: “It is really important that the most effective treatments are accessed by everyone, including marginalised and disadvantaged groups. This study will be crucial in helping us to understand how this can be achieved.”

Professor Simon Davies, of Keele University’s School of Medicine said: “We will use in-depth knowledge of what constitutes a strong and equitable home therapies programme to inform a wider survey of dialysis unit practices linked to patient outcomes.

“This will allow us to develop a bundle of interventions designed to support inclusion of those patients into home therapies who may not currently benefit from this treatment option.”

Professor Lisa Dikomitis, also of Keele University, added: “I am delighted to be part of this timely and important study, which is underpinned by a robust patient and public involvement and engagement strategy.

“Ethnographic and qualitative data will provide us with a better understanding of why certain groups in our society are less likely to have home therapy and how we can improve the uptake of such therapies.”

Dr James Fotheringham, of the University of Sheffield, who leading the health economics research for the study, said: “The internationally renowned expertise in health economics which the School of Health and Related Research brings to this project, ensures that the costs and benefits of these important treatments are fully understood so they can inform policy and clinical practice.”

A beautiful little girl with cancer takes a break from treatment. She is standing near a large bay of windows in the hospital's corridor. The girl is wearing a headscarf and is holding a stuffed rabbit toy. She is looking out the window with a peaceful expression.

Drug dosing technology to improve children’s cancer treatment

Written by Louise Stanley on 15/03/2021. Posted in Cancer outcomes.

A new project has been launched in collaboration with BHP founder-member the University of Birmingham aimed at aiding more precise drug dosing in children with cancer.

Children receiving chemotherapy treatment each process the drugs differently, leading to inconsistencies in drug concentrations in the blood (known as drug exposure).

Patients may not receive enough of the drug or in some cases may experience side effects following anthracycline treatment, predominantly in the form of dose-related cardiotoxicity.

A multidisciplinary team of experts working on the project, called ChromaDose, will develop a diagnostic drug monitoring tool to aid dose optimisation, enabling children receiving anthracycline chemotherapy – a type of the drug most commonly used to treat childhood lymphomas and leukaemias – to benefit from a personalised approach to treatment.

The technology behind ChromaDose, which is being led by UCL, will enable clinicians to calculate the patient’s drug exposure. Nurses administering the chemotherapy drug would collect a few drops of blood at different times following administration. These samples are then inserted into the ChromaDose bedside device using an innovative cassette design.

The machine automatically measures the amount of medicine within each blood drop and identifies the patient’s pharmacokinetic response (movement of drugs into and around the body), allowing ChromaDose to calculate the patient’s drug exposure.

Co-lead Professor Pamela Kearns, of the University of Birmingham, explained: “In 2021, there are nearly half a million survivors of childhood cancer in Europe and two thirds live with long term side effects from their treatment.

“One way to improve the side effect profile of a drug is to be more precise in the dosing. ChromaDose has the potential to allow us to individualise the dose of chemotherapy drugs to maximise effect on the tumour while minimising the side effects.

“I am looking forward to working with the team to move ChromaDose into clinical practice as a substantial step towards personalised medicine for children with cancer.”

Overall project lead Dr Stefan Guldin, of UCL Chemical Engineering, further explained: “We have come a long way from the first experiments in the lab to this unique opportunity to bring our technology into the clinic. The team we have been able to assemble in ChromaDose makes me confident that we can achieve our ambitious goals.”

Academics currently have the individual components which have shown promise when operated manually in a laboratory. They will now work to integrate these elements into an automated companion monitoring tool that will be able to provide reliable results within 30 minutes from insertion of the sample.

“The challenge of developing a fully-automated in-vitro diagnostic device for biochemical analysis on the ward cannot be underestimated,” explained Dr Alaric Taylor, Innovation & Design Lead at Vesynta Ltd, a UCL start-up. “Safety, performance, user experience and regulatory compliance are all competing factors.

“However, I believe that working within the ChromaDose consortium, with input and support from each and every stakeholder, makes the delivery of this technology possible.”

Co- lead Professor Gareth Veal, of the University of Newcastle, commented: “We have made great strides over a number of years in providing a national therapeutic drug monitoring service to support dosing decisions being made for childhood cancer patients across the UK.

“The development of a point-of-care diagnostic device funded through the i4i project could have a real impact on utilising drug monitoring approaches as routine cancer patient care in the future.”

The research team are working with a diverse group of stakeholders including children, parents, nurses, doctors, educators, designers, scientists and engineers. The Young Persons Advisory Groups at Great Ormond Street Hospital and North England were actively involved in the project planning stage, with over 60 participants, and remain important collaborators throughout the project. Additionally, parents and wider families of children who have experienced cancer will contribute through the Paediatric Oncology Reference Team.

Stakeholder satisfaction and user scenarios analysis will aid the translation of the ChromaDose innovation into the NHS healthcare system. This work is supported by partners at the National Institute for Health Research (NIHR) funded London In-Vitro Diagnostic Co-operative at Imperial College London. The expert team will map pathways for clinical integration alongside early stage health economic analysis, ensuring patient benefit is delivered rapidly and cost-effectively.

The ChromaDose project is funded by an NIHR i4i Product Development Award, which provides £980,000 for a nationwide multi-disciplinary team to conduct intensive research and development over 30 months. As project capstone, the team will seek regulatory approval from the notified body for widespread adoption.

Midlands’ maternity triage system goes nationwide

Written by Louise Stanley on 05/03/2021. Posted in Maternal health.

A maternity triage system developed by clinicians and researchers in the West Midlands has launched training online for the first time, becoming readily available to maternity teams across the UK.

Midwives, obstetricians, and doctors across the NHS can now access the Birmingham Symptom-specific Obstetric Triage System (BSOTS) programme and training materials online for free via the Meridian Health Innovation Exchange – part of BHP member West Midlands Academic Health Network (WMAHSN).

There is no standardised triage system in maternity care. The Birmingham Symptom Specific Triage System (BSOTS) assesses women presenting themselves with unexpected pregnancy related problems or concerns, and then allocates a colour code, so hospital staff can see at a glance who needs to be prioritised.

Developed collaboratively between BHP founder members Birmingham Women’s and Children’s NHS Foundation Trust (BWC) and the University of Birmingham, supported by the WMAHSN and MidTECH Innovation, BSOTS was established to provide a standardised method of safely and efficiently assessing women when they attend with unexpected clinical concerns.

Until now, there has been no consistent process available. BSOTS involves a brief standardised assessment of the women on presentation, followed by clear guidance developed to help midwives and clinicians determine the clinical urgency in which women need to be seen. This ensures that variation in treatment and outcomes is minimal and that participating maternity triage departments are working cohesively.

An initial evaluation at BWC showed that BSOTS increased the number of women seen within 15 minutes of attendance to maternity triage from 38% (159/421) to 53% (209/391). The system also appeared to reduce the time between attendance to medical review for those who required it.

By digitising the resources and training materials, trusts from further afield can sign up and implement the award-winning programme more easily and quickly than ever.

BSOTS has been adopted by 34 maternity units in the UK with a further 20 in the process of implementation, and 17 awaiting training. Sunshine Hospital in Victoria, Australia are the first international maternity unit to implement BSOTS with interest from others. Participating Trusts have already noticed positive changes in work organisation and practices, along with a reduction in staff anxiety often associated with triage work.

Its success in safeguarding women has seen the BSOTS programme gain support by the Royal College of Midwives (RCM) and the Royal College of Obstetricians and Gynaecologists (RCOG) who support its implementation.

The programme has also been recognised at the Health Service Journal (HSJ) Patient Safety Awards 2020, as Maternity and Midwifery Services Initiative of the Year and was shortlisted for its Patient Safety Innovation of the Year award.

Helen Hunt, Patient Safety Assistant Programme Manager at WMAHSN, said: “We are so proud to be launching BSOTS on the Meridian Health Innovation Exchange. Streamlining the care of expecting mums is vital and taking the programme online will allow more NHS Trusts and maternity departments across the UK to take a step forward and help ensure that this happens nationwide. We’re so excited to see the roll out.”

Sara Kenyon, Professor of Evidence Based Maternity Care at the University of Birmingham, added: “Previously, BSOTS training has been done either face-to-face or over Zoom, meaning that training and materials haven’t been as accessible to maternity teams as we would have liked.

“However, the new electronic sign-up process makes it easier for maternity sites across the country to access the resources necessary to put BSOTS into practice and improve the way maternity triage work is managed.”

Dr Nina Johns, Consultant Obstetrician at The Royal Wolverhampton NHS Trust and co-creator of BSOTS added: “The BSOTS programme has proved to be invaluable to midwives, obstetricians, and doctors across the UK; not only does it improve quality of care and the safety of pregnant women and staff, it also allows for better communication and creates a less stressful triage environment for staff.

“We hope that by digitising the sign-up process, many more teams will be able to access and implement the service to improve safety & clinical safety in maternity triage.”

Maternity teams will be able to sign up for access to the BSOTS training materials for free via the Meridian Health Innovation Exchange. Existing BSOTS users will also be able to sign up to access to the digital triage resources which can be used independently or in conjunction with BadgerNet.

To find out more about BSOTS, or to sign up to the programme, visit the Meridian Health Innovation Exchange website.

Birmingham’s brain tumour centre awarded Tessa Jowell Centre of Excellence status

Written by Louise Stanley on 02/03/2021. Posted in Cancer outcomes, Clinical trials, Experimental medicine.

The brain tumour centre at BHP founder-member University Hospitals Birmingham (UHB) has been recognised as a Tessa Jowell Centre of Excellence following rigorous expert-led assessments by the Tessa Jowell Brain Cancer Mission.

With more than 12,000 people diagnosed every year with a primary brain tumour in the UK[i], and 300 new patients seeking treatment at UHB, the award has been introduced to recognise hospitals for their excellence in patient care. It represents a step change in the neuro-oncology landscape across the UK.

UHB was measured on a range of criteria, including its excellent clinical practice and training opportunities; emphasis on patient quality of life; providing clinical trials and offering a high standard of research opportunities. Led by a committee of experts in the field and virtual site visits, the assessments were backed up by patient feedback about the care they received.

At least 88,000 British people are currently living with a brain tumour but over 5,000 people a year will lose their lives to it[ii]. The “Excellence” status provides reassurance about the availability of excellent care within the NHS and positive recognition for its staff at UHB who, despite the challenges of the Covid-19 pandemic, continue to go above and beyond for their patients. Due to the strain Covid-19 has placed on the NHS, UHB’s brain tumour centre now offers virtual clinics for patients.

Founded to design a new national strategy for brain tumours, the Tessa Jowell Brain Cancer Mission is committed to helping as many hospitals as possible achieve the “Excellence” status in the future. To achieve this, the mission is launching the Tessa Jowell Academy, a national platform allowing hospitals to share best-practice to improve their services, as well as one-year fellowships for doctors to further specialise in brain tumours.

Jess Mills, Co-Founder of the Tessa Jowell Brain Cancer Mission and Tessa’s daughter, said: “Mum’s mission throughout 50 years of her political life was to tackle systemic inequality. So, it was tragic whilst fitting, that her final campaign was a call to arms to create universal equality in access to excellence in cancer care throughout the NHS. It is with immeasurable pride that just 3 years later, the Tessa Jowell Brain Cancer Mission has begun the real-world translation of that vision into reality.

“We are thrilled to have awarded University Hospitals Birmingham for its excellent ongoing work for patients and commitment to support other centres in reaching the same level of Excellence. Shockingly, the UK still has one of the worst cancer survival rates in Europe, but in time, the Tessa Jowell Centres will make the UK a global leader in the treatment and care of brain tumour patients. We have a long way to go until the cutting edge of science is delivered to every patient, but this is a huge and transformational first step.”

Colin Watts, Professor of Neurosurgery at BHP founder member the University of Birmingham and Honorary Consultant Neurosurgeon at UHB, said: “We are delighted that our model of patient-centred, consultant-led, research-orientated care for brain cancer patients has been recognised in this way. This award is a tribute to the whole multidisciplinary team who put patients at the centre of everything they do and take real pride in delivering best practice for everyone.

“It is a privilege to be to be given this status from TJBCM partner organisations and we are very proud to affiliate ourselves with this recognition. We have worked hard as a team over the years to develop and improve patient care and will always strive to make a difference wherever possible. We will continue this process collaboratively by sharing and developing best practice within our service, externally and between other service providers for this cohort of patients.”

Cally Palmer, NHS England National Cancer Director, said: “This award is a fitting tribute to Tessa Jowell and her dedication to excellence in cancer care, as well as to all the NHS staff who have worked tirelessly throughout the pandemic to continue to provide life-saving cancer services, and it is great to see NHS hospitals across the country being recognised as centres of excellence. NHS services are open and ready to help those who need cancer care, and I encourage anyone who is experiencing any worrying symptoms to contact their GP immediately to improve chances of a successful recovery.”

Tessa Jowell Centres of Excellence:

1. 1. University Hospitals Birmingham
  2. Edinburgh Centre for Neuro-oncology
  3. King’s Health Partners of King’s College Hospital & Guy’s and St Thomas’s Hospitals in London
  4. Leeds teaching hospitals NHS Trust (Leeds General Infirmary and St James’s Hospital)
  5. Salford Royal Foundation Trust and The Christie (Manchester)
  6. Newcastle upon Tyne Hospitals NHS Foundation Trust
  7. Nottingham University Hospitals (NUH) NHS Trust
  8. St George’s University Hospital, Royal Marsden Hospital and Royal Surrey County Hospital
  9. University College London Hospitals NHS Foundation Trust

Over £700M is spent on cancer research in the UK every year, yet less than 2% of that is dedicated to brain tumours[iii]. The Mission will be supported by the All-Parliamentary Group on Brain Tumours chaired by Derek Thomas MP, to secure further support for NHS centres to enable more of them to achieve the “Excellence” status in the future. To kick-start additional monetary support, the Tessa Jowell Foundation, the charity set-up by Tessa’s family to lead the delivery of her legacy, has announced a fundraising appeal to raise £4M to enable the centres to excel after the network is launched.

[i] Cancer Research UK, https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/brain-other-cns-and-intracranial-tumours (Data: 2015-2017, UK)

[ii] Cancer Research UK, https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/brain-other-cns-and-intracranial-tumours#heading-Zero (Data: 2015–2017, UK). Accessed October 2020.

[iii] National Cancer Research Institute (NCRI) Cancer Research Database Data Package 2019

Birmingham spinout secures £800k for point-of-care diagnostics platform

Written by Louise Stanley on 24/02/2021. Posted in Early diagnosis and detection.

Birmingham-based Linear Diagnostics Ltd has secured £800,000 from the Midlands Engine Investment Fund (MEIF) and other investors in the company’s second round of funding, which will enable the company to commence the development of the hardware platform for its tests.

The finance will facilitate the ongoing development of the company’s high-speed platform technology for point of care diagnostics. The funding package includes backing from MEIF Equity Finance, managed by venture capital firm Midven, the University of Birmingham and the UKI2S Fund. The UK Future Fund matched the investment from the initial investors.

Linear Diagnostics was founded in 2011 by Professor Tim Dafforn and Dr Matt Hicks as a spinout from BHP founder-member the University of Birmingham’s School of Biosciences. Its diagnostics technology is based on research in linear dichroism, patented by University of Birmingham Enterprise, which uses polarised light to detect the presence of molecules in solutions.

The company has shown strong technical progress since its first investment, achieving clinical levels of accuracy in tests within its lab environment. Initially focusing on sexually transmitted infections (STIs), Linear Diagnostics is developing a rapid test for chlamydia and gonorrhoea. The test will be capable of detecting multiple infections in the same sample in around 15 minutes by labelling each infection indicator with a different coloured dye.

The World Health Organization estimates that worldwide, more than one million STIs are acquired every day. As most STIs show no or mild symptoms, point of care diagnostics will enable healthcare professionals to provide efficient, on-the-spot treatment, which will help reduce onward transmission and lower the risk of antibiotic resistance.

Brendan Farrell, Chairman & CEO of Linear Diagnostics, said: “We are very grateful to our existing investors for their continued support and to the UK Future Fund for providing matched funding. The funds received will enable Linear Diagnostics to develop a prototype single use cartridge and reader for our duplex test for chlamydia and gonorrhoea.”

Roger Wood, Director at Midven, said: “The requirement for rapid and accurate point of care diagnostics has been brought into sharp focus by the COVID-19 pandemic. There are many other disease areas that could equally benefit from this approach and Linear Diagnostics is making excellent progress with the development of its testing platform. This funding round will enable the company to continue its good work at pace.”

Oliver Sexton, Director at UKI2S, said: “Linear Diagnostics’ platform will be able to identify the presence or absence of genetic biomarkers in under 20 minutes. Such rapid gene-based diagnosis is transformative for diseases and disorders that respond to extremely rapid intervention or require diagnosis outside access to centralised laboratory services”

Ken Cooper, Managing Director at the British Business Bank, said: “This latest investment shows how MEIF Equity Finance can be used for further rounds of funding by businesses at different stages of their growth journey. It’s an example of how MEIF and the Government’s Future Fund are helping to support the continued development of innovative businesses across the Midlands, which is also likely to have a significant public health impact.”

Tim Pile, Chair of the Greater Birmingham and Solihull Local Enterprise Partnership, said: “It is hugely exciting to hear that Linear Diagnostics Ltd has secured MEIF funding. Given the challenges presented by Covid-19, it is critical we do what we can to advance our regional offering in diagnostic technology. We welcome this investment which will ensure better outcomes for patients and opportunities for businesses. GBSLEP is committed to helping create opportunities in the health tech sector which we see as a priority growth area in the region.”

The Midlands Engine Investment Fund project is supported financially by the European Union using funding from the European Regional Development Fund (ERDF) as part of the European Structural and Investment Funds Growth Programme 2014-2020 and the European Investment Bank.