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Author: Louise Stanley

Understanding pregnancy: Accelerating the development of new therapies for pregnancy-specific conditions

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Maternal health.

During pregnancy, women and pregnant individuals who do not identify as women* can develop a range of pregnancy-specific conditions, such as preeclampsia and gestational diabetes, that can adversely affect both their own health and that of the developing foetus during the pregnancy. These conditions can affect the lifelong health of both mother and child. Despite the danger that these conditions present to mother and baby, there are few approved, safe and effective medicines to treat them, and limited investment in novel therapy development.

To map out key barriers and potential enablers of preclinical research and experimental medicine to support the development of new medicines for pregnancy-specific conditions, the Academy of Medical Sciences, Birmingham Health Partners, and Concept Foundation organised a multi-sectoral FORUM workshop in September 2023. People with lived experience joined representatives from academia, the commercial sector, clinical practice (including doctors and midwives), regulatory authorities, funding bodies, charities, and patient advocacy groups at the meeting.

The result of this workshop is a new report – Understanding pregnancy: Accelerating the development of new therapies for pregnancy-specific conditions – which highlights the need to raise awareness of the importance of research in pregnancy, and give women opportunities to participate.

> Understanding pregnancy: Accelerating the development of new therapies for pregnancy-specific conditions – view and download the report here

This work builds upon the BHP-led Pregnancy Policy Commission which in 2022 published its Healthy Mum, Healthy Baby, Healthy Future: The Case for UK Leadership in the Development of Safe, Effective and Accessible Medicines for Use in Pregnancy report, proposing a clear roadmap to improve the lives of millions of people, not just for women while they are pregnant, but for future generations.

Professor Peter Brocklehurst, Emeritus Professor at BHP founder member the University of Birmingham, commented: “We need to better understand the biological mechanisms of pregnancy-specific conditions so that we can develop therapies that target these processes. To do this, we need more health data and biological samples from women with those conditions.”

Forum participants identified the following six priority areas for next steps:

    1. A cross-sectoral and cross-speciality network or coalition, including women with lived experience, to provide a platform for collaboration and to coordinate efforts to promote the development of new medicines for pregnancy-specific conditions.
    2. Additional interdisciplinary research and cross-sector collaboration to address key knowledge gaps (including the biology of the placenta, of the early stages of pregnancy, and of pregnancy-specific conditions), to enable appropriate use of animal models and physiologically based pharmacokinetic (PBPK) modelling, and to leverage routinely collected health data and patient samples.
    3. The establishment of a more enabling environment for research in pregnancy, for example through development of a stronger research base and a more supportive regulatory environment.
    4. Greater engagement with women to raise awareness of the importance of research into pregnancy and of opportunities to participate in this research, including when women contact the healthcare system.
    5. Education and training of healthcare professionals, including midwives, to promote research in pregnancy.
    6. Advocacy to secure greater prioritisation of research in pregnancy (and women’s health more generally) by policymakers, funders, and higher education institutions.

The workshop was chaired by Professor Peter Brocklehurst FMedSci, Emeritus Professor of Women’s Health at the University of Birmingham, and Dr Pauline Williams CBE FMedSci, an independent pharmaceutical medicine consultant and former Senior Vice-President and Head of Global Health R&D at GlaxoSmithKline.

* The Academy acknowledges that not all pregnant people identify as women. While the terms ‘woman’ and ‘mother’ are used here, many of the learnings from the workshop about obstetric/pregnancy-specific conditions are expected to be widely applicable. It is recognised that there will be specific experiences and challenges associated with obstetric conditions among pregnant individuals who do not identify as women that were not explored at the workshop given the lack of specific research in this area. 

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Birmingham scientists win funding to develop ‘lollipops’ for mouth cancer diagnosis

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

A ‘lollipop’ that can diagnose mouth cancer early could become a reality, thanks to a pioneering project funded by Cancer Research UK and the Engineering and Physical Sciences Research Council (EPSRC).

Scientists at BHP founder-member the University of Birmingham have been awarded £350,000 over the next three years to develop a prototype flavoured ‘lollipop’ from a material called a smart hydrogel.

Smart hydrogels – previously developed by the University’s Dr Ruchi Gupta and her team – work a bit like a fishing net: they absorb large quantities of water while ‘catching’ larger molecules, such as proteins. The ‘net’ can then be cut open to release the larger molecules for analysis in the lab. The idea is that patients suck on the lollipop, transferring a saliva sample into the hydrogel. Scientists can then release the ‘caught’ proteins by blasting the hydrogel with UV light and then analyse the liquid for saliva proteins which indicate the early stages of mouth cancer.

Around 12,400 people are diagnosed with cancers of the head and neck in the UK every year*. Currently, diagnosing mouth cancer can involve putting a flexible camera on the end of a tube through the nose or mouth and taking a biopsy for testing. This procedure is invasive, time-consuming and requires an endoscopist.

Mum of five, Rachel Parsons, needed a biopsy after being referred to Coventry University Hospital with a lump on her cheek in 2008. She admits she was unprepared for the procedure which, in her case, turned out to be painful.

“I had no idea what a biopsy really was,” said Rachel, from Coventry. “I had the kind of injection you get at the dentists and, when it wore off, it was really sore because I’d needed stitches.”

That was just the beginning of a 12-month nightmare for Rachel who ended up needing a nine-and-a-half-hour operation to remove a cancerous tumour from her cheek and replace the skin with tissue and veins from her forearm.

“The thought of putting a lollipop round your mouth instead of having a biopsy in the first instance is amazing,” said Rachel who has spent years as a patient ambassador, campaigning for more awareness of mouth cancer. “I wish something like that had existed when I was diagnosed.”

Dr Ruchi Gupta, Associate Professor of Biosensors at the University of Birmingham, said she was thrilled to receive funding to begin the next phase of the project: “Smart hydrogels have really exciting potential for diagnosing mouth cancer,” she said. “They can be easily moulded into shapes as a solid to ‘catch’ proteins in saliva.

“We’re really excited to start the next phase of this project. We’re hoping that we can be the first to make a device which is much kinder for diagnosing mouth cancer for patients and easier for GPs to use.”

Rachel, who still has numbness around her face and can’t open her mouth wide enough to eat a burger, added: “I’m so grateful for the research and treatment that saved my life. Things have improved immensely since then but what’s happening now could be absolutely brilliant for people diagnosed in future.”

Executive Director of Research and Innovation at Cancer Research UK, Dr Iain Foulkes, said: “Biopsies and nasoendoscopy are the gold standard for diagnosing mouth cancer, but it requires great skill to carry out and can feel unpleasant for patients. We want an accurate, faster and kinder alternative test which can help us diagnose cases of mouth cancer sooner.

“This project is an exciting first step towards an entirely new way to identify mouth cancers earlier. Research like this is guiding us towards a future where people can live longer, better lives, free from the fear of cancer.”

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Revolutionising diagnosis and management of cartilage tumours

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

The musculoskeletal radiology department at BHP member the Royal Orthopaedic Hospital (ROH) has developed a new website designed to enhance the diagnosis and management of cartilage tumours.

bactip.co.uk is a platform that equips healthcare professionals with the tools and knowledge to navigate the complexities of central cartilage tumours. By offering drawings and real case examples, it serves as a valuable resource for interpreting musculoskeletal radiology imaging findings related to these tumours, ensuring their accurate and consistent reporting. Developed collaboratively by experts in the field, bactip.co.uk offers an approach for assessing, diagnosing and monitoring these lesions.

A standout feature of bactip.co.uk is its integrated calculator, which streamlines the grading process based on tumour characteristics, like size and aggressiveness. This innovative tool aims to simplify decision making processes for healthcare professionals dealing with cartilage tumours. This advanced tool also standardises the reporting of central cartilage tumours, reducing subjective differences and improving patient care.

bactip.co.uk enables radiologists and clinicians to make informed decisions by offering an imaging follow up plan. Whether it involves suggesting a referral to an oncology specialist or safely discharging a patient from surveillance monitoring, the protocol provides a detailed framework customised for each unique case.

As a leading authority in orthopaedic excellence, the ROH musculoskeletal radiology department is proud to share its expertise through bactip.co.uk, an open-source free resource.

Dr A. Mark Davies, consultant radiologist at the ROH commented: “This initiative reflects our commitment to openness making sure that healthcare professionals worldwide can access our cutting-edge knowledge and best practices without any barriers. Our dedication to spreading knowledge and best practices aligns with our shared goal of enhancing patient outcomes on a global scale.”

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Birmingham researchers receive prestigious NIHR award

Written by Louise Stanley on . Posted in Birmingham Health Partners.

Professors Melanie Calvert and Richard Riley – both of BHP founder-member the University of Birmingham – have been recognised with a National Institute for Health and Care Research (NIHR) Senior Investigator Award.

Melanie Calvert – Director of the Centre for Patient Reported Outcomes Research and Professor of Outcomes Methodology – has been reappointed NIHR Senior Investigator for a second term and said: “I am delighted and honoured to receive this prestigious award for a second term. It is important recognition, not only of my work, but that of my brilliant team at the University of Birmingham, our international collaborators and wonderful patient partners. I look forward to providing senior leadership within the NIHR and building capacity for patient centred research.”

Melanie leads the Patient-reported Outcomes research theme at the NIHR Birmingham Biomedical Research Centre (BRC) and has led international initiatives to improve the design, analysis and reporting of patient-reported outcomes (PROs) in clinical trials and works with the Health Research Authority to improve ethical and inclusive PRO collection. Through global leadership and collaboration she has engaged patients and professionals, developing international guidelines which informed European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidance and are used by pharmaceutical companies, patient-partners and trialists worldwide. Her work has helped ensure that patient quality of life and symptom data is captured and reported in a rigorous way that can meaningfully inform patient care, regulatory decision-making, clinical guidelines and health policy.

Richard Riley, who has been newly awarded the accolade, is Professor of Biostatistics at the Institute of Applied Health Research and a researcher within the NIHR Birmingham BRC’s Data, Diagnostics and Decision tools research theme. He leads a team of statisticians undertaking applied and methodology research for healthcare, especially in regard to prognosis, prediction models, and evidence synthesis. He is Deputy Chief Statistics Editor for The BMJ and was named as a ‘Highly Cited Researcher’ in 2023. He works passionately to improve medical research by developing, promoting and educating about the importance of high methodology standards in study design, analysis and reporting.

He commented: “I am delighted to receive this award from the NIHR. Statisticians and methodologists play a critical role in undertaking and improving medical research, and having my contributions recognised by the NIHR is truly humbling. I would like to thank the many research collaborators and mentors who have supported my career, and I look forward to further championing methodology and guiding the NIHR community in the coming years.”

NIHR Senior Investigators are among the most prominent researchers funded by the NIHR. This award is presented to outstanding researchers developing health and care research capability to improve the future health of the nation, with reach into both academia and the health and care system.

Senior Investigators play an important role in guiding research capacity development and strengthening the career paths of NIHR researchers, which includes participating as mentors in the NIHR mentoring programme.

In addition to the title, Senior Investigators also receive an award of £20,000 per year of appointment to fund activities that support their research. They are usually appointed for 4 years, for a maximum of two terms to ensure turnover.

Major contract awarded for a concussion research programme from the US Department of Defense

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Early diagnosis and detection.

Birmingham experts in neurology have been awarded a seven-year contract by the U.S. Department of Defense – which could be worth up to $15.5m – to undertake a major research programme aiming to transform the way concussion is identified and managed.

Some 890 people across the UK, aged 18 to 60, will take part in the study which will measure the ability of a range of biomarkers – such as blood and saliva, mental health, vision, balance and sleep – to predict long-term complications from mild Traumatic Brain Injury (mTBI), also known as concussion. The  mTBI-Predict study will see researchers measure effectiveness of various methods to predict outcomes of mTBI after six, 12 and 24 months.

mTBI can be caused by physical impact to the head through accident, injury, sport, or even from shockwaves following explosions. Led by the Royal Centre for Defence Medicine (RCDM) and the University of Birmingham, researchers will use the UK TBI Research Network to recruit both civilian and military participants to the programme.

mTBI Predict will be supported by Birmingham Health Partners and University Hospital Birmingham, as well as a range of research institutions across the UK.

Professor Alex Sinclair, from the University of Birmingham, who will lead the study said: “Concern around the long-term effects of concussion is mounting. Even a minor injury to the head can cause concussion, which leads to brain injury with potentially serious effects on both immediate and long-term health.

“We have no precise way to tell who will have a serious consequence after a concussion. This means we can’t tell which patients will need more intensive treatment and which will recover spontaneously. The mTBI Predict research program will identify new ways to accurately predict whether concussion patients will develop long-term complications.”

Concussion has been declared a major global public health problem, with 1.4 million hospital visits due to head injury annually in England and Wales. Some 85% of these are classified as concussion and it is also estimated that up to 9.5% of UK military personnel in a combat role are diagnosed with concussion every year.

Major General Timothy Hodgetts CB CBE KHS, Surgeon General of the UK Armed Forces, commented:

“UK Defence has funded the initiation of this research, but it would not be possible to complete without the support from US DoD. This is a prime example of our longstanding bilateral research collaboration where we have a common purpose to address a significant and shared clinical problem. This study will be definitive in helping us identify those who need the most help and resources following a very common injury.”

The research programme brings together a team of experts including neuroscientists, psychologists, sport and exercise scientists, software developers and statisticians – coordinated by Birmingham Clinical Trials Unit.

The study will recruit patients with concussion related to sports injuries, road accidents, cycling accidents, falls and accidents at work, and military personnel experiencing concussion during training or active duty. It will involve military patients and expertise from the Defence Medical Rehabilitation Centre Stanford Hall and Royal Centre for Defence Medicine.

Dr. David J. Smith, from the US Department of Defense, commented: “The US Department of Defense is excited to support this study and continue to identify threats to the brain, such as blast overpressure, head impact, directed energy, and environmental hazards.

“These threats may have a direct impact on brain health. Our aim is to reduce risks to the brain, monitor exposures, and document them for long-term review. The goal is to look for multiple protection strategies to decrease exposures and protect brains better. This research will play a pivotal role in continuing our research investments partnering with the UK to better understand mTBI and concussion to prevent and reduce their effects.”

Although classed as mild brain injury, concussion leads to a disproportionate impact on future health, with three in 10 patients unable to work 12 months after their injury. The consequences of mTBI are profound, with many patients suffering long-term disability due to persistent headaches, imbalance, memory disturbance and poor mental health.

mTBI-Predict will look at biomarkers to enable faster diagnosis and assessment of a concussion, leading to improvements in treatment and long-term management, enabling a quicker return to play, work or duty.

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New research will target earliest stages of bone marrow cancer

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

A new programme, funded by Cancer Research UK and led by BHP founder-member the University of Birmingham, has set out to attempt to eradicate a major and incurable bone marrow cancer.

An interdisciplinary team of researchers will investigate the underpinning biology of the very early stages myeloma, a cancer that develops from plasma cells – a type of white blood cell – made in the bone marrow. This is game changing research because the early stage, called MGUS, is common and only an unpredictable minority of cases go on to develop the killer disease of myeloma.

MGUS patients have non-cancerous expansion of immune cells in their bone marrow. In most patients this will be stable for many years and will never cause significant harm. The problem is that, in some patients, the cells will become more aggressive and cause full-blown cancer.

For decades it has not been possible to sufficiently tell these two types of patients apart. Until now this challenge has been considered insurmountable resulting in all cases of myeloma being diagnosed very late. However, thanks to the funding by Cancer Research UK it is time to make a change. Using biological and bioinformatic research the team aim to devise ways of accurately predicting which patients with MGUS are truly at risk of developing life threatening myeloma and those that will not.

With the help of experts in the economic challenges faced by health providers such as the NHS the team will then will design the best possible screening strategies to detect the disease and the quickest possible route to clinical trials of ways to prevent myeloma occurring.

Lead researcher Chris Bunce is Professor of Translational Cancer Biology, in the School of Biosciences at the University of Birmingham. He said: “Despite decades of academic and pharmaceutical company research, costing eye watering amounts of money and human endeavour, a cure for myeloma remains elusive.

“All myeloma cases, however, arise from an easily diagnosed pre-condition that remains virtually ignored by researchers. This funding from Cancer Research UK reverses that stance and turns the focus onto the very early stages of myeloma with a view to stopping the disease in its tracks.”

The research aims to provide a deeper understanding of how specific chemicals in the blood change as patients transition from MGUS towards developing myeloma. These changes – first identified by researchers at the University of Birmingham – could help distinguish ‘high risk’ MGUS from ‘low risk’ MGUS, as well as helping to identify potential drug targets for treatment.

Mark Drayson, Professor of Clinical Immunodiagnostics in the University’s Institute of Immunology and Immunotherapy, and co-lead research for the project, said: “By bringing together different approaches and expertise we aim to overcome the existing barriers to developing an effective test for stratifying risk of progression from MGUS to myeloma that is recognised as both affordable and effective.”

Dr Marianne Baker, Science Engagement Manager at Cancer Research UK, said: “To beat cancers that are often diagnosed late, like myeloma, we need to understand the earliest stages of its development – the underlying biology of the disease. This is a historically underfunded area, so we’re excited to see what the project brings; the more our researchers discover, the less room cancer has to manoeuvre. It’s vital we translate results into innovations, like tests that can predict risk, and give treatment the best chance of success.”

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