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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 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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University of Birmingham awarded £7m NIHR funding to provide strategic leadership for its Research Support Service

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

The NIHR has selected BHP founder-member the University of Birmingham to run the National Collaborative for its Research Support Service (RSS) from 1 February 2024. 

The RSS was launched on 1 October 2023. The service provides expert research design, methodological support, advice, and collaboration to all researchers in England throughout the pre- and post-application/research process, regardless of geographic location and research interest. 

Since launch, the service has received more than 840 requests for support from researchers through its 8 hubs. The specialist centres in social care and public health have received a combined total of 171 requests for support.   

The new function

The new RSS National Collaborative will be run by the University of Birmingham. The university has demonstrated a clear commitment to work with all NIHR RSS hubs through collaboration. 

Among other responsibilities, the new function will:

  • provide strategic and operational leadership across the 8 individual NIHR RSS hubs
  • develop collaborative working with other components of the NIHR’s infrastructure. This includes the NIHR Clinical Research Network and incoming Research Delivery Network, in particular around the deliverability of studies within the chosen setting
  • identify, develop and share standards of good practice. The function will support their implementation, and provide the highest quality resources to support the development and delivery of health and care research
  • support Research Inclusion, and Patient and Public Involvement, Engagement and Participation in the hubs, to encourage a coordinated national approach

The aim of the new function is to enable the 8 hubs to provide consistency of service across the RSS. It will supply a core team, with dedicated senior academic, clinical and operational leadership. 

Professor Marian Knight, NIHR Scientific Director for Research Infrastructure, said: “The National Collaborative is critical to the successful delivery of the new Research Support Service, which since October has been providing expert advice and support to researchers across England. By leading the Collaborative, the University of Birmingham will work with the other RSS Hubs to ensure all researchers across England are provided with the tailored support they need and to develop an environment of continuous improvement across the service.”

Neil Thomas, Professor of Epidemiology and Research Methods, Operations Director of the RSS National Collaborative, said: “I am looking forward to leading this exciting collaboration alongside Professor Katie Morris, Director of the Birmingham Clinical Trials Unit, who is our Academic and Clinical Lead. We look forward to working with all 8 RSS Hubs and Specialist Centres, the NIHR and the wider research community in developing and delivering health and care research. Our vision of collaboration is wide ranging and we have ambitious plans to build capacity in our workforce and public contributors, contribute to the development of inclusive and innovative research methodologies, as well as harmonise systems across our service.”

Find out more about the Research Support Service.

LIBERATE heart attack trial treats first patient

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Experimental medicine.

The first patient has been treated in the LIBERATE clinical study to evaluate glenzocimab efficacy in myocardial infarction, which involves BHP members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust (UHB).

In 2022, the University  signed a partnership agreement with Acticor Biotech to evaluate glenzocimab efficacy in myocardial infarction in a new clinical trial called LIBERATE.

Having obtained full regulatory approval in August 2023, two clinical research sites, the Queen Elizabeth Hospital in Birmingham – part of UHB – and the Northern General Hospital in Sheffield, are involved in the study. The Queen Elizabeth Hospital opened to recruitment on 24th January 2024. It is expected that the Northern General Hospital in Sheffield will also open to recruitment by the end of February 2024.

The LIBERATE study, a randomiSed, double-blind Phase 2b trial, will enrol over 200 patients diagnosed with ST-elevation myocardial infarction (STEMI) and scheduled for percutaneous coronary intervention. The primary objective of the study is to evaluate both the safety and efficacy of glenzocimab at a dosage of 1000 mg compared to a placebo, specifically focusing on the reduction of myocardial infarct size at Day 90 post-treatment.

Professor Jon Townend, Chief Investigator of the trial who works across BHP members the University of Birmingham and UHB as Consultant Cardiologist and Honorary Professor of Cardiology, said: “We have entered the operational phase of the trial, and I extend my gratitude to the entire team in Birmingham and Sheffield for their outstanding efforts in managing patient recruitment in these critical emergency care settings, as well as for gathering qualitative data for subsequent analysis.”

Dr Mark Thomas, Associate Professor of Cardiology at the University of Birmingham and Honorary Consultant Cardiologist, who designed the trial and led its development, said: “This is the first time worldwide that this class of medication has been investigated in patients with heart attacks, after showing great promise in patients with stroke. We are grateful to our patients for helping us in our mission to find new treatments that may help to reduce the damage done by heart attacks.”

Professor Robert Storey, Professor of Cardiology at the University of Sheffield and Honorary Consultant Cardiologist and Director of the Cardiovascular Research Unit at Northern General Hospital, said: “This study is exploring the potential of glenzocimab in reducing the type of blood clotting responsible for heart damage during heart attacks. This exciting collaboration with University of Birmingham and Acticor Biotech holds the potential to bring significant benefit to people suffering from a heart attack.”

Adeline Meilhoc, Head of Global Clinical Development of Acticor Biotech said: “We are delighted to witness the operational start of the study, and we reiterate our complete confidence in our partners as crucial contributors of its success. Acticor Biotech is dedicated to advancing treatments for the acute phase of thrombotic diseases. Glenzocimab application in ST-segment elevation myocardial infarction (STEMI) represents a significant focal point for Acticor Biotech’s commitment to medical advancement.”

Aston University launches SPARK The Midlands to support health tech innovation

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

Aston University, a member of BHP, has launched SPARK The Midlands, a network which aims to bridge the gap between medical research discoveries of novel therapeutics, medical devices and diagnostics, and real-world clinical use.

SPARK The Midlands is the first UK branch of Stanford University’s prestigious global SPARK programme. It comes as a result of Aston University’s active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA) – a government-funded project aimed at helping companies drive their innovations towards market success.

The SPARK scheme helps to provide mentorship and forge networks between researchers, those with technical and specialist knowledge and potential sources of funding. SPARK members have access to workshops led by industry experts, covering topics such as medical device regulations, establishing good clinical trials, and creating an enticing target product profile to engage future funders.

While SPARK The Midlands will be based at Aston University, it will support multiple projects across the West Midlands from other BHP members including the University of Birmingham (UoB), Birmingham Women’s and Children’s Hospitals NHS Foundation Trust (BWC), as well as other regional institutions including Warwick University. It is also supporting a number of regional companies.

12 projects have been funded as part of cohort one, including a cross-BHP initiative involving Aston, UoB and BWC. Led by Dr Jan Novak from Aston’s School of Psychology,  the project will develop a device to categorise paediatric brain tumours using artificial intelligence (AI) and machine learning. Based on 24 years of data, the device will be able to help determine what type of brain tumour a patient has and what surgical approach to take.

Aston University researchers are involved in a further four projects within cohort one of SPARK The Midlands.

Luke Southan, SPARK UK director, said: “It is a privilege to be launching the first UK SPARK cohort here in the West Midlands. We have a real opportunity here to support not only new, transformative, standards of care for areas of genuine unmet clinical need, but also to support the growth of a major innovation cluster for the region.”

Pasi Sorvisto, founder and director of SPARK Finland and director of SPARK Europe, said: “We are truly excited to have a SPARK programme in the UK. SPARK The Midlands is a perfect example of what coming together enables in the region.

“The beauty of our European network is that we have come together in supporting scientists, students and healthcare professionals in developing great new solutions and businesses. We share experiences of what works and what doesn’t, we provide joint webinars and mentoring, we have joint events, and we support each other in building new solutions and businesses to global markets. “Together” is maybe the most common word in discussions at European SPARK network. Since we have a global network of SPARK programmes associated with top-tier institutions, each and every project in Europe has opportunities to build high value connections through our global network.”

SPARK The Midlands will host its first educational workshop on Tuesday 13 February at 15:00 GMT. It will be a hybrid event, hosted at Aston University’s John Cadbury House, and online. It is open to anyone interested in developing a therapeutic, medical device or diagnostic for public use, including academics, researchers, scientists, healthcare professionals, and postgraduate students. For more information and tickets visit the Eventbrite page.

For more information about SPARK The Midlands, visit https://www.sparkthemidlands.co.uk/