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.

Advanced Therapies Skills Training Network comes to Birmingham

Written by Louise Stanley on 28/06/2021. Posted in Experimental medicine.

The University of Birmingham has been confirmed as the third National Training Centre in the Advanced Therapies Skills Training Network (ATSTN) initiative.

The initiative is designed to develop and deliver specific practical skills to address the growing need in the UK for skills in vaccine and advanced therapy medicinal product (ATMP) manufacturing.

As one of the three initial National Training Centres, BHP founder-member the University of Birmingham will deliver advanced technology courses on-site in collaboration with local companies and institutions to provide training complementary to the ATSTN initiative. These include modules on ATMP manufacturing design and clinical adoption, as well as documentation and implementation of ATMPs, which will be delivered as a combination of on-site, online learning and virtual reality modules.

The first courses will be launched in September 2021 and will cover the fundamental aspects of ATMPs and Good Manufacturing Practice (GMP). The University of Birmingham will also offer master’s degree level modules on GMP standards, which are a vital requirement for the authorisation, manufacture, and commercialisation of ATMPs.

Professor Phil Newsome, Director of Research in the College of Medical and Dental Sciences at the University of Birmingham, commented: “We are delighted to provide our leading expertise, playing such a pivotal role in delivering these much-needed skills for the UK’s advanced therapies sector. This collaboration between industry and academia will create a truly world-class offering, ensuring the UK remains at the forefront of the manufacture and delivery of vaccines and advanced therapies. Moreover, it will further strengthen and leverage the rapidly-growing health and life science sector in Birmingham and the Midlands.”

The National Training Centres are a part of the ATSTN initiative, which also includes an online training platform to provide remote learning for those currently working in the vaccine manufacturing and advanced therapy industry, and a ‘career converter’, which maps an individual’s transferrable skills from adjacent sectors into recommended roles for this industry.

The ATSTN, driven by industry and coordinated by the Cell and Gene Therapy Catapult (CGT Catapult), was launched in December 2020 with £4.7m in funding awarded from BEIS. The initiative was designed in collaboration with industry to create opportunities to upskill, through digital and practical on-site courses, current professionals and leverage skills from individuals coming from other sectors.

Matthew Durdy, Chief Executive Officer, Cell and Gene Therapy Catapult, commented: “The UK ATMP industry is expanding rapidly, and to support that tremendous growth the industry needs skilled people. The UK is making one of the biggest commitments anywhere in the world to training in this sector, keeping it as the “go to” place for the cell and gene therapy industry. As part of the ATSTN programme, the University of Birmingham is well placed to develop and deliver high-impact training courses utilising its world leading delivery technologies”.

Sponsored by the Department for Business, Energy & Industrial Strategy (BEIS), ATSTN’s national training centres includes RoslinCT with its academic partners and the National Horizons Centre.

a mother and daughter select healthy foods from a selection of fruits and grains

Increased risk of chronic kidney disease in people with ‘healthy’ obesity

Written by Louise Stanley on 21/06/2021. Posted in Inflammation and chronic disease.

People with ‘healthy’ obesity have a 66% increased risk of chronic kidney disease compared to metabolically healthy individuals with normal weight, finds a new study led by the University of Birmingham.

Those that are metabolically healthy (do not suffer with metabolic conditions such as hypertension, diabetes, high cholesterol or cardiovascular disease) and are overweight but do not have obesity are at a 30% risk of chronic kidney disease compared to healthy people with normal weight, the study found.

The research also found that the increased risk was greater in those aged under 65, while also the more the number of the metabolic complications a person has the higher risk of chronic kidney disease even in the normal weight range.

The research, published in the American Journal of Kidney Disease, was carried out in collaboration with University Hospitals Birmingham NHS Foundation Trust and the University of Warwick.

The retrospective population-based cohort study examined the GP records of around 4.5 million individuals from the UK and tracked their health over an average of almost five-and-a-half-years. Of the 4.5 million individuals, 1,040,921 (23.4%) and 588,909 (13.2%) were metabolically healthy overweight and metabolically healthy obese, respectively.

Chronic kidney disease has a major impact on global health and cost the UK National Health Service £1.45 billion in 2009-2010. In 2017, 697.5 million people in the world had the disease, and it accounted for 1.2 million deaths. The prevalence of chronic kidney disease increased by almost 30% between 1990 and 2017, while the number of deaths caused by the condition rose by 41.5% in the same period. Similarly, the prevalence of obesity is also on the rise, tripling between 1975 and 2016.

First author Dr Jingya Wang, Research Fellow at the University of Birmingham, said: “Our results demonstrate that individuals with metabolically healthy obesity might have a higher risk of developing chronic kidney disease compared with normal weight individuals, especially those younger than 65 years.

“Looking to the future, a clinical trial of a weight loss intervention could be considered in these individuals to help us establish whether this can reduce their high risk of chronic kidney disease.”

Dr Abd Tahrani, Senior Lecturer in Metabolic Endocrinology and Obesity Medicine at the University of Birmingham, says: “It is likely that weight loss in people with metabolically healthy obesity is likely to reduce their risk of chronic kidney disease as it will also reduce their risk of future type 2 diabetes, and hypertension, both of which can worsen kidney function and result in chronic kidney disease, however this needs to be examined in future trials.

“In addition, we know from previous trials that weight loss in individuals with normal weight can reverse non-alcoholic fatty liver disease for example, hence weight loss could offer an important strategy to prevent obesity complications in this population.”

Dr Krish Nirantharakumar, also of the University of Birmingham, said: “Furthermore, our results suggest that individuals with normal weight who have metabolic abnormalities are also at a higher risk of chronic kidney disease and as such might benefit from meticulous metabolic control to reduce the risk of developing the condition.

“Ultimately, chronic kidney disease is largely preventable, and therefore, it is important to identify and treat the underlying modifiable causes and risk factors.”

This new study follows previous research led by the University of Birmingham and published in 2017 in the Journal of the American College of Cardiology which showed that individuals living with obesity who are metabolically healthy have an increased risk of cardiovascular disease events compared to those who are normal weight without metabolic abnormalities.

Neil Thomas, Professor in Epidemiology and Research Methods at the University of Birmingham, adds: “This new study and our previously published study together demonstrate that individuals who are metabolically healthy can develop organ damage over time.

“Therefore, metabolically healthy obesity should not be considered ‘benign’ or harmless and addressing obesity in metabolically health people might reduce organ damage including chronic kidney disease.”

Young patients with cancer to benefit from £1million investment in genomic testing

Written by Louise Stanley on 11/06/2021. Posted in Cancer outcomes, Early diagnosis and detection, Experimental medicine.

Children and young people living with cancer from across the West Midlands, Oxfordshire and parts of Southern England will now benefit from improved genetic testing, thanks to a seven-figure donation to Birmingham Children’s Hospital Charity from Children with Cancer UK, in partnership with Kwik-Fit.

Home to one of the largest children’s cancer centres in the UK, BHP member Birmingham Children’s Hospital cares for over 200 patients with cancer, leukaemia and brain tumours every year, from the West Midlands and beyond.

Genomic testing for patients diagnosed with cancer is incredibly important and over the last decade, large scale sequencing projects have identified pertinent DNA changes, which have enabled scientists to develop new and improved cancer drugs and treatments to specifically target these variations.

Sequencing all possible DNA changes in a single test gives scientists the best possible chance of detecting the genetic changes driving a child’s cancer; and knowing the genetic makeup of a child or young person’s cancer, or tumour, allows clinicians to offer a more tailored treatment.

Targeted therapies have improved the number and different types of treatment offered to children and young people, aimed at saving more lives and improving the quality of life for patients living with cancer.

The UK’s largest genetics laboratory, the West Midlands Regional Genetics Laboratory, based at BHP member Birmingham Women’s and Children’s NHS Foundation Trust, provides cancer genetic services for patients across the West Midlands, Oxfordshire and parts of Southern England, covering a population of 12million.

Now a donation of just over £1million to Birmingham Children’s Hospital Charity has allowed the laboratory to purchase a high-throughput next generation sequencing platform. This investment is possible thanks to the incredible fundraising efforts of Kwik-Fit’s staff, customers and suppliers who raised the substantial sum after Kwik-Fit employees chose Children with Cancer UK as the company’s national charity partner.

The NovaSeq 6000 is a state-of-the-art piece of DNA sequencing equipment which has enabled the rapid expansion of cancer genetic testing at the West Midlands Regional Genetics Laboratory.

Initial forecasts provided by NHS England and NHS Trusts across the West Midlands, Oxfordshire and parts of Southern England suggest that approximately 560 children and young people per year could benefit from large cancer panel genetic testing following the installation of the NovaSeq.

The significant gift also allowed for the refurbishment of the laboratory in which the NovaSeq will sit.

The Chairman of Birmingham Women’s and Children’s NHS Foundation Trust and its Charity, Professor Sir Bruce Keogh, former Medical Director of the NHS in England, said: “The NovaSeq 6000 has dramatically enhanced our ability to identify diagnostic and prognostic biomarkers for childhood and young people’s cancers, thereby enabling our expert scientists and doctors to quickly optimise and develop more effective and less toxic treatments for children and young people with cancer.

“We’re incredibly thankful to Children with Cancer UK and all the employees at Kwik-Fit for enabling us to expand our cancer genetic testing capability in this way. It really will make a difference to thousands of families living with a cancer diagnosis.”

Children with Cancer UK, the charity dedicated to the fight against childhood cancer, is a long-term supporter of Birmingham Children’s Hospital and is making its second £1million donation to the hospital’s charity. The first helped ensure the opening of a brand new Children’s Cancer Centre in 2018.

Children with Cancer UK Trustee, Nick Goulden, said: “We are delighted the new NovaSeq 6000 has been installed at the West Midlands Regional Genetics Laboratory, ready to serve its young cancer patients across the region. By offering personalised treatments through genetic sequencing, it’s another step towards our ultimate goal of saving the life of every child and young person diagnosed with cancer.

“We are also incredibly grateful for our year-long partnership with Kwik-Fit who shared this vision with us. Through their innovative and dedicated fundraising, Kwik-Fit employees raised £1million to make all of this possible and the legacy of our relationship will benefit the lives of thousands of children and young people in the future.“

Kwik-Fit’s partnership with Children with Cancer UK, which took place before the pandemic, saw its staff participate in events such as the Virgin Money London Marathon and the Simplyhealth Great North Run. It also organised various fundraising activities including bake sales, static bike challenges, car washes and sponsored walks. In addition, staff swapped cars for cycles as part of the company’s first-ever ‘Tour De Branch’ – a nationwide bike ride in which over 80 employees covered 2,500 miles between 120 Kwik-Fit centres.

Mark Slade, managing director of Kwik-Fit, said: “We were delighted to hit our fundraising target of £1million which has enabled Birmingham Children’s Hospital Charity to invest in such an important piece of equipment.

“I would like to congratulate and thank all of the Kwik-Fit staff for their tremendous effort and dedication and all our customers and partners who supported us – we would not have been able to achieve this target without them. We hope that this vital testing equipment will make a massive difference to the outcome for many families in the future.”

Better treatment for miscarriage patients is also more cost effective

Written by Louise Stanley on 13/05/2021. Posted in Clinical trials, Maternal health.

A new drug combination that is better at treating miscarriage is also more cost effective than current standard NHS treatment, finds a new study led by BHP founder-member the University of Birmingham and Tommy’s National Centre for Miscarriage Research.

A previous study by the same team and published in The Lancet in August last year, found that a combined drug treatment is more effective than the standard medication for women having miscarriages without symptoms – also known as missed, delayed or silent miscarriage.

Missed miscarriage occurs when a baby has died in the womb but the mother hasn’t had symptoms, such as bleeding or pain. Current hospital restrictions on surgery mean that many women face waiting for the miscarriage to happen by itself, which can take weeks and still might not happen, or being offered medication to speed the process along.

National guidelines recommend a treatment called misoprostol, which is successful in most cases – but some women wait anxiously for weeks, repeating the medication and eventually needing surgery.

The research published in The Lancet in August 2020 showed that misoprostol is more effective when combined with mifepristone, an anti-progesterone drug used to induce labour. The trial found that the combined drug treatment worked in 83% of cases, compared to 76% in the misoprostol and placebo group – and crucially, it reduced the need for surgery. One in four women (25%) given the placebo later needed an operation to complete the miscarriage, compared with less than one in five (18%) of those who had the new medication.

Now the team has carried out a further study to assess the cost-effectiveness of mifepristone and misoprostol combined compared with misoprostol alone for the medical management of a missed miscarriage.

The National Institute for Health Research (NIHR) funded study involved 711 women across 28 UK hospitals with a diagnosis of missed miscarriage in the first 14 weeks of pregnancy, who were randomly assigned to receive either mifepristone or a placebo drug followed by misoprostol two days later.

Published in the British Journal of Obstetrics and Gynaecology, the study found the new combined drug treatment was on average £182 cheaper for each successfully managed miscarriage than the current standard NHS medication.

As this is the largest ever study into the most effective medical treatment for missed miscarriage, and the results are so clear, researchers and campaigners are calling for guidance from the National Institute for Health and Care Excellence (NICE) to be updated in light of the newly published findings. In the meantime, Tommy’s experts encourage anyone diagnosed with missed miscarriage to ask their doctor about the combined drug treatment.

Senior author Tracy Roberts, Professor of Health Economics at the University of Birmingham, said: “Pregnancy loss causes heartbreak for millions of families, and it is crucial that we find better ways to care for everyone going through miscarriage. Our findings could have huge benefits if they’re translated into clinical practice, with better outcomes for patients and lower costs for care services.”

First author Dr Duby Okeke Ogwulu, of the University of Birmingham’s Institute of Applied Health Research, added: “We hope the NICE guidance will be updated in light of this new evidence, so that everyone who needs it has access to the most effective treatment.”

Tommy’s CEO Jane Brewin commented: “Besides the physical harm, miscarriage can have serious psychological consequences, which can be made worse by the trauma of a failed treatment forcing mothers to endure weeks of carrying a baby they know has died.

“One in four pregnancies ends in loss, and while our researchers work to understand how we can prevent this, it’s vital their latest findings are put into practice so that everyone going through miscarriage has the best possible care. Particularly given Covid-19 pressures on the NHS, our new study could be applied to make better use of precious resources, as well as reducing the toll miscarriage can take on parents.”

An estimated 23 million miscarriages occur every year worldwide – equating to 44 pregnancy losses each minute. Miscarriage (defined as the loss of a pregnancy before 24 weeks) costs the UK at least £471 million a year, through direct impact on health services and lost productivity, but scientists expect the costs surpass £1 billion a year when factoring in longer-term physical and mental health impacts.

Claire Bromley, aged 32, from Sittingbourne in Kent, chose surgery when she had a miscarriage last year, as her previous experience when medication failed was so distressing.

Claire said: “The whole process took around 3 months and was extremely traumatic, so I hope this new drug will mean others don’t have to suffer like I did. I was told medication would take a few hours to work, but started bleeding and cramping in minutes, while stuck in hospital waiting for other prescriptions. Despite taking effect so fast, the medication didn’t work, so I was sent for surgery – and when that failed too, I had to take the pills again. With my second miscarriage, I chose surgery right away to avoid the risk of repeating such a long and painful treatment.”

Katy Allan, aged 43, from South Yorkshire has experienced multiple miscarriages and a range of treatment, initially having surgery that caused internal scarring and later choosing medication in the hope it would cause less damage.

Katy said: “The treatment for my third miscarriage was a four-month long nightmare, with several rounds of medication and hospital staff trying to physically remove the pregnancy while I was awake, ending in painful surgery; it was one of the most horrendous experiences of my life and I remain completely traumatised. I couldn’t move on physically or mentally because I was pregnant and not pregnant for months, with tests remaining positive and hormones still racing long after we heard those spine-shivering words of ‘I am so sorry but there is no heartbeat’. The long ordeal of treatment made miscarriage even harder so I hope this new research can help to prevent others from going through what I did.”

Revolutionising diagnosis and treatment of life-threatening post-partum haemorrhage

Written by Louise Stanley on 12/05/2021. Posted in Early diagnosis and detection, Maternal health.

Post-partum haemorrhage (PPH) accounts for 27% of all maternal deaths worldwide, according to the World Health Organization (WHO). The burden of PPH disproportionately affects mothers from low- and middle-income countries, which account for 86% of all maternal deaths.

PPH is defined as blood loss from the genital tract of 500 ml or more within 24 hours of birth. PPH usually happens within a day of giving birth, but it can occur up to six weeks after a birth.

To find possible solutions to the terrible problem of PPH, researchers at BHP founder-member the University of Birmingham are conducting the E-MOTIVE trial based on the WHO ‘first response bundle’ in five countries: Kenya, Sri Lanka, South Africa, Tanzania and Nigeria.

Kristie-Marie Mammoliti, one of the lead researchers for the University of Birmingham explained the thinking behind the trial: “Surviving childbirth shouldn’t be a privilege; it should be the norm. Tragically this is not the case for so many women around the world. As PPH is the leading cause of maternal mortality globally, we are working together with our low– and middle-income country partners to find solutions to stop women from bleeding to death after childbirth.”

Professor Hadiza Galadanci, from one of the University’s partners in Nigeria, commented: “One of the most frightening sights in Obstetrics is to see blood pouring from a woman after birth and to try all you can to stop it and you are not able to. If E-MOTIVE strategy is implemented in low- and middle-income countries, the light at the end of the tunnel to reducing maternal deaths due to PPH will be bright.”

The E-MOTIVE trial has the potential to revolutionise how medical institutions diagnose and treat PPH, and remove it from the list of life-threatening conditions facing pregnant women.

As we approach International Mother’s Day on Sunday 9 May, it is important for everyone to care and be aware of the risks that women across the world face when bringing life into the world, and how these risks can be reduced.

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.

Bayer to invest in childhood cancer trial at the University of Birmingham

Written by Louise Stanley on 10/05/2021. Posted in Cancer outcomes, Clinical trials.

Significant funding from Bayer, a global enterprise with core competencies in the life science fields of healthcare and nutrition, is enabling the University of Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU) to deliver a new study arm of an international clinical trial which aims to identify more effective treatments for a rare type of childhood cancer.

Rhabdomyosarcoma is a soft tissue cancer which usually forms in skeletal muscle tissue and hollow organs including the bladder and uterus. Despite survival rates for the first occurrence of disease increasing from 25% in 1970 to more than 70% today, around a third of patients will relapse at least once which further increases their risk of dying, as treatment options after relapse are currently limited and innovative new drugs for this disease have been lacking.

The funding will support evaluation of regorafenib, an oral cancer therapy from Bayer, in relapsed rhabdomyosarcoma patients, aiming to determine whether this drug combined with standard treatment can improve survival rates, reduce the chance of relapse and improve long-term quality of life for patients. The product from Bayer is already approved as a monotherapy across certain forms of colorectal cancer, gastrointestinal stromal tumours, and hepatocellular carcinoma, and will now be investigated in this rare paediatric indication. The study will also explore biomarkers to evaluate whether they can be used to predict relapse and improve prognosis. The new study arm is one part of the international multi-arm, multi-stage Frontline and Relapse RhabdoMyosarcoma (FaR-RMS) clinical trial, which is already underway at the University of Birmingham, funded by Cancer Research UK.

Dr. Scott Z. Fields, Head of Oncology Development at Bayer commented: “Bayer is committed to developing new cancer treatments for which there is a great medical need, such as for paediatric cancer patients. We are pleased to be a partner on this important study supported by academic experts at the University of Birmingham and the European Paediatric Soft-Tissue Sarcoma Group, and are looking forward to the next steps of this trial and the benefits it could bring in the future for patients.”

Professor Pamela Kearns, Director of the CRCTU at BHP founder member the University of Birmingham, explained: “This new partnership with Bayer highlights our world-leading strengths in paediatric cancers and the excellence of our industry trials work at the University of Birmingham, and further evidences our strengthening capabilities with the forthcoming Birmingham Health Innovation Campus and its Birmingham Precision Medicine Centr e (BPMC) Industry Trials Hub.

“Our internationally-leading expertise in complex clinical trial delivery will inform this trial throughout as we seek to validate more effective treatments to enable children with rhabdomyosarcoma to return to remission and lead longer, healthier lives.”

Life Sciences Minister Nadim Zahawi said: “Birmingham is poised to be one of the UK’s powerhouses for innovation and it’s why the government recently designated it a Life Sciences Opportunity Zone – helping to capitalise on its expertise and attract inward investment from leading pharmaceutical and life sciences businesses.

“Today’s multi-million funding from Bayer is evidence of this thriving innovation ecosystem in action, and will enable the University of Birmingham to carry out a ground-breaking clinical trial to help accelerate treatments for children with cancer and improve their quality of life, all while cementing the UK’s status a global leader in life sciences.”

Michelle Mitchell, chief executive of Cancer Research UK, said: “We know that despite more children and young people surviving cancer than ever before, there is more that needs to be done as cancer still represents the leading cause of death by disease for this age group.

“It’s fantastic to hear that Bayer is investing in the FaR-RMS trial to help improve the lives of children and young people with this kind of rare cancer. It’s a testament to the strength of charity-funded research to be able attract this kind of high-level investment to the UK, which helps fuel innovations required to bring much needed new treatments to patients.”

Professor Meriel Jenney, Deputy Medical Director at Cardiff and Vale University Health Board, is Chief Investigator of the Far-RMS trial. She commented: “We strongly welcome this partnership with Bayer. The FaR-RMS trial is designed to facilitate the efficient testing of new drug combinations for the highest risk patients with rhabdomyosarcoma across Europe and beyond, through its multi-arm, multistage approach. This exciting partnership is the first of what we hope may be several partnerships to bring targeted agents into the FaR-RMS trial. The focus on biomarkers alongside the clinical data will also help us to understand better which patients with rhabdomyosarcoma respond to treatment and to find new, smarter ways of assessing that response.”

Richard Torbett, Chief Executive of the ABPI said: “We are delighted to see Birmingham leading valuable research to find new cancer medicines for children, and industry investing in the West Midlands. Our work with Birmingham Health Partners is to connect industry with Birmingham’s extraordinary life sciences capabilities to tackle global health challenges, and today’s announcement is exactly what we want to see.

“Partnerships like this between academia, companies and the NHS lead to amazing breakthroughs which benefit people not just in the West Midlands but across the UK and the world.”

The BPMC Industry Trials Hub offers comprehensive design of trials which are conducted to industry standard as well as critical trial data, curated to provide a ‘fit for filing’ package which offers accelerated progress to clinical adoption. BPMC will be part of the Birmingham Health Innovation Campus – the only science park in the region dedicated to health and life sciences, creating opportunities for transformative collaborations between the NHS, academia and industry partners.