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Author: Louise Stanley

Birmingham teenager first in UK to receive groundbreaking diabetes treatment

A young patient identified by the ELSA study as having early stages of Type 1 Diabetes, has received treatment to delay the condition.

Sam, aged 14 and from Kings Norton, was the first to receive the new drug, Teplizumab, at the Clinical Research Facility at Birmingham Children’s Hospital.

Sam’s dad, Chris, has Type 1 diabetes and knowing that family members are more likely to develop the disease, Sam was screened for early stages of the condition and learnt he would develop Type 1 Diabetes. However, there was good news for the family when Sam was offered Teplizumab, a new treatment to delay the onset of the chronic illness. Past trials have proven that Teplizumab delays insulin-dependent diabetes for up to three years.

Sam’s mum, Louise, explained: “I know from Sam’s dad just how stressful life with Type 1 Diabetes is, having to constantly monitor your blood sugar and carry insulin with you at all times. We’re so happy that Sam doesn’t have to worry about his blood sugar yet, especially while he is doing his GCSEs. He can just be a normal teenager.”

Teplizumab is prescribed on a case-by-case basis for children who have been recently diagnosed with type 1 diabetes and are at early stages.

Dr Renuka Dias, a researcher from University of Birmingham’s Department of Applied Health Sciences and Consultant Paediatric Endocrinologist working at Birmingham Women’s and Children’s Hospital, said: “Being able to delay insulin-dependent diabetes will have a huge impact on a child’s life. It means we are letting children have a normal childhood for much longer.”

Dr Dias and her specialist team at the Clinical Research Centre who were involved in Sam’s care have also been integral to a first-of-its-kind study, led by the University of Birmingham, to screen children aged 3 to 13 to find out their risk of developing type 1 diabetes. The study aims to allow treatment to begin sooner and, as in Sam’s case, delay the start of the condition.

The ELSA study has screened over 20,000 children in the UK for Type 1 Diabetes in the last two years. The study is now scaling up throughout Europe.

Unfortunately, it often takes a child becoming seriously unwell for a diagnosis of Type1 Diabetes to be made. Through the study, families identified with a child who is at-risk can begin educating themselves about the condition and learning about the options for management before they find themselves in that crisis situation.

Support and education has been made available to study participants. In addition, some children, like Sam, will be eligible to explore treatment options that could delay the onset of the condition.

Parth Narendran, Professor of Diabetes Medicine at the University of Birmingham and lead for the Type 1 Diabetes clinical service at the Queen Elizabeth Hospital Birmingham (QEHB), said: “We hope that the ELSA study will lead to the roll-out of Type 1 Diabetes early detection programme for children in the UK and that many more children could then benefit from potential treatments to delay Type 1 Diabetes in future.”

Birmingham Women’s and Children’s Hospitals, the University of Birmingham, and University Hospitals Birmingham – which operates QEHB – are founder-members of Birmingham Health Partners. Fellow BHP members Birmingham Community Healthcare NHS Foundation Trust is an ELSA Study partner.

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New UK network to strengthen regulatory environment for advanced therapies

A new network has been established to foster collaboration among regulators, industry, and researchers to ensure there is a world-leading regulatory environment in the UK for advanced therapies that supports companies in the development, trial, and launch of these innovative treatments.

The network has been established by the Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of the cell and gene therapy industry, and the Birmingham Health Partners Centre for Regulatory Science and Innovation (CRSI), funded by Innovate UK and support from the MHRA.

The effective regulation of advanced therapies is vital to ensure that patients can access these transformative treatments promptly, to prepare the healthcare sector for the large-scale deployment of these therapies, and to ensure patient safety.

To help achieve this, the network will work with the UK regulators, predominately the MHRA, to identify effective and efficient regulatory strategies that address the unique challenges of these therapies. By sharing its recommendations with therapy developers and regulatory and healthcare stakeholders, it will support the UK to build a first-in-class regulatory ecosystem that welcomes and encourages healthcare innovation. This aims to enable the timely development of, and improved access to, safe and effective advanced therapies.

The network is one of seven new Centres of Excellence in Regulatory Science and Innovation established by Innovate UK to help shape the development and approval of medical innovations in the UK.

Matthew Durdy, Chief Executive of the CGT Catapult, said: “Advanced therapies are both an opportunity for patients and an opportunity for the UK. This initiative is part of a drive to keep the UK as a leader in this field.”

Melanie Calvert, Deputy Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient Reported Outcomes Research, Professor of Outcomes Methodology at the University of Birmingham, NIHR Senior Investigator and co-lead of the NIHR Birmingham Biomedical Research Centre’s Patient Reported Outcomes research theme, said: “As the number of advanced therapies requiring regulatory approval increases, it is essential that regulatory frameworks are developed that are fit-for-purpose. Our focus at Birmingham is understanding how the patient voice can help shape regulatory decision making and ensuring that we understand the risks and benefits of treatment from the patient perspective. I am excited to leverage our extensive expertise in the field and work with our partners to provide patients with timely access to transformative treatments.”

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Karen Crowdy and Linda Everard named first BHP People award winners

The BHP People award is a new reward and recognition scheme from Birmingham Health Partners, designed to shine a spotlight on our colleagues who play a vital role in the success of clinical trials and research studies, and whose work is integral to groundbreaking scientific endeavours.

By championing individuals including research nurses, statisticians, pharmacists and many others, BHP People also highlights the incredible diversity of careers in research and the essential contributions that these professionals make. As well as celebrating individual excellence, the initiative reflects the shared dedication of our diverse partner organisations to driving collaborative research.

The inaugural BHP People award winners are:

  • Dr Karen Crowdy, Director of Research Strategy and Operations at the Aston Institute of Health and Neurodevelopment (IHN). Karen has been recognised for her outstanding contributions to research delivery, collaboration, training, and culture, as well as her transformative impact on IHN’s growth and success.
  • Linda Everard, R&D Implementation and Performance Manager at Birmingham and Solihull Mental Health NHS Foundation Trust. With a passion for mental health research and service improvement, Linda has been recognised for ensuring that as many service users as possible have access to clinical trials and high-quality research.

Nominating Karen, Aston University’s Professor Claire Farrow, Deputy Dean Research and Enterprise in the College of Health and Life Sciences, said: “As a result of Karen’s work the Institute of Health and Neurodevelopment is thriving. She supports academics to deliver a programme of pioneering research into paediatric conditions such as epilepsy, child brain tumours, and neuro-immunological diseases, leading to the development of personalised interventions that will make a difference to health care professionals, families and children.

“Much of the research that she supports also tackles critical health challenges in the Birmingham area, including respiratory health, child obesity, and diabetes, ensuring research has a direct impact on health inequalities.”

Beyond her strategic influence, Karen understands what makes a great research culture and has spearheaded multiple initiatives to bring together researchers, support early-career researchers, negotiate cotutelle agreements, and stimulate research collaboration and discussion.

Professor Farrow added: “Karen’s creativity combined with exceptional organisation and drive have positioned IHN as a leader in advancing personalised interventions and evidence-based healthcare solutions for children and families. She is a very worthy winner of this award, exemplifying the core values of the BHP People scheme.”

We sat down with Karen to find out a little more about her career journey to date, and how vital cross-organisational collaboration is to research in Birmingham – read her story here: “BHP People – find your niche.

Linda was nominated by BSMHFT’s Head of Research and Development, Emma Patterson, who said: “Without Linda, we quite simply would not be able to run clinical trials. She leads a highly skilled, enthusiastic and motivated team and provides them with opportunities to expand their knowledge and skills by developing their own research.

“She plays a crucial role in training and mentoring the next generation of investigators, supporting new PIs as they take on NIHR portfolio trials and guiding them toward becoming future Chief Investigators. Thanks to her dedication, our research portfolio continues to grow, reaching new clinical areas and broadening opportunities for both staff and service users.

“Beyond her operational impact, Linda is deeply committed to making high-quality research accessible to as many service users as possible. As a co-founder of the Trust’s Lived Experience Action Research (LEAR) Group, she has helped ensure that service users are involved at every stage of research development and delivery. She continues to drive innovation by establishing research champions and engaging underrepresented communities, making her an invaluable force in the advancement of mental health research.”

We met with Linda to find out a little more about her journey from clinical psychology to research delivery, and how she is embedding a culture of research at BSMHFT. Read her story here: BHP People – research is everyone’s business.

The BHP People award will be presented quarterly, focusing on a different pair of member organisations each time.

BHP People – “research is everyone’s business”

Linda Everard, R&D Implementation and Performance Manager at BSMHFT, is one of the is one of the inaugural recipients of the new BHP People Award.

We met with Linda to find out a little more about her journey from clinical psychology to research delivery, and how she is embedding a culture of research in BSMHFT.

Q: Can you briefly run us through your career so far and how you came to work at BSMHFT?

LE: I originally planned to go down the clinical psychology route after completing my undergraduate degree in psychology. I worked in assistant psychologist roles within learning disabilities, CAMHS, and early psychosis, and that’s how I first joined this trust, working half in research and half in a clinical role within psychosis services.

I absolutely loved the research element, and when my boss at the time asked if I wanted to get more involved, I thought, “Why not?” That led me to a research coordinator post in early intervention services, which then developed into programme management. I first managed the DHSC-funded National EDEN Study, and then the NIHR-funded Super EDEN programme in psychosis, which was a turning point for me. Seeing the bigger changes happening in services—sometimes without individuals or even staff realising—made me rethink my career path. I realised I wanted to stay in research rather than pursue clinical psychology.

From there, I moved into programme grant management, and when that project ended, a role came up in R&D managing the delivery team. I got the post in 2015, and now, as Implementation and Performance Manager, I oversee the delivery and governance teams within the R&D department. I absolutely love what I do. It’s incredibly rewarding to see the impact research can have on shaping services and improving care.

Q: What do you think is they key to successfully engaging service users and communities in mental health research?

LE: It can be challenging compared to primary care, where recruitment seems that little bit easier. The key is building strong relationships and trust – not just with service users, but also with our clinical teams who play such a crucial role in connecting us with the right populations.

A lot of our current efforts focus on outreach, particularly within harder to reach communities who perhaps haven’t been involved in any kind of research before. The trust runs engagement events across the patch, and we always make sure the R&D team has a stand and a visible presence at these, providing information and making connections. Transparency and openness are essential, and we actively create spaces for conversation, such as our Lived Experience Action Research (LEAR) Group. This group, made up of service users and carers with an interest in research, helps to promote participation across different settings. Their involvement is invaluable in strengthening engagement and ensuring research is accessible and meaningful to those who need it most.

Q: What role do you see clinical trials playing in advancing mental health care, and how can we ensure they are accessible to diverse groups?

LE: Clinical trials are essential for improving mental health care, but ensuring diverse participation is a challenge we need to address. Something I really want to take forward in the coming years is strengthening engagement with community leaders, whether that’s religious leaders or other trusted figures, because historically this is where we’ve fallen short.

We have an incredibly diverse population here in Birmingham and Solihull, yet many groups aren’t represented well in studies. Some trials, looking at psychosis and schizophrenia in particular, would really benefit from greater diversity and this would lead to more meaningful and applicable findings. To achieve this, we need to enhance our outreach efforts, both within communities and through stronger collaboration with clinical teams.

One positive shift has been the increasing diversity within our own workforce due to expanding our team. Our department is made up of passionate individuals from a variety of backgrounds, cultures and experiences, creating a rich blend of perspectives, skills and ideas. This in turn has allowed us to better understand and address the needs and perspectives of the different populations we serve and will be key to continuing to attract a broader group of participants into clinical research.

Q: Can you talk to us a little more about the research champions you are establishing – what will their role be and what impact do you expect them to have?

LE: We’re still in the early stages, but the goal is to establish two groups of research champions: staff and patients. We want to build a network of people with a genuine interest in research who can act as connectors on the ground. Staff research champions will bring together individuals from different teams to support studies, while patient champions will help recruit participants from various groups and communities.

It’s also about nurturing the researchers of the future. Many doctors coming through need to complete research but have very limited time. By involving them in the research champion programme, we can get them trained, give them a taste of research and recruiting, and show them firsthand how research impacts people’s lives. I think research can be seen as an ‘extra’ rather than an integral part of healthcare, and we want to change that.

Ultimately, we want to embed research into the culture of the trust so that it becomes part of everyday practice, and effectively “everyone’s business”, rather than something only the R&D department handles. There’s still a long way to go, but that’s what makes this job so exciting—there’s always more to be done to drive research forward and make it accessible to everyone.

BHP People – “find your niche”

Dr Karen Crowdy, Director of Research Strategy and Operations at the Aston Institute of Health and Neurodevelopment, is one of the inaugural recipients of the new BHP People Award.

We sat down with Karen to find out a little more about her career journey to date, and how vital cross-organisational collaboration is to research in Birmingham.

Q: Can you briefly run us through your career in research and how you came to work at Aston and within IHN?

KC:  I began my career in research with a PhD in Neurophysiology at Bristol University and afterwards, worked in several postdoc positions and first experienced the art of grant writing.. While I enjoyed the work, I realised that the traditional academic route wasn’t the right fit for me, so I started exploring other ways to apply my qualifications in science.

I transitioned into a role with the Natural Environment Research Council’s commercialisation team, which was quite a shift in scientific focus. There, I gained valuable experience in intellectual property licensing and spinout companies. Later, I moved to Birmingham and joined Aston University’s Business Partnership Unit as a Business Development Manager, where I focused on patents and spinouts across the university.

After maternity leave, I joined the newly established Research Support Office, bringing me back closer to research, specifically within the College of Health and Life Sciences. At the time, research support wasn’t widely recognised as a profession, but over 15 years, I’ve seen it evolve significantly, now with its own professional body, ARMA.

In 2019, Aston launched its university research institutes to enable strategic investment in research, and I joined the Institute of Health and Neurodevelopment (IHN) as Research and Operations Manager. My role has since grown to Director, where I’ve focused on building partnerships with the Children’s Hospital, regional NHS partners, and universities internationally, including through BHP. It’s been an exciting journey, and I’ve never looked back!

Q: What do you think are the key factors in building successful partnerships between institutions?

KC: For me, successful partnerships require a blend of top-down strategy and bottom-up relationship-building—something Birmingham Health Partners does exceptionally well. Communication is key, particularly in connecting the right people to collaborate on research.

It’s also important to identify practical mechanisms to help people work together effectively. For example, clinicians in hospital settings often struggle to find the headspace for research amidst their busy schedules. One approach we’re finding very useful is bringing clinicians from the Children’s Hospital to the Institute, where they can work in a dedicated research environment. Being physically embedded in this setting not only enables closer connections with our own researchers, but allows us to support them with things like grant applications, making collaboration easier and more productive. It’s all about creating opportunities and removing barriers to build relationships.

Q: The initiatives you’ve led have had a significant impact on early career researchers (ECRs). What advice would you give to ECRs starting their journey in health and neurodevelopment research?

KC: I always say to ECRs, find your niche—something you’re truly passionate about. Research often extends beyond the typical nine-to-five, so it’s crucial to love what you do.

Don’t be afraid to network and engage with others, even those you might see as more senior, like professors. At the end of the day, they’re just people, and building those relationships is vital for your growth. Be proactive, put yourself out there, and take every opportunity to connect with others in your field.

Q: Finally, what excites you most about the future of the research you’re involved in?

KC: What excites me most is the growing partnership between IHN, Aston, and the Children’s Hospital. We’re working on several ongoing projects and preparing to apply for larger funding to expand these efforts. Supporting this growth through co-funded studentships and pump-priming projects is particularly exciting. Watching these relationships develop and seeing the collaboration strengthen is incredibly rewarding, and to know that eventually these projects will lead to positive outcomes for patients is a very exciting prospect.

New national Centre of Excellence in AI and digital health awarded to Birmingham

BHP founding member the University of Birmingham has been awarded £1M to help the UK unlock the opportunity of AI and digital healthcare while ensuring technologies are safe and effective.

Birmingham will host the ‘Centre of Excellence for Regulatory Science and Innovation in AI & Digital Health Technologies’ known as ‘CERSI-AI’, alongside six key founding partners who bring together knowledge and skills from academia, the NHS, the regulators and industry, and will also work with a wider international network.

The founding partners represent an established UK network with exceptional strength in the innovation and regulation of AI, including universities (University of Birmingham, University of York), industry (Hardian Health, Newton’s Tree, Romilly Life Sciences, and the Association of British HealthTech Industries) and the NHS (University Hospitals Birmingham NHSFT and NHS Greater Glasgow and Clyde).

Working across the health and technology ecosystem, the Centre will identify and address current and future needs and opportunities in the regulation of AI and digital healthcare products and services on behalf of the government. Key to the Centre’s role will be balancing the needs of innovators, such as speed and market certainty, with those of the end-users, such as cost-effectiveness, safety, equity and sustainability, to ensure resulting technologies are able to truly improve people’s lives.

Professor Alastair Denniston, Executive Director of CERSI-AI, said: “We have a national mandate to work with the regulators. We identify problems, use scientific methodology to create solutions and then close relations with government, strengthened through the establishment of this Centre, mean that we can implement these solutions quickly. Our vision is to enable the UK to become the best place for innovators to develop, evaluate and market new products and services, ensuring benefit for both patients and healthcare providers.”

Professor Neil Hanley, Pro-Vice-Chancellor and Head of the College of Medicine and Health at the University of Birmingham and Executive Director of Birmingham Health Partners, said: “I’m really excited by this award. We have a tremendously strong reputation for working in regulatory and implementation science. Nowhere is this more relevant than in the Government priority of AI, so it is wonderful we have been chosen to take this forward as the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust under the umbrella of Birmingham Health Partners. Alongside our Birmingham Health Innovation Campus, this is yet more evidence underlining the national significance of our Health & Life Sciences District.”

Innovate UK – the UK’s innovation agency, in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), Office for Life Sciences, and the Medical Research Council have announced a total of seven Centres of Excellence for Regulatory Science and Innovation (CERSIs), including the Centre hosted by University of Birmingham. The projects, led by academic institutions, independent innovators, or regulatory leaders forming collaborative partnerships, will receive funding up to £1 million each, to lead the way in safer, faster pathways for innovative medicines and devices.

The new network of Centres aims to improve healthcare by simplifying how treatments move from lab bench to patient bedside. By helping researchers and businesses address regulatory challenges and opportunities, the Centres will help accelerate the delivery of pioneering treatments, ensuring patients benefit from cutting-edge innovations.

These seven CERSIs will tackle key challenges in regulatory science, in areas such as Advanced Therapies, Precision Medicines, Digital Healthcare, Drug Discovery and Diagnostics. Over the coming year, the CERSIs will develop tools, frameworks, and guidance to help shape the development and approval of medical innovations in the UK.

Science Minister, Lord Vallance, said: “New technologies are transforming our economy at rapid pace. Our system of regulation must keep up with that, so that we can quickly and safely seize the economic and social benefits that new innovations could unlock. This is particularly true for life sciences, where innovative medical technologies, treatments, diagnoses and therapies are just around the corner.

“That is why we are launching CERSIs. They will make a valuable contribution to regulatory innovation – and will complement wider efforts to make the UK’s regulation fit for the future, such as that of our Regulatory Innovation Office.”

Ailsa Kennedy-Ballard, Deputy Director Innovation Programmes & Partnerships at Innovate UK, said: “Innovate UK is pleased to announce these seven new CERSIs, which represent a landmark in healthcare innovation regulation.

“Backed by up to £1 million each, they will drive safer pathways for groundbreaking medicines and devices, ensuring the UK remains at the forefront of global medical advancements.

“By fostering collaboration between academia, business and regulators, these Centres will pave the way for life-changing innovations to reach patients more swiftly and safely.”

Dr June Raine, MHRA Chief Executive, said: “The establishment of CERSIs cements the UK’s role at the forefront of regulatory science, driving forward the innovations of tomorrow while upholding our unwavering commitment to public health. This first-of-its-kind programme embeds innovation at the very heart of our regulatory processes. 

“By empowering UK academic institutions to shape the future of regulatory science, it ensures medical advancements reach patients more quickly and safely. Through close collaboration with academic and industry leaders, we are building a regulatory system that doesn’t just keep pace with innovation but actively propels it forward.” 

Dr Glenn Wells, Deputy Executive Chair at Medical Research Council said: “We are delighted to partner with Innovate UK and the MHRA to establish new CERSIs.

“Regulation plays an essential role in improving the nation’s health, by supporting the MHRA to engage with our community we will help shape the regulatory landscape and leverage the MHRA’s world leading research to advance innovations in healthcare and regulatory science.”

More information on CERSI-AI can be found at: www.cersi-ai.org.

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