Birmingham health researchers, with industry partners including health technology companies Dignio and Datatrial, have been awarded £1.1 million by UK Research & Innovation (UKRI)’s Innovate UK, to investigate patients’ experience of cell and gene therapies. The funding has been provided as part of the Industrial Strategy Challenge Fund’s Medicines Manufacturing programme.
Cell and gene therapies offer ground-breaking opportunities for the treatment of disease and injury. As therapies of this kind are so new, the impact upon patients receiving them has not yet been studied – until now.
The PROmics study will be led by Melanie Calvert, Professor of Outcomes Methodology and Director of the Centre for Patient Reported Outcomes Research (CPROR), and will use state-of-the-art technology to assess the effect of novel cell therapies on both patient symptoms and quality of life.
Due to begin in December, the project is a joint venture between the Midlands & Wales Advanced Therapy Treatment Centre (MW-ATTC), CPROR and Dignio, a Norwegian remote health monitoring company, which is responsible for developing the technology. The company carries out its UK operations from the University of Birmingham Enterprise business incubator, and specifically located its UK operations at the heart of the Birmingham Health Partners ecosystem, which accelerates patient access to innovative medicines and technologies. Datatrial, based in Newcastle, will facilitate integration of ePRO data with clinical outcome and manufacturing data. Other key partners include the Cell and Gene Therapy Catapult and the two other centres in the Innovate UK-funded Advanced Therapy Treatment Centre network; iMATCH (Innovate Manchester Advanced Therapies Centre Hub) and Northern Alliance.
Professor Melanie Calvert explained: “The project will develop an electronic capture system to assess quality of life and symptoms, both at the point of receiving therapy and on a longer-term basis following discharge from hospital. Patients involved in the study will input into the design and build of this system, to ensure it is user-friendly and meets their needs.
“The data generated by patients will then be used to assess the effectiveness of treatments, support patient care and provide a crucial evidence base for regulators and policy makers. Ultimately, the PROmics study will help establish the safe and efficient delivery of new Advanced Therapy Medicinal Products (ATMP) to patients and also maintain the UK’s leading role globally for developing new therapies.”
The therapies being studied are known as Advanced Therapy Medicinal Products (ATMPs) and are based on engineered genes, tissues or cells. Medical researchers have made substantial advances in recent years, and have identified their huge potential for future medicine, but this new category of treatments will require stringent monitoring to ensure their safety and effectiveness in patients.
Dr Ian Campbell, Interim Executive Chair, Innovate UK for UKRI, said: “The projects announced today will bring real benefits to patients and boost the knowledge economy as part of the government’s modern Industrial Strategy. This is vital for the UK as a global leader in the development of advanced therapies and medicine manufacturing.” Innovate UK has funded not only the PROmics study but the development of the MW-ATTC itself.
The MW-ATTC is jointly led by the National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre and NHS Wales. Professor Philip Newsome, director of the MW-ATTC, commented: “This exciting project will have a major impact on the safe and efficient delivery of cell therapies across the UK and is a good example of our close working relationships with innovative SMEs.”
The project will draw on expertise from many stakeholders in the ATTC network; London's network of Advanced Therapy Centres (ATCs); ATMP developers and producers such as Chiesi and Autolus; patients, clinicians and UK regulators and payers.