An innovative, end-to-end partnership for the delivery of precision medicine, underpinned by our clinical expertise and excellence in academic research.
In a highly competitive marketplace, developing effective products in an efficient, patient-focused way is a growing challenge. In particular, bringing together the right stakeholders, across function and expertise, represents one of the areas where research and development can falter or fail.
Birmingham Precision Medicine Centre (BPMC) is a unique centre designed to deliver a flexible and comprehensive service to address industry needs for translational medicine. Whether co-designing trials, performing complex ‘omics’ analysis or developing companion diagnostic tools – BPMC is able to support, enable and facilitate every step of the drug development pipeline, with complete life-cycle academic overview and study design support to address specifc needs and requests.
Professor David Wraith, Director of the BPMC and the Institute of Immunology and Immunotherapy, on the opportunities presented by the new centre.
What does BPMC offer?
- Comprehensive trial design using the latest methodologies, delivered at industry standard
- Development of customised companion diagnostics to deliver in-line learning on efficacy
- Trial data, curated to provide an ICH e6 GCP 'fit for filing' package, offering accelerated progress to market
- Bespoke retrospective and prospective sample collection and release systems with cutting-edge molecular pathology
- Comprehensive patient deep phenotyping with access to CyTOF-based immune phenotyping, digital imaging of cells and tissues, and molecular phenotying at the level of metabolism and transcription
- Access to internationally-leading expertise in regulatory science and patient reported outcomes
- Evolving design and evaluation methodologies to support outcomes-based approvals and reimbursement
- Access to a large, diverse and stable population of around 5 million people
The combined expertise of the BPMC board of experts will provide a unique opportunity for colleagues from industry, biotech and SMEs to access, in a single unit, academic and clinical services often fragmented across several vendors, minimising timing and costs associated with the clinical translation of drug development. It supports patient-centred, tailored solutions through expertise in:
Access to a critical cluster of clinical and academic key opinion leaders based in the well-established Birmingham Health Partners ecosystem, bringing together:
- The University of Birmingham, a global top-100 university, with a comprehensive, multi-disciplinary single campus and a medical school which trains around 400 doctors per year
- University Hospitals Birmingham, one of the largest NHS acute trusts in the UK with access to over 2 million patients across four hospitals including the Queen Elizabeth Hospital, Europe’s largest teaching hospital
- Birmingham Women’s and Children’s, the first UK trust to integrate paediatric and women’s health
- The West Midlands Academic Health Sciences Network (AHSN), providing access to 17 NHS trusts and a population of 5.7m across the region enabling reach, adoption and access to the largest stable patient cohort in the UK.
The Birmingham Centre for Clinical Trials encompasses the most significant cluster of clinical trials expertise in Europe, including the UK’s largest academic cancer clinical trials unit and a dedicated childhood cancer trials unit. Birmingham provides access to unique speciality-specific established national and international clinical networks and trials cohorts combined with the expertise of clinical academic key opinion leaders in:
- Paediatric cancers
- Liver disease
- Inflammatory diseases
- Rare diseases
- Haemato-oncology
- Advanced therapies (including one of three national Advanced Therapies Treatment Centres)
With recognised global leaders in clinical trials design and accelerated delivery, we are able to develop and deliver complex, novel trial methodologies including basket, umbrella and platform, building on our world-leading capabilities in paediatric cancer, rare disease and precision medicine trials where patient cohorts are typically small.
Our academic-centred, professional trial management expertise can deliver collaborative clinical trials in partnership with industry to ICH e6 GCP standard so that the final trial data package meets the regulatory filing requirements for EMA and FDA.
We offer cutting-edge clinical-academic regulatory science leadership working in partnership with MHRA, FDA and EMA in defining regulatory policy and guidance including in areas such as AI, real-world evidence and patient-centred drug development, supported through the UK’s only Centre for Patient Reported Outcomes Research and Centre for Regulatory Science and Innovation.
Leading healthcare technologies clinical evaluation, testing and trials capability is delivered through our Medical Devices Testing & Evaluation Centre, NIHR Medtech & In-vitro diagnostics Cooperative and specialist devices trials teams.
We provide a single campus, integrated multi-‘omics platform capability supporting:
- Identification of novel disease biomarkers
- Patient stratification into clinical trials
- Development and validation of companion diagnostics
- Delivery of biological end-points in trials.
Our capability to integrate across a series of well-established, NHS and academically-supported single campus facility for full service deep immune phenotyping and molecular ‘omics, includes:
- Human Next Generation Sequencing facility (transcriptomics); comprehensive cytogenetic and molecular genetics services (genomics) delivered through the UK’s largest Genomics Laboratory Hub in the UK, servicing a population of over 11 million
- Access to a wide range of human samples supported by a bespoke retrospective and prospective sample collection and release systems with cutting-edge molecular pathology
- Immune phenotyping and molecular pathology
- Microbiomics
- Metabolomics
At a time of incredible flux within the healthcare technologies sector, with the uncertainties around both Brexit and the implementation of the Medical Devices Directive, BPMC will be able to provide early advice for technology companies developing medical diagnostics and devices, plotting the steps that they will have to take to exploit their technologies and get them to clinical adoption.
The BPMC will:
- Help companies and academics to understand how regulation will influence the development of their technologies
- Offer a clinical trial design and delivery service, match-making the technologies with appropriate clinicians, providing early understanding of the ways in which their product would be used
- Provide expertise to design and manufacture prototypes in-house as well as offer the ability to move to midscale manufacturing
- Offer an ecosystem of small companies to create an entrepreneurial community, which will use shared knowledge and experience to drive innovation
- Provide a network of trusted consultants and companies (law firms, packaging firms), who will help companies to move their technologies through to the point of clinical application
- Provide access to business planning support for companies working on the commercialisation of medical devices and technologies
Birmingham’s informatics capabilities are helping us to understand and unlock the value that health data, analytics, AI and machine learning can deliver to the NHS, industry and patients. We do this through developing insights from well-curated datasets across multiple diseases, with expert services and trusted governance systems fully embedded within the NHS. BPMC sits within this data ecosystem and will have access to data from:
- One of six national Health Data Research UK Sites – the only one with a core NHS partner
- Leading 30% of the HDR UK Digital Innovation Hub activity
- Connected electronic healthcare records covering over 2 million patients affected by diverse pathologies and co-morbidities, with full prescription and procedural data, for accelerated patient stratification and recruitment as well as the ability to undertake longitudinal studies and post-marketing surveillance within a diverse and stable population
- Ability to scale across a wider West Midlands patient base of nearly 6 million through data-sharing technology platforms such as Genomics Networked Information Exchange (GeNIE) platform and our region-wide image sharing solution, Regional Image Sharing Platform (RISP).
Professor Pamela Kearns introduces the BPMC Industry Trials Hub, which will streamline clinical trials by enabling closer collaboration between industry and academia
Professor Elizabeth Sapey explains how industry partners can work with PIONEER – the Health Data Research Hub for Acute Care – to improve patient experience and treatment
Case studies
DECOVID: using AI to provide better care for ICU patients
The DECOVID project applies cutting-edge data science and artificial intelligence to understand COVID-19 in detail across the UK, and create new ways to support doctors caring for the most unwell COVID-19 patients in intensive care units.
DECOVID is mapping COVID-19 in the UK, providing country-specific, multi-ethnic data which will extend our understanding of the disease, as currently clinicians rely on data from China and Italy.
In addition, the project links to routinely-collected health data across the UK to minimise the data collection burden on frontline NHS staff – and the data is available in as near to real-time as possible, thanks to links with PIONEER, the HDR UK Health Data Research Hub for Acute Care.
Finally, DECOVID will test analytical tools for use in improving clinical care of COVID-19 patients in intensive care.
See also:
- DECOVID launch story
- Introducing PIONEER – the Health Data Research Hub for Acute Care
- Introducing INSIGHT – the Health Data Research Hub for Eye Health
- New Centre for Systems Modelling and Quantitative Biomedicine
- Getting the picture, faster – the Regional Image Sharing Project
- Digitalising disease data – the Genomics Networked Information Exchange platform
We are part of a ground-breaking new study of COVID-19 – aiming to identify specific genes that may explain why some people are more affected by the virus than others. The genomic sequencing may also be useful in the search for effective treatments.
The GenOMICC Study Consortium will see 170 NHS hospitals including UHB work with researchers to sequence the genomes of 20,000 people who are severely ill with COVID-19. To date, UHB is the third-highest recruiter to the study.
Dr James Scriven, Principal Investigator at UHB, said: “Birmingham has been hit hard by COVID-19. Over the last three months more than 3,000 patients have been hospitalised with COVID-19 across the four UHB hospitals with hundreds requiring intensive care treatment. One of the puzzling features of this infection is why some patients develop severe disease while others have only minimal symptoms. This important study that will provide a unique insight into whether there is any genetic predisposition and may pave the way for new treatments in the future.”
See also:
- Read more about the GenOMICC study
- Preliminary genomic analysis sheds lights on coronavirus introduction to UK
- Field genomics: portable sequencer tracks infectious disease outbreaks
- Digitalising disease data – the Genomics Networked Information Exchange platform
- Clinical trial reveals genetic fault that reduces the effectiveness of leukaemia treatment
- Passion for genomics
- West Midlands Regional Genetics Laboratory
- Genomics Birmingham
- Centre for Rare Diseases
CATALYST – a major trial which will rapidly test new therapies for patients hospitalised due to COVID-19 – has opened in Birmingham, and sees us partner with two UK drugs companies to provide the pharmaceuticals being tested.
The trial will initially test four drug and cellular therapies using an exciting new adaptive trial design to more rapidly assess their effectiveness, with up to 40 patients recruited to each arm. CATALYST is a true Birmingham Health Partners team effort, designed by the Inflammation – Advanced and Cell Therapy Trials Team (I-ACT) at the University of Birmingham’s Cancer Research UK Clinical Trials Unit, working in close partnership with University Hospitals Birmingham and the Birmingham National Institute for Health Research Biomedical Research Centre (NIHR Birmingham BRC) to run the trial. It will be delivered in close collaboration with the Oxford and University College London NIHR BRCs.
Oxford based biopharmaceutical company Izana Bioscience will provide the first of four potential treatments – namilumab (IZN-101) to be tested.
The second drug, Infliximab (CT-P13) WAS developed by Slough-based Celltrion Healthcare UK.
See also:
- Major COVID-19 drugs trial begins in Birmingham
- First drugs announced in major BHP COVID-19 trial
- Rare childhood cancer clinical trial to be run in Birmingham
- Record year for clinical trials at BWC
- BHP tops the league table for clinical trials recruitment
- Birmingham Centre for Clinical Trials
- Birmingham Clinical Trials Unit
- Cancer Research UK Clinical Trials Unit
- NIHR Surgical Reconstruction & Microbiology Research Centre