Delivering innovative translational precision medicine research at the University of Leicester

Lead Research Organisation: University of Leicester

Abstract

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Technical Summary

Previous funding from five consecutive Confidence in Concept (CiC) awards, together with strategic investment from the University of Leicester, has generated a sustainable pipeline of projects successfully consolidating and expanding our translational research capabilities. This is evidenced by a 9:1 return on investment from CiC funding (>£12 M). A key advance in the last twelve months has been the rebalancing of the projects across the translation pipeline to increase diagnostic and device development projects, whilst also supporting projects later in the pipeline, e.g. the assessment of ‘breathomics’ and related blood biomarkers of patient response to treatment. In addition our mature projects are now beginning to deliver real world benefits for patients, e.g. having recently delivered an intervention into a first in man clinical trial. The successful delivery of CiC funded translational research projects into healthcare has been accelerated through enhanced interactions with the Leicester Precision Medicine Institute and the University Hospitals of Leicester NHS Trust, plus engagement with major strategic awards from MRC/EPSRC Molecular Pathology node, the NIHR Biomedical Research Centre, CRUK/DoH Experimental Cancer Medicine Centre and the Clinical Research Facility in Emergency Medicine. The award of the next phase of MRC CiC funding will enable us to further enhance our portfolio of projects to deliver novel diagnostics and therapeutic interventions in collaboration with key industrial partners to improve patient outcomes. We will capitalise on innovative translational opportunities that align with the AI & Data Economy and Ageing Society ‘Grand Challenges’ (from the Life Sciences Sector Deal). This strategic alignment will be supported by pumppriming interdisciplinary collaborations that implement artificial intelligence approaches in diagnostics and exploit our leading position as an academic AI Powerhouse (1 of only 3 in the UK). The CiC will be complemented by targeted support from the University’s Research and Enterprise Division, plus engagement with Science Park Leicester and the Innovation Hub to maximise follow on funding translational opportunities (through UKRI) and business engagement. Close linkage with Midlands Engine partners will enable us to support our colleagues to develop the translational skills that will support the growth of the Life Science sector within the Midlands region.
 
Description BHF Accelerator Award (Leicester)
Amount £20,000 (GBP)
Organisation British Heart Foundation (BHF) 
Sector Charity/Non Profit
Country United Kingdom
Start 06/2020 
End 05/2021
 
Description Medical and biological significance of exhaled M. tuberculosis detected by community level face mask sampling in Pretoria.
Amount £537,490 (GBP)
Funding ID MR/T031255/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 07/2020 
End 01/2022
 
Description Optical Coherence Tomography in Children
Amount £247,312 (GBP)
Organisation Ulverscroft Foundation 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2021 
End 12/2022
 
Description Use of mask sampling using vacuum formed Masks - South Africa
Amount £150,030 (GBP)
Organisation World Health Organization (WHO) 
Sector Public
Country Global
Start 10/2020 
End 03/2021
 
Title Application of Artificial Intelligence in Paediatric Ophthalmology - a pilot study 
Description A database of paediatric optical coherence tomography (OCT) scans which contains images of children retinas. The database contains scans from normal controls and children with retinal abnormalities.The project is supporting full annotation of the scans. In the process of seeking FDA approval as a validation set for new OCT hard- and software. 
Type Of Material Computer model/algorithm 
Year Produced 2018 
Provided To Others? No  
Impact The database under development will facilitate a multi-end point searchable database to be used as a learning and test data sets for the developed algorithm. Outputs will aim to provide earlier detection of retinal abnormalities and the earlier diagnosis of genetic disease leading to differential treatment outcomes and better prognosis for a range of eye and other physiological abnormalities with genetic components. 
 
Description ATACCC (Assessment of Transmission and Contagiousness of COVID-19 Contacts) - mask sampling 
Organisation NIHR Health Protection Research Unit
Country United Kingdom 
Sector Public 
PI Contribution Prof Barer is an expert in the manufacture and analysis of mask mounted capture strips for exhaled microorganisms.
Collaborator Contribution NIHR HPRU are undertaking a study of Covid transmission risk in human volunteers - they requested capture masks and analysis from Leicester
Impact No outputs as yet.
Start Year 2020
 
Description Application of Artificial Intelligence in Paediatric Ophthalmology - a pilot study 
Organisation Leica Microsystems GmbH
Country Germany 
Sector Private 
PI Contribution The research team at Leicester is at the forefront of paediatric OCT imaging and have previously published seminal papers in the field. One of our landmark papers is on the classification of retinal development disorders (foveal hypoplasia) which allows clinicians to grade, diagnose and provide prognosis for children with arrested retinal development. Gave access to the largest reference dataset for paediatric OCTs worldwide.
Collaborator Contribution MTA signed in 2019 to allow Leica to share the code for their software. This will allow direct access to the encrypted images from the scans so it could be used for the AI system (training, optimization and validation). This would also allow batch processing and thus scaling up the dataset further. Leica are interested in further collaboration, but are awaiting data from the PI, which is expected in July 2020.
Impact 3x 1 year NIHR academic foundation trainee posts - to perform segmentation of scans and developing AI-based technique for segmentation. NIHR Academic clinical fellowship. Scoping with industrial partners (e.g. Translational Imaging Innovations). Gave confidence for follow-on funding (MC_PC_18054).
Start Year 2019
 
Description Application of a phage-PCR based technology to develop novel diagnostic tools for Tuberculosis 
Organisation Luminex Corporation
Department Luminex (Canada)
Country Canada 
Sector Private 
PI Contribution The capability to conduct a prospective cohort study with TB and non-TB patients. Provide access to patient samples and identify eligible samples for recruitment.
Collaborator Contribution Collaborators in Nottingham hold the I.P. for the assay methodology used which has been licenced to the SME biotechnology company, PBD Biotech Ltd (who are partly owned by University of Nottingham). PBD Biotech have agreed to cover the labour costs of performing the tests (In-kind contribution). Luminex contribution: will place a proprietary platform for developmental work at UoL and UoN and provide support for platform adaptation (in-kind value unknown). Oxford Immunotec are contributing expertise and equipment to enable automation of the assay- by automating the separation of lymphocytes from whole blood.
Impact None to date. (Reviewed March 2021 - Updated march 2021)
Start Year 2019
 
Description Application of a phage-PCR based technology to develop novel diagnostic tools for Tuberculosis 
Organisation Oxford Immunotec Global
Country United Kingdom 
Sector Private 
PI Contribution The capability to conduct a prospective cohort study with TB and non-TB patients. Provide access to patient samples and identify eligible samples for recruitment.
Collaborator Contribution Collaborators in Nottingham hold the I.P. for the assay methodology used which has been licenced to the SME biotechnology company, PBD Biotech Ltd (who are partly owned by University of Nottingham). PBD Biotech have agreed to cover the labour costs of performing the tests (In-kind contribution). Luminex contribution: will place a proprietary platform for developmental work at UoL and UoN and provide support for platform adaptation (in-kind value unknown). Oxford Immunotec are contributing expertise and equipment to enable automation of the assay- by automating the separation of lymphocytes from whole blood.
Impact None to date. (Reviewed March 2021 - Updated march 2021)
Start Year 2019
 
Description Assessment and contagiousness of COVID contact (mask supply and analysis) 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Prof Barer has expertise in the production of capture strips to assess exhaled microorganisms and their analysis - these were supplied to Imperial College and analysed in Leicester
Collaborator Contribution Imperial College are examining Covid infectiousness in human volunteers - they requested the masks as a way of estimating viral shedding in breath
Impact No outputs.
Start Year 2020
 
Description Creating a decoy trap to block Covid19 (ACE2 Receptor mimic) 
Organisation Medical Research Council (MRC)
Department MRC Laboratory of Molecular Biology (LMB)
Country United Kingdom 
Sector Academic/University 
PI Contribution Prof Brindle's group has expertise in in vitro evolution of binding proteins.
Collaborator Contribution Dr Bailey of the Pirbright Institute contributed expertise in Covid-19 biology Dr Sale of the MRC contributed expertise in cloning and protein structures
Impact Have produced four decoy proteins that block binding of Cov2 spike protein RBD to Vero cells, as well as an antagonist that blocks viral RBD protein binding. These data are being prepared for publication. (Reviewed march 2021 - Updated march 2021)
Start Year 2020
 
Description Creating a decoy trap to block Covid19 (ACE2 Receptor mimic) 
Organisation The Pirbright Institute
Country United Kingdom 
Sector Academic/University 
PI Contribution Prof Brindle's group has expertise in in vitro evolution of binding proteins.
Collaborator Contribution Dr Bailey of the Pirbright Institute contributed expertise in Covid-19 biology Dr Sale of the MRC contributed expertise in cloning and protein structures
Impact Have produced four decoy proteins that block binding of Cov2 spike protein RBD to Vero cells, as well as an antagonist that blocks viral RBD protein binding. These data are being prepared for publication. (Reviewed march 2021 - Updated march 2021)
Start Year 2020
 
Description Developing a translatable assay for determination of Mycobacterium tuberculosis lipid body content in sputum - a biomarker of TB treatment response 
Organisation QuantuMDx Group Ltd.
Country United Kingdom 
Sector Private 
PI Contribution We instigated the analysis of Mycobacterium tuberculosis (Mtb) Lipid Bodies (LBs) frequencies in sputum more than 20 years ago. A member of the research team has more than 5 years' practical experience of this technique. We have current MRC funding to validate LBs as a biomarker of treatment response and will analyse ~300 patient sputum samples from the RIFASHORT TB clinical trial through this. We have extensive experience examining different lipid fluorophores by microscopy, utilising the characteristic wavelength emission shift of Nile Red in LBs to improve determination of LB content in pure culture and to demonstrate the potential of plate-based fluorometric analysis of lipid content.
Collaborator Contribution QuantuMDx have developed proprietary sputum lytic protocols and Capture-XT to selectively capture, clean and concentrate Mtb. QuantuMDx research staff will provide expertise for any project-specific optimisation of Capture-XT parameters if required for optimal performance for the needs of this project. We are confident that by combining the expertise and technology of both teams we will be able to deliver an assay with greater potential for translation.
Impact This project links P2D and CiC funding - CiC funding as a follow on from the discussions and person exchange initiated by P2D award. This project has been affected by COVID as lead scientist (Jonathan Decker) has been seconded to another project supporting COVID diagnostic research. Work is expected to re-commence on this project mid 2021. The relationship wit QuantuMDx is ongoing. Reviewed March 2021.
Start Year 2019
 
Description Development of Ang2-selective ligand-trap 
Organisation Inotrem SA
Country France 
Sector Private 
PI Contribution Development and validation of high affinity ligand trap system for human Ang2. Molecular 'know how' to test the affinity for mouse model being developed by Inotrem. Set up for the production of trap proteins for validation by Inotrem.
Collaborator Contribution Inotrem: Developed mouse model of sepsis, anti-sepsis small molecule. LifeArc: patent and commercailisation rights to Ang2 ligand trap system (joint owned with UoL).
Impact Biophysical screening for selectivity and affinity complete - Ang2 trap functional against mouse protein - can move towards mouse models. Licencing agreement with Inotrem. Patent approved: Publication number: WO2014096855 ANGIOPOIETIN-2 SPECIFIC TIE2 RECEPTOR; Patent granted in EU, US, AUS. This collaboration is ongoing and has been strengthened across two CiC awards. The relationship has just entered a more significant phase with focused delivery plans, for both parties, to move towards validation for sepsis.
Start Year 2018
 
Description Development of Ang2-selective ligand-trap 
Organisation LifeArc
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Development and validation of high affinity ligand trap system for human Ang2. Molecular 'know how' to test the affinity for mouse model being developed by Inotrem. Set up for the production of trap proteins for validation by Inotrem.
Collaborator Contribution Inotrem: Developed mouse model of sepsis, anti-sepsis small molecule. LifeArc: patent and commercailisation rights to Ang2 ligand trap system (joint owned with UoL).
Impact Biophysical screening for selectivity and affinity complete - Ang2 trap functional against mouse protein - can move towards mouse models. Licencing agreement with Inotrem. Patent approved: Publication number: WO2014096855 ANGIOPOIETIN-2 SPECIFIC TIE2 RECEPTOR; Patent granted in EU, US, AUS. This collaboration is ongoing and has been strengthened across two CiC awards. The relationship has just entered a more significant phase with focused delivery plans, for both parties, to move towards validation for sepsis.
Start Year 2018
 
Description Face Mask Sampling for microorganism and virus detection - commercial product design 
Organisation 42 Technology
Country United Kingdom 
Sector Private 
PI Contribution Prof Barer has expertise in the manufacture and use of sterile strips for capture of exhaled Microorganisms - particularly Tuberculosis
Collaborator Contribution FIND provides funding support for diagnostics applicable to developing countries. 42T are experts in design for manufacture solutions and novel medical device development.
Impact No outputs as yet. (Reviewed March 2021 - Updated March 2021)
Start Year 2020
 
Description Face Mask Sampling for microorganism and virus detection - commercial product design 
Organisation Foundation for Innovative New Diagnostics (FIND)
Country Switzerland 
Sector Charity/Non Profit 
PI Contribution Prof Barer has expertise in the manufacture and use of sterile strips for capture of exhaled Microorganisms - particularly Tuberculosis
Collaborator Contribution FIND provides funding support for diagnostics applicable to developing countries. 42T are experts in design for manufacture solutions and novel medical device development.
Impact No outputs as yet. (Reviewed March 2021 - Updated March 2021)
Start Year 2020
 
Description Molecular characterisation of viral:host cell interactions that may underlie hyperinflammation and mortality in COVID-19 
Organisation Galecto Biotech
Country Sweden 
Sector Private 
PI Contribution The Leicester research group (Prof Bibek Gooptu) has expertise in analysis of the Gal-3-Fibrosome - a putative mechanism for Covid-19 mediated hyperinflammation.
Collaborator Contribution Galecto possess expertise in synthesis and manufacture of small molecules targeting the Gal-3-Fibrosome - they are supplying molecules for Prof Gooptu to analyse.
Impact No outputs to date. (Reviewed March 2021 - Updated March 2021)
Start Year 2020
 
Title A near patient paracetamol test 
Description Development of a novel detection system suitable for near patient measurement of paracetamol. 
Type Of Technology Detection Devices 
Year Produced 2019 
Impact Next phase is further development of a device format suitable to be tested in a future MRC DPFS funded project. This device will address the need for a rapid, near patient test for circulating levels of paracetamol in blood to enable early detection of overdoses, improve patient outcomes and reduce time in the Emergency Department. 
 
Title The Fail-safe Interatrial Shunt Device 
Description The Fail-safe Interatrial Shunt Device enables left atrial depressurisation via a left atrial pressure responsive reversible interatrial shunt to prevent decompensation leading to acute heart failure. 
Type Of Technology Detection Devices 
Year Produced 2020 
Impact This approach promises to substantially reduce health care costs by further reducing acute heart failure admissions and eliminating the need for a dedicated team to monitor and respond to changes in pulmonary artery pressure signals. 
 
Description Bringing the OCT to the patient, and not the patient to the OCT 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact 591 participants in 82 different countries engaged with the Webinar which was presented by an expert panel from the world-renowned University of Leicester Ulverscroft Eye Unit (UK) sponsored by Leica and TII:

Comparisons between hand-held OCT and table-mounted OCT
Clinical applications including detection and assessment of foveal and optic nerve abnormalities and monitoring of disease progression
Research applications with a focus on nystagmus, childhood glaucoma, and cerebral malaria

In short, discover how hand-held OCT (namely, Leica EnVisu) in ophthalmology procedures can support you in the diagnosis of physiological and pathologic conditions of the eye.

(Reviewed March 2021 - Updated March 2021)
Year(s) Of Engagement Activity 2020
URL https://theophthalmologist.com/webinar/clinical-applications-of-hand-held-oct-bringing-the-oct-to-th...