"Stricter regulatory requirements, escalating R&D costs and a 90% failure rate of drugs in development are impacting the pharmaceutical industry's ability to bring new drugs to the market to address the needs of a growing patient population with a rising disease incidence. Cardiotoxicity is a leading cause of drug attrition and accounts for up to 28% of US post-marketing drug withdrawal. An integrated approach is now required to reduce costs and improve success rates by eliminating compounds with poor cardiotoxicity profiles at an earlier stage in development. Clyde Biosciences is a specialised provider of cardiovascular testing services driven by a team of experts with unparalleled experience in cardiac electrophysiology. The company has developed the CellOPTIQ assay platform, comprising novel instrumentation and cell culture, maturation and preservation protocols to fulfil unmet needs in Safety Pharmacology, Mechanistic Toxicology and Cardiology Research. CellOPTIQ provides a comprehensive cardiotoxicity assessment to deliver reliable, high resolution functional output from a range of cardiac cell types including human-induced pluripotent stem cell derived cardiomyocytes (hiPSC-CM), improving the accuracy and reducing the time, cost and complexity of pre-clinical cardiotoxicity screening. All drug actions on the heart can be explained in terms of effects on 3 parameters of Excitation-Contraction Coupling (E-C Coupling): electrical activity, calcium and contraction. Studying the E-C Coupling process is critical for the understanding of cardiac cell function. CellOPTIQ is the only assay which measures the three principal features of Excitation-Contraction Coupling (E-C Coupling) in one simultaneous experiment to produce a quality of data unsurpassed among related assays. In collaboration with Censo Biotechnologies, a commercial stem cell technology provider, and academics from Glasgow University, this project seeks to transform CellOPTIQ into a robust, high throughput automated assay, advancing assay performance, cell differentiation, assay efficiency and throughput to overcome current commercial bottlenecks. CellOPTIQ will offer the drug discovery industry a new 'gold standard' cell assay for preclinical cardiotoxicity assessment, establishing Clyde Biosciences as a leading service provider within the growing global _in vitro_ cardiotoxicity testing market, addressing all requirements for cardiac safety evaluation and supporting industry efforts to improve the speed, accuracy and cost effectiveness of drug development programs. The project will lead towards increased business productivity, export led growth and competitiveness for Clyde Biosciences and Censo Biotechnologies in the global safety pharmacology and specialised cell assay market valued at $1 billion and will generate new knowledge for all partners to stimulate further innovation."

"In the UK today, over 1.2 million people suffer from Chronic Obstructive Pulmonary Disease (COPD) which costs the NHS over £1.5 billion. Patients suffering from COPD are unable to empty air out of their lungs because their airways have been narrowed, mainly due to bronchitis and emphysema. The disease profoundly limits the quality of life of its suffers. It is strongly associated with the elderly and as our population ages, the incidence and cost of the disease is expected to rise. This is despite falling rates of smoking - the major cause of the disease in the UK. The WHO identifies COPD as the fourth most common cause of death due to both smoking and air pollution. There is no cure. Despite the compelling need for better treatments, there has been little progress in the last 40 years. Treatments include patients inhaling bronchodilators which open up their airways and corticosteroids, which seek to reduce lung inflammation. These provide some short term respite to the condition but do nothing to stop or reverse the damage to the patients lungs. A new method to screen for drugs that can treat the diseases is urgently needed. Our goal for the CAM project is to use stem cell technology to develop a new drug screening technology. In the CAM project, we propose to develop a capacity to transform stem cells into one of the cell types which has a critical role in the development of COPD, known as alveolar macrophage. These cells are found in the lung and are responsible for detecting, engulfing and destroying bacteria and other pathogens and also dying human cells. For patients suffering from COPD, these cells fail to function properly so that they do not perform the essential role maintaining healthy lungs and instead may cause exacerbate the dysfunction of the lungs -- contributing to the chronic nature of the disease. As well as creating alveolar macrophage, we will demonstrate that the ""inflamed"" state of these cells can controlled by drugs and that these effects can be measured by testing systems in our labs. If we can do this, we will have made substantial progress towards providing a wholly new research technology which will support the discovery of new drugs. Our hope is that the CAM project will accelerate research into ways to address the chronic inflammation which is an important contributor to this terrible disease."

The typical patient diagnosed with Glioblastoma multiforme (GBM), which constitutes 45% of all malignant primary brain and CNS tumours, is aged 50-60 and will survive 15 months after diagnosis. The Patient Derived iPSCs for High Grade Glioma (PDi:HGG) project will provide a new strategy for researchers to develop treatments specifically for this cancer. If successful, the project will have a profound and widespread impact on cancer research. We will bring together two different areas of science which have each developed rapidly in the last ten years. During this time, the capacity to transform human cells into an induced Pluripotent Stem Cell (iPSC) has become a mainstay of biological research. Separately, there has been a growing appreciation that solid tumours include a small number of “cancer stem cells”, which if not entirely removed by therapy can cause the cancer to return. These cancer stem cells are elusive and designing treatments that target them has been largely unsuccessful. PDi:HGG will use iPSC technology to create iPSCs from cells extracted from patients suffering High Grade Glioma, mainly GBM. The project will use the stem cells and derivatives created to support the development of new cancer drugs, which specifically target cancer stem cell differentiation.

Human liver hepatocytes are extremely valuable cells both for drug development laboratories and for patients whose own livers have become damaged either through viral infections, poor diet and/or long term excessive alcohol consumption. There is already a shortage of donor livers for transplantation and this is set to worsen in the future as liver failure rates continue to increase. It is known that stem cells can be multiplied greatly in culture and changed into hepatocytes to give an endless supply. However, the liver also has other cell types in it which contribute to efficient liver function. In this project we will identify these cell types and their ideal ratios to liver hepatocytes. This should form the basis for further development work towards recreating functional liver tissue from human stem cells.

The consortium of Altrika, the University of Edinburgh’s School of Chemistry, Roslin Cellab and Barts and The London bring R&D, manufacturing, clinical and commercialisation experience to the challenge of tracking clinically relevant cell populations in vitro and in vivo. The absence of an in vivo tracking methodology leads to R&D, manufacturing and clinical constraints, valuable researcher time and cell yield losses, and associated costs. This project utilises an innovative, non-toxic cell label that is stable, cost-effective and easy to detect. It will demonstrate applicability to a range of regenerative medicine therapies for unmet clinical needs, as well as increasing the efficiency of R&D activities and manufacturing processes, and improving the efficacy of clinical delivery. Given the growth of regenerative medicine, this platform could reduce industry costs by as much as $275m in 2020.