Scotland is at the heart of recent advances in data-driven healthcare and precision medicine.
We often hear that healthcare stands on the threshold of its precision medicine future. In many ways the future has already arrived. A third of new drugs approved by the United States Food & Drug Administration in 2017 were precision, or personalised, medications, according to the Personalized Medicine Coalition. However, many challenges remain before the true potential of precision medicine—an approach for disease treatment that tailors treatment to the individual genomic and health profile of each patient – can be realised. Scotland offers unique, world-class resources for companies and research organisations developing solutions to these challenges and building the precision medicine future.
That’s why biopharmaceutical giant AstraZeneca selected Scotland as one of just a small number of major centres for its global genomics initiative. AstraZeneca’s ten-year project aims to sequence 2 million genomes from around the world and to apply that data toward developing new medicines.
“We see genomics as the foundation of what science can do,” Mene Pangalos, AstraZeneca Executive Vice President Innovative Medicines and Early Development Biotech Unit and Global Business Development, told attendees at the 2016 NHS Research Scotland Conference. His talk marked the launch of a major partnership between AstraZeneca and Stratified Medicine Scotland-Innovation Centre. SMS-IC brings together industry partners with the National Health Service in Scotland (NHS Scotland) and four Scottish medical universities in a centralised network to capitalise on Scotland’s many precision medicine and other data-based capabilities to drive biomedical advances and business success. “Working together with…Stratified Medicine Scotland will be a really important part of our strategy,” Pangalos stated. “This collaboration will provide access to consented genomic samples, electronic health records and importantly the ability to recall patients for deeper clinical investigation to help us better understand the underlying causes of disease.”
Scotland has made significant investments to integrate and make its unique precision medicine resources available to collaborators around the world. Gavin Nichols, former Vice President, Research and Development Innovation, IQVIA, says that Scotland is emerging as “a focal point for driving stratified medicine, population health management and outcomes research, across the whole globe.”
The Scottish precision medicine ecosystem helps drive advances
SMS-IC is at the centre of a major initiative to help industry and academic investigators utilise Scotland’s population of patients willing to participate in studies, as well as its existing anonymised databases of longitudinal patient electronic health records. The Scotland-wide consortium also provides links to industry and the Scottish academic investigators, clinical specialists, and genomic and bioinformatics experts needed to carry out data-driven translational and clinical research. The £20 million SMS-IC housed within the Clinical Innovation Zone at Glasgow’s new Queen Elizabeth University Hospital Academic Medical Campus serves as the central hub for a government-supported initiative known as the Precision Medicine Ecosystem (PME). As a one-stop-shop, the PME enables public and private enterprises and their academic collaborators from around the world to identify and access Scottish tools, talent, and patient data—as well as potential investment—to accelerate the real world adoption of precision medicine. That’s why, along with AstraZeneca, several other companies have come to Scotland to find partners for growth.
SMS-IC CEO Diane Harbison understands from her two decades of leadership roles in the biopharmaceutical industry that many barriers remain for realising precision medicine’s promise. “The great challenge today,” she says, “is how can we know if a drug will work? Some drugs work for a significant proportion of the population but for other drugs such as statins, in a significant proportion of patients they don’t work at all or they cause unwanted side effects. That leads to a phenomenon known as ‘trial and error prescribing’ where patients are prescribed a series of different drugs until one that works is identified. Our goal is to work with our collaborators to identify and stratify patient populations early on to predict the right medication at the right time and at the right dose for specific subsets of patients.” Companies such as AstraZeneca are utilising Scottish resources to stratify patient populations to ultimately hone in on those groups that can predictably benefit from treatment.
“We see ourselves as enablers,” Harbison says. “We help companies and academic investigators based both here in Scotland and globally find collaborators at our four medical research-intensive universities. We also provide access to populations with disease targets, make connections to Scotland’s genomic infrastructure, and tie all of this into Scotland’s large network of specialist, innovative service providers and clinical research organisations. Precision medicine studies begin with data-based patient identification and recruitment.".
Patient recruitment for clinical studies made easy
“One of the biggest issues for CROs is patient recruitment,” says Lewis Cameron. He serves as Global Head of Clinical Development at Covance, a global clinical research organisation (CRO) with a significant presence in Scotland. “Treatments are more and more specific to patients. Clinical trials have consequently become much more focused. You need the capability to identify the right patients for your study.” Identifying and stratifying patient populations can prove the difference between a successful and a failed drug trial. For many advanced drug studies, for example in oncology, Cameron finds that Scotland can offer “straightforward access to the best sites with the best physicians, with guaranteed recruitment and guaranteed speed.”
That is one of the reasons that Covance and some of the world’s most recognised CROs—including IQVIA, PPD, INC Research, and ClinTec—are in Scotland. Indeed, both IQVIA and PPD have strategic partnerships with NHS Scotland to accelerate the development of new medicines.
Harbison says, “SMS-IC can help CROs and other partners identify and stratify patient populations for their precision medicine and stratified medicine studies quickly and precisely due to our single, unified health system, NHS Scotland. The unique patient identifier, the Community Health Index or CHI number, ensures that Scottish population’s medical data gets tracked from cradle-to-grave with this primary key identifier for their electronic health records. Every time a patient meets with a care provider that information gets recorded, coded and entered into the national database. The CHI number and the NHS make it easy to track patients anywhere in Scotland throughout their entire lives.”
The health service also proactively invites patients to elect to participate in clinical studies via SHARE. Individuals who self-select via SHARE—more than 136,000 Scots at present—permit SHARE to make their coded data from their anonymised electronic health records available to investigators. They can then quickly identify potential target populations for study.
In addition, Generation Scotland, a unique partnership between the Scottish University Medical Schools and NHS Scotland, with funding from the Scottish Government, serves as the repository for blood and other tissue samples from more than 30,000 people from across Scotland, with associated clinical measurements such as blood pressure and information about health and lifestyle. The majority of participants in Generation Scotland have also given permission to link to their medical records and to be contacted about participation in further research.
Other disease-specific databases offer pathways to stratified patient recruitment for clinical studies. For instance, SCI-Diabetes (Scottish Care Information - Diabetes) tracks real-time clinical information for all 300,000 people with type I and type II Diabetes in Scotland. It is updated daily from all hospital clinics and 1,200 GP practices. For clinical studies, the Diabetes Research Register holds data for more than 10,000 patients. This research register uses the latest clinical data on each patient to identify suitable patients for studies, thus increasing the recruitment rate and decreasing the screen failure rate.
Harbison says. “When investigators or companies come to SMS-IC, through our network of contacts, we can help them get access to quality biological-samples through our highly networked biorepositories, the right patients and their electronic data records,” for data-driven clinical research in multiple therapeutic areas. This can greatly reduce the time and cost for clinical trials. Covance’s Cameron says, “In some indications, Scotland gives us access to the whole national patient population. We can identify the best doctors for our studies. Without having to go to many scattered sites, we have access to large, easily followed patient populations.”.
Robust databases for data-driven clinical research
The rise of precision medicine demands powerful genomic technology and significant bioinformatics capabilities. SMS-IC and PME have worked to create enhanced data management services for geographically dispersed and heterogeneous datasets. Cross-talk among databases remains an industry-wide challenge. Recently, SMS-IC successfully coordinated a consortium bid for a substantial grant from Innovate UK that will integrate masked health records, genomic data, associated imaging, and tissue in bio-repositories for nonalcoholic steatohepatitis (NASH), a leading cause of death due to liver inflammation and damage brought about by buildup of fat in the liver. Similar projects are projected for other major diseases. Harbison says, “Eventually it will be like having an encyclopedia for each disease.” .
In addition, SMS-IC is co-ordinating several nationally-funded Exemplar Projects underway at Scottish universities that utilise PME services to advance precision medicine in important diseases. They include chronic obstructive pulmonary disease (COPD), Multiple Sclerosis, ovarian and pancreatic cancer, and rheumatoid arthritis. For instance, PRECISION-Panc, a consortium of SMS-IC, NHS Scotland, the University of Glasgow’s Translational Research Centre, and bioinformatics provider Aridhia Informatics Ltd., seeks to match the best new treatment options for individual pancreatic cancer patients based on the genetic subtypes of their cancer. SMS-IC supports the collection of a wealth of patient-specific data held within the NHS so it can be melded with the genomic data generated. Pancreatic cancer patients’ molecular Multi-Disciplinary Cancer Care Team can employ the data as a prototype treatment decision-support tool. Eventually, patient care in Scotland and beyond will draw on the PRECISION-Panc tool and others being developed by the Exemplar Projects as models for data-driven treatment decision making in multiple serious diseases.
Informatics, science and capital to make precision medicine a reality
Early stage and clinical researchers employing Scotland’s various databases and pursuing data-driven studies have a range of bio- and health-informatics service providers to draw on. Among them, Aridhia’s multidisciplinary team of data scientists and healthcare experts has developed a self-service, cloud-based precision medicine platform, AnalytiXagility, to enable the aggregation and collaborative analysis of streams of clinical and genomic data from multiple sources in real-time. Pamela Brankin, Aridhia’s Head of Marketing and Communications, explains, “This [platform] not only supports critical decisions to be implemented in optimal timeframes, but also allows researchers to respond rapidly to emerging results.” The platform is being used in numerous clinical studies and demonstration projects across multiple databases sources.
Among the pilot studies, REPROCELL, a global pioneer in preclinical drug target stratification, recently employed AnalytiXagility to demonstrate some of the earliest stage disease-target stratification for preclinical study ever shown. The study combined the data from fresh tissue assays with genomics for testing treatments for COPD. This project showed how drug developers can link genotype to patient variation in drug responses at a much earlier stage than has previously been possible. According to Brankin, the new model can enable early preclinical predictions of COPD drug efficacy and patient stratification, improving clinical study outcomes and accelerating the availability of new and effective medications.
Dedicated funding sources exist for Scottish SMEs and international life sciences companies that wish to become part of Scotland’s concerted national programme of cutting-edge innovation in precision medicine. The Genomic Industrial Catalyst Fund aims to help facilitate industry collaboration, technology development and validation in the area of precision medicine in Scotland. Scottish Enterprise also supports innovative companies based in Scotland. For instance, Scottish Enterprise recently contributed a £3.4 million Seek & Solve R&D grant as part of a total £10.5 million investment in BioClavis. The US spin-out from molecular-profiling company BioSpyder will adapt that company’s proprietary gene-profiling TempO-Seq platform into a novel diagnostic tool for precision medicine in a number of indications.
The growth of Scotland’s vibrant CRO industry has benefited from the nation’s precision medicine assets. One of the industry’s fastest growing CRO’s and still in private ownership, ClinTec, has grown from its Scottish roots to a global CRO with a presence in over fifty countries. ClinTec COO Dr Robert Reekie says, “Being in Scotland is incredibly important to our success. Working on our global clinical trials, we have biometrics and data experts, specialist providers, local life sciences graduates and other staff all sourced right here on our doorstep in Scotland. We’re building on a foundation of effective resources that drive our growth internationally.” To find the talent needed as precision medicine gains an increasingly central role in the biomedical industry, he points to the Master’s Degree in International Clinical Research and Technology which Clintec established in collaboration with Edinburgh Napier University and the high calibre of new graduates available to Clintec from the Master’s degree programme in Clinical Trials and Stratified Medicine at Glasgow University.
Reekie says, “Do we tap into Scottish resources? Is being headquartered in Scotland an advantage? Absolutely.”.
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