A team led by Prof Faisal Sharif has established the University of Galway as a global leader for cardiovascular CT scanner-based research and clinical trials.
Prof Sharif’s vision was to bring to Galway the most advanced cardiac imaging modalities available today through the development of a dedicated state-of-the-art research cath lab and a CT scanner to establish a world-class cardiovascular research centre for the West of Ireland.
This significant piece of clinical research infrastructure is being funded through a grant of €5 million from Research Ireland and an additional €11 million, which the HSE has raised.
The first phase of the project saw the procurement and installation of a dedicated research CT scanner. The second phase involves the refurbishment of existing facilities to create a world-class dedicated research cath lab (cardiac catheterisation laboratory).
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Prof Sharif is head of discipline of AI and medical technologies at the University of Galway. He also directs cardiovascular research and is a founding member of the BioInnovate Ireland innovation hub and a funded investigator of the Research Ireland Curam research centre.
“Over the past number of decades, the Irish government made a concerted effort to attract life sciences companies to Ireland,” he says. “The bottom line has been a very significant investment by medtech companies. A huge amount of that was in manufacturing. We are very good at that, but a shift happened about 15 years ago to a focus on innovation and new technologies.”
The global leaders not only want manufacturing excellence, they need a world leading research environment as well as the ability to carry out clinical trials to validate their products.
His work as an interventional cardiologist as well as with BioInnovate Ireland led Sharif to engage with the industry quite extensively. “Although they were making devices here in Galway, the clinical testing was being done in Europe, Australia, New Zealand and elsewhere. That meant people and devices had to travel to those places at huge cost. I asked why they were not doing trials here in Ireland.”
One of the issues was the need for a dedicated research facility to support the trials. “We didn’t have a dedicated CT scanner to test people in protected time,” he explains.
What he means by protected time is that it is not competing with the needs of patients in a hospital setting. “If you look at the newspapers, you see delays in hospitals and a demand and supply mismatch. The last thing you can do is ask for a research patient scan to be carried out ahead of a hospital patient. It is not easy to do trials in very busy health service. We needed a dedicated cath lab and CT scanner with protected time to scan research patients.”
The new CT scanner has already proven its worth both in research and clinical trials. “We were able to carry out 1,400 scans in the first 18 months,” he says. “And the integration of emerging novel imaging software allows us to study coronary blockages in detail. For example, we can determine the calcium, lipid, or fibrous composition of each plaque, which further allows us to tailor the treatment plan to reduce an individual’s risk of heart attack.”
The application of AI and advanced data analytics is producing other benefits. “With 1,400 patients, three coronary arteries and multiple risk factors, we have generated a very large dataset which can be used to discover novel signals and predict future events using new artificial intelligence, machine learning and deep learning algorithms. In one case, we have found a biomarker for early-stage coronary artery disease.”
In the clinical trial space, the team has worked on a trial of a new cholesterol-lowering drug produced by a global pharma company. The company wanted to do CT scans to see if patients had mild arterial blockage. Half of the people on the trial get the new drug and half get standard treatment. After two years, we will scan again to see if there has been a reduction in plaque as well as cholesterol. They came to us because of our ability to recruit patients as well as the exceptional quality of data we produce.”
Another multinational pharma has now come in with a drug trial for the CT scanner and the team has carried out a first-in-human trial for a new heart sensor device. “Success breeds success. We have a staff of 16 and they are not paid by the university or the HSE, it’s a self-sustaining model paid for by trial firms.”
Technology is important but Sharif is keen to emphasise the central role played by the team. “We have a very dynamic and diverse team, including research nurses, research fellows, data analysts and data scientists. I have been invited to be involved in multiple clinical trials on other sites and have seen them fail to recruit patients because they don’t have dedicated research nurses on the team to explain the trial to people, and so on. When you have a team like we have, you can recruit the patients, bring trials to successful conclusions and become financially self-sustaining.”
