Fidelma Dunne discusses the new clinical trial and its importance to the wider healthcare ecosystem.
Prof Fidelma Dunne is the director of the Institute for Clinical Trials at the University of Galway. She holds multiple degrees in the medical space, has authored more than 270 peer-reviewed publications, was a Fulbright scholar at Columbia University, has sat on a number of medical boards and has been the recipient of several high profile awards globally.
But she can remember a time when she was told that “people like you don’t become doctors”. People like her meaning women in what was then a highly male-dominatred industry. Back then, she explained, people were put into slots and there were really only a few careers that were deemed socially acceptable, teaching, the civil service or working in a bank.
“I didn’t want any of those, and I wasn’t going to do them. So I think when somebody tells you, no, you can’t do that, then that makes you want to do it more,” said Dunne.
It had long been an ambition of Dunne’s to go into the medical field, having ruminated on the idea since she was a teenager in secondary school.
Taking inspiration from a “very wise and elderly family GP”, the Roscommon native, who has lived the majority of her life in Galway, was struck by his empathy and a gift he had that enabled him to extract the full story from his patients.
“It always amazed me how somebody could talk to a person and identify what the problem was, find a solution and you will be better. So I was intrigued by all of that.” What also fascinated the young Dunne was the mystery of it all, whereby you don a detective’s hat of sorts and through a process of investigatory work you build your patient narrative.
“I liked storytelling and conversation and observing this man in practice, I could see that,” she mused.
So, she sat the Leaving Cert, went to university and navigated a long and successful career in healthcare, primarily in the field of diabetes and its impact on pregnant women.
Bringing us to today, where Dunne is the director of the Institute for Clinical Trials at the University of Galway, which is part of a consortium preparing to launch an innovative first-in-human cancer cell therapy.
Breaking new ground
The new therapy, which is being explored and expanded upon by the University of Galway, Galway University Hospital, Hooke Bio and Lift BioSciences, recently received a grant from the Disruptive Technologies Innovation Fund, to the tune of €11.9m. The largest amount to date awarded by the organisation for innovation.
What it is really all about, stated Dunne, is the combination of academic skills with industry expertise to innovate solutions that can adequately address current, unmet clinical needs.
In this case, the consortium is working on a groundbreaking first-in-human immuno-therapy aimed primarily at people with metastatic head and neck cancers, as well as women with cervical cancer. All of whom have exhausted their other treatment options.
The aim beyond its impact on the field of research, is to improve and prolong lives, using Immuno-Modulatory Alpha Neutrophils as the body’s defence system.
The University of Galway will contribute its expertise in oncology and cell therapy clinical trials, as well as translate laboratory research into clinical applications, for example predictive biomarkers.
“The technology for the development of these cells is coming from Lift BioSciences, so they’re going to give us the, you could almost call it, the recipe to make these cells and then the cells are going to be manufactured in the university, in the center for cell manufacturing in Ireland.
“That’s really a very high spec center for the development of all types of cellular therapies to help patients and then we’re going to take those cells, package them, and give them to patients who really need them,” explained Dunne.
With the clinical trial set to begin in 2026, the study will first establish the safe and effective dose of immune-cell cancer therapy, combining it with other immune-based therapies aimed at overcoming resistance to treatment.
10 to 12 patients will be selected and the programme is likely to span three to four years, before the results can be fully assessed.
“It demonstrates to me how working together, with academic partners, clinicians and industry partners, can really provide solutions. From the initial concept through the basic science journey, all the way through to the development and manufacturing of something into the clinical arena that helps patients.
“So, it brings us on the journey from the beginning to the end and we’re hugely excited,” she said.
Westbound
Dunne also noted the importance of contributing to and scaling Ireland’s medical research industry, particularly as the west continues to build a global reputation as a technological and medical hub for domestic and international ventures.
She explained, if you consider the infrastructure currently in place, firstly you have the Institute for Clinical Trials and a wealth of employees skilled to oversee new studies.
In the nearby research facility there is room for patients to be seen and treated with trial therapies and then there is the hospital, which is responsible for identifying patients who meet the trial criteria.
“So these are all in very close proximity and that’s really important,” she noted.
But then, if you take in the wider picture and look at the overall structure established in the west, she stated “we are surrounded by companies, large and small multinationals and we haven’t really materialised or used these companies for effective delivery of healthcare here in the west.
“These companies have all been designing things, manufacturing things, exporting things, employing people. But we haven’t really been delivering trials.
“So I think the reason the west of Ireland is important is we have this very rich ecosystem of companies in close proximity to clinicians, patients and academic partners. But nationally, there has been a barrier in delivering clinical trials, and that’s what we’ve been trying to overcome over the last 18 months, with very good success.”
Of her own motivations and looking back on her career, Dunne explained when you evaluate your journey as a clinician through the lens of your life’s work, it becomes clear that, while you can deliver clinical care every day of the week, you’re never going to make progress unless that clinical care evolves.
“The quality of life for patients will never get any better unless you come up with new treatments, new ways to deliver the treatments, new ways to measure how effective the treatment is,” she said.
“The icing on the cake for a clinician is if you can demonstrate that your research practice is improving the lives of patients, beyond what you could do in the clinical setting. So I’m hugely motivated by this.”
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