Professor Frank Barry
Professor of Cellular Therapeutics, Scientific Director Regenerative Medicine Institute (REMEDI), Co-Director Centre for Cell Manufacturing Ireland (CCMI), NUI Galway
Professor Tim O’Brien
Established Professor of Medicine, Director REMEDI, Co-Director CCMI, NUI Galway
Dr Meadhbh Brennan
Associate Professor, School of Engineering and REMEDI, NUI Galway
An all-island strategy to develop and invest in gene and cell therapy will benefit healthcare and attract multinationals interested in the advanced therapy medicinal products (ATMP).
There is huge potential for gene and cell therapy to contribute to global wellbeing by developing technologies that can repair or regenerate damaged or aged genes, cells and tissues. Ireland, with its strong advanced manufacturing base, can be a hub of excellence for these activities.
Developing an all-island strategy
The key ingredient is an agreed all-island strategy to develop and invest in the gene and cell therapy industry. This strategy is being driven by two pioneers of the regenerative medicine field in Ireland, Professor of Cellular Therapeutics Frank Barry and Professor of Medicine Tim O’Brien, both based at NUI Galway and Saolta University Healthcare Group.
In 2004, they co-founded the Regenerative Medicine Institute (REMEDI) with the support of Science Foundation Ireland (SFI) – a big step for regenerative medicine in Ireland. Funding was also secured from the programme for research in Third Level Institutions for the Centre for Cell Manufacturing Ireland (CCMI), an advanced facility currently licensed to manufacture cell therapies for treatment of patients in clinical trials.
Ireland’s advanced manufacturing sector is worth about €140 billion in exports and employs 261,400 people.
Challenges facing transformative therapy
SFI has awarded over €12 million research funding in areas of gene therapy and cell therapy in the last 10 years. Experts believe these therapies will be the next major innovation to change medicine. Already, gene modified cells are being used successfully to treat blood cancer, where stem cells are modified and delivered back into a patient to target and kill cancers that had previously been untreatable.
Medicines based on cells and genes have transformative potential, but they are also complex to develop and manufacture – that’s where Ireland’s challenge lies. Significant government support and investment will be required to overcome these challenges.
The strategic position paper, put forward by Professors Barry and O’Brien and colleagues at REMEDI, outlines the benefits of having an all-island approach to gene and cell activities and the development of manufacturing and commercialisation infrastructure for ATMPs.
Ireland’s advanced manufacturing sector is worth about €140 billion in exports and employs 261,400 people. The strategy can create an ecosystem to accelerate the development of ATMP focused enterprises and increase the attractiveness of Ireland as a place for ATMP related foreign investment.
Integral to achieving this is the establishment of a highly skilled workforce. NUI Galway leads the way, with masters and PhD programmes in regenerative medicine and cell manufacturing, training the next generation of researchers to place Ireland at the forefront of advanced therapies.
Opportunities in regenerative medicine
REMEDI has recruited Dr Meadhbh Brennan, a biomedical engineer who holds a prestigious European Research Council award to study the potential for extracellular vesicles (EVs) – the by-products of stem cell manufacturing – to be developed into medicines with their own therapeutic value. The key is to discover optimal environmental cues to collect EVs, thus developing an off-the-shelf medicine available to patients with damaged tissue.
The near future at REMEDI will see COVID-interrupted clinical trials of regenerative medicines for patients with osteoarthritis resuming. A clinical trial in diabetic kidney disease, using a mesenchymal stromal cell product manufactured by NUI Galway spin- out Orbsen Therapeutics, will also continue.
These trials and other research has EU support with eight NUI Galway-led consortia supported through the Horizon 2020 programme.
The health and economic arguments for Ireland investing in the gene and therapy sector are clear, with patients globally set to benefit.
The ATMP manufacturing strategic position paper is available at nuigalway.ie/ATMPstrategy.