September 2015 An Taoiseach Opens New Research Centres to Benefit Frontline Patient Care

The clinical translational research facility will be a significant development for health care and medical technology sector in Ireland

Enable the best researchers and health professionals to carry out studies that will change people’s lives for the better

Currently over 100 clinical trials underway involving people with cancer, diabetes, cardiovascular disease, amongst others

NUI Galway will open the Lambe Institute for Translational Research and HRB Clinical Research Facility at University Hospital Galway today. The co-location of these two facilities in one building on hospital grounds will mean basic laboratory research conducted in the translational research facility can be evaluated in clinical trials in the clinical research facility and ultimately benefit patients faster.

Some examples of the types of studies undertaken in the two facilities will include:

• Predicting risk of breast cancer due to inherited characteristics
• Stem cell trials to help improve blood flow in legs of diabetic patients and prevent amputation
• Clinical trials in blood cancer patients to establish whether new treatments can be combined with existing treatment for better outcomes.
• How implantable medical devices can provide new solutions for patients

Officially opening the building today, An Taoiseach said: “I am delighted to celebrate the opening of this new clinical and translational facility made up of the Lambe Institute for Translational Research and the Health Research Board Clinical Research Facility. This project represents a truly innovative partnership between NUI Galway, Health Research Board, Saolta University Health Care Group, and HSE supported by private philanthropy through Galway University Foundation.

Ireland is recognised as an emerging global hub for the ‘medtech’ sector. Galway is at the very heart of this development and NUI Galway is the powerhouse for much of this progress.

In July 2011, I officially opened a new Engineering building at NUI Galway. Last February I launched the Biomedical Sciences building. Today we open a unique clinical and translational research facility. Taken together these three facilities complete an ecosystem of education, research, innovation and healthcare in the West of Ireland.

This latest facility represents the point where research and health care meet – where “bench” meets “bedside”. The advances made by researchers and clinicians in this facility will undoubtedly lead to better frontline health outcomes and will ultimately improve patients’ lives.”

NUI Galway President, Dr Jim Browne, said, “Today is a milestone in the development of medicine at NUI Galway.

NUI Galway has given strategic priority to the development of biomedical engineering science. Over the past two decades we have invested heavily in this area, with major new research facilities on our campus. Our researchers advance scientific knowledge to address health challenges. Here in this building that scientific knowledge is being developed into novel treatments, which are then carefully applied in the clinical setting and tested in clinical trials led by NUI Galway.”

Dr Graham Love, Chief Executive of the Health Research Board highlights, “The HRB Clinical Research Facility is not just a building - it is a game changer. Turning health research discoveries into real benefits for people’s health and patient care doesn’t happen by itself. This HRB facility will enable the best researchers and health professionals to carry out studies that will change people’s lives for the better.

The HRB CRF will provide a safe place for patients to take part in clinical trials and access the latest treatments. It will be a centre of learning for young researchers and health professionals– so we are investing in our future. And it will also create opportunities for partnership between the health system, academia and industry that we know will support health system innovation and economic development.”

Commenting, Maurice Power, CEO, Saolta University Health Care Group said, “This exciting new facility brings together leading-edge medical research directly to the bedside of patients at University Hospital Galway and the wider Hospital Group.  For our patients, the facility will provide inpatient and outpatient beds, a minor operations room, endoscopy, endocrine and cardiorespiratory suites, a phlebotomy room and a biometrics unit.  As well as its primary function in benefiting our patients it will also allow our Hospital Group attract and retain the highest calibre of medical professionals."

Philanthropy has played a central role in this development. Galway University Foundation acknowledged the support of philanthropic donors, in particular, Dr Ronan and Ann Lambe, the 50 plus member of the Corrib Medical Network, Bank of Ireland and the National Breast Cancer Research Institute. Speaking at the launch Dr Ronan Lambe, said:  “It is a great privilege for my wife and I to be associated with such a state of the art facility which will enhance the reputation of NUI Galway as a centre of excellence for Bio Medical Research.”   

The proximity of the University to UHG will enable direct patient access and collaborative trial input from the hospital Oncology/Haematology Clinical Trials Unit. The CRF will ensure that patients in the West and North West of Ireland have access to a number of new cancer therapies that would otherwise not have been available to them. Clinical trials are active in the treatment of melanoma, multiple myeloma, mantel cell lymphoma, breast, prostate, lung, gastrointestinal and gynaecological cancers.

Some Examples of trials that are underway at the two facilities

Case Study 1 – Predicting risk of breast cancer due to inherited characteristics

The incidence of breast cancer is increasing and the role genetics play is not yet fully understood for the majority of women. We calculate that less than 10% of women with a strong family history have an abnormality in the BRCA1 or BRCA 2 genes which are known to be associated with a risk of developing breast cancer.

According to Professor Michael Kerin, Interim Director of the Lambe Institute for Translational Research,

“In the West of Ireland we have a very high incidence of breast cancer and examining the genes that cause this cancer is a key research priority and has contributed to multiple international studies, including one which identified 74 new genetic changes associated with breast cancer. The HRB-Clinical Research Facility will allow new trials to be developed around these genetic targets.”

Case study 2 Preventing amputation in patients with diabetes mellitus

Patients with Diabetes Mellitus can often experience limited blood flow to the leg. Many patients present with gangrene, pain at rest or ulceration in the leg. While bypass of the obstruction is possible in some patients amputation may be required for one in every three patients with this complication. In fact an amputation occurs every 30 seconds somewhere in the world due to diabetes mellitus and thus new treatments are urgently required.

A new study, which will take place across the HRB Clinical Research Facility, the Lambe Institute for Translational Research and University Hospital Galway will take stem cells isolated from patients’ bone marrow, grow them in a specially designed laboratory at NUI Galway and then inject them into the leg in the dedicated clinical research space. This research is a first-in-person study which aims to assess the safety and feasibility of this approach and is funded by the Health Research Board and Science Foundation Ireland.

According to lead researcher, Professor Tim O Brien, Dean, College of Medicine, Nursing and Health Sciences, NUI Galway and Consultant Endocrinologist at University Hospital Galway,

“The aim is to see if injections of stem cells along the leg will improve blood flow and prevent the need for amputation in these patients. This first-in-person study is designed to assess the safety and feasibility of this approach and if this is demonstrated larger studies will be required to assess efficacy. Having a dedicated laboratory provided by the Lambe Institute in close proximity to the HRB Clinical Research Facility on hospital grounds transforms our ability to do this research and provide our patients with early access to trials in a safe environment. The provision of the new facility along with recent capital developments in Galway including the Biomedical Science Research Building, the Centre for Cell Manufacturing Ireland and the Galway Blood and Tissue Establishment provides the complete infrastructure to perform studies of stem cell therapy in Ireland.”

Case study 3 Tackling blood cancer

Multiple myeloma is the second most common blood cancer and it has a particularly high incidence in Ireland. It is important to look for new therapies to treat people who relapse or are unresponsive to existing treatment. Another clinical trial which will take place across these two new facilities will test the efficacy of a new drug in combination with existing treatments to see if it improves outcomes for these patients.

Professor Michael O’Dwyer, HRB Clinician Scientist at NUI Galway says,

“Based on promising results of an initial trial, we are now moving forward to test the impact of a stronger dose of the new drug in combination with existing treatments. If this is successful, the treatment should be available to Irish patients sometime later this year. The availability of labs and clinical facilities in one place is fantastic. It creates a situation where we have the optimum facilities, skills and patients which means we are very competitive in attracting international trials. This is important because it has been shown that regardless of the outcome of trials, patients who get to participate in trials do better than those who don’t.”

Case Study 4 Prevention is better than cure – Diabetes in pregnancy

Diabetes in pregnancy, known as Gestational Diabetes Mellitus (GDM) poses many risks to both mother and baby. The prevalence of GDM is 12% of all pregnancies in Ireland but varies considerably across Europe with prevalence of up to 20% reported for some populations.  It is known that if women adopt and maintain a healthy lifestyle during pregnancy, they can help create optimal health outcomes for both mother and the baby they are carrying. However, there is currently little evidence that actually shows the benefits of preventing of diabetes in pregnancy. 

In order to build evidence in this area Professor Fidelma Dunne Consultant Endocrinologist, NUI Galway and Galway University Hospital is the Irish Principal Investigator on a new European randomised controlled trial called DALI. “This study is comparing the impact of diet, exercise, taking Vitamin D, and various combinations of these lifestyle changes, on reducing the risk of developing gestational diabetes in at-risk pregnant women. The HRB Clinical Research Facility is one of 11 centres around Europe where this EU FP7 funded study is taking place.”

She continues, ‘It is essential that we increase the evidence base and highlight the importance of preventing and managing diabetes in pregnancy for mother and baby.’

According to Professor Martin O’Donnell, Director of the HRB Clinical Research Facility at NUI Galway, “In tandem with our focus on improving clinical care of patients, a clear priority for the HRB Clinical Research Facility is to improve health at a population level, through prevention of disease. At the HRB-CRFG we are conducting a range of studies that will inform optimal approaches to preventing stroke, heart attack and dementia in populations, with a focus on nutrition, blood pressure, obesity, diabetes and lifestyle behaviours.”

Case Study 5 - Predicting responses to chemotherapy in breast cancer patients

The era of personalised medicine means that chemotherapy is now more targeted towards specific cancer subtypes. However the prediction of response to common chemotherapeutic agents still poses a problem for clinicians. It would be beneficial to be able to predict treatment response by a simple blood test and save women, who are not getting the benefit from chemotherapy, the trauma of continued treatment and instead give them the option of an alternative and better regimen.

According to Professor Michael Kerin, Interim Director of the Lambe Institute for Translational Research,

"We have exciting data from trials which suggest that specific biomarkers (microRNAs) circulating in the bloodstream can predict response to treatment in breast cancer. As a result of this we may be able to select better therapies for patients. The research questions raised will be translated into new clinical trials in conjunction with the HRB-Clinical Research Facility.”

If you would like more information on the work of the HRB Clinical Research Facility, please email crfg@nuigalway.ie

-ENDS-

Osclaíonn an Taoiseach Ionaid nua Taighde a rachaidh chun tairbhe Príomhchúram Othar

Forbairt shuntasach do na hearnálacha cúraim sláinte agus teicneolaíochta leighis in Éirinn a bheidh sa tsaoráid taighde aistrithigh agus chliniciúil

Cuirfear ar chumas na dtaighdeoirí agus an lucht gairme sláinte is fearr tabhairt faoi staidéir a chuirfidh feabhas ar shaol daoine

Sa bhreis ar 100 triail chliniciúil ar siúl faoi láthair le daoine a bhfuil ailse, diaibéiteas, galar cardashoithíoch ag gabháil dóibh

Inniu osclóidh OÉ Gaillimh Ionad Lambe don Taighde Aistritheach agus Saoráid Taighde Chliniciúil HRB in Ospidéal na hOllscoile, Gaillimh. De bhrí go mbeidh an dá shaoráid seo in aon fhoirgneamh amháin ar thailte an ospidéil beifear in ann an buntaighde saotharlainne a dhéanfar sa tsaoráid taighde aistrithigh a mheas sna trialacha cliniciúla sa tsaoráid taighde chliniciúil agus dá bhrí sin feicfidh othair an tairbhe i bhfad níos sciobtha.

I measc na gcineálacha staidéar a dtabharfar fúthu sa dá shaoráid beidh:

-          An baol a bhaineann le hailse chíche a fhorbairt mar gheall ar thréithe dúchais a réamh-mheas

-          Trialacha gascheall chun sreabhadh fola i gcosa othar diaibéiteach a fheabhsú d'fhonn teascadh a sheachaint

-          Trialacha cliniciúla in othar a bhfuil ailse fola ag gabháil dóibh le déanamh amach an féidir cóireálacha nua a chur le seanchóireálacha chun torthaí níos fearr a fháil

-          Conas is féidir le feistí leighis ionchlannaithe réitigh nua a chur ar fáil d'othair

Dúirt an Taoiseach inniu agus é ag oscailt an fhoirgnimh go hoifigiúil: “Tá an-áthas orm ceiliúradh a dhéanamh ar oscailt na saoráide nua seo áit a bhfuil Institiúid Lambe don Taighde Aistritheach agus Saoráid Taighde Chliniciúil an Bhoird Taighde Sláinte.  Léiríonn an tionscadal seo comhpháirtíocht thar a bheith nuálach idir OÉ Gaillimh, an Bord Taighde Sláinte, Grúpa Cúraim Sláinte Ospidéil Saolta, agus Feidhmeannacht na Seirbhíse Sláinte; comhpháirtíocht atá maoinithe ag daonchairdeas príobháideach trí Fhondúireacht Ollscoil na Gaillimhe.

Samhlaítear Éire mar mhol domhanda atá ag teacht chun cinn go láidir san earnáil leighis-teicneolaíochta. Tá Gaillimh i gcroílár na forbartha seo agus tá OÉ Gaillimh mar lárionad do chuid mhór den dul chun cinn seo.

I mí Iúil 2011, d'oscail mé an foirgneamh nua Innealtóireachta go hoifigiúil in OÉ Gaillimh.  I mí Feabhra seo caite d'oscail mé an foirgneamh Eolaíochta Bithleighis. Inniu osclaímid saoráid uathúil taighde chliniciúil agus aistrithigh.  Nuair a chuirtear le chéile na trí shaoráid seo tá éiceachóras iomlán againn d'oideachas, taighde, nuálaíocht agus cúram sláinte in Iarthar na hÉireann.

Seasann an tsaoráid is déanaí seo don phointe ina dtagann taighde agus cúram sláinte le chéile – an pointe ina dtagann an “teoiric” agus an “cleachtadh” le chéile.  De bharr na hoibre a dhéanfaidh taighdeoirí agus cliniceoirí sa tsaoráid seo is cinnte go mbeidh torthaí sláinte príomha níos fearr ann agus ar deireadh cuirfear feabhas ar shaol na n-othar.”

Bhí an méid seo a leanas le rá ag an Dr Jim Browne, Uachtarán OÉ Gaillimh, “Is buaicphointe i bhforbairt an leighis in OÉ Gaillimh atá sa lá inniu. 

Tá tús áite straitéiseach tugtha ag OÉ Gaillimh d'fhorbairt na heolaíochta innealtóireachta bithleighis.  Le scór bliain anuas tá infheistíocht láidir déanta againn sa réimse seo, agus saoráidí móra taighde ar an gcampas mar thoradh air seo. Cuireann ár dtaighdeoirí eolas eolaíoch chun cinn d'fhonn aghaidh a thabhairt ar dhúshláin sláinte.  San fhoirgneamh seo táthar ag déanamh cóireálacha nua as an eolas eolaíoch seo, agus ansin tá siad sin á gcur i bhfeidhm sa suíomh cliniciúil agus á dtástáil i dtrialacha cliniciúla faoi stiúir OÉ Gaillimh.”

Dúirt an Dr Graham Love, Príomhfheidhmeannach an Bhoird Taighde Sláinte, “Tá níos mó ná foirgneamh i gceist le Saoráid Taighde Chliniciúil HRB, is athrú iomlán ar chur chuige atá ann. Tá obair mhór i gceist le fionnachtana taighde sláinte a aistriú isteach i bhfíorbhuntáistí do shláinte daoine agus do chúram othar. Cuirfidh an tsaoráid HRB seo ar chumas na dtaighdeoirí agus na ngairmithe sláinte is fearr dá bhfuil ann staidéir a dhéanamh a athróidh saol daoine chun feabhais.

Beidh áit shábháilte ag othair sa tsaoráid HRB chun páirt a ghlacadh i dtrialacha cliniciúla agus chun teacht ar na cóireálacha is nuaí. Lárionad foghlama do thaighdeoirí óga agus do ghairmithe sláinte a bheidh ann – táimid ag déanamh infheistíochta inár dtodhchaí. Chomh maith leis sin, cruthóidh sé deiseanna comhpháirtíochta idir an córas sláinte, an lucht acadúil agus an tionscal a thacóidh le nuálaíocht sa chóras sláinte agus le forbairt gheilleagrach.

Dúirt Maurice Power, Príomhfheidhmeannach, Grúpa Cúraim Sláinte Ospidéil Saolta, “Tugann an tsaoráid nua seo taighde ceannródaíoch leighis chuig an othar sa leaba in Ospidéal na hOllscoile, Gaillimh agus sa Ghrúpa Ospidéil níos leithne.  Cuirfidh an tsaoráid na nithe seo a leanas ar fáil dár n-othair: leapacha in-tí agus eisothair, seomra do mhionobráidí, seomraí ionscópachta, inchríneacha agus cardairiospráideacha, seomra fleibeatóime agus aonad bithmhéadrachta.  Chomh maith le feidhmiú go príomha ag déanamh leasa dár n-othair cuirfidh sé ar chumas an Ghrúpa Ospidéil na gairmithe leighis is fearr a mhealladh agus a choinneáil.”

Bhí ról lárnach ag an daonchairdeas san fhorbairt seo.  Thug Fondúireacht Ollscoil na Gaillimhe aitheantas don tacaíocht a fuarthas ó dheontóirí daonchairdiúla, go háirithe an Dr Ronan agus Ann Lambe, breis is 50 ball de Líonra Leighis na Coiribe, Banc na hÉireann agus an Institiúid Náisiúnta don Taighde ar Ailse Chíche.  Ag labhairt dó ag an seoladh dúirt an Dr Ronan Lambe:  “Is iontach an phribhléid dom féin agus do mo bhean a bheith bainteach le saoráid den scoth a chuirfidh go mór le cáil OÉ Gaillimh mar ionad barr feabhais don Taighde Bithleighis.”   

Mar gheall go bhfuil an Ollscoil chomh gar don Ospidéal beidh teacht ag taighdeoirí go díreach ar othair agus beidh ionchur comhoibríoch trialach ag an Aonad Trialacha Cliniciúla Oinceolaíochta/Haemaiteolaíochta san ospidéal. Cinnteoidh an tSaoráid Taighde Chliniciúil go mbeidh teacht ag othair in Iarthar agus in Iarthuaisceart na hÉireann ar theiripí nua ailse nach mbeadh ar fáil dóibh murach an tsaoráid seo. Tá trialacha cliniciúla ar siúl faoi láthair chun cóir leighis a chur ar fáil in aghaidh: meileanóma, mialóma iolrach, liomfóma ceall maintlín, alise chíche, phróstataigh, scamhóige, ghastraistéigeach agus ghínéiceolaíoch.

Roinnt samplaí de na trialacha atá ar bun sa dá shaoráid

Cás-staidéar 1 – An baol a bhaineann le hailse chíche a fhorbairt mar gheall ar thréithe dúchais a réamh-mheas

Tá níos mó cásanna den ailse chíche ag teacht chun cinn agus níltear cinnte fós faoin ról atá ag géinitic i bhformhór na mban. Áirímid go bhfuil níos lú ná 10% de mhná le stair láidir teaghlaigh a bhfuil mínormáltacht sna géinte BRCA1 nó BRCA 2, géinte atá bainteach leis an mbaol a bhaineann le hailse chíche a fhorbairt.

Dar leis an Ollamh Michael Kerin, Stiúrthóir Gníomhach Institiúid Lambe don Taighde Aistritheach,

“In Iarthar na hÉireann feictear líon an-ard d'ailse chíche agus is príomhthosaíocht taighde é na géinte is cúis leis an ailse seo a scrúdú agus tá go leor staidéir idirnáisiúnta déanta sa réimse seo, staidéar amháin a d'aithin 74 athrú nua géiniteach bainteach le hailse chíche. Tabharfaidh Saoráid Taighde Chliniciúil HRB deis dúinn trialacha nua a fhorbairt bunaithe ar na spriocanna géiniteacha seo.”

Cás-staidéar 2 – Teascadh in othair le diaibéiteas mellitus a sheachaint

Is minic go gcuireann sreabhadh teoranta fola sa chos as d'othair a bhfuil diaibéiteas mellitus ag gabháil dóibh. Go hiondúil bíonn morgadh, pian agus tú ar do shuaimhneas nó othrasú sa chos ag cur as d'othair. Cé gur féidir seach-chonair a dhéanamh ar an mbacainn i gcásanna áirithe, tá an baol ann go mbeidh teascadh i gceist d'othar amháin as triúr a mbaineann an aimhréidh seo dóibh. Go deimhin, tarlaíonn teascadh chuile 30 soicind in áit éigin ar domhan de bharr diaibéiteas mellitus, agus is ar an mbunús sin a theastaíonn cóireálacha nua go géar.

Déanfaidh staidéar nua – a bheidh ar bun idir Saoráid Taighde Chliniciúil HRB, Institiúid Lambe don Taighde Aistritheach agus Ospidéal na hOllscoile, Gaillimh – a bhaineann le gaschealla a thógáil ó smior na n-othar, iad a fhás i saotharlann speisialta ar leith in OÉ Gaillimh agus iad a instealladh sa chos ar an láthair taighde chliniciúil faoi leith.  Tá an taighde seo ar an gcéad staidéar a bhaineann leis an taighde daonna agus é mar aidhm aige an cur chuige ó thaobh sábháilteachta agus indéantachta a mheas; tá an taighde á mhaoiniú ag an mBord Taighde Sláinte agus ag Fondúireacht Eolaíochta Éireann. 

Dar leis an bpríomhthaighdeoir, an tOllamh Tim O Brien, Déan, Coláiste an Leighis, an Altranais agus na nEolaíochtaí Sláinte, OÉ Gaillimh agus Comhairleoir le hInchríneolaíocht in Ospidéal na hOllscoile, Gaillimh,