Suchergebnisse

Blanaid Mee,1 Eoin Gaffney,2,3 Sarah McGarrigle,4 Sharon A Glynn,5,6 Elisabeth M Connolly,7 Paul H McCormick,7 Delia Flannery,7 Katrina O'Connor,7 Margaret Lawson,1 Lisa Ryan,1 Timothy Nugent,1 Ronan Ward,1 Francis J Sullivan,6 Joanna Fay,8 Tony O'Grady,8 Elaine Kay,8 Joe Eustace,9 Louise Burke,9 Stephen Finn,1 Richard Flavin1 1Department of Pathology, St James's Hospital, 2Trinity College Dublin, Dublin, 3National University of Ireland Galway, Galway, 4Department of Surgery, School of Medicine, Faculty of Health Sciences, Trinity College Dublin, Dublin, 5Department of Pathology, National University of Ireland Galway, 6Prostate Cancer Institute, National University of Ireland Galway, Galway, 7Department of Surgery, St James's Hospital, 8Department of Pathology, Beaumont Hospital, Dublin, 9Department of Pathology, Cork University Hospital, Cork, IrelandAbstract: Ireland has an established reputation in specialized global pharmaceutical manufacturing. However, simple high-volume manufacturing will not sustain the Irish pharmaceutical industry, and government agencies recommend a greater focus on innovation and research and development (R&D). Biobank Ireland Trust sought the views of the Irish pharmaceutical industry on the potential benefits of a national biobank network (NBN), national biobank web portal (NBWP), and center for translational molecular oncologic pathology (CTOP). Questionnaires were sent to 19 companies and eleven responded. Questionnaire A was completed by six companies presently engaged in R&D in Ireland – three pharmaceutical companies, two spin outs, and one contract research organization. Six of six respondents reported that: a NBN would benefit their company; the development of a NBWP was important; and finally, they forecast that the requirement for biobanked material would continue to increase. While three of six predicted that a NBN would facilitate an expansion of current R&D activities. The relative importance of accessing biobanked material and data varied. An associated NBWP was considered essential to enable researchers to rapidly determine the content of the NBN for research, including preclinical studies. Individual companies had requirements for biobanked material from a wide variety of cancer sites, sample types, and sample derivatives. Questionnaire B was completed by five pharmaceutical companies currently not engaged in R&D in Ireland. Four of five reported that a CTOP would benefit their company. All five stated that a CTOP could cultivate industry–academic collaborations. All five also determined that NBN–NBWP–CTOP infrastructure would assist in promoting Ireland as an R&D center. Finally, four of five indicated that an NBN would make Ireland more competitive for new clinical trials. This pilot survey suggests that an NBN with associated infrastructure would greatly facilitate research conducted by the pharmaceutical sector in Ireland.Keywords: pharmaceutical industry, Irish biobanks, NBN, CTOP, NBWP, biobanked material

Biobank Ireland Trust (BIT) was established in 2004 to promote and develop an Irish biobank network to benefit patients, researchers, industry, and the economy. The network commenced in 2008 with two hospital biobanks and currently consists of biobanks in the four main cancer hospitals in Ireland. The St. James's Hospital (SJH) Biobank coordinates the network. Procedures, based on ISBER and NCI guidelines, are standardized across the network. Policies and documents—Patient Consent Policy, Patient Information Sheet, Biobank Consent Form, Sample and Data Access Policy (SAP), and Sample Application Form have been agreed upon (after robust discussion) for use in each hospital. An optimum sequence for document preparation and submission for review is outlined. Once consensus is reached among the participating biobanks, the SJH biobank liaises with the Research and Ethics Committees, the Office of the Data Protection Commissioner, The National Cancer Registry (NCR), patient advocate groups, researchers, and other stakeholders. The NCR provides de-identified data from its database for researchers via unique biobank codes. ELSI issues discussed include the introduction of prospective consent across the network and the return of significant research results to patients. Only 4 of 363 patients opted to be re-contacted and re-consented on each occasion that their samples are included in a new project. It was decided, after multidisciplinary discussion, that results will not be returned to patients. The SAP is modeled on those of several international networks. Biobank Ireland is affiliated with international biobanking groups—Marble Arch International Working Group, ISBER, and ESBB. The Irish government continues to deliberate on how to fund and implement biobanking nationally. Meanwhile BIT uses every opportunity to promote awareness of the benefits of biobanking in events and in the media.