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Enabling Clinical and Translational Research

Overview


 

Quicklink to items on this page:
MMI's vision for biobanking
Background to biobanking
GeneLibrary Ireland Design Phase
Biobanking Stakeholder Seminar
MMI Position Paper on Biobanking
MMI Guidelines for Standardised Biobanking
European Biobanking Network - BBMRI

 

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MMI's Vision for Biobanking

MMI's vision for biobanking is the creation of an all-island, standardised and carefully phenotyped repository of biological specimens and associated clinical data, accessible to acedemic and industry researchers and to start-uo and spin-out companies to underpin biomedical research and to fuel innovation and commercialisation.

Background to biobanking

A biobank is a collection of blood and/or tissue donated by healthy volunteers and/or patients with linked medical information which is made available for medical research and commercialisation of the products of medical research. Biomedical researchers need to study information and samples from large numbers of people, particularly in the understanding of complex disease processes and in investigating the role that different genes play in health and disease. Such information and large numbers of samples are not easily obtained and their collection often proves costly and time consuming. These biomedically-relevant and quality assured biological specimens also provide a powerful and valuable resource for the biotechnology and pharmaceutical industry to develop and validate new biomarkers for screening, monitoring and treating diseases. Such biological resources along with the information derived from the human genome are playing a key role in the development of more targeted therapies for patients based on understanding an individual’s genetic make-up, a particular example being herceptin in HER2-overexpressing breast cancer.

Currently, there is no population based biobank in either Ireland or Northern Ireland and no all-island clinical biobank. A number of disease specific bio-collections in oncology, cardiovascular disease, neuropsychiatric disorders and HIV have been funded by research funding bodies when supporting research into disease or as part of developing a clinical research facility. The Prostate Cancer Research Consortium is an example where a bio-resource has been established as a multi-disciplinary, trans-institutional collaboration with a view to sharing tissue, blood and DNA from patients with prostate cancer across Dublin for medical research. It is difficult to estimate the investment to date in biobanking by the major funding agencies but significant funding has been committed over the years to assemble individual bio-collections. For the most part, these ad hoc bio-collections have not been assembled with a view to being made available as a national and/or all-island resource but rather are used mainly by the researchers in the institution(s) involved in their assembly or their collaborators.

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GeneLibrary Ireland Design Phase

The Design Phase Report of GeneLibrary Ireland was submitted to the Health Research Board and the Research and Development Office in 2009. As proposed GeneLibrary Ireland would be an all-island control biobank with 10,000 DNA and blood samples from healthy volunteers, together with key phenotypic information which would provide the invaluable control population to study the genetic determinants of common diseases that significantly impact patients in Ireland and Northern Ireland. The preparation of the design phase of GeneLibrary Ireland, through MMI with Queen’s University Belfast and the University of Ulster, has united representatives from seven institutions across two jurisdictions together with patient representatives, all of whom have contributed their significant expertise to the configuration of an all-island control biobank. The overall view of the GeneLibrary Ireland international Scientific Advisory Board was that; ‘the design phase of GeneLibrary Ireland is an excellent plan how to establish a world-class all-island biomedical research infrastructure that is well embedded in the emerging European research infrastructure landscape’.

Unfortunately due to the severe fiscal environment and despite exploring every possibility, funding could not be secured to move to the implementation phase of GeneLibrary Ireland.

Please click here to download a copy of the Gene Library Ireland Design Phase Report

For more information on the preparation of the GeneLibrary Ireland Design Phase  please click here

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Biobanking Stakeholder Seminar

In 2009 MMI hosted a Stakeholder Seminar entitled ‘GeneLibrary Ireland - building an all-island biobanking framework through collaboration’ to provide an overview of the vision for GeneLibrary Ireland and to promote the benefits of a structured framework for harmonised biobanking to support clinical and translational research studies on the island of Ireland. As part of this seminar a representative from the Department of Health and Children presented an outline of the principles in the proposed Human Tissue Bill and the implications of this legislation for research involving human tissue donated from living donors and biobanks in the future.

For more information on the Biobanking Stakeholder Seminar click here

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MMI Position Paper on Biobanking

The requirement of the research and commercialisation sectors for access to large collections of standardised biological specimens will increase in the coming years. There is a need and an opportunity therefore to develop a joined-up, all-island approach to biobanking to ensure that all future investment in biobanking results in the collection of biological specimens in a linked, networked and harmonised manner and their use as a public resource. This has led MMI to agree a position paper on a strategic approach to the development of biobanking on the island of Ireland. This world-class, All-Island Bio-resource Infrastructure will provide the large standardised biological materials with linked clinical data needed to drive advances in pharmacogenetics, disease screening tools, biomarker discovery and validation and to ensure our competitiveness in the era of personalised medicine.

Click here to download a copy of the MMI position paper on a strategic approach to biobanking.

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MMI Guidelines for Standardised Biobanking

As a contribution towards a more strategic national approach to biobanking, and building on the work undertaken in the Design Phase of GeneLibrary Ireland, MMI has  developed guidelines to standardise the collection, processing and storage of biological materials donated for use in research.

The aim of the Guidelines is to ensure sample quality, consistency and integrity of bio-collections at different clinical and research centres in Ireland. The use of standardised  protocols for sample collection, processing and storage will help to ensure consistency and harmonisation across the different sites.

These Guidelines have been drafted with reference to international best practice in biobanking. The Guidelines have been approved by the Board of MMI and a have undergone a consultation phase to get the input of the research community engaged in  biobanking prior to publication.

Molecular Medicine Ireland is delighted to announce the publication of these Guidelines for Standardised Biobanking. In addition, these Guidelines have undergone  international peer review and are published in the most recent edition of the ISBER  Biopreservation and Biobanking Journal 2010. 8;1:3-63 (see link to download this  publication; liebertonline.com/toc/bio/8/1).

In his guest editor piece for this edition of the publication Prof. H.-Erich Wichmann, Director and Chair of Epidemiology at the Institute of Epidemiology at Helmholtz Zentrum München and Chair of BBMRI’s Work Package on Disease Oriented Biobanks stated that ‘Molecular Medicine Ireland has made an important step in developing SOPs which will be instrumental in standardising biobanking in Europe and in BBMRI’. He added that ‘BBMRI is happy to accept them as a first version of the BBMRI laboratory manual’. For further information on BBMRI please click here

MMI believes that the adoption of these Guidelines, for all new bio-collections would be a first step towards harmonising biological collections across different research/clinical centres and a contribution towards a more strategic approach to biobanking nationally.

MMI hopes that all those who support or are engaged in research that involves biobanking, including research funding agencies; hospitals and clinical research centres; clinical networks and disease groups will adopt these Guidelines as the basis for all newly funded collections of biological material. If the Guidelines are adopted in this way, MMI will have taken a significant step towards a more strategic approach to biobanking in Ireland and ensuring a greater return for public investment in biobanking.

The MMI Guidelines on Standardised Biobanking are available in hard copy, please contact Suzanne Bracken at suzanne.bracken@molecularmedicineireland.ie if you would like to obtain a copy. Electronic version is available here

MMI is currently developing an electronic library of standard operating procedures for biobanking which will be launched shortly.

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European Biobanking Network - BBMRI

Over 200 organisations - including national funders - in 24 EU Member States are jointly planning EU infrastructure to deliver the bigger and better resources today's research needs.

European infrastructures already manage over 10 million samples and BBMRI's goals to increase this number, to improve quality, to reduce fragmentation, to extend the reach of European researchers.

For more on BBMRI's plan to realise more fully the potential of European biomedical research click here

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Pictured above are participants at Gene Library Ireland's Stakeholders Seminar.