Biobanking, Biomarkers and Personalized Medicine in EU
The Biobanking and Biomolecular Research Infrastructure (BBMRI), which started the preparatory phase in 2008, started to pool all of the major biobanks in Europe. Together these represent ~12 million blood, body fluid, and tissue samples. In the following two years, BBMRI created the preconditions to make the biological materials and data available, as well as to standardize the analyses platforms and sample preparation. The project not only includes the organization and funding of the EU biobank, but also aims to establish a complete resource for EU life scientists, including a variety of affinity binders and molecular tools as well as a biocomputing infrastructure that will work with standardized protocols, making data generated from those materials more comparable. The BBMRI was selected for FP7 funding as one of six EU infrastructure projects that are supposed to benefit all EU researchers.
No single biobank can be large enough to generate statistically significant data of specific disease subtypes and it takes more than a few dozen or even hundreds of cases in well-defined diseases to correlate disease history or patient response to a certain therapy and to biomarkers. The 134 associated partners of the BBMRI could together provide about 2.4 million samples from population-based biobanks, and a further 10 million from disease-orientated biobanks. The project will seek to overcome the current fragmentation in biobanking, and could also become an interesting tool for the biopharmaceutical industry when validating biomarkers. The information generated from BBMRI will be useful for the development of personalized medicine.
The joint initiative, which will tie together Europe’s top research groups across almost every area of molecular and cell biology, also has a political dimension. Because the protection of the data obtained from biological samples continues to be a sensitive subject, the initiative will need to conform with all the national legislations involved. For that purpose, the partners plan to establish a widely-accepted and harmonized set of practices in line with the heterogeneous landscape of European and national regulations. For instance, the protocol to be added to the Convention of Human Rights, which was approved by the EU Council in 2007 and has now been sent out to member nations for ratification, states that the confidentiality of the information obtained through diagnostic, predictive and pharmacoge- netic tests of the samples must be assured. The researchers will have to find procedures that assure a high degree of data protection while simultaneously allowing use of the patient data to acquire deeper insights into the causes of disease. Three types of biobanks have been considered as source of biomarkers in EU (Riegman et al. 2008).
- 1. Population banks. Their primary goal is to obtain biomarkers of susceptibility and population identity, and their operational substrate is germinal-line DNA from a huge number of healthy donors, representative of a concrete country/ region or ethnic cohort.
- 2. Disease-oriented banks for epidemiology. Their activity is focused on biomarkers of exposure, using a huge number of samples, usually following a healthy exposed cohort/case-control design, and studying germinal-line DNA or serum markers and a great amount of specifically designed and collected data.
- 3. Disease-oriented general biobanks (i.e. tumor banks). Their goals correspond to biomarkers of disease through prospective and/or retrospective collections of tumor and no-tumor samples and their derivates (DNA/RNA/proteins), usually associated to clinical data and sometimes associated to clinical trials. Those data are usually not collected for a concrete research project, except in case of clinical trials, but from the healthcare clinical records. The amount of clinical data linked to the sample determinate the availability and biological value of the sample.
Currently, the Biobanking and BioMolecular resources Research Infrastructure Austria (BBMRI.at) is the Austrian national node of the European biobanking research infrastructure BBMRI-ERIC. BBMRI.at consists of and links Austrian universities and biobanks with the goal to establish a national biobanking research infrastructure for accelerating biomedical research. BBMRI.at aims to establish a state-of-the-art biobanking infrastructure in Austria and to increase close cooperation and harmonization between biobanks. These are prerequisites to facilitating access and fostering the use of biological samples and data for academic and industrial research. Biologic samples and data collected in biobanks are valuable resources for innovations in personalized medicine, and development of biomarkers, diagnostics and therapeutics.