Following the rapid progress of genomic research in humans and their ancestors, biomedical and health research has expanded from the study of rare monogenic diseases to common, multifactorial diseases. However, genetic background of most complex diseases is determined by a large number of small, often additive effects from genetic predisposition, lifestyle and the environment.

Both the discovery of critical genes and pathways as well as the follow up analyses of the impact and significance of these will critically depend on biobanks, large collections of well-documented, up-to-date epidemiological, clinical and biological information and accompanying material from large numbers of patients and healthy persons representing general population. Biobanks are a key resource in unraveling also the association between genetic background, life style and environmental risk factors for various diseases and their trait components.

Biobanks are characterized by a collection of biological samples, such as blood, tissues or DNA, plus associated epidemiological, clinical and research data. The biobanks may also consists of biomolecular research tools, key resources in analyses aiming at unravelling genetic and environmental factors underlying diseases and influencing their outcome. Research tool resources are also required for identification of new targets for therapy and may help to reduce attrition in drug discovery and development. Thus, biobanks, if well collected, characterized and accessible provide a critical competitive advantage for the advancement of biotechnology, and human health and disease related activities in Europe. Biomedical quality-assessed samples and data as well as biomolecular resources and molecular analysis tools are essential for academic and industry-driven research to treat and prevent human diseases.

Goals of BBMRI

The preparatory phase aims to provide the basis for the actual operational biobanking infrastructure and plans to provide a strategy and structure for:

• a pan-European inventory of major European biobanks
• complementation of existing resources and technologies
• establishment of clear access rules
• facilitation of transnational combination and exchange of biological materials and data
• ensuring coordinated development of resources and technologies
• reducing the fragmentation of the scientific community
• developing a sustained financial basis for years to come

BBMRI will increase the scientific excellence and efficacy of European research in the biomedical sciences as well as expand and secure competitiveness of European research and industry in a global context and attract investments in pharmaceutical and biomedical research facilities, also from outside of Europe.

BBMRI will be composed of a network of centres organized in a distributed hub structure comprising:

• biobanks of different formats (collections of blood, DNA, tissue, etc., together with medical, environmental, life-style and follow-up data),
• biomolecular resources (antibody and affinity binder collections, ORF clone collections, siRNA libraries, proteins, cellular resources etc.),
• enabling technologies and high-throughput analysis platforms and molecular tools to decipher gene, protein and metabolite functions and their interactions,
• harmonized standards for sample collection, storage, pre-analytics and analysis,
• harmonized databases and biocomputing infrastructure and
• ethical, legal and societal guidance platform.

The Structure of BBMRI

Key components of BBMRI are comprehensive collections of biological samples from different (sub-) populations of Europe, which should be linked with continuously updated data on the health status, lifestyle and environmental exposure of the sample donors. This can only be achieved in a federated network of centres established in most, if not all, European Member States. Therefore, the format of BBMRI should be a distributed hub structure in which the hubs coordinate activities, including collection, management, distribution and analysis of samples and data for the major domains. The biobanks, biomolecular resources and technology centres, which are members of BBMRI, are associated with their specific domain hub. Furthermore, a variety of public or private partners (e.g., universities, hospitals, companies), which provide biological samples, data, technologies or services, may be associated with certain BBMRI members.

• BBMRI members represent the key providers of resources and technologies. Members are leaders in the field and drivers of innovation and scientific excellence. Membership is non-exclusive so that members link BBMRI to other national, European (e.g., other FP7 programs) and global initiatives (e.g., the emerging OECD global network of Biological Resource Centres or WHO programmes).
• Associated partners and subcontractors provide certain resources (services, data, samples, materials) to BBMRI. An associated partner, for instance, a hospital or research institute which provides biological samples and data, may be either reimbursed or compensated for its contribution by being granted free access to resources and technologies of the BBMRI. Associated partners may also be ministries, governments, research councils, and funding agencies from interested countries whether or not they currently support biobank or biomolecular resource infrastructure projects
• Users may come from different fields of academia and industry. Access will be provided in the context of specific research projects and on the basis of secured funding. Incentives may be provided for EU Member States and for industry to enter into general user agreements.

This structure provides great flexibility so that new members and partners can be connected at any time and so that it can be adapted to emerging needs in biomedical research. The IT infrastructure which employs federated database architecture and grid computing technology will integrate the complex network of hubs, members and partners. Hubs will be coordinated and directed by an executive management, which is supported by a governance council as well as by a high-calibre advisory board and receives input from the stakeholder forum to guarantee clear responsibilities as well as open and transparent decision-finding processes.

BBMRI will link to several ongoing international activities, such as those pursued by P3G, the Innovative Medicines Initiative, ISBER, the OECD, and the WHO, as well as research projects funded under FP5/FP6 and new projects under FP7. To avoid duplication of activities, BBMRI will exchange concepts and experience with these activities.

BBMRI will contribute to the scientific excellence of Europe by

• providing access by investigators to high quality biological resources and data,
• supporting training of a new cadre of professionals in biobanking,
• participating in current and future national EU framework programme health research projects,
• enabling synergies between epidemiologists, clinicians, geneticists, pathologists and molecular biologists in national centres of excellence,
• partnering with the pharmaceutical, biotech and computing industries.

BBMRI will provide a competitive advantage and fruitful environment for development of service and technology companies by acting as an R&D partner as well as a customer.

The implementation and development of its "distributed hub structure" is designed to allow the extension of the infrastructure by incorporating existing and new components that meet the criteria of excellence of BBMRI and that have physical locations in the convergence regions as well as the outermost regions thus providing a pan-European solution.

BBMRI will speed up development of personalised medicine and disease prevention and will embrace some of the needs of basic research as well as of the biotech and pharmaceutical industries. Thus it will enable improvements in public health and will help some bottlenecks in the drug discovery and development process. BBMRI will strongly boost political and scientific momentum to harmonise ethical, legal and quality standards across Europe.

BBMRI will contribute to EC policy developments by

• harmonising existing standards,
• providing opportunities for integrated transnational education and training,
• preparing the ground for harmonized legislation with respect to use and exchange of biological samples,
• leading to harmonization of funding schemes throughout Europe to provide sustained funding to guarantee maintenance of and access to key resources.

BBMRI Fact Sheet

Participating Members

Scientific Partners: 30
Funding Organisations (ministries, research councils): 24
Associated Partners: >150

8. Budgetary information

Preparatory cost: 5 M€
Construction cost: approx. 170 M€
to be further determined in the preparatory phase
Operation cost (total): approx. 15 M€/year

Timetable until operation

Preparatory phase: 27 months
Construction phase: 12 months for core network / 36 months for fully established infrastructure
Operation: 20 - 30 years