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Periodic Report Summary 2 - BBMRI-LPC (BBMRI - Large Prospective Cohorts)

Project Context and Objectives:
Recently, biomedical research has crossed international borders in large, collaborative studies showing the value of multidisciplinarity and scale advantage. These studies have yielded valuable insights and some led to new and better medicines and treatments for diseases. However, disease-focused studies provide less insight in the real disease onset, the relative disease burden in the population, and the actual comparability of selected patients. Large prospective cohort (LPC) studies following up initially healthy participants for years or decades are considered more reliable and wide range of diseases can be studied. LPC studies require large numbers of subjects which is costly, but particularly benefited from the advent of high throughput techniques providing opportunities for powerful study designs.

Specifically, we aim in BBMRI-LPC to:
(1) Evaluate/improve the harmonization of individual data on health, lifestyle and other exposures;
(2) Develop/implement harmonized definitions of diseases;
(3) Improve biobanking and research technologies and develop innovative solutions facilitating high-quality, fair access to samples and data;
(4) Provide free transnational access by us-ers through study proposals selected by open pan-European calls;
(5) In the framework of the selected studies, generate and provide access to whole genome sequences, transcriptome, proteome, metabolome and methylome data;
(6) Build new public-private partnerships involving large-scale prospective cohorts, and strengthening the existing ones, allowing transparent industrial access to academic expertise;
(7) Build a network transferring the expetise of established European large-scale biobanks to new biobank initiatives under development in other countries.

Project Results:
During the second period of BBMRI-LPC, the road to transnational access was truly initiated. While networking and training were still very active, the 2nd and 3rd BBMRI-LPC scientific calls for access completed the competitive procedure for getting support for access. Several multinational projects of high scientific quality were granted access to samples and data of the BBMRI-LPC partici-pating cohorts.
The BBMRI-LPC calls open up new collaborations and novel avenues for scientific breakthroughs within EU. Moreover, the Process of Access, perhaps the most important outcome of BBMRI-LPC, has been well-clarified and documented, noting both the strengths and the weaknesses requiring pan-European attention and improvement.

The project dissemination and training activities are well on-going. The project website has all the functionality requested at the beginning and is of major help for both project beneficiaries and for the call applicants. In addition to this, a Helpdesk for biobanks and “Biobanking article of the week”-features have been continued.

The 2nd and 3rd LPC Forum meetings were organized on September 23rd, 2014 (Tallinn, Estonia) and on September 24-25, 2015 (Budapest, Hungary). The LPC Forum organizing team has made a major effort to find representatives of biobank initiatives in all European countries with special focus on Eastern Europe. Several approaches have been used to reach ministries and individual scientists. As a result, the Forum organizing team now has contacts in essentially all European countries, including information from more than 100 emerging biobanks.

In Period 2, two practical biobanking courses have been organized for transferring information and expertise from the established to the emerging biobanks. Also, in the frame of BBMRI-LPC, several site-visits and meetings have been taken place in order to provide the experience of well-performing biobanks to new or starting biobanks and sample collections. “Handbook for Practical Biobanking” directed to the early stage biobanks has been compiled and is accessible on the project website.

BBMRI-LPC has collaborated closely with the BBMRI-ERIC Common Service ELSI. The general ethical concerns for the future developments of biobanks and the property issues have been addressed through presentations in international congresses. Specifically, the issue of data sharing has been worked out in the con-text of the development of Big Data. In addition, the challenge of intellectual and biological property has been addressed to contribute in identifying current road-blocks for data sharing.

Importantly, the standard BBMRI-LPC MTA/DTA document was constructed during Period 2 by the ELSI experts specialized in biobanking and biolaw issues. The BBMRI-LPC MTA/DTA is offered as an option to be used when data and samples are transferred in the BBMRI-LPC access process.

A quality control (QC) study has been set up among the BBMRI-LPC partners to evaluate the usability of samples from existing cohorts for the metabolomics studies. Many of these cohorts have been set up at a time when metabolomics did not yet exist as a methodology and therefore the specific demands on sample quality could not be foreseen. At first stage, 9 biobanks enrolled in the study. A presentation of the results was given at the Annual Consortium Meeting in April 2015, in Barcelona. Collated results are expected by May 2016 for publication and public release.

Research on sample management and analysis carried out within BBMRI-LPC aims to provide a scientific evidence base for higher performance instrumentation, methodologies and protocols in biobanking. To achieve real-life interoperability of services there is a need to focus on a research program on the processes used by the service providers (biobankers) balanced with customer (researcher) demands on costs, speed, versatility and sample quality. Data accumulated is used to launch and test the evidence-based protocols for joint use at the participating core facilities, including high quality DNA and RNA isolation and integrity evaluation methods.

Establishment of academic-industrial interactions has been significantly hampered by the international crisis, which has hit the pharma companies hard and is only now gradually subsiding. Yet, many of the BBMRI-LPC parties have established regional, often bilateral public-private inter-actions (PPI). To get a better view on these PPI dynamics, an inventory of the existing and emerging interactions between the BBMRI-LPC related biobanks and/or academic centers and the private sector is being created through a series of interviews with the key opinion leaders.

New academic-industry interactions are delivered by the transnational access projects and through the quality management development. In parallel, the same activities are advancing multi-omics approaches to yield systems-level insights.

The 2nd and 3rd scientific BBMRI-LPC call for access were published on March 15th, 2015 and November 1st, 2015, respectively. To support the applicants with their prospective research proposals, a specific BBMRI-LPC access website ( was launched prior to opening the 2nd BBMRI-LPC call. The BBMRI-LPC catalogue of samples and data [accessible on the access website] was extended to be able to show information on individual sample basis. The BBMRI-LPC Exposure Data Library [accessible on the access website] represents an important milestone as well as a long-term investment to support the BBMRI-LPC scientific calls and future joint research projects by facilitating data identification, selection as well as harmonization and prioritization. Progress has been made in completing an inventory of currently available endpoints in the BBMRI-LPC participating cohorts.

For determining the access costs to samples and data in population-based cohorts within BBMRI-LPC and beyond, development of a web-based cost calculator has been initiated.

As a result of the three BBMRI-LPC scientific calls, extensive insight into the Process of Access is being generated. Mapping the various features of the access process and recording the country- and cohort-specific differences is expected to promote better and more refined access solutions in the future. Indeed, this information will be one of the most essential outcomes of the BBMRI-LPC project.

The diversity in national legislations and local rules across Europe are currently making the transnational access to LPCs in Europe cumbersome. Whilst the all three BBMRI-LPC calls for the scientific access projects and their review process were accomplished in a very short time and were highly effective per se, the duration of the subsequent access provision process has been disappointingly long. This is largely due to the necessary local requirements, like specific application and review procedures, obtaining ethical clearance and updating registry linkages. The procedural tedium along with the magnitude and heterogenei-ty of the logistic, administrative and regulatory hurdles has been highlighted by the Process of Access. These observations help to identify a number of areas where infrastructure developments can be made for improving the time-efficiency of the future access provision to LPCs in Europe.

Potential Impact:
As a focused extension to BBMRI, addressing access to existing LPCs and establishment of new LPCs, the BBMRI-LPC project will greatly contribute to the consolidation of a unified infrastructure for biobank-related research in Europe and to better coordination of the largest European prospective studies. The BBMRI-LPC research infrastructure further implements the ERA visions by creating a network together with BBMRI to create a centre of knowledge. This proposed network will promote innovative diagnostics and therapeutics for the health of the EU citizens and beyond.

Further integration of the population cohorts should strengthen the position of Europe as the major player of biobank research of LPCs across the world. Creating this single area for access to LPCs for research in Europe will therefore strengthen the competitiveness of Europe in biomedical sciences, with an expected increase in the number of high-profile publications and subsequent acceleration of innovative health care solutions for the benefit of the patients. BBMRI-LPC is facilitating multinational studies initiated by investigators from any European country and provides access to resources developed by all European countries.

The European biobanking field is currently dominated by Western and Northern European Member States. Establishment of the LPC Forum with representatives from all European countries will help to initiate new European biobank initiatives, particularly in Eastern Europe. As these countries need evidence-based information on the health and disease status of their citizens, establishment of population cohorts in the member states that do not yet have them, will have a major structuring impact on cohort-based health research in Europe. In the context of implementing the European Cohesion Policy and observing the objectives of the Warsaw Declaration to address health inequalities in Europe, BBMRI-LPC will make common tools and procedures available for all biobank operators throughout Europe. Fostering strong synergies with BBMRI-ERIC andthe BBMRI-ERIC Common Service ELSI, the BBMRI-LPC network will harmonize biobanking technologies and quality management towards the omics era, host global connections and structure investigator networks. A specific niche of the current programme will be promotion of academia-industry collaboration and strengthening Europe’s attractiveness for industry R&D, and developing partnership with and access to broad communities of medical researchers through the Expert Centers.

The current BBMRI-LPC consortium unites 21 LPCs. Since national population cohorts are being organized through the National Nodes, BBMRI-LPC will also strengthen the structuring of national infrastructures. The strong impact of National Nodes is seen to be a necessity for success in building biobanking infrastructures. Involvement of National Nodes will also increase the attractiveness of Europe for industrial perspective through sharing common tools, standards and procedures. This paves the road towards harmonized biobanking culture in Europe and a new generation of professionals in biobanking-related research. More importantly, the active involvement of National Nodes will also ensure an efficient and informed involvement of sample donors and citizens. Strengthening national infrastructures will also increase the attractiveness of European countries for industry trials (with a major economic impact), improve health innovation, and the promotion of evidence-based medicine with its impact on cost containment in the healthcare system. In addition, improved scientific competitiveness will facilitate access to the H2020 Health Priority funding to multi-national investigations involving large population cohorts.

The BBMRI experience in cross-border collaboration will have a major impact on global initiatives, with numerous BBMRI partners working on the harmonisation of biobanking related procedures at the global level. No similar initiative for multinational cooperation and cross-border culture currently exists in the world.

Thus the BBMRI-LPC will open new perspectives for BBMRI and the National Nodes, with worldwide competences for the exploitation of biobanks for better diagnostics, treatments and prevention of human diseases. These activities could be foreseen to result in establishing a global organisation of biobank research infrastructures, in which Europe would play a leading role as the unique experience of BBMRI and BBMRI-LPC will obviously be highly valuable in finding possible solutions.

Besides improving the access to samples, data and standard procedures, the BBMRI-LPC project will facilitate integrated research across different cohorts by independent investigators. With the specific innovation and joint research activity model of the LPC, novel tools for genetic, proteomic and metabolic analysis of samples will be developed, and advanced access for sample-related omics data will be developed by upgrading existing biobanks from sample repositories to data hubs. Whole genome sequences and various omics data of prospective population cohorts will be generated. This innovative approach reaches far towards future models of biobanking research by combining the necessity for integrated access to both samples and advanced omics data thus accelerating the innovation process and saving costs of sample storage in the long term.

According to OECD, biobanks are an essential part of the infrastructure under-pinning life sciences and biotechnology. They have the potential for a substantial impact on the economic growth of the regions in which they are located. This aspect is well developed with the specific goal of BBMRI-LPC to support the biobank infrastructure development in Eastern Europe. The long-term impact of the BBMRI-LPC project is foreseen on the economy, health and welfare in general. The long term impacts should be seen as new medical applications, new therapies, new diagnostics, personalized medicine and new biomedical industries increasing European competitiveness, reducing socio-economic differences and increasing possibilities for equal health care across the Europe.

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