Michael Hummel: There are three essential requirements for the networking of biobanks. First, the IT infrastructure must allow searches for

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1 newsletter n Q2_2017 Editorial In the future it will be possible to search for samples and data throughout Europe Dear colleagues, We are happy to announce that the German Biobank Alliance will start its activities together with the German Bio bank Node on May 1! This is the very positive outcome of a long and intensive time of preparation, which finally led to this excellent initiative serving the entire German biobank community. Eleven biobank sites spread over Germa ny are being funded by the Federal Mini stry of Education and Research (BMBF) together with two IT development sites, the TMF and DIN, and the German Bio bank Node as the coordinating struc ture. This German Biobank Alliance will not be a closed shop but stay open to the whole community, and everybody is welcome to join our endeavor. Here we give you an overview of what is planned for the next three years. And we have asked some of our colleagues and collaborators what they think of the current German developments we are happy to share these voices with you. Also, have a look at our website bbmri.de and watch the film clip we have produced on personalized medicine! Enjoy the merry month of May - Michael Hummel & Cornelia Rufenach University hospitals all over Germany established centralized biobanks over recent years, providing high-quality samples and data for research purposes. The aim now is to form a network and to make these biobanks available to researchers, on a regional, national and international basis. Prof. Michael Hummel, the coordinator of the German Biobank Node (GBN) at Charité in Berlin, is driving the networking of German biobanks forward. Prof. Hummel, how is GBN pursuing this mission? Michael Hummel: There are three essential requirements for the networking of biobanks. First, the IT infrastructure must allow searches for samples across different biobanks in order to generate a critical mass of specific samples for a research project. Second, the biomaterials and data must be of comparable quality to permit such use. The third requirement is the harmonization of the ELSI aspects. Prof. Dr. Michael Hummel (National Coordinator of GBN/GBA) research and help to accelerate the development of new diagnostic and therapeutic agents. How will you implement this? GBN pursues the mission to network the centralized biobanks in Germany, so that in the future biobankencompassing collectives combined with clinical data can be used for bio medical research. This will en able considerable progress in medical Michael Hummel: Over the next three years, eleven German biobank sites will work closely together in the German Biobank Alliance (GBA) funded by the German Federal Ministry of Education and Research (BMBF). This network will help us to use funds and resources more effec GBN Central Office Publications & Events Topics German Biobank Alliance p. 3 p. 6 p. 7

2 tively in the long term. However, we will not work in an ivory tower. We will actively involve all stakeholder groups - not only researchers, patients and clinicians, but also the public, funding bodies, political groups, the media and medical companies from the very beginning. How will you collaborate with biobanks which are not being funded in the alliance? Michael Hummel: The German Biobank Alliance (GBA) is an open structure. The long-term aim is to bring all German biobanks together. Biobanks not receiving funding at present can become a part of this alliance if they adhere to the agreements that are defined by the consortium contract. Depending on requirements, these biobanks may participate actively in the GBA IT structure as part of the network, but also on an informal level. The IT and Quality Management tools developed in GBA should help in the latter case, so that every biobank can actively participate in the network at a later point in time even without external funding. What s Germany s position in the European biobank community? Michael Hummel: The German community will play a very substantial role in the European context. Thanks to the participation of GBN, Germany is very involved in BBMRI-ERIC, the European biobank hub. For example, we participate in a working group that is drafting quality guidelines and we are very active in the Common Services ELSI and IT. There are a number of German working groups that, together with IT experts from other BBMRI member states, are working intensively to create corresponding IT structures at the European level. I have the honor of managing these activities as the Director of the BB- MRI-ERIC Common Service IT. In the future, we will be able to search not only aggregated data in a directory, but search in European biobanks for suitable samples and data using a so-called Sample Locator. Once potential biomaterials have been identified, we will also support the next step: a precise definition of requirements and the provision of samples and data through the Sample Negotiator. This tool has already been developed and will shortly be used for searches in the directory. The funding of GBA, starting now, will be watched closely by other European countries. Germany will thereby set an example for many countries in Europe. We are already well positioned within the European community, and the new funding is certainly giving us a further boost. How will biobanks work 10 years from now? Michael Hummel: I imagine that biobanks will not only collect, store and manage samples and make them available for research, but they will also generate data from these biosamples. Instead of making the samples physically available, the biobanks will more and more supply analytical data, together with metadata or clinical data. This is already the case for some of our colleagues in northern European countries. They are engaged in projects in which biobanks generate analytical data and researchers can request the data but do not have to carry out the analyses themselves. Samples are sent only if they are needed for supplementary studies. The establishment of a national node for BBMRI was very fast and effective in Germany. The created structures and the developments in the German Biobank Node are exemplary and can serve as a best-practice example for other BBMRI nodes. The implementation of the projects now planned will enable the German biobank community to lay the foundations for successful networking across Europe. Prof. Dr. Kurt Zatloukal, Director BBMRI.at and member of the Scientific Advisory Board of GBN One of the key questions is to what degree sample data generated in research projects must remain within the research project or whether such externally generated data can flow back into the biobanks and following clearly defined rules can be made available to the research community. Shortly speaking, in the future it will be more about the data and less about the biosamples. This is an exciting prospect. Interview: Wiebke Lesch Why do we need biobanks for biomedical research? Erwin Böttinger and Michael Hummel explain how biobanks will shape research and and precision medicine. Find the video Biobanken und die Zukunft der Medizin (Biobanks and the future of medicine) on our website

3 German Biobank Alliance German biobanks join forces to cooperate across Europe The German biobanks are engaging in a pioneering collaborative effort towards professionalization of individual biobanks, implementation of functional national networks and development of IT infrastructures of European dimensions. I would like to sincerely congratulate the partners of the German Biobank Alliance, but also the German authorities for their foresight and strategy, and wish them good luck! Prof. Dr. Fay Betsou, Chief Scientific Officer IBBL (Integrated BioBank of Luxembourg) and Chairman of the Scientific Advisory Board of GBN work and collaborations to proceed together. GBA is operating under the umbrella of the German Biobank Node (GBN) that started in 2013 as a project funded by the BMBF. GBN represents the German national biobank community in the European initiative BBMRI- ERIC and functions as the German hub for BBMRI-ERIC. In the first funding period, GBN had the primary goal of generating concepts for IT networking, quality assurance and public relations. These concepts now create the basis for implementing a German Biobank Network which enables an efficient and broad interaction at the national level. 3 Starting in May 2017, 11 German biobank sites will collaborate in the German Biobank Alliance (GBA) to set the foundations for a new generation of biobank where samples and data can be accessed by researchers within Germany and across Europe. To enable exchange of biomaterial and data between German biobanks and European infrastructures, GBA will first develop, validate and implement tools as well as harmonize standards in participating biobanks. The German Federal Ministry of Education and Research (BMBF) is funding the project with 12 million euros for the next three years. The German Biobank Alliance is an excellent opportunity for the biobank community in Germany, says Michael Hummel, national director of the German Biobank Node (GBN). It will help to accelerate biomedical research in the long run. According to the proposal, GBA will establish, operate and develop a German research infrastructure of biobanks and biomolecular resources in order to facilitate the access to resources as well as support highquality biomolecular and medical research. An extensive harmonization process will be necessary between the different German biobanks, as well as with BBMRI-ERIC, for the exchange of biosamples and related data. IT networking, common quality standards and measures, as well as ELSI regulations, will have to be considered. All participating biobanks will sign a consortium agreement that addresses general harmonization issues, quality management issues, regulations for exchange of samples and data, and ethical and legal aspects. The agreement will enable I am very excited about the launch of the German Biobank Alliance. High-quality cross-linked biobanks form the basis to gain meaningful and reproducible results for medical research. The quality and availability of biomaterials as well as associated data is of crucial importance. Especially with respect to rare diseases, the networking of biobanks and the harmonization of data formats and processes is essential. Among other things, the German Biobank Alliance will devote itself to these topics and thus make an important contribution to the improvement of molecular research. We are well prepared to enter the next phase of our ambitious project. The acceptance in the community is very high and has been strengthened by the activities in the working groups for IT, quality and public relations. The motivation of the participating biobanks is very high, which makes the work extremely successful and productive, says managing director Dr. Cornelia Rufenach, who is in charge of overseeing the operations of GBN. Prof. Dr. Thomas Illig Scientific Head of Hannover Unified Biobank (HUB)

4 German Biobank Alliance in a nutshell Eleven German biobanks will build up the first version of the German Biobank Alliance. In order to realize this alliance, the local biobank infrastructures need to be prepared and adapted to facilitate sample and data exchange within Germany and Europe. This includes the expansion of the IT infrastructure, the application of common quality standards, the use of broad patient consents, and the willingness to cooperate at a national and international level. Interdisciplinary Center for Biobanking-Lübeck (ICB-L) operating since 2009 Integrated Research Biobank (IRB) operating since 2010 Hannover Unified Biobank (HUB) operating since 2012 UMG Biobank, University Medical Center Göttingen operating since 2012 Centralized Biomaterial Bank of the RWTH Aachen University operating since 2011 Interdisciplinary Biobank and Database Frankfurt (ibdf) operating since 2011 AACHEN FRANKFURT LÜBECK HANNOVER GÖTTINGEN WÜRZBURG HEIDELBERG JENA LEIPZIG ERLANGEN GREIFSWALD BERLIN German Biobank Node Central Office at Charité; operating since 2014 LIFE-Biobank operating since 2010 Integrated Biobank Jena (IBBJ) operating since 2002 University of Erlangen-Nuremberg Medical Informatics IT Expert Center BioMaterialBank Heidelberg (BMBH) operating since 2011 German Cancer Research Center (DKFZ) - Medical Informatics in Translational Oncology IT Expert Center MUNICH Joint Biobank Munich consortium since 2012 Interdisciplinary Bank of Biomaterials and Data Würzburg (ibdw) operating since 2013

5 newsletter n Q2_2017 Views of involved GBA partners The German Biobank Node (GBN) supports the improvement of quality management systems in biobanks and thus helps to promote standardization measures for sample collection. BBMRI-ERIC welcomes this efforts because it will raise future sample quality to the highest level for biomedical research. Andrea Wutte Quality Manager BBMRI-ERIC DIN is looking forward to the collaboration with the German Biobank Node and the German Biobank Alliance in this new BMBF project. The development of a strong European network together with BBMRI to focus on the optimization of quality management for biobanking is a very important subject with high market relevance. Therefore, we are glad to support this BMBF project by bringing national efforts to an international level and broadening its impact. We are excited at the prospect of the promising work ahead! The German Biobank Alliance will develop and implement an education and training program for technicians in the field of biobank ing. For the first time in Germany, this important occupational group will get the opportunity to be trained using online education modules and f-2-f trainings in all relevant biobanking topics. The increase in knowledge and anticipated better understanding of biobanking aspects will lead to improved sample quality, so that biomedical research will benefit in the long run. Dipl.-Ing. Lena Krieger Project management at DIN e.v. Deutsches Institut für Normung PD Dr. Sara Nußbeck Head of UMG Biobank Most recently, I learned about the Node s interactive stakeholder engagement workshop. Stakeholders can affect and be affected by actions, objectives and policies of an organization. Hence, the first step is to identify who the stakeholders are. Only then they can be characterized by their attitudes, motivations and concerns. The German Biobank Node / BBMRI. de has successfully started doing this and will extend their efforts in the future with a German Stakeholder Forum. Michaela Mayrhofer, PhD Chief Policy Officer CS ELSI/Senior Project Manager BBMRI-ERIC

6 newsletter n Q2_2017 German Biobank Node New location for the central office The GBN office has moved from the Benjamin Franklin campus of Charité to the historic Virchow campus in northern Berlin - just in time for the start of the new funding period. A fourth city hospital was built between 1898 and 1906 in the Wedding district of Berlin on the initiative of Rudolf Virchow. The Rudolf Virchow hospital was the last to be built in the so-called pavilion style (architect Ludwig Hoffmann). 57 individual buildings were built on an area of 270,000 square meters, one of which is the water tower. The GBN office is on the ground floor and has sufficient space for the new employees who will coordinate the GBN / GBA activities. Please pay us a visit you cannot miss the water tower on the Virchow campus - and as long as Tegel airport is still in operation, we are very easy to reach! The date of the house-warming party will be announced soon. New postal adress: Charité - Universitätsmedizin Berlin Campus Virchow Klinikum German Biobank Node (GBN) Augustenburger Platz 1, Berlin At the Virchow campus: Nordstraße 8 Profile Martin Lablans at DKFZ in Heidelberg coordinates the GBA IT Expert Centers Martin Lablans heads a research group developing methods to network distributed repositories of biosamples and corresponding data. To this end, his doctoral thesis in computer science established a decentralized search method, to federate data and sample repositories while preserving each owner s sovereignty using socalled bridgeheads. To address issues of distributed data integration, he cocreated Mainzelliste, a pseudonymization service integrated with several academic and commercial software systems, and the Samply suite of interconnected software compo nents for data integration and federa tion. These software components are among the building blocks of the German Cancer Consortium (DKTK) and the OSSE (open-source registry solution for rare diseases) funded by the German Federal Ministry of Health, and prospectively, BBMRI-ERIC and the German Biobank Alliance. Contact: m.lablans@dkfz.de SAVE THE DATE GBN ELSI Workshop on Return of genetic data to donors of biomaterial 17. October 2017, Berlin (Kaiserin-Friedrich Stiftung), 11am - 6pm GBN is organizing a workshop in Berlin on 17. October 2017 to start a dialog between science (including biobanks) and the public on how to approach the return of genetic (raw) data to donors, taking into account associated ethical, legal and logistical problems. The aim of the workshop is to develop recommendations for biobanks and researchers involving all relevant stakeholder groups. The details of the workshop will be announced shortly, but please mark the date in your calendar.

7 Publications Between GBN interviewed important biobank stakeholders to explore their opinions, attitudes, and needs regarding the future strategy and their expectations in centralized biobanks. Key findings of the research are published in the recently published book Gesundheitsforschung kommunizieren, Stakeholder Engagement gestalten. To order it, send an to: Chassang G (2017) The impact of the EU general data protection regulation on scientific research. Ecancermedicalscience. 11:709. doi: /ecancer Thasler RMK, Berghammer AJ, Kirchner T, Slotta-Huspenina J, Becker KF, Schiergens T, Thasler WE, and Wichmann HE (2017) Federated Biobanking with Corporate Service Unit: The Munich Biobank Alliance Blueprint. Biopreservation and Biobanking. February 2017, 15(1): doi: /bio Forthcoming Events ISBER Annual Meeting Due North: Aligning Biobanking Practice with Evolving Evidence and Innovation May 2017 Toronto (CAN), Westin Harbour Castle Hotel http: /meetings.isber.org/2017/ 16. Annual Meeting of the section Molecular Diagnostics of DGKL May 2017 Tutzing / Starnberger See (GER), Auditorium Akademie Tutzing Annual Meeting of the German Society of Pathology (DGP) Pathology: Innovation and Cooperation June 2017 Erlangen (GER), Heinrich-Lades-Halle Global Biobank Week Towards Harmony in Biobanking September 2017 Stockholm (SWE), The Brewery - Conference Centre Stockholm Deadlines - submission of abstracts: 1. May & for travel fellowship: 5. May 14. Annual Congress of the German Society of Clinical Chemistry and Laboratory Medicine (DGKL) Laboratory medicine - from omics and big data to primary care October 2017 Oldenburg (GER), Weser-Ems-Hallen Oldenburg GBN ELSI Workshop Return of genetic data to donors of biomaterial 17. October 2017 Berlin (GER), Kaiserin-Friedrich Stiftung The German Biobank Node (GBN) is the central contact and exchange point for the German Biobank community - not only for researchers, but also for other stakeholder groups. Our aim is to facilitate exchanges of experience between national biobanks but also the participation in the European network of biobanks (BBMRI-ERIC). The development of standards for quality assurance as well as the elaboration of an IT concept for the sample and data exchange are our major projects. Imprint German Biobank Node Newsletter Q2 April 2017 National Coordinator: Prof. Michael Hummel Executive Director: Dr. Cornelia Rufenach Charité - Universitätsmedizin Berlin Institut für Pathologie CVK Augustenburger Platz Berlin Contact: germanbiobanknode@charite.de Tel