“Biobanks are one of four essential building blocks of medical research, alongside medical informatics, systems medicine and bioinformatics. These components are closely linked with the joint goal of unlocking different sources of data, information and knowledge and making them readily available for medical research and treatment”. With these words, Prof Dr Michael Krawczak (Chairman of the TMF Board, University Clinic Schleswig-Holstein, Campus Kiel) inaugurated the Sixth National Biobank Symposium with 260 participants, taking place in Berlin on December 6 and 7. This year again, the German Biobank Node joint the organisation of the annual meeting and the German Biobank Alliance reported on the latest developments via numerous presentations .

Biobanks are a key resource

“Biobanks are a key resource for molecular diagnostics. Without the management of biobanks by experts, you can’t offer any molecular diagnostics for clinical routine,” said Dr Albrecht Stenzinger, describing the role of biobanks in bioinformatics. The molecular methods are so far accompanied by only a limited number of therapy options, “yet a whole arsenal of therapy options is envisaged.”

Biobank operators want higher safety standards for refrigeration systems

The industry session focused on the topics of safety and reliability of biobank systems and systems. . The biobank operators urged the manufacturers to ensure that the refrigeration systems operate more reliably and should be linked with services that take effect in the event of a system failure. In future, manufacturers could provide risk analyses with the systems. Furthermore, the commissioning cycles were discussed, which were frequently described as tedious.

German Biobank Alliance and Medical Informatics Initiative have similar objectives

“The aims of the German Biobank Alliance and the Medical Informatics Initiative can be summarised in a nutshell by ‘sharing biomaterial’ and ‘sharing data’,” reported Prof Dr Hans-Ulrich Prokosch (University Clinic Erlangen-Nuremberg). Biomaterials are ultimately data too, which means that both initiatives are confronted with comparable challenges in the development of their corresponding IT infrastructures. They could build on each other reciprocally and should work closely together.

The same applies to the establishment of relationships with patients: Patients have a connection to the hospital treating them; consent management, potential re-contacting or information on research results would need to be based there, which would require the integration of various projects and infrastructures.

“Digital Health”: Personalised medicine needs more and more accurate data

In his evening lecture, Prof Dr Hans Lehrach of the Max-Planck Institute for Molecular Genetics in Berlin explained that 197,000 patients in Europe die each year from adverse drug reactions. Medicinal therapies are often ineffective because they are not supported by individual patient data that predicting whether a medicine will work or not.

He also asked the question whether everybody will have a personal data-based model in future, on the basis of which a doctor can individually tailor treatment in the sense of personalized medicine to the individual. However, personalised medicine needs more and more accurate data to enable modelling. The aim is a “predictive modelling of drug reaction,” stated Lehrach. But we are still very far from this goal in practice.

German Biobank Node and BBMRI-ERIC: Strengthening research in the network

“We need to shift from a scientifically driven organisation to a service driven organisation,” said Erik Steinfelder, new Director of the European BBMRI-ERIC network, to the biobank community. In order to act sustainably, biobanks must respond to and incorporate the needs of all stakeholders.

The German Biobank Node (GBN) would like to establish better conditions, especially for researchers, to ensure that the usage of the approx. 4.5 million liquid and 3 million tissue samples of the German Biobank Alliance continues to grow in future. The prerequisite for this is a central directory, which enables a quick overview and uncomplicated access to the available samples.

Since the start of GBN's second funding phase in May 2017, eleven biobanks have been working together in the German Biobank Alliance in order to network and harmonise their structures. The activities have progressed very successfully, announced Dr Cornelia Rufenach and Prof Michael Hummel (GBN). The foundations for a Germany-wide exchange of samples and data via suitable IT interfaces will be laid whithin the next three years. GBN has continued to developed generic SOPs for biobanks, which are now being implemented. Sample donors will be informed about biobanking starting in the spring of 2018 via a nationwide campaign initiated by GBN.

Sustainability: Business plan and catalogue of services required

“Professionalisation and standardisation will be the key topics in the development of biobanks over the next decade.” This is the opinion of the Swiss Dr Daniel Simeon-Dubach (medService – Biobanking consulting & services). He reported on an international survey concerning the business planning of biobanks, which 276 biobanks responded to. Biobanks are still relatively young and only around a quarter of them have a business plan in place. In particular, there is no strategy to generate new customers.

To be able to calculate the costs incurred by biobanking services, it would first be necessary to develop a uniform service description. Dr Romy Kirsten (National Centre for Tumour Diseases Heidelberg) discussed a TMF-funded project for biobank cost calculation. A catalogue with consensus-based biobank services would be worth pursuing so that projects can consider these costs when applying for funds.

EU-DSGVO: Many questions are still unresolved; the community needs to develop its own solutions

Unfortunately, the European Data Protection Basic Regulation did not solve the fragmentation of German data protection legislation, according to Irene Schlünder (TMF). National legislation should also extend beyond EU law when regulating how to handle patient data. Many questions are still unresolved; therefore, the research community now needs to develop solutions themselves.

The Working Group of the Ethics Commissions drew up a template for patient information and declarations of consent in 2017, which also envisage the option for industry-sponsored clinical studies to collect biomaterial under broad consent. Prof Dr Roland Jahns (University Clinic Würzburg) explained that this naturally also includes the patient’s right of withdrawal.

Harmonisation of processes as part of quality management

Having a consistent high-quality standard is the prerequisite for the long-term and sustainable usability of biomaterial samples for scientific research. From the autumn of 2017 on, ring trials with tissue, or liquid samples have been conducted at the German Biobank Alliance (GBA)'s eleven sites, with the aim of harmonising and improving pre-analytical processes by comparing various biobanks, while identifying elements that influence the sample quality. Initial results are expected in the spring of 2018.

Dr Ronny Baber from the LIFE Biobank presented the effects of biobank-associated properties on the stability of biomarkers. A study demonstrated the effects of storage duration and temperature, type and filling level of the test tubes as well as handling cycles as influential factors on the quality of the biomaterial.

Poster prizes

The symposium ended with the presentation of poster prizes. Awarded were:

• Antje Müller (1st prize): Two Data Protection Levels for Managing Biomaterial Collections at the IPA (Free Topics)
• Christoph Döllinger (2nd prize): Development of a Data Query Tool for Sample Research using Clinical Data (IT Support and Interoperability)
• Jörg Geiger (3rd prize): Biobanks from the Perspective of the Public – Fears and Expectations (Free Topics)