In 2008 the government of Luxembourg announced a bold new initiative for health sciences and technologies in Luxembourg with the objective to strengthen biomedical research, enhance innovation and healthcare, and stimulate economic development in the biotechnology sector. Biomedical research requires high quality human biological specimens such as tissue and blood from healthy donors and patients with various diseases.

The creation of the biobank IBBL (Integrated BioBank of Luxembourg) constituted a key infrastructural element of this initiative. IBBL is a centralised facility that works together with the people living in Luxembourg and collects, stores and distributes biospecimens and related data to research organisations where human diseases are studied.

But IBBL is more than a traditional biobank: it has built an integrated infrastructure, catalysing partnerships, and also aiding in sample analysis and the provision of technologies and research. IBBL is also differentiated by its high standards of quality and ethics, which are rigorously applied across the board. IBBL’s vision is to be an international centre of excellence in biobanking and to accelerate the introduction of personalised healthcare for the benefit of the people living in Luxembourg.

Collaboration is a way of life in Luxembourg and therefore an effective partner network is essential. IBBL works with a number of public and private sector research partners, in Luxembourg, Europe and beyond. IBBL’s philosophy is to be flexible and adaptable to a potential partnership while maintaining rigorous privacy and ethical standards. IBBL’s role can range from straightforward sub-contracting to research leadership.

IBBL has set up collaborations with all hospitals in Luxembourg for the collection of biospecimens, and then re-distributes these as samples to national and international research partners, including the Centre de Recherche Public-Santé (CRP-Santé), the Luxembourg Centre for Systems Biomedicine (LCSB), and the University of Luxembourg. On an international level, IBBL is involved in European FP7 framework programmes and regularly collaborates with the International Society for Biological and Environmental Repositories. In addition, IBBL cooperates with industry partners in the development or validation of new technologies, and provides sample processing and storage services to a number of international clients.

What is personalised medicine and what is IBBL’s role in this context?

Personalised medicine is the vision adopted by a new generation of healthcare that moves away from a ‘one size fits all’ approach to one in which treatments are customised to the genetic and molecular make-up of each individual. Such healthcare allows for a more effective diagnosis, prognosis and treatment, as it recognises that there are individual differences in the causes and progression of diseases.

In order to advance in the field of biomedical research and make Luxembourg become a leader in the adoption of personalised medicine, IBBL co-founded the Personalised Medicine Consortium (PMC), a collaborative and interdisciplinary initiative that brings together several key research institutions in Luxembourg, including IBBL, the Luxembourg Centre for Systems Biomedicine (LCSB) at the University of Luxembourg, the Centre de Recherche Public-Santé (CRP-Santé) and several other members.

IBBL provides research support infrastructure to the PMC and its partners by collecting, storing and redistributing high quality biospecimens and related clinical and analytical data for defined research projects in the priority domains identified by the PMC: cancer, type II diabetes, Parkinson’s disease, and a national
cohort study.

What is bioinformatics’ role in personalised medicine?

A key element of personalised medicine is to look at the information stored in a person’s DNA, the molecule present in every cell of the body that harbours our genes. The combined action of our genes ultimately determines how we function as a networked system. Changes in the genetic information can lead to perturbations in the system, which in turn can cause diseases. Bioinformatics integrate systems data to relate multiple genetic changes to the health status of an individual. The knowledge gained from bioinformatics can be used for the design of tailored therapies, which is the aim of personalised medicine.

How have you built your information system at IBBL?

The main mission of IBBL is to collect biological samples and data, but it also offers sample testing services to its partners and clients. To ensure the smooth and secure running of these operations, a number of infrastructural elements have been set up. A Laboratory Information Management System (LIMS) registers each step in the lifecycle of a biological sample, which allows it to be traced from the moment of collection to re-distribution. In addition, any medical data associated with the sample is securely stored in the LIMS. This system provides a high quality operational tool and represents the core of our informatics structure. Alongside this system, IBBL has set up a web-based solution for electronic clinical record forms (eCRFs). IBBL has also put in place a high performance computer system to meet the needs of its in-house laboratories and offering of services. Whenever the demand exceeds the capacities of this system, IBBL works with LCSB, where specialised bioinformatics infrastructure and staff are centralised.

Health is a highly valuable asset for any generation of people. What kind of privacy protection system have you put in place?

IBBL maintains a high degree of security and data protection with regards to its biological samples and the identity of donors. IBBL produces and distributes sample collection kits with pre-labelled receptacles, which are de-identified at the moment of collection through a pseudonymisation process. IBBL has entrusted an external organisation, a Trusted Third Party (TTP), with the storage and protection of all personal identifying information.

What’s the Trusted Third Party scheme you’ve built?

IBBL’s Trusted Third Party scheme was conceptualised in collaboration with the Centre de Recherche Public Henri Tudor and then developed by the company ebrc, who also hosts and maintains it.
The scheme is based on Oracle Healthcare Master Person Index (OHMPI), which has a powerful matching engine to compare complex data records even if they are stored in different databases. All personal identifying information is separated from medical data and samples at the time of collection and assigned a randomly generated pseudonym. All medical data and samples are stored at IBBL whereas the personal information is stored and protected by the external TTP.

How do you take care of information and data on the long term?

Neither IBBL nor the researchers who receive the samples hold the key required to reconnect the samples and medical data with the identity of the donor. The TTP does however retain the possibility of reconnection. This process requires the intervention of medical staff or an ethics committee and will only occur under specific circumstances, for example if research findings are made which could reasonably be of benefit to the donor.

This will differ from one case to another, and IBBL is in on-going discussions with the ‘Comité National d’Éthique de Recherche’ (CNER) and the ‘Commission Nationale pour la Protection des Données’ (CNPD) to work out the best possible practices.

To ensure continuous privacy, IBBL uses three key software systems: the laboratory information management system from LABVANTAGE, the web-based eCRF solution from ARONE, and the Trusted Third Party solution from ebrc, which are tested to be secure and provide traceable data storage and which are
21CFRPart11 compliant.

The IBBL in-house data are backed up and archived on multiple sites. Operations do not necessarily require a fast recovery time objective, hence a recovery point objective of one day is acceptable. Nevertheless data integrity is essential. IBBL uses technologies and formats that will still enable access to data in 10 or even 20 years’ time.

Privacy requires rigorous processes to obtain the donors’ consent. How does this work for samples stored at IBBL?

When collecting biological specimens and health information from donors, IBBL respects their rights and obtains their consent as required by law and by the regulations of the CNER in Luxembourg. All donors are volunteers and either healthy citizens or patients. They receive information about the study from medical staff and are given ample time to consider their participation. The nature of the consent will provide the exclusion criteria for the subsequent use of the sample, i.e. who receives it and what kind of analysis can be performed with it. IBBL maintains a rigorous application procedure for any future partners or clients who want to work with samples stored at IBBL, to maintain high ethical standards even beyond the walls of IBBL.

What’s the eCRF?

The eCRF is an electronic Case Report Form (CRF) that contains relevant medical information and patient history associated with the donated samples. It is stored at IBBL alongside the information provided in the consent form and serves to annotate the respective samples.

Does IBBL find an added value in complying with specific regulations?

IBBL is dedicated to providing the highest standards of quality throughout the collection, storage, and transport of samples and associated data. To this end, IBBL operates a traceable and auditable quality management system to ensure that our procedures, infrastructure and staff meet the highest operating standards. IBBL is seeking to obtain NF96-900 Certification and ISO 17025 Accreditation by the end of 2013. By respecting standards and complying with specific regulations, IBBL is in a position to guarantee quality and trust to its donors, partners
and clients.

IBBL runs a High Performance Computing system. How is this environment robust and scalable?

The high performance computing system at IBBL was set up for bioanalytical analysis of data generated by the sequencer, an instrument that allows for genetic analysis on a large scale. The system was chosen to match the instrument requirements and configured to allow for the storage of the large amounts of data that this type of instrument generates. The operating system is a very stable Linux-based system that has proven its robustness over the years. Besides, the research environment is prone to use open source solutions, as the vast majority of the tools in the field are developed at academic institutions. This enables not only a virtuous circle in the development of new algorithms but also guarantees that we will never be ‘trapped’ in an inflexible proprietary solution. Care has also been taken in the hardware design, so that it can be easily expanded if necessary.

In 2011, IBBL and its Cloud provider ebrc won a EuroCloud award. How important is this recognition?

IBBL’s internal quality management system requires a continuous evaluation and validation of the quality, security and sustainability of existing solutions. The EuroCloud award that ebrc and IBBL received for the TTP service project is an external recognition of the quality of the measures in place.