• Why does Luxembourg need a biobank?
• Role of biobanks in personalized medicine and disease intervention (Fast Facts)
• What is personalized medicine?
• Why is personalized medicine important?
• What role do biobanks play?
• Why are modern biobanks needed?
• What is a biobank?
• How does a biobank work?
• Which organizations use biobanks?
• How are biobanks funded?
• About the Integrated Biobank of Luxembourg (Fast Facts)
• What is the IBBL and what are its basic functions?
• Who founded IBBL?
• Biobanking at the IBBL
• How does IBBL maintain the highest Biobanking ethical standards?
• A Biorefinery to support research
• A Bioinformatics/Technology centre to analyze data
• Research priorities of Luxembourg’s personalized medicine Consortium and the role of the IBBL
• Creation of the Personalized Medicine Consortium
• Cancer program
• Type 2 diabetes program
• Parkinson’s disease program
• Creation of a normal population cohort to prevent disease

The rising cost of healthcare threatens to limit treatment options for the broader population and slow access to new interventions. Healthcare costs are expected to increase dramatically in Europe by 2015 and reach $4 trillion in the US. Luxembourg has one of the top health care systems in the world and needs to sustain an infrastructure that helps all its citizens lead healthier, more productive lives.

A more accurate understanding of diseases in relation to the individual has significant potential to drive medicine forward, save lives and contain prohibitive healthcare costs. Developing effective diagnostic tests can mean effective, earlier intervention, improved prevention strategies, identifying targets for new drugs and improved monitoring of side-effects.  Recent advances in medical science promise to change markedly the practice of medicine. In the future, medical care will be focused on the individual patient with most treatments designed specifically designed to cure that patient following a molecular diagnosis of the disease, a search of large databases to find the best treatment options and the advice of several doctors expert in this disease.  

This ongoing revolution in medicine is often called Personalized Medicine. The Integrated Biobank of Luxembourg (IBBL) is a central part of Luxembourg’s strategy to ensure that its patients are among the first to benefit from advances in personalized medicine.

• Personalised medicine involves the study of genetic and molecular information to predict the risk of disease and identify new targets for treatments
• Personalised medicine is a move away from the traditional ‘one size fits all approach’ to a system that delivers more efficient, targeted healthcare tailored to an individual’s risk profile or disease sub-type
• Modern biobanks provide a valuable resource of securely protected genetic and molecular information with the technology and expertise to help researchers analyse data against medical records and environmental factors. Only in this way, can medical research pinpoint the correlation between certain genetic and lifestyle factors to better understand the physiopathology of disease and how disease should be prevented and treated
• Modern biobanks such as the IBBL are crucial to progressing advances in personalised medicine to improve the health of populations worldwide, whilst reducing prohibitive healthcare costs
• The IBBL is partnering with leading research institutes and the ‘Partnership for Personalized Medicine’ to help identify markers of disease and support in the development of effective diagnostic tools, with an initial focus on lung cancer. Results could decrease lung cancer mortality through efficient and accessible screening, improved accurate diagnosis and earlier ‘curative treatment’

Personalised medicine is a move away from the traditional ‘one size fits all approach’ to a system that delivers more efficient, targeted healthcare. For example, identifying hormone synthesis and HER2 expression of certain breast cancer tumours allows effective treatment to be administered accordingly and the presence of inherited BRCA1 and BRCA2 genes allows monitoring of women at significant risk.

A more accurate understanding of diseases in relation to the individual has significant potential to drive medicine forward, save lives and contain prohibitive healthcare costs.

Developing effective diagnostic tests can mean effective, earlier intervention, improved prevention strategies, identifying targets for new drugs and improved monitoring of side-effects.

The rising cost of healthcare threatens to limit treatment options for the broader population and slow access to new interventions. Healthcare costs are expected to dramatically increase in Europe by 2015 and reach $4 trillion in the US. Luxembourg has one of the top health care systems in the world and needs to sustain an infrastructure that helps all its citizens lead healthier, more productive lives.

Modern biobanks collect, store and analyse donor samples, such as tumour tissue, serum, blood and plasma, whilst employing strictly governed protocols and advanced computer technology to protect donor confidentiality.

Biobanks play a critical role in modern medicine. All diseases result from some factor (infection, diet, chemical, mutation etc.) disrupts normal functions in our bodies. Scientific advances in the past 20 years now make it possible to understand precisely the molecular defects in many diseases and to use this information to develop new approaches to improve public health and reduce the cost burden on society.

To understand disease, researchers need to study high quality biospecimens and clinical data. Most research laboratories lack the resources and infrastructure needed to collect tissue and data for modern medical research. For that reason biobanks have been established to meet this need.

To develop personalized treatments for disease, scientists study diseased tissue and correlate abnormalities with the clinical problems of the patient in order fully understand the molecular basis of each patient’s disease. Modern biobanks are a crucial part of this process because they provide well characterised biospecimens, accurate annotations, precise validation tools and advanced technology, securely and ethically.

Biobanks collect, store and analyse biospecimens, making the results available to research organisations investigating new treatments for diseases. Biospecimens can include any kind of tissue or body fluid donated by an individual, such as tumour biopsies, blood or urine.

As well as providing access to samples and data, some modern biobanks also offer access to validated reference material, genomic and population-genetic data, and molecular resources, which would be too expensive for many individual academic institutions.

Human biological samples are donations, collected following informed consent from patients or healthy volunteers. Biobanks are required to implement high ethical standards and safeguards to protect donor confidentiality. Research requests for samples and data undergo rigorous review by independent, governing bodies to ensure the best possible, ethical use of material and data. Biobanks request applicants to describe the proposed experimentation, specifying the desired biospecimens and accompanying data. The applicants must show they have the expertise to perform the proposed research, using an established methodology, and verifying they have sufficient funds to complete the proposed studies. In addition, applicants must demonstrate evidence that the project has obtained ethical clearance and that they will not attempt to identify individual biospecimen donors.

Users can include local and international institutions, such as hospitals, academic institutions, private health foundations and pharmaceutical companies. The transnational flow of research data is essential for stimulating advances in medicine.  However, legal restrictions on the export of biological samples can make transnational research difficult. New generation biobanks, offering increased on-site data collection and analysis and research collaborations with local institutes, enable the samples to remain in the country of origin and the research data to be shared.

The general approach is to support investigators in their research without inhibitory costs. Some biobanks rely on government and charitable funding to cover some or all of their costs. Others depend on private contributions. Further funding may be achieved by charging specific types of organisations - e.g. biopharmaceutical industry, insurance companies, governments and IT companies - user fees for accessing samples, collecting royalties on intellectual property developed using the biobank resources, and through the sale of knowledge from mining data.

• The Integrated BioBank of Luxembourg (IBBL) is a new biobank which aspires to become a hub in Europe for studies in personalized medicine.
• The IBBL aims to lead advances in biobanking and biospecimen research to ensure the highest quality specimens and data for research.
• The IBBL is dedicated to complying to international standards in sample collection, storage, distribution, and analyses
• The IBBL is an independent, not-for-profit foundation founded by public research centres: Centre de Recherche Public -Santé, CRP-Henri Tudor, CRP-Gabriel Lippmann, and the University of Luxembourg and developed in partnership with the Translational Genomics Research Institute (TGen), Arizona, USA
• The IBBL is part of the Luxembourg Government’s long-term commitment to develop Luxembourg as a centre of excellence in biomedical research, promoting its research capabilities and encouraging collaboration with the international medical community
• The IBBL is committed to the strictest ethical standards, working with ethical bodies and introducing robust processes to protect donor privacy

The IBBL is a collaborative effort to facilitate medical research for the next generation in healthcare, whilst establishing new standards in biospecimen research, data protection and technology expertise. The IBBL aims to build a solid infrastructure to support a successful biomedical research industry in Luxembourg and facilitate rapid translation of discoveries intro improved care. (not only a biobank (store and distribute samples and data) but also a research lab, a technology centre and a partner to researchers. 

The IBBL is focused on unique research programmes and works closely with research teams by providing them with biospecimens and clinical data and by analyzing biospecimens using sophisticated molecular analyses that are not feasible in individual research laboratories.

The IBBL was created in 2008 as part of the “Health Sciences and Technologies Action Plan” to develop Luxembourg as a centre of excellence in biomedical research. The IBBL was founded by research centres; Centre de Recherche Public – Santé, Centre de Recherche Public Henri Tudor, Centre de Recherche Public Gabriel Lippmann - and the University of Luxembourg in partnership with the Transnational Genomics Research Institute (TGen) Arizona, USA.

• Developing a centralised biobank to acquire appropriately consented, standardised and rigorously collected human tissue specimens, including their transport and preservation
•  Producing samples of  the highest scientific value for those investigating diagnoses, causes, prevention and the successful treatment of disease
• Ensuring a rigorous quality and ethics review process for the collection of biospecimens and data.

Human biological samples are either contributions from research participants, patients or from healthy volunteers. The IBBL is dedicated to protecting the privacy of the donor. It employs the highest ethical protocols and works with a number of ethical bodies to ensure that collection methods and data protection conform to high standards to safeguard the privacy of donor data. Rigorous application processes are upheld to assure the best possible use of material and research data.

• Providing researchers with high quality extracts (DNA, RNA, protein)  to identify markers of disease and understand the molecular and genetic causes of disease
• Offering consistent, automated, high quality processing of biospecimens according to the needs of each research project
• Developing tissue microarrays (TMs) for screening large numbers of tissue samples for particular characteristics.

• Offering a core technology centre housed within the IBBL. In partnership with TGen and other groups in Luxembourg, the centre will assist researchers to mine complex disease data
• Partnering with local proteomics institutions to develop tools to analyse blood proteins, allowing scientists to explore the disease process and develop simple tests for early diagnosis and treatment monitoring
• Developing high capacity gene sequencing capabilities to enable scientists to classify disease sub-sets, identify susceptibility to disease, predict treatment response and identify and validate potential prognostic biomarkers
• Developing computer technology to provide a secure resource to foster information-sharing and collaboration between clinical researchers in Luxembourg and around the world

The IBBL partners with Luxembourg scientists and with globally recognized research centres to support world-class medical research and stimulate advances in personalised medicine to address the most critical health issues affecting populations in Luxembourg and those around the world.

The IBBL is an integral partner in a large Personalized Medicine Consortium (PMC) in Luxembourg, which links the Partnership for Personalized Medicine (PPM), the Luxembourg Centre for Systems Biomedicine (LCSB) and the IBBL.
The IBBL supports the PMC by facilitating the creation of research teams in priority research areas and by collecting the appropriate tissues and data, and in providing some background characterization of tissue samples as needed by the research teams. Each disease team is composed of a complex array of individuals and organizations to ensure that it has the expertise needed to conduct the research.

The PMC will initially focus on three disease areas where Luxembourg is able to create excellent research programs that will advance science and have the potential to impact morbidity and mortality associated with the diseases: cancer, Type II diabetes and Parkinson’s disease.

Cancer as a generic disease remains a major health problem for developed countries and is becoming a major problem in developing countries. According to the American Cancer Society, 68% of the people diagnosed with cancer between 1999 and 2005 survived their disease; only 50% of the people diagnosed in 1974-75 survived.  However, despite this improvement in treatment and outcome, cancer remains the number one or two cause of death in most western countries. Luxembourg, like other developed countries, has a relatively high incidence (2344 cases in 2008) and mortality (919 deaths in 2008). The lifetime risk of cancer is approximately 33% with lung and colon cancer accounting for 25% of the cases and 40% of the cancer deaths.

The IBBL already partners with CRP-Santé in personalized medicine (Partnership for Personalized Medicine or PPM). The initial focus of the PPM initiative was defined as lung cancer and involved partners in the United States (Dr. Lee Hartwell, Fred Hutchinson Cancer Research Center, and the Translational Genomics Research Institute (TGen) in Arizona). The PPM investigators seek to discover, evaluate and verify biomarkers in blood or tumour to stratify late stage lung cancer patients to the most appropriate chemotherapeutic protocol. The PPM project is part of the PCM initiative and will soon expand to include lung, colon and breast cancers. All three cancers represent serious health challenges in Luxembourg and existing data already illustrate the need for a personalized approach to the treatment of all three cancers.

Changing life styles over the past 30 years have led to a dramatic increase in type II diabetes. The Diabetes Atlas estimated that in 2007 Luxembourg had a 6.9% prevalence of type II diabetes in the population most at risk (ages 20-79; 344,000 people or 24,000 cases). However, because of the insidious onset of the disease it was likely that only 50% of the affected population had symptoms that resulted in a clinical diagnosis of diabetes. If life styles do not change, diabetes in Europe will increase by at least 20% by 2025. Diabetes represents a substantial burden on the health care system because of the complications associated with the disease. It was estimated that complications from diabetes cost the Luxembourg health system over 80 M € in 2007. Complications from diabetes are responsible for 11% of all deaths in Europe.

Luxembourg has a core of excellent scientists, both basic and clinical, with an interest in diabetes and in working together in a focused effort on finding prognostic and predictive biomarkers for diabetes. A goal of the PMC research team in diabetes will be to find blood or urine biomarkers that aid clinicians in finding the most appropriate treatment for each patient.

Neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD) are common chronic diseases of ageing.  These diseases are increasingly common and lead to substantial morbidity and mortality. It has been estimated that there are between 600 and 1000 PD patients in Luxembourg, but the disease can be difficult to diagnose and the true number could be much higher.

The IBBL is partnering with the Luxembourg Centre for Systems Biomedicine (LCSB) at the University of Luxembourg and the Centre Hospitalier du Luxembourg (CHL) who have identified PD as one of their major priorities and are creating PD research team under the PMC umbrella. The combination of a strong clinical program and an innovative systems biologic approach to characterizing and understanding PD has the potential to make new discoveries in PD and to attract various partners in the pharmaceutical and biotech industries to work with the Luxembourg group to test new therapies for PD and perhaps also AD.  The LCSB has a strong collaboration with the Institute for Systems Biology in Seattle to apply the strategy of systems biology research to the problems of PD.

To complement the studies carried out by the three research teams in the PMC, the IBBL proposes to also create a 10,000 person cohort of normal individuals in Luxembourg to serve as controls for studies by the PMC and to provide important data on the demographics of disease in Luxembourg. Study of the cohort over time will also help Luxembourg develop strategies to prevent some of the chronic diseases that plague our ageing population. The cohort will be harmonized with the cohorts being coordinated through the P3G consortium. Luxembourg through the IBBL is already part of this consortium of over 30 countries that are conducting population studies on over 2.6 million individuals. By creating a harmonized cohort in Luxembourg, it will be possible to utilize the data from other countries to enrich the Luxembourg cohort and to increase the value of the information obtained. The cohort will include adult volunteers up to 69 years of age. Each participant will sign a consent form allowing their anonymized data to be used for research and agreeing to provide blood and urine samples for research. As part of the enrolment process, each participant will complete an extensive questionnaire related to demographic background, health, diet and life style issues; in addition some simple biological measurements such as height, weight, waist and hip circumference, and blood pressure will be collected.  It is expected that individuals would be recontacted at 5 year intervals to update the questionnaire information and to collect additional biological specimens.