Biopreservation & biobanking

THE EUROPEAN, MIDDLE-EASTERN AND AFRICAN SOCIETY FOR BIOPRESERVATION AND BIOBANKING (ESBB): CURRENT STATUS AND PLANS FOR THE FUTURE

Hewitt RE

European, Middle Eastern and African Society for Biopreservation and Biobanking (ESBB), 20 Boulevard du Roi René, 13100 Aix-en-Provence, France

Ethically correct and technologically excellent biopreservation and biobanking are crucial issues for future developments in the field of Predictive, Preventive and Personalised Medicine. This is the major focus of ESBB, which is a new society coming under the umbrella of the European Association for Predictive, Preventive and Personalised Medicine, EPMA.

The ESBB was created in August 2010. Its mission is to promote the field of biobanking and support research related to healthcare, agriculture and environment. ESBB works by exchanging, enhancing and disseminating professional knowledge, by identifying and solving field-relevant problems, and by creating high professional standards in biopreservation and biobanking. The society is open for professionals interested in all aspects of biobanking, including biopreservation science, biobank management, quality assurance, informatics, automation, ethical, legal, regulatory and social issues. A tight collaboration between ESBB and EPMA is crucial for future development in predictive and personalised medicine.

BIOBANKING ACCESS RULES AND EXCHANGEABILITY IN MULTI-CENTRE MEDICAL RESEARCH NETWORKS

Riegman PHJ, de Jong B

Erasmus MC Tissue Bank, Department of Pathology, Josephine Nefkens Institute, Erasmus MC Rotterdam, The Netherlands

A large part of innovation in modern medical care is based on medical translational research. The part investigating personalised medicine, drug targets, predictive and new biomarkers needs to have access to a sufficient critical mass of samples. Individual institutes are no longer able to generate the needed numbers in time and, therefore, need to join multi-centre research projects. For biobanks this means the samples and data needs to be exchangeable, and the access rules should stimulate the initiation of multi-centre research.

The biggest challenge for hospital-integrated biobanks is to overcome the “It’s mine”-syndrome. Its causes need to be identified and, where possible, adapted trying to find the appropriate ways to get supplier and receiver in cooperation by win-win solutions.

The sample/data quality is important for exchangeability. However, is any of QA and QC programmes sufficient to secure an optimal exchangeability? What kind of infrastructure is needed to initiate cooperative projects?

HOSPITAL ORGANIZATION TO PROVIDE ACCESS TO SAMPLES AND CLINICAL DATA FOR TRANSLATIONAL AND CLINICAL RESEARCH IN ONCOLOGY

Chabannon C, Malenfant C, Bechlian D, Daufresne LM

Institut Paoli-Calmettes & Université d’Aix-Marseille & Inserm UMR891, all in Marseille, France

Human biobanks can be categorized in population based biobanks and disease-oriented biobanks, of which tumour banks represent one example. Access to human samples in the context of disease-oriented biobanks involves hospitals. However, hospital organization is primarily directed at providing quick and accurate diagnosis, thus allowing for appropriate treatment. Including the “secondary objective” of providing high-quality biological resource in the day-to-day routine of administrative and healthcare personnel represents a challenge. To meet this challenge, it is important to identify the various situations in which human cells and tissues can be obtained from patients: diagnosis of disease predisposition, screening, diagnosis of clinically established disease, follow-up of treatment efficacy, biomedical research, etc. In all these situations, it is then important to understand technical and regulatory conditions allowing for the scientific use of human cells and tissues, and how these conditions overlap or compete with good clinical practices.

EXPERIENCE IN COLLECTING PATIENT INFORMED CONSENT FOR RESEARCH USE OF BIOSPECIMENS IN THE NICE CHU BIOBANK, A MEMBER OF THE CANCEROPÔLE PACA BIOBANK NETWORK

Hofman P  ^1,2,3, Hofman V  ^1,2, Bonnetaud C  ¹, Gaziello MC  ¹, Mauro V  ¹, Selva E  ², Santini J  ⁴, Chabannon C  ^3,5, Mouroux J  ⁶

¹ Nice CHU Biobank, Pasteur Hospital, Nice, France

² Laboratory of Clinical and Experimental Pathology, Pasteur Hospital, Nice, France

³ Canceropôle PACA biobank network, France

⁴ Head and Neck Institut, Antoine Lacassagne Center, Nice, France

⁵ Paoli-Calmettes Institut, Marseille, France

⁶ Department of Thoracic Surgery, Pasteur Hospital, Nice, France

Nowadays, the use of biological samples of human origin is strictly subordinated to regulations that integrate bioethical principles. The purpose of this presentation is to give through the principles of the procedure of collecting patients’ informed consent at the Biobank of CHU de Nice, France. This is also to assess the number of obtained consents in comparison to the number of collected samples between 01/09/2004 and 31/12/2009, the number of consents obtained before or after collecting the samples, and the number of patients’ refusal to collect their biological resources. The balance-sheet is settled for three major collections (thoracic, thyroid and head and neck tissues). The overall results showed that 88% of consents were obtained during the above given period. Refusal was notified by writing in nine cases only. Taken the facts together, our procedure is quite efficient and provides optimal conditions for the use of collected samples in the context of national and international research projects.

MAKING THE LINK: BIOBANK AND MEDICINE

Leitsalu L  ¹, Metspalu M  ^1,2,3

¹Estonian Genome Center, University of Tartu, Tartu, Estonia

²Institute of Molecular and Cell Biology, University of Tartu, Tartu, Estonia

³Estonian Biocentre, Tartu, Estonia

There are several existing and prospective links between the Estonian Genome Center of the University of Tartu and the overall healthcare sector. This deepening integration will allow for genetic information to be utilized more effictively in clinical application, and, besides the basic research in human genetics and -genomics is a primary goal of the Center.

• i) A year before the EGCUT was officially etsablished, the Estonian Human Genome Research Act was created to regulate the genome center and its biobank, the Estonian Biobank. One of the recuirements stated by the HGRA is that gene donors have the right to receive information on their genetic data, hereditary characteristics, and genetic risks obtained from genetic research conducted, and that accessing that information should be accompanied by counseling. This implies that the medical field is prepared to do so.

• ii) The recruitment of donors was carried out through primary care providers from all over Estonia. To accomplish this, a group of primary care providers interested in collaboration with the EGCUT were especially trained for the process of recruitment. This arrangement introduced the option of including preexisting data from medical records. Having the primary care providers as recruiters also established a relationship with the medical field from early on. Even though the active recruitment phase has been finished, the network of recruiters has been saved and is utilized by the EGCUT for follow up or occasional special projects. Since 2007, EGCUT is a research and development isntitution of the University of Tartu - the single University in Estonia with a medical school. EGCUT has started to collaborate with the Department of Medicine to develop the necessary training program for health care providers that would include genomic information.

• iii) Another factor that supports linking the genome center is the development of the necessary infrastructure within Estonia needed to promote electronic exchange of medical data. A nationwide technical infrastructure has been established by the state. This so called “X-road” provides a connection between all Estonian public sector databases and allows secure data exchange. This infrastructure provides an excellent means for updating, supplementing, and verifying health information in the database of EGCUT, as is required by the HGRA. More importantly, this platfrom of secure data exchange is a direct path allowing genetic data to be added to overall health data. Once the healthcare system is prepared for implementing genomic information into medical care, genetic risk estimates will be able to be taken into account together with the rest of a patient’s health information, rather than being considered in isolation.

The goal for the EGCUT is to implement the central national health database, accessible to all physicians in Estonia, which would contain genomic data along with all other medically relevant information on the patient. This could be utilized in medical counseling as an effective application of genomic information in clinical care.