Biobanks in Spain. An overview.

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1 Biobanks in Spain. An overview. ENRIQUE DE ALAVA UNIVERSIDAD DE SALAMANCA-CSIC Salamanca, Spain

2 BIOMEDICINE AND HEALTH CARE ENVIRONMENT INHERITED GENES LIFESTYLE GENOME PROTEOME

3 BIOMEDICINE AND HEALTH CARE ENVIRONMENT INHERITED GENES LIFESTYLE GENOME PROTEOME TREATMENT HEALTH DISEASE RESISTANCE SENSITIVITY PERSONALISED MEDICINE

4 BIOBANK -An establishment that manages -A collection of biological samples- -Plus clinical information -Organized as a service -With a clear design, and quality ethical criteria -For biomedical research.

5 BIOBANK -An establishment that manages -A collection of biological samples- -Plus clinical information -Organized as a service -With a clear design, and quality ethical criteria -For biomedical research.

6 Biobank aims To obtain, process and store biological samples and their associated data. To provide samples to research groups. To ensure a rational, effective, ethical and legal use of the available resources.

7 Structure of a Biobank External Scientific Committee External Committee on Ethics Metabolic diseases Cardiovascular diseases CENTRAL NODE Oncological diseases Neuropsychiatric diseases ASSOCIATED CENTERS RESEARCH GROUPS

8 SPANISH LAW ON BIOMEDICAL RESEARCH: requisits for a biobank - Authorized by the regional governments ( National Registry to be created by the Ministry of Science) - Structure of the organization: - Activities: - Scientific director & person responsible for database - External Committees - To ensure fulfilling all legal requirements - Registry of activities - Guarantee of quality, safety & traceability of samples, data y procedures - Respond to enquires & claims - Good-practice manual/documentation - Annual report

9 The actual value of a biobank lies on the existence of cooperative research projects of excellence. Design an action plan before creating a biobank

10 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

11 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

12 Translational research

13 How Biobanks (tumor banks) are Key to Translational research in Molecular Pathology of Cancer?

14 How tumor banks are Assess new predictive factors Assess the value of a known target in a new entity Look for new therapeutic targets Validation of a new diagnostic marker Implementation of new diagnostic procedures

15 How tumor banks are Assess new predictive factors Assess the value of a known target in a new entity Look for new therapeutic targets Validation of a new diagnostic marker Implementation of new diagnostic procedures

16 How tumor banks are Assess new predictive factors Assess the value of a known target in a new entity Look for new therapeutic targets Validation of a new diagnostic marker Implementation of new diagnostic procedures

17 How tumor banks are Assess new predictive factors Assess the value of a known target in a new entity Look for new therapeutic targets Validation of a new diagnostic marker Implementation of new diagnostic procedures

18 How tumor banks are Assess new predictive factors Assess the value of a known target in a new entity Look for new therapeutic targets Validation of a new diagnostic marker Implementation of new diagnostic procedures

19 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

20 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

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24 Regional networks, 2009 Redes en desarrollo: Castilla-León Cataluña Andalucía Asturias Red promovida por el CNIO: Madrid Canarias Galicia Hasta 21 Centros de 8 CCAA. 6 hospitales no asociados en ninguna red territorial.

25 CNIO Network Red CNIO: 24 Centros de 9 CCAA. Madrid Canarias Galicia Baleares Fuente:

26 Tumor banks (Jan 2009) Regional: Castilla y León Cataluña Andalucía Asturias CNIO: 24 Centros de 9 CCAA. Madrid Canarias Galicia Other networks.

27 Quality of tissue fixation (for tissue microarray) VIMENTIN WEAK 13% CD 31 MIB1 OK 87% WEAK 16% NEGATIVE 3% RESULTS KI-67 (MIB-1) NEGATIVE 9% WEAK 28% OK 81% Vimentin CD31 OK 63%

28 Quality of RNA (for DNA arrays) RNA DEGRADATION MODERATE 3% NON ASSESSABLE 3% WEAK 9% OK 85% Ratio 260/ % < 1.8 > 2.2

29 Papers in peer-review journals with explicit reference to biobanks ,00 Number: 99 Median IF: 7,256 8,00 7,00 6,00 5,00 4,00 3,00 2,00 1, ,

30 Projects assisted by the Tumor Bank Network : : : : :

31 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

32 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

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34 National DNA Bank of Spain STRUCTURE Central Node Coordinating center: Universidad de Salamanca Director: Dr. Alberto Orfao Oncological Node Coordinating center: Centro de Investigación del Cáncer (Salamanca) Coordinator: Dr. Enrique de Álava Cardiovascular Node Coordinating center: Fundación IMIM (Barcelona) Coordinator: Dr. Jaume Marrugat Metabolic Node Coordinating center: IDIBAPS-Hospital Clinic (Barcelona) Coordinator: Dr. Ramón Gomis Neuropsychiatric Node Coordinating center: Institut d Investigació Sanitària Pere Virgili (IISPV) (Reus) Coordinator: Dra. Elisabet Vilella Regional Blood Transfusion Centers Consejería de Sanidad JCyL Hospital Vall d Hebron Centro de Estudios de Mastocitosis de Castilla la Mancha Foundations for Fibromialgy and Chronic Fatigue Syndrome

35 BNADN: AVAILABLE SAMPLES (2008) Control population: N.of samples Cell lines - Spanish population - Population of Castilla y León - Nonagenarians 30 Prevalent diseases: Neuropsychiatric diseases Metabolic diseases Cardiovascular diseases Oncological diseases Other diseases: - Fibromialgy and Chronic Fatigue Syndrome Mastocytosis Immune-mediated inflammatory diseases and controls Total:

36 National DNA Bank, node on oncological diseases

37 National DNA Bank, node on oncological diseases Colorectal ca. Breast ca. Lung ca. Head&neck ca. NHL Acute leukemia CLL Chronic MP syndrome Frozen tissue Cells Plasma/serum 500 patients of each Clinical data Epidemiological data Follow up data

38 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

39 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

40 European Research Infrastructure Bio- Banking and Biomolecular Resources ROADMAP PROPOSAL FOR D.3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS

41 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS AIM To generate a concept on how to integrate clinical biobanks in Europe in national hubs.

42 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS NATIONAL HUBS Austria Germany Greece Finland France Hungary Italy Netherl. Spain UK Cardiovascular Metabolic Neuropsychiatric Oncologic Orphan diseases? Respiratory Allergy

43 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS Country A Disease C NATIONAL HUBS

44 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS Country A Disease C NATIONAL HUBS Cordina tor

45 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS NATIONAL HUBS Country A Disease B Country A Disease C Country A Disease D

46 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS NATIONAL HUBS Country A Disease B Country A Disease C Country A Disease D National Coordin

47 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS IDENTIFICATION OF BIOBANKS CARDIOVASCULAR METABOLIC NEUROLOGIC CANCER I. M. I. D. ALLERGIC RARE DISEASES DNABank (R. Gomis) DNABank (E. Vilella) DNABank/RTICC Tumor Bank Network (E. de Alava) DNABank SPAIN DNABank (J. Marrugat) (S. Marsal) Research Network on Allergy (M. Blanca) CIBERER (F. Palau) AUSTRIA

48 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS NATIONAL HUBS Country A Disease B Country A Disease C Country A Disease D National Coordin Country B Disease B National Coordin Country B Disease A Country B Disease D

49 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS NATIONAL HUBS Country A Disease B Country A Disease C Country A Disease D Disease Coordin National Coordin Disease Coordin Country B Disease B National Coordin Disease Coordin Disease Coordin Country B Disease A Country B Disease D

50 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS NATIONAL HUBS Country A Disease B Country A Disease C Country A Disease D Disease Coordin National Coordin Disease Coordin Country B Disease B National Coordin Disease Coordin Disease Coordin Country B Disease A Country B Disease D

51 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS NATIONAL HUBS Country A Disease B Country A Disease C Country A Disease D Country B Disease B -Clinical Phenotypes -Typesofsamples Disease Coordin National Coordin Ethical/legal (ELSI) frame National Coordin Disease Coordin -Clinical Phenotypes -Typesofsamples Disease Coordin Disease Coordin Country B Disease A Country B Disease D

52 DELIVERABLE 3.7.: CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS PROPOSAL FOR A NATIONAL HUB ADVISORY BOARDS coordinating centre NATIONAL CONTACT DISEASE NODE 1 DISEASE NODE 2 DISEASE NODE 3 DISEASE NODE X

53 KEY POINTS Coordinating Centre: National contact: scientific management Common data-base (information in samples/data available, ) Quality control (common-harmonized- SOPs, minimal data set, ) Responsible of QMS Disease nodes: Coordinating node: Scientific board: defining common diagnostic criteria (international standards), minimal clinical data, Subnodes: institutional (hospital) based biobanks Centralized vs decentralized sample/data process Advisory board: Representatives of legal entities, funding agencies, directorate, coordinators of disease nodes

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58 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

59 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

60 Scientific/health care questions: Questions Better organizative protocols to better face the increment of numbers of tissue requests (translational research, bioinformatics). Better sample selection, preparation and storage. Which sample types to collect (just tumours?, normal blood?, tumour DNA as well?, plasma/serum of tumour patients?). Which storage formats (just snap frozen?, cell suspensions?) Quality of the process. Developing standards, SOPs, which ISO certifications?. Who should have access to the samples?, to which samples?, how?. Private-for-profit institutions?. The role of a scientific committee. Definitions and normalisation systems for diagnosis and topographical information to guarantee uniformity of pathological annotation, (CIE-9?, SNOMED?),... Role of the tumour banks in the development of new drugs. Central unit?, intermediate partner between industry and oncologists?. Intellectual property.

61 Questions Information technology How to identify/label samples in a European perspective. Quality of the data and standards. Data integration (clinical, pathological, epidemiological, relationship with tumour registries). Data protection and database safety. Managing knowledge.

62 Questions Questions on ethics-law-funding-social Towards a European Legal framework. Ownership of tumour banks. How to finance tumour banks. Who?. The role of Ethics committees.

63 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

64 Outline Biobanks in Spain Why What for Network of biobanks National Biobanks Towards National Hubs of clinical biobanks What else

65 Gracias! Gracias!

66 BIOBANKS AND TRANSLATIONAL RESEARCH SAMPLE BIOBANK MOLECULAR TRANSLATIONAL RESEARCH ANALYSIS PATIENT LABORATORY DIAGNOSTIC & THERAPEUTICS MARKERS MOLECULAR PROFILING EXPERIMENTAL RESULTS

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