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Biobanks in Spain. An overview. ENRIQUE DE ALAVA UNIVERSIDAD DE SALAMANCA-CSIC Salamanca, Spain
Biobanks in Spain. An overview.
ENRIQUE DE ALAVA
UNIVERSIDAD DE SALAMANCA-CSICSalamanca, Spain
BIOMEDICINE AND HEALTH CARE
LIFESTYLEENVIRONMENT
INHERITEDGENES
GENOMEPROTEOME
BIOMEDICINE AND HEALTH CARE
LIFESTYLE
HEALTH-------------DISEASE
ENVIRONMENTINHERITED
GENES
RESISTANCE-------------
SENSITIVITY
GENOMEPROTEOME
PERSONALISED MEDICINE
TREATMENT
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.
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.
Biobank aims
• To obtain, process and storebiological samples and their associated data.
• To provide samples to research groups.
• To ensure a rational, effective, ethical and legal use of the available resources.
External ScientificCommittee
CENTRAL NODE
ASSOCIATED CENTERS
Metabolicdiseases
Cardiovasculardiseases
Neuropsychiatricdiseases
Oncologicaldiseases
RESEARCH GROUPS
Structure of a Biobank
External Committee on Ethics
- Authorized by the regional governments ( National Registry to be created by the Ministry of Science)- Structure of the organization:
- Scientific director & person responsible for “database”- External Committees
- Activities:- 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
SPANISH LAW ON BIOMEDICAL RESEARCH: requisits for a biobank
The actual value of a biobank lies on the existence of
“cooperative research projects of excellence”.
Design an action plan beforecreating a biobank
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
Translational research
How Biobanks (tumor banks) are Key…
to Translational research inMolecular Pathology of Cancer?
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
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
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
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
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
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
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.
CNIO Network
Red CNIO:24 Centros de 9 CCAA.
• Madrid• Canarias• Galicia• Baleares• …
Fuente: www.cnio.es
Tumor banks (Jan 2009)
• Regional:– Castilla y León– Cataluña– Andalucía– Asturias
• CNIO:– 24 Centros de 9
CCAA.– Madrid– Canarias– Galicia
• Other networks.
Vimentin
MIB1
CD31
Quality of tissue fixation (for tissue microarray)
RESULTS
VIMENTIN
OK87%
WEAK13%
KI-67 (MIB-1)
OK63%
WEAK28%
NEGATIVE9%
CD 31
OK81%
WEAK16%
NEGATIVE3%
Vimentin
MIB1
CD31VimentinVimentin
MIB1MIB1
CD31CD31
Quality of tissue fixation (for tissue microarray)
RESULTS
VIMENTIN
OK87%
WEAK13%
KI-67 (MIB-1)
OK63%
WEAK28%
NEGATIVE9%
CD 31
OK81%
WEAK16%
NEGATIVE3%
Quality of RNA (for DNA arrays)RNA DEGRADATION
OK85%
MODERATE3%
WEAK9%
NON ASSESSABLE
3%
0102030405060708090
%
1.8-2.2 < 1.8 > 2.2
Ratio 260/280
Papers in peer-review journals with explicit reference to biobanks
0
5
10
15
20
25
30
35
2002 2003 2004 2005 2006 20070,00
1,00
2,00
3,00
4,00
5,00
6,00
7,00
8,00
9,00
2002 2003 2004 2005 2006 2007
Number: 99 Median IF: 7,256
0
20
40
60
80
100
120
140
2003 2004 2005 2006 2007
Projects assisted by the Tumor Bank Network
• 2003: 70
• 2004: 80
• 2005: 120
• 2006: 125
• 2007: 130
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
Consejería de Sanidad JCyL
Foundations for Fibromialgy and Chronic Fatigue Syndrome
Regional Blood Transfusion Centers
Central NodeCoordinating center: Universidad de SalamancaDirector: Dr. Alberto Orfao
Oncological NodeCoordinating center: Centro de Investigación del Cáncer (Salamanca) Coordinator: Dr. Enrique de Álava
Metabolic NodeCoordinating center: IDIBAPS-Hospital Clinic (Barcelona) Coordinator: Dr. Ramón Gomis
Neuropsychiatric NodeCoordinating center: Institut d’InvestigacióSanitària Pere Virgili (IISPV) (Reus)Coordinator: Dra. Elisabet Vilella
Cardiovascular NodeCoordinating center: Fundación IMIM (Barcelona) Coordinator: Dr. Jaume Marrugat
National DNA Bank of SpainSTRUCTURE
Hospital Vall d’Hebron Centro de Estudios de Mastocitosis de Castilla la Mancha
BNADN: AVAILABLE BNADN: AVAILABLE SAMPLES SAMPLES (2008)(2008)
- Spanish population- Population of Castilla y León
- Fibromialgy and Chronic Fatigue Syndrome
Prevalent diseases:- Neuropsychiatric diseases- Metabolic diseases- Cardiovascular diseases
- Oncological diseases 3.011
913 238
1.899
938
3.4881.828 1.000
N.of samples Cell linesControl population:
Other diseases:
Total: 16.395
865 157
- Nonagenarians 30
- Mastocytosis 165- Immune-mediated inflammatory diseases and controls 3.258
1.395
National DNA Bank, node ononcological diseases
500 patients ofeach
• Colorectal ca.• Breast ca.• Lung ca.• Head&neck ca.• NHL• Acute leukemia• CLL• Chronic MP syndrome
• Frozen tissue• Cells• Plasma/serum
• Clinical data• Epidemiological data• Follow up data
National DNA Bank, node ononcological diseases
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
European Research Infrastructure Bio-Banking and Biomolecular Resources
ROADMAP PROPOSAL FOR D.3.7.:“CONCEPT FOR NATIONAL HUBS OF CLINICAL
BIOBANKS”
To generate a concept on how to
integrate clinical biobanks in Europe in
national hubs.
AIM
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
NATIONAL HUBS
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
…
Allergy
Respiratory
Orphan diseases
Oncologic
Neuropsychiatric
Metabolic
Cardiovascular
…UKSpainNetherl.ItalyHungaryFranceFinlandGreeceGermanyAustria
?
NATIONAL HUBS
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
Country ADisease C
NATIONAL HUBS
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
Country ADisease C
Cordinator
NATIONAL HUBS
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
Country ADisease B
Country ADisease D
Country ADisease C
NATIONAL HUBS
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
Country ADisease B
Country ADisease D
Country ADisease C
NationalCoordin
IDENTIFICATION OF BIOBANKS
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
…CIBERER (F. Palau)RARE DISEASES
Research Network on Allergy (M. Blanca)ALLERGIC
DNABank (S. Marsal)I. M. I. D.
DNABank/RTICC Tumor Bank Network (E. de Alava)CANCER
DNABank (E. Vilella)NEUROLOGIC
DNABank (R. Gomis)METABOLIC
DNABank (J. Marrugat)CARDIOVASCULAR
…AUSTRIASPAIN
NATIONAL HUBS
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
Country BDisease B
Country ADisease B
Country BDisease A
Country BDisease D
Country ADisease D
Country ADisease C
NationalCoordin
NationalCoordin
NATIONAL HUBS
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
Country BDisease B
Country ADisease B
Country BDisease A
Country BDisease D
Country ADisease D
Country ADisease C
DiseaseCoordin
DiseaseCoordin
DiseaseCoordin
NationalCoordin
NationalCoordin
DiseaseCoordin
NATIONAL HUBS
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
Country BDisease B
Country ADisease B
Country BDisease A
Country BDisease D
Country ADisease D
Country ADisease C
DiseaseCoordin
DiseaseCoordin
DiseaseCoordin
NationalCoordin
NationalCoordin
DiseaseCoordin
NATIONAL HUBS
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
Country BDisease B
Country ADisease B
Country BDisease A
Country BDisease D
Country ADisease D
Country ADisease C
DiseaseCoordin
DiseaseCoordin
DiseaseCoordin
NationalCoordin
NationalCoordin
DiseaseCoordin
Ethical/legal
(ELSI) frame- ClinicalPhenotypes
- Types of samples
- ClinicalPhenotypes
- Types of samples
ADVISORY BOARDS
coordinating centreNATIONAL CONTACT
DISEASE NODE XDISEASE NODE 1
DISEASE NODE 3DISEASE NODE 2
PROPOSAL FOR A NATIONAL HUB
DELIVERABLE 3.7.: “CONCEPT FOR NATIONAL HUBS OF CLINICAL BIOBANKS”
• 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
KEY POINTS
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
QuestionsScientific/health care 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.
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.
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.
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
Outline
Biobanks in Spain
• Why• What for• Network of biobanks• National Biobanks• Towards National Hubs of clinical biobanks• What else
Gracias!Gracias!
BIOBANKS
AND TRANSLATIONAL RESEARCH
PATIENT
SAMPLE BIOBANK MOLECULAR
ANALYSIS
LABORATORY
EXPERIMENTAL
RESULTS
DIAGNOSTIC & THERAPEUTICS
MARKERS
TRANSLATIONAL RESEARCH
MOLECULAR
PROFILING
