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The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI National Coordinators' meeting- Amsterdam February 10-11th, 2013
16

The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

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Page 1: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

The Italian Node of BBMRI

Angelo Paradiso

Filippo Belardelli

BBMRI National Coordinators

Meeting

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Page 2: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

National Hub

Regional hub

Research Centres

Universities

Accredited biobanks

The Italian National Node

a distributed hub structure,

Thematic hub

Accredited

biobank

Page 3: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

Distribution of the major Italian biobanks

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

According to a recent survey 53 Italian biobanks confirmed the interest to participate in BBMRI (list available at www.bbmri-eric.it/ )

Page 4: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

Thematic and multispecialty networks

participating in BBMRI

BioBIM- Biobanca InterIstituzionale Multidisciplinare (BioBIM)

da Vinci European Biobank (daVEB)

European Vascular Biobank (VAS)

Hub italiano delle biobanche di popolazione (HIBP)

Italian Network on Genetic Isolates (INGI)

Rete Nazionale di Biobanche Ospedaliere Multispecialistiche

(MHB)

Rete delle biobanche patologiche (NIPB)

Rete Italiana di BioBanche Oncologiche (RIBBO)

Telethon Network of Genetic Biobanks (TNGB)

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Page 5: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

Regional initiatives on

biobanks Italy’s health care system is a regionally based

National Health Service

The tasks of Regional Authorities with regards to

biobanks are:

definition of criteria for management

Authorization

control

Since 2011, the Conferenza Stato Regioni e

Province autonome has set up a Working group

on biobank management, for the definition of

common criteria for the authorization of biobanks

for research.

Some Regions have already put in place specific

resolutions and laws

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Page 6: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

Additional support to the national

infrastructure

In kind contribution:

Network of Scientists and experts provide expertise

Health care and research institutions are markedly contributing

to the national network with their infrastructures and personnel

(Institutes of Research and Treatment (IRCCS), University

hospitals, research centres)

Scientific societies (i.e. AIOM (medical oncologists); SIAPEC

(anatomopathologists) work together and with patients

associations (i.e: FAVO) in synergy with the node

Different types of stakeholders are also contributing with

important initiatives

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Page 7: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

Support to the Italian Biobanking Network

In the last years, the Ministry of Health allocated:

15 M€ to the Regions to support biobanks

3.3 M€ to support some major networking projects

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Page 8: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

Integration between regional and thematic networks in

the Italian BB network

BBMRI National Coorfìdinators'

meeting-Amsterdam February 10-11th,

2013

Region 1 Region 2 Region 3 Region 4 Region 5 Region 6 Region n

multispecialty

oncology

genetic bb

archive tissues

population and

isolates

Italian regional biobank networks

Ita

lian

th

em

atic a

nd m

ultis

pe

cia

lty B

B n

etw

ork

s

Page 9: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

The President of the ISS, on Ministry of Health mandate, establishes

BBMRI-it

Scientific committee Steering committee

The Italian Node of BBMRI

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Page 10: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

DESIGN OF THE STRUCTURE OF THE ITALIAN NODE

Steering committee

Stakeholder forum

Scientific secretariat

Scientific committee

and Coordination of

Services

Service 1

map of Italian biobanks

Service 2

Harmonization Service 3

Information Technology (IT)

Service 4

Technology and Reagent

Service 5

Quality Management,

SOPs, validation, training

Service 6

Ethical, legal and societal

issues

Service 7

Model for Regional biobank networks

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Page 11: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

Service Tasks

Common biobanking

and resources services

Map and monitoring of biobanks, repositories and biomolecular

resources

Periodic delivery of a high-resolution web-based questionnaire

for monitoring

Relation with european and international biobanking research

infrastructures and networks

Case study of networks of biobanks at regional level

Monitoring of procedures and standards for the different types of

biobanks (i.e., population-based, clinically oriented, and research-driven)

and of their regular updating

Improvement of the inter-operability among biobanks, according to their

specific main activity

Improvement of the quality and overall efficacy of the infrastructures

Criteria for the accreditation & certification

Criteria for the periodic auditing

Services of the Italian network

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Page 12: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

Service Tasks

Information

Technology (IT)

Services

Platform for collection, query, exchange and delivery of data

Setting up and management of the web site of the network

Platform for access of samples and related clinical data

Promotion of interoperability between bb

Connection of biobanks, services, regional and thematic networks

Services of the Italian network

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Service Tasks

Common Technology

and Reagent Services

Establishment of a National catalogue of facilities, reagent providers and

services for the biobank network

The catalogue will also include Expert Centres which can provide: latest

technology, adequate IT solutions, cost efficacy, high level of standardisation,

professional quality management, confidentiality, flexible solutions for

generation of intellectual property, and ethical and legal compliance.

Page 13: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

Service Tasks

Quality Management Implementing quality management criteria in biobanks;

Harmonizing and standardizing Standard Operating Procedures (SOPs);

Setting up training in quality control for biobanks’ staff;

Promoting certification biobank program;

Setting up quality management system.

Services of the Italian network

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Service Tasks

Ethical, legal and

societal issues

Definition of the bioresource status;

Definition of the status of biobanks;

Public consultation, informed consent modeling, accesso to bioresources;

Patentability;

Good practices in biobanking;

Governance of biobanks;

Networking of biobanks;

Network of Ethical Committees;

Permanent training;

Biobanking 2.0.

Page 14: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

Website

www.bbmri-eric.it ( new version is forthcoming)

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Page 15: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

BBMRI.it (2013)

2013

1 Formal delegation by the Ministry of Health

to the ISS for the participation in BBMRI-

ERIC

2 Taking over of the new Governance body

and definition of the final Node structure

3 Meeting of the institutional organs and the

scientific community

4 Assembly of the biobanks participating to

the Italian Node of BBMRI (October ESBB

meeting, Verona)

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013

Page 16: The Italian Node of BBMRIold.iss.it/binary/eric/cont/BBMRI_ITALIA_diapo.pdf · The Italian Node of BBMRI Angelo Paradiso Filippo Belardelli BBMRI National Coordinators Meeting BBMRI

BBMRI.it (2013)

2013

1 Harmonization

SOPs, QCs

IT,

ELSI

2 One Step Access

Meta-Db

Availability Db

Actual Db

3 Interaction with other Research

Infrastructures including:

ECRIN

EATRIS

BBMRI National Coordinators' meeting-

Amsterdam February 10-11th, 2013