Biobanks for quality
q
y
and
networks for quantity:
two cornerstones
for human health research
Jeanne-Hélène di Donato
[email protected]
ESBB meeting
Marseille, November 2011
From collections to biobanks
Knowledge through collections
1550 : Ambroise Paré :
Briefve collection de
l'administration
anatomique
1540 : Botanic garden
of Padova
XVIIIe : Anatomic
Cabinet of
F
Fragonard
d
To collect the more exhaustive
samples as possible
with the best possible indexation
To obtain the best
description
And to produce knowledge
For discovering,
Teaching,
Enhancing scientific progress
Collections became "personal"
Each researcher set up his "own" collection as a
scientific tool for his own researches
Different protocoles for preparation
N traceability
No
bili off samples
l quality
li
Poor sharingg
Unused collections
Lost of the collections
The research needs are important
Access to biological resources
P f off quality
Proof
li andd security
i
Take into account ethical questions
‘Professionalization’ of the management of collections
Guaranty the rights of
stakeholders
//
Value the secondary use of
Biological Resources
OECD BRC definition
1999-2001
 Infrastructure
s uc u e co
concept
cep
 For 4 domains (Animal,
Plant, Micro-organism
and human)
Essential part of the infrastructure underpinning biotechnology. They
consist of service providers and repository […]. BRCs contain
collections
ll ti
[ ] BRC mustt meett th
[…].
the high
hi h standards
t d d off quality
lit andd
expertise demanded by the international community of scientists and
industry […].
[ ] They must provide access to biological resources on
which research and development in the life sciences and the
advancement of biotechnology depends.
Biobanks Guidelines
AATB
MRC
ISBER
EMEA
NIH
NCI
OECD
IARC
CEE
CCNE
AFNOR
ANAES
INCa
….
General
policy and
Organisation
National / International
General / Specific
Infrastructure
survey
Collections
management
and quality
samples
The lost of "traceability" is alreaydy a reality
Mai 2010
Lib i off Fl
Libraries
Flesh:
h Th
The Sorry
S
State
St t
of Human Tissue Storage
Silberman
"One bank at a major university
claimed to have more than
12,000 samples of glioblastoma
in its collection. Only 18 of those
were good enough to use.
use "
Juillet 2011 vol 475(7357)
Better provenance for biobank
samples
Simeon-Dubach et Perren
"We analysed 125 papers retrieved in a
PubMed search using
g the key
y words
'biomarker discovery' for the years 2004
and 2009. More than half of these
contained no information about the
biospecimens used. "
Difficult Transition
Collection
Researcher
Can be recognised through
his
is publications
publicatio s
Private use
Biobank
Manager
ge
BRC
Collection Sharing
Has
difficulties to
value his
work
Biobanks become important challenge
International bibliography, an exponential growth
PubMed on « Bioban* »
250
200
Titre
Title
150
Title&&Résumé
summary
Titre
Extrapolation until
the end of 2011
100
50
0
1993
2000
2005
2009
2010
2011
A real worldwide markets for biobanks
This report analyzes the worldwide markets for biobanks
The emergence of biobanks opens new markets
which reach up to 22 billion $
Organisation of biobanks for
human health research
The French example
French Biobanks for human health research
5
80
80 public
bli biobanks
bi b k
for human health research
24
6
35
78 % are in hospitals
with direct access
to donors
and samples
to associated
i d data
d
(clinical and biological)
Biotechs
37 legal authorisations
High added value on biological resources
(cultures xenograft,
(cultures,
xenograft in vitro diagnosis,
diagnosis
medical devices)
Biobanks are Professional Infrastructures
Necessary capacity
N
i
to assume
•Security
•Traceability
Traceability
•Quality
•Ethics
Ri ht off St
Rights
Stakeholders
k h ld
•Patients
•Physicians
•Researchers
•Scientific Networks
•Society
Activities of the Biobanks
Service
provision
Q li controls
Quality
l
Reception of BR
Preparation
Establishment of the
collection
Storage
Transfer of BR
Documents and records
Collection management
What is Quality
Quality?
?
Quality of Samples
Based on Scientific Expertise
Using the best SOPs
Obtaining perfect samples
for research (now and in the future)
Research areas expand all the
time
Needs change
Techniques progress
Quality Management System
(QMS)
To define the best sample quality
To assess the biobank organisation
To assess the stakeholders’ satisfaction
Organisation of QMS
Optimisation of
U i Collections
Using
C ll i
Premises
Staff
Organisation of
the infrastructure
Finances
Respect of Regulation
Equipment
Quality Position for Biobank
Quality
requirements
q
Quality of
Infrastructure
Biobank
Collection
BR for research
Samples for health control
+
Quality of
Collection
+
Quality of
Samples
French position for BRC certification
ISO 9001:2000 standard
QMS
Requirements for survey
of Biological resources
quality
French NF S 96-900 standard
BRC quality
Requirements for
biobank organisation
OECD best practices for
BRC
Certification
20
NF 96-900
26
CRB
certified
4
ISO 9001
2
ISO 9001 & NF S96-900
French organisation
Financial help
p
Legal
g authorization
To help public biobanks to
develop their quality
management system
To obtain the perfect
traceability of biobanks
and collections
Certification
National Network
"BIOBANQUES"
Q
To assure quality
management system and
quality of biological resources
To allow a national strategy and
cohesion between biobanks and
to ensure interface with BBMRI
A sustained strategy
Infrastructures
1990
2000
2010
Networks
Biobanks and networking
Cornerstones of networks
Structure
Scope
Tools
Governance
Common objectives
Members
Rights and duties of each member
Consortium agreement
Survey of sample quality
Biological resources and collections
Communication
"Customers"
Customers' requirements
Financial support
Harmonisation of procedures
Catalogue
Different types of networks
Biobank
Biobank
Thematic
Biobank network
Biobank
Biobank
Biobank
Geographic
g p
Network
1 pathology / 1 group of pathologies
Harmonisation of procedures
C
Common
Catalogue
C t l
Scientific valorisation of collections
1 region
Mutual help
Regional Visibility
Biobank
Research team
Bi b k
Biobank
Technical Plateform
Patients Association
Network for
research
Translational Research
One biobank can participate in
different networks
Example with European Network of
Biobanks for rare diseases
Généthon
French network
BIOBANQUES
TREAT-NMD
A network in the
neuromuscular field
Myobank-AFM
EuroBioBank
BBMRI
Neuromuscular Tissue
Bank, Padua
Carlo Besta biobank
Milan
16 biobanks
Italian Telethon biobank network
Network analyse by BBMRI
BBMRI Report 2010, Septembre 21
Biobanking is not
a new practice
But it becomes a new professional activity
Veryy well organised
g
to collect samples
Make them available for research
With open collections
Based on the high quality management
and reactivity, biobanks can participate
in networks
Thanks