Joint presentation by International Society for Biological and Environmental Repositories (ISBER) and European, Middle Eastern & African Society for Biopreservations & Biobanking (ESBB) at the EU Science: Global Challenges, Global Collaboration Conference held March 4-8, 2013 in Brussels, Belgium. The session on biobanking included presentations from BBMRI, P3G, ISBER/ESBB, BioShare, Nat. China Biobank and a discussion on ethical/legal issues in biobanking focusing on the current plan for the EU data protection regulations. The presentation was authored by Rita Lawlor, President ESBB; and Marianne Henderson, ISBER Past President.

1. - Harmonizing International Biobanking-
Key to Global Science and Public Health
International Society for European, Middle Eastern and
Biological and African Society for
Environmental Repositories Biopreservation and Biobanking
www.isber.org www.esbb.orgRegional Chapter of ISBER
March 6, 2013
EU Parliament Session
1

2. International Society for Biological and Environmental Repositories
is the leading international forum that addresses the
technical, legal, ethical, and managerial issues relevant to
repositories of biological and environmental specimens
Our mission is to create opportunities for sharing ideas
internationally, and harmonize approaches to evolving
challenges in biobanking, and biological and environmental
repository operation. ISBER fosters collaborations, creates
education and training opportunities, and provides an
international showcase for state-of-the art policies, processes,
and research

3. European, Middle Eastern&African Society forBiopreservation and Biobanking
ESBB has an
important
regional focus
for biobanking
issueswithin the
region of
Europe, the
Middle East
and Africa

4. Major Goals of ISBER & ESBB
• Disseminate information on repository management
• Develop Best Practices
• Educate and Train on biobanking disciplines
• Provide a centralized information resource for repositories
• Unite members to address "hot button" topics
• Provide a voice for repositories to influence regulations to
facilitate global research and collaboration

5. Our Members Represent a Wide Variety of Biorepositories
• Clinical-based biobanks/ tissue banks
• Population biobanks
• Culture collections
• Environmental biobanks
• Museum biobanks
• Biobanks of human, animal, plant and microbial
samples

6. ISBER & ESBB Members Represent the Continuum of the
Biobanking Chain in Health Care
1. Donors / Patients /Clinicans
2. Biobankers
3. Researchers / Academics / Industry
4. Vendors / Suppliers
5. Legal, Ethical, Social, Information Specialists

7. Collect/Process/Inventory/Store
Biorepository
obtains informed Search/Request
consent
Biorepository Collection
Develop Life Cycle Evaluate
Use
New research protocols
Publish/ Submit to Distribute
New Clinical Application Regulatory body
(diagnostic, prognostic, Analyze / Verify /
therapeutic) Validate

8. 2012 ISBER Best Practices for Repositories
• Specimen Collection, Processing, Storage And Retrieval
• Legal And Ethical Issues in Biobanking
• Specimen Access, Distribution, Use And Destruction
• Repository Planning
– Facilities
– Storage Equipment And Environments
– Quality Management
– Safety Effective Practices
– Records Management and Best Practices
– Biological Material Tracking From Repositories
Across the Globe
• Training
• Cost Management & Sustainability

9. Focus on Education and Training
Educational workshops and webinars covering all areas
of biobanking
Self assessment tool (SAT) to measure adherence to
Best Practices
Encouraging the advancement and publication of quality
biospecimen science on collection and handling
practices.
Education to increase awareness of ethical, legal and
social policy that affects biobanking
9

10. Tools for Collaborative Biobanking
SPREC - Standard PREanalyticalCode to annotate
preanalytical variations impacting biospecimen integrity
BRISQ – BiospecimenReporting for Improved Study Quality
to provide consistent and standardized information to better
evaluate, interpret, compare, and reproduce experimental
results
ISBER Proficiency Testing – focus on Intra- and Inter-
Laboratory Variability as well as sample variability to assure
comparability of samples and testing.

11. Global Working Initiatives – ISBER/ESBB
Facilitate International
Collaborationthroughharmonizationof IT and Data
forexchange
PromotecollaborationamongAcademia / Industry /
Government
Integrate Environmentaland Animal specimen
collectionpractices
Provideunique biospecimens locator for Rare Diseases
Focus on biobankinfrastructurebuilding in Africa and low
resourcecountries

12. World maps resized by a) population, b) burden of disease, c) density of
medical schools, d) density of workforce

13. 21st Century Personalized Medicine
20th Century (Not Sustainable) 21st Century
 Focus on treatment  Focus on predisposition, early
detection and biological
processes
 Diagnosis based on  Diagnosis based on molecular
morphologic and pathologic characterization and biological
analysis processes
 Expensive; perpetuates  Evidence-based; continually
unsuccessful approaches assesses standard of care
 No systematic connection  Connects bench  bedside 
between research, bench in seamless feedback loop
preclinical trials and clinical
care
The Ideal: 21st Century Medicine that is
Predictive, Pre-emptive, Personalized
A.Barker, NCI

14. 21st Century Personalized Medicine
It is vital that as a community, we
harmonize our processes and
procedures for Global biobanking in
the 21st century.
At stake is the pace -- and the
ultimate success -- of our shift
towardstruly personalized medicine
A.Barker, NCI 14

15. Classification of Cancers

16. Cancer Phenotypes

17. Molecular Taxonomy Cancer “Biotypes”

18. From Generic to Precision Treatment

19. Industry Projections
Initiation of Biomarker Driven Clinical Trials Demand for Biomaterials Outpacing Supply
60 1,600
$2,583
23.2%
# of Clinical Trials with Biomarkers
Non-commercial
1,400
50 CAGR
Total Sales ($mm)
Commercial
1,200
40
1,000
30
$840
800
20
600
10 400
- 200
<2009 2009 2010 2011
-
2009 2014
Source: Presentation by Biomerieux at the Biomarker World Congress Source: Visiongain. Biobanking for Medicine: Technology and
2012 (May 2012) Market 2010-2025. 2011

20. Enabling Global Collaboration Effectively
Investment in the
harmonization of quality
biobanking practices is the
fuel for advancing
sustainable global public
health