March 6, 2013

EU Parliament Session1

- Harmonizing International Biobanking -Key to Global Science and Public Health

International Society for Biological and Environmental Repositories www.isber.org

European, Middle Eastern and African Society for Biopreservation and Biobankingwww.esbb.org Regional Chapter of ISBER

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

European, Middle Eastern & African Society for Biopreservation and Biobanking

ESBB has an important regional focus for biobanking issues within the region of Europe, the Middle East and Africa

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

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

1. Donors / Patients /Clinicans2. Biobankers3. Researchers / Academics / Industry4. Vendors / Suppliers5. Legal, Ethical, Social, Information Specialists

ISBER & ESBB Members Represent the Continuum of the Biobanking Chain in Health Care

Biorepository Collection

Life Cycle

Collect/Process/Inventory/Store

Biorepository obtains informed

consent

Distribute

Search/Request

DevelopNew research protocols

New Clinical Application (diagnostic, prognostic,

therapeutic)

Publish/ Submit to Regulatory body

Analyze / Verify / Validate

Evaluate Use

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– Records Management– Biological Material Tracking

• Training• Cost Management & Sustainability

Effective Practices and Best PracticesFrom Repositories Across the Globe

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

Tools for Collaborative Biobanking

SPREC - Standard PREanalytical Code to annotate preanalytical variations impacting biospecimen integrity

BRISQ – Biospecimen Reporting 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.

Global Working Initiatives – ISBER/ESBB

Facilitate International Collaboration through harmonization of IT and Data for exchange

Promote collaboration among Academia / Industry / Government

Integrate Environmental and Animal specimen collection practices

Provide unique biospecimens locator for Rare Diseases

Focus on biobank infrastructure building in Africa and low resource countries

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

21st Century20th Century (Not Sustainable)

Focus on treatment Focus on predisposition, early detection and biological processes

Diagnosis based on morphologic and pathologic analysis

Diagnosis based on molecular characterization and biological processes

Expensive; perpetuates unsuccessful approaches

Evidence-based; continually assesses standard of care

No systematic connection between research, preclinical trials and clinical care

Connects bench bedside bench in seamless feedback loop

A.Barker, NCI

The Ideal: 21st Century Medicine that is Predictive, Pre-emptive, Personalized

21st Century Personalized Medicine

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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

towards truly personalized medicine

A.Barker, NCI

Classification of Cancers

Cancer Phenotypes

Molecular Taxonomy Cancer “Biotypes”

From Generic to Precision Treatment

Industry Projections

<2009 2009 2010 2011Year Started

-

10

20

30

40

50

60

# of

Clin

ical

Tri

als

wit

h Bi

omar

kers

Source: Presentation by Biomerieux at the Biomarker World Congress 2012 (May 2012)

Demand for Biomaterials Outpacing Supply

Source: Visiongain. Biobanking for Medicine: Technology and Market 2010-2025. 2011

2009 2014 -

200

400

600

800

1,000

1,200

1,400

1,600

Non-commercial

Commercial

Tota

l Sal

es ($

mm

)

$840

$2,58323.2%CAGR

Initiation of Biomarker Driven Clinical Trials

Enabling Global Collaboration Effectively

Investment in the harmonization of quality biobanking practices is the fuel for advancing sustainable global public health