Biobanks: Patients’ Role and Expectations

F.Bignami BBMRI Stakeholder’s Forum Brussels September 16th 2009

Fabrizia BIGNAMI, PhDEurordis Therapeutic Development DirectorEuroBioBank Administrative Coordinator

www.eurordis.org

www.eurobiobank.org

Biobanks: Patients’ Role and Expectations


Outline

1. The EuroBioBank network:

when patients take the initiative

2. Patients as actors in research

3. Patients' expectations from BBMRI

4. Patients' contribution to BBMRI


The EuroBioBank Network

ACTIVITIES

Rare diseases are defined as affecting less than one citizen in 2,000.

30 million people in the 27 EU member states are affected.

EuroBioBank® is the first operating network of biological banks in Europe providing human DNA cell and tissue samples for research on rare diseases.

The EuroBioBank network tackles two of the main problems facing European research on rare diseases:

- lack of human biological material- quality of samples.

• Identify and localise rare disease biological material of interest to researchers

• Process and store a critical mass of rare disease sample collections

• Maintain a centralised website with an online catalogue offering an easy access to the referenced samples available

• Distribute high quality material and associated data to users

• Promote quality biobanking practices (collection, transport, storage and exchange of biological material) adapted to each type of material (DNA, tissue, cell)

• Map ethical issues related to the use of biomaterial samples

• Disseminate knowledge and know-how to the scientific community

• Identify collaboration with the medical and scientific community in the field of rare diseases


• Initiated in 2001 by 2 Patient Organisations:

• the European Organisation for Rare Diseases (Eurordis) and

• the French Association against Myopathies (AFM)

• Financed by the European Commission between 2003-2006 (FP5) (12 founding biobanks from 8 EU countries: Belgium, France, Germany, Hungary, Italy, Malta, Slovenia and Spain)

• EuroBioBank was awarded the Newropeans Grand Prix 2004 for Research and Technology

• In 2006, the EuroBioBank network was cited by the IPTS/ESTO work group as a European model of coordination and of integration of Biological Resources Centres for the optimisation and improvement of the use of human biomaterial at European level

• Since January 2007, EuroBioBank has been a partner of the TREAT-NMD network of excellence in charge of the workpackage “Develop and Manage Supernational BioBanks”

• In 2008 EuroBioBank joined the BBMRI as associated partner

History of the network


Key results

• A network of 13 biobanks from 7 EU countries and Israel all complying with a common Charter

• More than 400,000 samples available across the network

• Approximately 13,000 samples collected and 7,000 samples distributed each year

• A web-based central catalogue (www.eurobiobank.org) enables a search by type of biological material, disease and biobank

• Consensus documents developed by the network:

-30 Standard Operating Procedures (SOPs)

-An Informed Consent form

-A Material Transfer Agreement (MTA)

• 93 high profile research publications acknowledging EuroBioBank (2003-2008)

• A book “Outstanding Legal and Ethical Issues on Biobanks”

http://www.eurobiobank.org/


Patients as actors: a specificity of the EuroBioBank Model

• Two Rare Disease patient groups instigated the EuroBioBank network (AFM and Eurordis).

• They have transformed an urgent need into a concrete and long lasting structure.

• They will continue putting the patient at the centre of all the EuroBioBank activities.

• Patients are not just samples providers, but front-line actors who: Organise and conduct bio-samples collection campaignsSpread easily accessible information about biobanksMake and consolidate the links between all involvedparties (researchers, physicians and biobankers) for a more effective research on rare diseases


Patients as actors: Other examples

• Registries and databases that patients:•Create•Support financially•Have legal responsibility and rights and contributed to manage

• Clinical trials that patients:•Instigate•Contribute to the design and management•Benefit from ( e.g. rapid access to all results)•Support financially

• Research projects for which patients:•Establish the network of specialists•Provide or identify the sources of funding•Help to reduce burdens


Patients as actors: expectations from the BBMRI

Patients expect BBMRI:

• To be the place where international harmonisation of biobank practices is achieved in the respect of the international recommendations already existing. Today, very different practices have a different impact on patients’ rights (e.g. different type and use of inform consent or methodology to withdraw consent)

• To actively involve patients in the concrete reflections on the governance of the future Biobank Infrastructure. (e.g. consultation of patients for collection campaigns, for defining priorities for use of rare samples, for information to lay public,…)


Patients as actors: expectations from the BBMRI

Patients expect BBMRI:

• To be recognised as the reference infrastructure for biobanking activities for research in EU so:

• to easily attract concerned professionals’ and people/patients for collaboration

• to optimise resources and provide centralised efficacious tools to make high quality biological material available for the research community. (e.g. central database allowing rapid identification of the required sample wherever it is stored)

•to ensure sustainable long term services that will contribute to accelerate the progresses of research on diseases


Patients as actors in BBMRI

Patients can concretely contribute to several BBMRI activities, such as:

• The definition of rules and best practices for:

the collection and distribution of samples (incentives for donors, consent, evaluation of requests, etc.)

the collection management and use of sample-associated sensitive data

the return of information on the results issued from the use of the samples

the ownership of material and results

• The awareness campaign on biobanking activities towards lay public and policy makers, so to ensure that biobanks will be recognised as a fundamental element to progress in the scientific and medical knowledge benefiting to the whole society. ( consequence on the long-term funding)


Patients as actors in the BBMRI

The BBMRI Stakeholders’ Forum:

a good starting point

A more direct and official involvement of patients in specific BBMRI activities should be systematically seek identifying most appropriate patients’ representatives

for each activity.


Thank you !

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EURORDISPlateforme Maladies Rares 102 rue Didot – Paris 75014 – FranceTel + 33 1 56 53 52 10 Fax + 33 1 56 53 52 15

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Biobanks: Patients’ Role and Expectations

Health & Medicine