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Residence Palace, Brussels 09 June 2010

BBMRI: A Step CloserStakeholder’s Forum Report

A Step Closer

BBMRI Stakeholder’s Forum

Residence Palace, Brussels

09 June 2010

CONTENTS

1. The report and its aim

2. Introduction

3. BBMRI: European and International Context

4. Stakeholder Workshops- Industry Stakeholders Workshop

- Patient Stakeholders Workshop

- Clinical and Scientific Stakeholders Workshop

5. General Talking points- Importance of Public Engagement for Biobanking

- Improving and Funding Interoperability

- Expert Centres

- Ethical Review

- Making Use of Dormant Resources

- Intellectual Property

Appendix I – Meeting Agenda

Appendix II – Meeting Evaluation Form Summary


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THE REPORT AND ITS AIM

This report seeks to summarise the discussions thattook place and the talking points that emergedduring the BBMRI Stakeholders Forum meeting inBrussels on 9th June 2010, which brought togetherresearchers from academia and industry, patientorganisations, research administrators, ethicists andlawyers from all over Europe.

The report should be considered as a follow-up tothe report produced from the BBMRI StakeholdersForum meeting on September 15th, 2009. Thereport has been produced from a combination ofthe meeting rapporteurs’ summaries and BBMRIStakeholders Forum staff. Presentations fromplenary sessions and workshops, as well as allprevious reports are all available on theStakeholders Forum section of the BBMRI website(www.bbmri.eu).

INTRODUCTION

Allied to the rich history of healthcare in Europe,biobanking is seen internationally as a specificEuropean strength. However, Europe is unable tomaximise the potential of its biobanks because thecommunity is heavily fragmented and needs toharmonize. The EU is now looking to create the firstpan-European legal entity designed to helpbiobanks interoperate and collaborate to improveEuropean research capabilities.

BBMRI (The Biobanking and BiomolecularResources Research Infrastructure), as one of thefirst European Research Infrastructure projectsfunded by the European Commission, is coming tothe end of its preparatory phase. The inititative islooking to soon afterward provide access for thescientific community to the millions of biosamplesin collections and banks around Europe.

In opening the meeting, Chairman of the BBMRIStakeholders Forum, Michael Griffith stated thatthe meeting had been specifically designedaccording to the recommendations from theSeptember 2009 event. Griffith stated the forumobjective to put the stakeholders at the centre ofthe planning and development of BBMRI througha transparent mechanism to ensure that the publicinterest is maintained. “It is essential that we areopen to public scrutiny and to ensure thatstakeholders are properly informed and can makeinformed decisions. Creation of an internationalcommunity of BBMRI stakeholders, is the first partof that process”, he said.


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BBMRI: EUROPEAN ANDINTERNATIONAL CONTEXT

“The health-related global challenges (AgingSocieties, Public Health, Pandemics and Security)can only be addressed by providing access tobiological materials allied to information fromhealthcare”, said Kurt Zatloukal, coordinator of theBBMRI preparatory phase. BBMRI is designed as aninstrument to help the scientific community gobeyond the frontier of knowledge and capacity ofwhat they can achieve alone. “BBMRI is seen at theEuropean Commission level as a very visible exampleof a research infrastructure which can not onlysupport research but can also have very wideimpacts for society, health and for the developmentof an efficient and attractive Europe,” said HervéPero, of DG-Research, European Commission.

The need to construct not only aEuropean, but a global network forbiobanking activities was wellrecognised at the meeting. BBMRI isattempting to establish parallelcontact with initiatives outside ofEurope (for example in China, USA,Korea). “The OECD has producedguidelines on human biobanks andgenetic research databases whichhave already achieved a basicoperability on a global scale, providevery good principles for setting upinfrastructure and also place emphasis on stakeholderinvolvement” said Zatloukal. “Very similar projectshave emerged recently in parallel both in the EU andin the USA, and we can use these OECD principles toimplement a global network”, he said.

BBMRI-ERIC: KEy RolE oF MEMBER StatES

Of the variety of legal options for theimplementation of its preparatory phase, it is quiteclear that BBMRI finds the ERIC (European ResearchInfrastructure Consortium) legal instrument as themost suitable for its distributed “multisided hub andspoke” structural model. The ERIC is an instrumentspecifically designed by the European Commissionfor the projects under its ESFRI roadmap, whichallows consortia to operate in different MemberStates under one legislation and also offers VAT-freestatus. The vision of BBMRI-ERIC is to establish acentral headquarters in a nominated member statewith BBMRI ‘hubs’ in member states who officiallycommit to being members.

“It was nice to hear recently that BBMRI is one of themost advanced on the ESFRI roadmap, so we canbe proud that we have made significant progress”,said Eero Vuorio, Executive Manager of BBMRI.BBMRI should be submitting its application for ERICstatus in autumn 2010, with an expected start date ofspring 2011. “The BBMRI-ERIC statutes are essentiallyready, but it has not been an easy process, and someitems remain unresolved, not least the determinationof the sizes of the national contributions”, Vuorioadded.

Although the decision-making process is still inprogress, official commitments for the construction

of BBMRI-ERIC have been receivedfrom six European Member Statesand BBMRI is on the nationalroadmap in a further eight countries.In addition, Austria has made an offerto be the official host of BBMRI-ERIC.“Further national fundingcommitments, albeit with stringsattached, can also be used towardsbuilding the BBMRI-ERIC, and moreand more countries are preparingnational roadmaps in this regard”said Vuorio.

Hervé Pero welcomed the BBMRI-ERIC proposal andemphasized that in order to ensure sustainability,communication with politicians – both at theEuropean and Member State levels - will be vital.“We need to ensure that our political decision makers

Hervé Pero

“BBMRI can not onlysupport research but

can also have verywide impacts for

society, health andfor the developmentof an efficient andattractive Europe”

- Hervé Pero


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are aware of all the direct and indirect impacts andreturns for stakeholders which will be generated ifwe build the BBMRI-ERIC” Pero said. “The finaldecisions for membership of BBMRI-ERIC are madepolitically in finance departments whereunfortunately, scientists are relatively small players.These impacts have very strong socio-economicimplications and need to be demonstrated to thefinance minister in each Member State” he said.

BBMRI: toWaRDS IMPlEMEntatIon

Vuorio described how BBMRI has grown into a 53-member consortium with over 280 associatedorganisations from over 30 countries, making it thelargest research infrastructure project in Europe.Some of the key achievements of the BBMRIpreparatory phase are highlighted in table 1.1 below.

Vuorio highlighted the discussion on interoperabilityversus standardisation. “BBMRI is based oninteroperability of existing biobanks” he said. “You

cannot standardise what is already existing, onlywhat is to come” – touching on some of the issueswhich remain under discussion including ethical andlegal issues, data and sample managementprocesses, and pilot/demonstration projects.

BBMRI needs to operate not only within the ERIClegal framework but also at the local level asbiobanking activities will always remain in the localenvironment. It is very clear that BBMRI will notproduce data online which is related to individualdonors – only data that has been aggregated andthat summarizes ‘healthy’ populations or patientdisease groups will be made available. Consentissues will look to implement the OECD guidelines.Best practices on handling biological materials, andstandard operating procedures will consult theconsensus documents produced by the WHO/IARC,ISBER and the NCI.

Access policy is currently under discussion in BBMRI.The European Commission has very specificrequirements in the ERIC guidelines that accessshould be open and fair to all scientific communities.This is a particular challenge for biobank samplesdue to their own national juristictional ethical reviewand the informed consent requirements that cannotbe overruled by any European Directive. “Inaddition, in order to provide fair access toresearchers, BBMRI must agree on registrationprocedures, standard agreements, quality

Eero Vuorio

“BBMRI is based on interoperability ofexisting biobanks”

- Eero Vuoriouu

Herve Pero, Eero Vuorio, Derick Mitchell, Michael Griffith, anne Cambon-thomsen


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In addition to the stated deliverables of theBBMRI preparatory phase, some additionalachivements have been highlighted.

1. Inventory of the European BiobankingEnvironment – a comprehensive overview ofover 260 biobanks, from both population anddisease-based.

2. Demonstration of increased interoperabilityin prototypes, pilot projects and large EC-funded projects.

3. Strong emphasis on interaction with publicswith active participation of patientorganisations.

4. Socio-Economic Impact Studies.

5. Close interaction with other science fieldsand research infrastructures.

6. Increased coordination of national biobankingactivities in several Member States.

7. Driving innovation on new It solutions onhow to provide anonymity, particularly byavoiding re-identification when complexdata becomes integrated.

8. Creation of next generation analyticalapproaches for Metabolomics, Cryobiology,Infectious diseases – (e.g. linking of highsecurity labs to healthcare for newpandemics, creating patient-specific stemcells, etc.)

9. Providing a way to structure nationalBiobanking Infrastructure and networks (e.g. BBMRI.nl, BBMRI.se etc.)

10. assisting in building research infrastructuresin a single member states (e.g. BiocentreFinland)

TABLE 1.1

Key Achievements of BBMRI PreparatoryPhase (2008-2010)

assurances, integrated data sets and the provisionfor enrichment of annotations” said Martin Yuille ofthe University of Manchester. “We need to work outthe specifics of how these can be done, based onour experience and based on the practices thatevolve”, he said.

Kurt Zatloukal


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STAKEHOLDER WORKSHOPS

Parallel workshops were organised to identify themain areas of discussion within a particularstakeholder group. The following summarydescribes the cross-stakeholder discussions whichtook place in each workshop in order to identifycommon ground and consensus to move theproposed infrastructure forward.

InDuStRy StaKEHolDERS WoRKSHoP

This workshop involved senior leaders and expertsfrom the industries with specific biobanking interests(e.g. biopharmaceutical, biotechnology, diagnostic,biostorage etc.). Presentations focused on thepotential for public-private-partnership inbiobanking within the pre-competitive research area.

In his summary of the workshop, rapporteur AlfredoCesario from San Rafaele Hospital, Rome,highlighted the ‘apparent’ clash in the interests andmotivations of industry and the public sector inbiobanking. “This in fact, is not a clash at all, he said,as both sectors can actually obtain what they arereally interested in, without having to compromiseon their respective ideals and principles”.

“There is now a great opportunity to create win-winsituations in the area of public-private-partnershipswith regard to biobanking”, said Klaus Lindpaintnerof Biobanks LLC (see also talking point e.). “Thebiopharmaceutical industry is currently establishingwhere it can push the sharing limit and there isgeneral agreement that items can be shared such as‘drug target validation’ and in cases where largeinternational studies are required”, he said.

There was general agreement among stakeholdersthat the Expert Centers that BBMRI wishes toestablish (see talking point c.) would have therequisite expertise to share with industry andindustry would have complimentary tools to sharewith these expert centers.

The current economic difficulties and pressures fromwithin the biopharmaceutical industry have beenwell-documented. “Industry needs to considerdifferent approaches to collecting annotatedsamples to enable the identification and validationof drug targets in a rigorous manner ”, said JulieCorfield of Astrazeneca. “There is also an ethicaldilemma – you could say industry is duty bound tooptimise and share those samples (if consentpermits) with the people who may have thenecessary skills to develop a platform of evidencethat is appropriate for a target”, she added.

Pre-competitive research is an area which is undermuch discussion within industry at the moment withmany biopharmaceutical companies operating insmall consortia at this level. “Astrazeneca are lookingat fundamentally redefining our boundaries of whatwe mean by pre-competitive at the policy level toprovide the framework for an operating model”,Corfield said. Astrazeneca recently identified threeareas which they “must do” in this pre-competitivearea in order to transform projects by sharingwithout affecting their competitiveness; (a) targetvalidation tools and approaches; (b) informationsharing in regard to “failed” targets, and (c) workingtogether in areas where the company lacks sufficient‘data power’ to generate knowledge (e.g. patientregistries).“Biobanks can make a huge contributiontowards patient stratification and development ofbiomarkers, which is very much aligned with themomentum behind the personalized healthcarephilosophy”, Corfield said.

What is happening in the Innovative MedicinesInitiative (IMI) is a good example of how industry hasbeen prepared to come together and share. AnnMartin of IMI described how many of the currently-funded IMI projects have biobanking elements tothem and David Myles of GlaxoSmithKline spokeabout the UBIOPRED IMI project, which isinvestigating the underlying causes of severe asthma.“The key is to identify what you are happy to share”,

“The key is to identify what youare happy to share”

- David Mylesuu


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said Myles. For him, where the industry couldreally come together is in finding a betterunderstanding of the different types of diseasesthey are attempting to fight. “Industry is facing acliff-face with costs going up and successes goingdown”, he said. “We recognise that we cannot dothings in the old way, and with multiple differentphenotypes in many diseases, you cannot hope toachieve or to afford it” he said. “Ultimately industryneeds to spread the risk across the publicsector/industry/academia. Not one sector has allthe necessary skills, resources, expertise but if theindustry are to find new therapies, we have a greatopportunity here to come together to do this”, headded. Already some disscussions are taking placeon the Intellectual Property (IP) arising from theresults of the first IMI projects and many feel thatthis will be the benchtest of these large-scalepublic-private partnerships.

In the discussions that followed, the speakers wereasked how the “sharing” process would work inpractice? “In the case of a company-sponsoredclinical trial, ask the company to take not onebiosample, but two – one for analysis within thecompany and one for storage within a publicdatabase”, said Lindpaintner. As a company is asponsor, the dialogue on sharing would have to bebetween the company and the publichealth/academia/government as to how thisshould be carried out.

Neil Formstone, a patient representative of theWales Cancer Bank, stated that samples were onlytruly useful when they were accompanied by acomprehensive package of medical data. “The costsof collecting and maintaining this anonymised data,as well as obtaining the sample, will have to beborne, in whole or part, by the end user or else therewill be no funds to undertake this vital part of theprocess. This may entail the Expert Centres in partfunding some of the costs in collecting and holdingthis data”, he said.

“A compromise could be that industry pays forcollecting the sample and for collecting part of thedata, as long as the public sector is made aware thatthis is happening. There may be a way to leveragethe amount of money that is already being spent onthese large studies, by adding an additional amountof funding to create the kind of more broadly-annotated database that goes along with thesample”, suggested Lindpaintner.

Is this consistent with other positions inpharma/biotech? “It is very clear that challengesremain in terms of the willingness to share, andhow it fits with other business decisions inindustry,” said Corfield. “Defining the appropriateclinical data which can be shared or combined witha sample, and once defined, adopting consistentinformation standards for the annotation of bothclinical data and samples are significant challengesfor us all”, she said. Ann Martin highlighted one ofthe IMI projects currently under evaluation forsetting up a business model for re-use of ElectronicHealth Record (EHR) data through an independentbroker. The goal is to provide a platform thatfunctions across many EHRs that providesanonymized access to patient data for the purposeof clinical research.


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PatIEnt StaKEHolDERS WoRKSHoP

This workshop involved prominent members ofeuropean patient organisations, especially thosealready involved in biobanking for both commonand rare diseases. A series of presentations focusedon the role of patient organisations in biobanking,communication with patients about biobankingresearch as well as the integration of biobanks withpatient registries.

In his review of the workshop content, rapporteurAlastair Kent from Genetic Alliance UK summarisedthe presentations and discussions through a numberof recommendations for action by BBMRI.

a. Public & Patient Appreciation and Understanding

BBMRI should consider how the ground can beprepared for public understanding of biobanking, inparticular with regard to engaging with local andnational patient organisations, for them to be in aposition to act as advocates for the adventure ofbiobanking.

All citizens of Europe have the potential to beapproached to become involved in biobanking atsome stage. Even if not, it is important to feel part ofa community which endorses the legitimacy of theadventure in order to enable it to be sustainable. Inaddition, the network of biobanks within BBMRIshould develop good practices in patient engagementand learn from examples beyond the EU. BBMRI hasthe potential to offer a regulatory role in enforcingthese good practices in patient engagement. In thisregard, the development of a web portal for publiccommunication would be very useful.

b. Communication and Language

a contingency should be in place within the“national hubs” of BBMRI for the demonstration ofa commitment towards the development andimplementation of a local language disseminationstrategy for patient participation in that memberstate.

BBMRI should look at robust models for thecreation and dissemination of information,appropriate translation (both linguitically andculturally), and must pay particular attention onthe right of ethnic minority populations to beconsidered for participation in biobank research.

c. Donor Communication

BBMRI should collect examples of successfulstrategies from different types of biobanks whohave addressed the issue of donor communicationat different points of the donor participationprocess.

This includes communication prior to recruitment;before, up to and including the point at whichconsent is obtained; during the research process;and afterwards in relation to the significance ofresults.

d. Publication of Results

It is recommended that BBMRI develop a strategyby which the results from studies, in particularnegative results, can be publicly communicated.

Negative results can accrue from either doing“good science” that produces an outcome with nodifference, or by producing “bad science”. Bothpossibilities have implications for researchers dueto possible consequences for investors, otheracademics, etc. How you bring the informationinto the public domain is difficult and will requirerealistic processes of dissemination.

e. Capacity Building

BBMRI must invest in capacity building for Patientorganisations.


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Not all patient organisations are equally developedin relation to available resources, knowledgeand/or state of evolution. Training courses forpatient engagement in biobanking would be mostwelcome in this regard. The ERIC Statutes shouldincorporate patient organisation representatives asmembers to address patient involvement beyondtokenism.

f. Opportunity to Participate

there should be systematic development of theawareness of the opportunity to participate inbiobanking.

There is no such thing as the “right to participate”in biobanking. However, BBMRI should look at waysin which it can create a “virtuous circle” so thatprofessionals and the public together can be awareof what is going on in relation to biobank research,and that due respect is offered in relation to wheredifferent stakeholders are coming from. Examplesof this in practice include posters in clinics, ‘opt out’clauses, information leaflets attached to consentletters, etc.

Patient Stakeholder Workshop - nathalie Kayadjanian, Jan Geissler, Filippo Franchini, Michael Griffith


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“A network is the natural environmentof biobanking.

”- Manuel Morente

Manuel Morente

ClInICal anD SCIEntIFIC StaKEHolDERSWoRKSHoP

This workshop was designed to stimulate discussionamong clinical and scientific investigators involvedin biobanking whose research activities will besignificantly improved through access to BBMRIresources. Participants included researchers fromclinical trials units, physicians and scientistsproviding and storing tissue for biobanking,pathologists responsible for maintaining biobanksand members of ethics committees). Presentationsfocused on quality management & good practices,networking and clinical trial, ethical and governanceissues, and using biobanks for genetic studies oncommon diseases.

A network is the natural environment of biobanking”.So said Manuel Morente, of the National Centre forCancer Research (CNIO), Madrid. “Networking withinand between countries is essential as no centre orcountry has the potential to solve complex healthquestions on its own”, he said. “Of course, there aredifferent types of networks but the diversity can beaccommodated within a common set ofstandardized procedures, quality control programsand good coordination”. There are also limitations tonetworking, he added, and not all ‘peculiarities’should be erased when defining the commonaspects. Morente went on to emphasize that ‘Public’biobanks are essential for clinical trials as theyensure transparency and accountability.

There are many variables and bottlenecks in thehealthcare environment which impact on thebiological quality of a sample. For example, 75% ofcauses of errors in biomarker development happenat the stage of handling samples. How this relates tothe quality of research data produced from thesesamples is something we really need scientificevidence on. So said Bharat Jasani, from the Schoolof Medicine in Cardiff University, Wales whoemphasized the importance of using sampletracking systems for tissue biobanks.

Emmanuelle Rial-Sebbag from INSERMconcentrated on the ethical and social challengesthat are required when building and implementingbiobank networks to ensure people have ‘control’over their samples and data. BBMRI has performeda review of ethical and legal approaches across 25different countries, which it is hoped, will lead tothe identification of ‘core’ ethical items forconsideration in BBMRI-ERIC.

“The main challenge in this context is that thecurrent ethical methodology of biomedical researchand clinical trials does not systematically work whenapplied to biobanks, particularly in relation toinformed consent. Also there is a need for changesin the operational governance of biobanks with anenhancement of interactions between science andsociety (balancing different ‘logics’)”, she added.Rial-Sebbag also proposed a new concept forInformed Consent, which she called ‘EnlightenedConsent’. “Rather than being a legal requirement,consent should be a mechanism to involveparticipation within a flow of information linkingparticipants, scientists and the community”, she said.

“The next frontiers for biobanking are datainformation storage and access”, said Samuli Ripatti,


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Clinical Stakeholders Workshop - Bharat Jasani, Samuli

Ripatti, Frank Wells, Emmanuelle Rial

of the Institute of Molecular Medicine (FIMM),Helsinki who highlighted the progress being made inresearch into the genetics of common diseasesthrough Genome Wide Association Studies (GWAS).“As we turn biological information into digitalinformation, we turn biobanks into databases. Thisinformation needs to be made amenable to meta-analysis, modeling, development of predictionmodels, etc.”, he said. Ripatti described the work ofthe Global Lipid Genetic Consortium, which islooking at the underlying causes of high levels ofcholesterol. “The main lesson we have learned in ourproject is the importance of Information TechnologyManagement to provide the linkage betweenbaseline information and complex sets ofphenotypic and genotypic data", he said.

In his summary of the discussions, rapporteur PierreHainaut of the International Agency for Research onCancer (IARC) identified that the data producedfrom genetic studies involving biospecimens canhave a significant impact on the participant as aperson (e.g. low risk vs. high risk genetic traits).“Researchers need to be aware of these impacts andthe scope of their consent procedures needs to takethis into account”, he said.

A discussion on how to motivate and raise theparticipation rates of the medical community inbiobanking identified personal attitudes, a feeling of‘ownership’ over sample collections and lack of timeand resources as the major obstacles to theirparticipation. In order to increase the scientificrecognition of medical practitioners participating inbiobanking, Anne Cambon-Thomsen of INSERMproposed the idea of a ‘Bioresource Impact Factor’as a means of measuring how a biobank is used.“The idea behind it is to change the feeling of ‘loss’

when a biobank gives access to its samples, to afeeling of ‘benefit’ because if your biobank is used alot, you can have a measure of that”, she said. Inaddition, a recommendation was made that doctorsshould be trained in biobanking practices as part oftheir medical studies.

The role of BBMRI in enhancing quality standardswas also highlighted and research into evidence-based procedures and protocols that are adapted toeach particular context was called for. “BBMRI mayset ’baseline’ standards and requirements for joiningthe network (technical, ethical, access rules, etc.) butnot everything needs to meet the higheststandards”, Hainaut commented.

Based on the experience of Wales and Spain,discussions on the optimal strategy formanagement of national biobanking networkswithin BBMRI suggested that Quality Control (QC)can be used as a way to bring operators andtechnical staff of biobanks together in face-to-facemeetings with the national coordinator acting asan ‘honest broker’. “Also, there is a whole new fieldof research opening up where biomarkers becomemore important for assessing the quality ofspecimens and BBMRI may help to develop thisfield at the European level” said Hainaut.

anne Cambon - thomsen

“The next frontiers for biobankingare data information storage and

access”

- Samuli Ripatti


questions on biobanking, the results of these studieswill form the foundation of a public communicationand awareness strategy to be developed during theBBMRI implementation phase.

The need to take biobanking out into the curriculumof public schools and medical training was alsoemphasized. “In a very proactive manner, start toeducate the population of Europe”, said KlausLindpaintner. “We are all patients, and eventually weare all going to be part of it, and the sooner we tryto engage the public, the better off we are”, headded.

The issue of resources within the biobankingcommunity was raised by several stakeholders. “Weshould count on the stakeholders who are involvedin biobanking in order to translate the informationinto lay language. If you agree to be in partnershipwith all stakeholders, then the resources can befound from this community” , said Fabrizia Bignamifrom the European Organisation for Rare Diseases(EURORDIS).

B. IMPRoVInG anD FunDInGIntERoPERaBIlIty

“Finding ways to interoperate and collaborate hasmajor implications for funding mechanisms as youcannot fund harmonization in a competitive fundingenvironment – the groups that apply for funding areforced to come up with new and different solutionsto the same problem” said Zatloukal. “At a certainstage, for some specific fields, you have toencourage collaboration and we have to look at howto create values by collaboration through newfunding schemes”. he said. Peter Riegman of

GENERAL TALKING POINTS

a. IMPoRtanCE oF PuBlIC EnGaGEMEnt FoRBIoBanKInG

As biobank networks become more prominent andnumerous, there is an essential need to educate notonly the public, but also researchers in academia andindustry on what the role and value of biobanks is.This was the opinion of the majority of stakeholdersat the meeting.

A realistic, rational and effective strategy for publiccommunication was called for. “This strategy shouldbe devised to reach people and messages should beprepared according to people’s needs and what theywant to know, rather than what scientists are ableand not able to say in lay words”, said Alastair Kent.Support was expressed for the funding of a WebPortal which incorporates targeted information(depending on the relevant stakeholder needs),using e-learning and social networking to educatelarge numbers of professionals and publics onbiobanking principles and practices.

“We have to approach this challenge from bothsides”, said Kurt Zatloukal – those involved inbiobanking need to make themselves available todeliver the right message but also the public needto be willing and open to receive an interaction andinterface.

A strong emphasis on interaction with publics hasalready begun in the BBMRI preparatory phasethrough focus groups in a number of Europeancountries. Allied with the soon-to-be publishedEurobarometer information, containing ten specific

Klaus lindpaintner, Manuel Morente, Fabrizia Bignami,

Kurt Zatloukal, Derick Mitchell, Michael Griffith14 |


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must use the same reference guidelines and material,ensuring that the data generted in any centre wouldbe of identical quality to that produced by anyother”, said Zatloukal.

D. EtHICal REVIEW

How can we trust that the research will beperformed according to sound ethical principles? –so asked Anne Cambon-Thomsen, workpackageleader of the Ethical, Legal and Social Aspects of theBBMRI Preparatory Phase. Just like a scientificreview of a project, BBMRI needs an ethical reviewprocess as well. The existing situation is that localResearch Ethics Committees (RECs) have to givetheir approval for a project where the samples arecontained within that country.

At the moment BBMRI are planning to issue a call forexpression of interest for membership of a BBMRIethical review panel. “This would consist of a smallgroup of experts who have specific expertise onassessing ethical aspects of European projects andon whose expertise we can rely on”, said Cambon-Thomsen. “BBMRI is currently favouring a ‘hybridmodel’ where a standing committee meets regularlywith a certain mandate which can be renewed, whileat the same time having external experts givinginput on these projects”, she said. “This is a verywelcome development”, said Frank Wells of theEuropean Forum for Good Clinical Practice (EFGCP).The idea of BBMRI is not to go over the heads of anyexisting ethics committee but rather to send theBBMRI opinion in the form of advice, to the localethics committee, so they can take this into accountin their own assessment. Jochen Taupitz, a memberof the German National Ethics Council questionedthe relevance of any decision from such a panel inthe case where there is no need for a researcher toconsult an ethics committee or if a local ethicscommittee does not exist. “Then the opinion of theBBMRI committee will be the only one considered inthis case”, was Cambon-Thomsen’s response.

ERASMUS, Rotterdam asked if BBMRI can ‘adapt therules’ for competition to reward sharing. “This willlead to people trying to find each other, rather thanwalking away”, he said.

“Compliance with minimal standards are necessaryto achieve interoperability. However, mostinternational guidelines on biobanking are based,not on scientific evidence, but on individualexperience. How to achieve this interoperability willrequire different solutions for different levels; forexample the ethical and legal levels”, said Zatloukal.

C. ExPERt CEntRES

How BBMRI-ERIC interacts with industry is a sourceof much debate. “The relationship betweenPharma/Biotech needs to be established in atransparent manner. BBMRI needs to be aware of thesensitivities and should create honesty about theneed for interaction, which requires clear rules forengagement”, was the consensus from thestakeholders in the patient workshop.

The Expert Centres solution supported by BBMRIwill build the interface between the public andprivate sectors as a non-profit joint-venture set upin the pre-competitive environment.

“Human biological material cannot be sold as it isagainst international legal conventions” said KurtZatloukal. Furthermore there is valuable informationand knowledge related to the samples that cannotbe shared by shipment but requires personalinteraction. Therefore expert centres should createa framework that not only provides access tosamples and data but also facilitates sharing ofknowledge between academia and industry.

The principle of the BBMRI expert centres is that theresearch performed is a “transformation” of the finitestarting material into data and knowledge that canbe easily shared. The BBMRI plan is to establishexpert centres in different parts of the world. Eventhough some countries have restrictions on exportof samples over borders, the data arising from theanalysis of a sample can be shared. If the analysis isdone in the environment where the samples havebeen generated, this removes these restrictions andreduces costs for transfer and shipping. “All centres

Frank Wells, Samuli Ripatti


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E. MaKInG uSE oF DoRMant RESouRCES

There are banks of biosamples lying in freezers allaround Europe (e.g. hospital archives, samples leftover from clinical trials etc.) - a huge resource thathas immense value waiting to be liberated. However,there can be large ethical and quality issuesassociated with these retrospective collections andthe samples may not always be well characterised.

The general understanding among stakeholders atthe meeting was that once a sample is in arepository, it should be exploited for the benefit ofeverybody. “Make sure we don’t miss theopportunity that is out there on specimencollections that are being carried out in clinicaldevelopment studies in large pharmaceuticalcompanies”, was the message from KlausLindpaintner. “I think there is a clear synergy to beleveraged to create a win-win opportunity wherenobody is giving up anything as yet and whereadded value can be created”, he said.

A recommendation from the Patient StakeholderWorkshop was that pressure should come fromBBMRI to industry to make better use of theirdormant resources. “In this context, the relationshipwith Industry is a two-way one. BBMRI is not justgiving basic research to industry, but recognisingindustry’s contribution toward the generation ofscientific knowledge. “If you can capitalise on this,you can create a win-win-win situation wherepatients, industry and the clinical and academiccommunity can all benefit”, said rapporteur AlastairKent.

F. IntEllECtual PRoPERty

Publicly-funded biobanks (e.g as part of a university)are under increasing pressure from governments to

alastair Kent

generate funds and valorise their research. Thispressure finds expression in the form of IntellectualProperty (IP) which can be a severe impediment tosharing.

In the Expert Centre model proposed by BBMRI, thedata generated from analysis of samples is publishedearly to ensure that the IP is not generated at thisstage of the process. “This shift of the role of IPtowards the product was actually proposed by amajor biopharmaceutical company - a very welcomedevelopment”, said Zatloukal.

A discussion was called for on the differentmotivations and altruism that exist betweenindustry vs. public initiatives in relation to sharingand IP. David Myles responded that the primarymotivation for companies within the IMI projects isto increase their success rate. The UBIOPREDconsortium discussions on IP reached a mutualunderstanding where all participants within theproject (both public and private) would have freeaccess to all the information and could make useof it. “Academic centres, through their technologytransfer offices could get their own IP, throughmaybe design of a kit, which industry would bemore than happy to pay for the use of”, he said.Carine Malcus of Biomerieux confirmed that thereis a better recognition also in the diagnosticindustry that innovation can come from apartnership and not just from a company alone.

Patient Organisations do not have a problem withIP arising from their donations, was the messagefrom Neil Formstone. “As long as you are open andhonest about where that sample will go, then thereis no problem. However, there remains a need forindustry to ensure understanding among donorsthat their sample is going to be utilized for whatthey want to see – future health benefits – and thatyou are not simply squabbling over financialconsiderations”, he said.

“you can create a win-win-win situation where patients, industry and the

clinical and academic communitycan all benefit”

- Alastair Kentuu


| 17

PATIENT PARTICIPATION DOCUMENT

As part of the final session of the meeting, FabriziaBignami of EURORDIS, representing patientstakeholders, presented Kurt Zatloukal with the“Patient Participation in BBMRI” consultationdocument. This document is intended to be used asa guideline of basic principles reflecting patientparticipation in both new and existing biobankswithin the implemented research infrastructure.After an extensive consultation process, thedocument – endorsed by many prominent Europeanpatient organisations - was presented forconsideration in the drafting of policies andprocedures for the implementation of the researchinfrastructure.

Presentation of patient paper - Michael Griffith, Fabrizia

Bignami, Kurt Zatloukal

CONCLUSION

The long term aim of the Stakeholders Forum, asdescribed by Derick Mitchell in his closingsummary, is to ensure that there is an establishedrole for stakeholders within the implementedBBMRI infrastruture. “Our vision is to be thecatalyst for biomedical and biobanking research inEurope and our strategy will be to combineeducational and engagement processes to ensurethat this dialogue is not only continued butincreased”, he said. There has been clear supportfrom the coordinators of the BBMRI preparatoryphase and from stakeholders alike and there is aplan for the forum within the BBMRI-ERICproposal. “We are greatly encouraged by theemphasis being placed on this, and we need towork to ensure that the Governing Authority of theBBMRI-ERIC (i.e. member state representatives)are similarly motivated”, he said.

18 |


WELCOME AND INTRODUCTION

Welcome and Introduction Michael Griffith, Chair of BBMRI Stakeholder’s Forum

Support to Existing and Future Research InfrastructuresHervé Pero, Head of Unit, Research Infrastructures, DG-Research, European Commission

SESSION 1: BBMRI – A STEP CLOSER

This session focused on BBMRI preparatory phase goals and achievements and elaborated on theproposed implementation status of the BBMRI-ERIC. Future interactions with clinical, industry,academic, patient and user stakeholders were highlighted.

Session Chair: Michael GriffithBBMRI Stakeholders’ Forum

Panel Chair: Derick MitchellBBMRI Stakeholders’ Forum

PRESEntER tItlE oF talK

Eero Vuorio “BBMRI (2008-2010)

University of Turku, Finland Successes and Challenges”

Kurt Zatloukal “BBMRI-ERIC:

Medical University of Graz, Austria Towards Implementation”

Martin yuille “User access to resources and

University of Manchester, UK services provided by BBMRI”

anne Cambon-thomsen “Ethical Review Processes in BBMRI”

INSERM, France

10:40am PanEl anD oPEn FoRuM DISCuSSIon

SESSION 2: PARALLEL STAKEHOLDER GROUP WORKSHOPS

As part of a comprehensive consultation and engagement process, individual stakeholder workshopsessions aimed to focus attention on the unmet needs of each stakeholder group. Summary session inthe main meeting room followed.

APPENDIX I: MEETING AGENDA

| 19



Emmanuelle Rial “Ethical and Governance Issues in

INSERM, Toulouse, France Biobanking”

Bharat Jasani “Quality Management and Good

School of Medicine, Biobanking Practice”

Cardiff University, Wales

Manuel Morente “Sample Handling and Identified

Spanish National Biobank Network Bottlenecks”

Coordinator, Head of the CNIO’s Tumor

Bank Unit

Samuli Ripatti “Using harmonized biobanks to

Instititue of Molecular Medicine, identify genes - modifying risks for

Finland common diseases”

2B: PATIENT STAKEHOLDERS WORKSHOP

Session Chair: Michael GriffithBBMRI Stakeholders Forum

Rapporteur: alastair KentGenetic Interest Group, European Genetic Alliances Network (EGAN)


Jan Geissler “Communication to Patients”

European Cancer Patients Coalition

nathalie Kayadjanian “Why patient organisations should

French Association for Neuromuscular be involved in biobanking”

Diseases (AFM)

Filippo Franchini “Case Study of Integration of

European Network for Research on Biobank with Patient Registries”

Alternating Hemiplegia (ENRAH)

2A: CLINICAL AND SCIENTIFIC STAKEHOLDERS WORKSHOP

Session Chair: Frank WellsEuropean Forum for Good Clinical Practice (EFGCP)

Rapporteur: Pierre HainautInternational Agency for Reseach on Cancer (IARC)

20 |



Klaus lindpaintner “Public Private Partnership in the

Biobanks LLC context of biobanking”

Julie Corfield “Precompetitive Research – Industry

AstraZeneca UK Perspective”

David Myles and ann Marie Martin “Joint Undertakings to promote Public-

GlaxoSmithKline and IMI Private Partnership”

SESSION 3: STAKEHOLDERS OPEN FORUM

The BBMRI Stakeholder’s Open Forum Panel has been assembled from a combination of meetingspeakers and stakeholder representatives. As part of a comprehensive process of dialogue andexchange of ideas, this panel engaged in a 60-minute open forum to allow for interactivecommunication and engagement with relevant stakeholders. Individual and consensus questions willbe addressed to the panel and feedback and comments will be greatly welcomed from the broadspectrum of participants.

Session Chair: Michael GriffithBBMRI Stakeholders’ Forum

Panel Chair: Derick MitchellBBMRI Stakeholders’ Forum

SUMMARY OF WORKSHOPS

PANEL AND OPEN FORUM DISCUSSION

Forum Panelists:

Kurt Zatloukal Manuel MorenteMedical University of Graz, Austria CNIO

Fabrizia Bignami Klaus LindpaintnerEURORDIS Biobanks LLC

CLOSING REMARKS

Derick MitchellBBMRI Stakeholders’ Forum

2C: INDUSTRY STAKEHOLDERS WORKSHOP

Session Chair: Colin MacKayEuropean Federation of Pharmaceutical Industries and Associations (EFPIA)

Rapporteur: alfredo CesarioIRCCS San Raffaele, Università Cattolica del Sacro Cuore, Rome, Italy

| 21


The following answers are in order of abundanceof responses received.

Q1: What was the most enjoyable aspect of thismeeting?

1. Networking opportunities and exchange of ideas across different disciplines and backgrounds.

2. Practical insights and discussions with pathologists.

3. Feedback on BBMRI current status.4. Patient Stakeholder Workshop.5. Great forum to understand the trends within

BBMRI from an “outside-in” viewpoint.

Q2: From today’s discussions, what do you thinkare the main benefits of BBMRI?

1. Establishing the European Biobanking Community.

2. Fostering collaboration and presentation of new ideas.

3. Uniform approach towards quality and innovation of research.

4. Respecting citizens while enabling better science through collaboration.

5. Raising awareness of the need to provide access to large numbers of samples and data.

Q3: From what you learned today, what are yourmain concerns about BBMRI?

1. Funding.2. Transparency on resources dedicated to

BBMRI-ERIC and National Members.3. Harmonization of previously standardized

work.4. Quality of samples vs. quality of data.5. The breaks in the chain of data from point of

care to analysis – can render data useless.6. Lack of accreditation of expert centers –

essential so users know the quality of material and associated data.

Q4: Have you any advice for how we can improveour forum?

1. Have the Stakeholders Forum more frequently and in other parts of Europe.

2. Focus more on sample ID and traceability.3. More information on how BBMRI aim to build

the centralized system.4. More information about the range of quality

systems/standards and how they can be applied to different biobanks.

5. Create awareness among public organizations and educational systems in member states.

Q5: are there any questions raised which yourequire further clarification on?

1. How to avoid too much legal framework in order to prevent rigidity when sharing data.

2. Localisation of expert centres and process of selection/individualisation in Member States.

3. What is forseen for biobanks who do not join BBMRI?

4. Some more detail on the ethical issues.

APPENDIX II: MEETING EVALUATION FORM SUMMARY

BBMRI Stakeholder’s Forum BBMRI Stakeholder’s Forum

22 |

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For more information on activities of the BBMRI Stakeholder’s Forum:

Contact [email protected] or visit www.bbmri.eu


Upcoming Conference “BBMRI – Biobanking for Science” September 23-25, 2010Novotel Amsterdam City, Amsterdam, NL

On September 23-25, 2010, the BBMRI consortium is organising the “BBMRI – Biobanking for Science”conference focusing on scientific excellence in the various aspects of biobanking at the NovotelAmsterdam City, Amsterdam, NL.

The conference "BBMRI - Biobanking for Science” brings together leading scientists in the field, youngscientists, biobanking managers and practitioners to discuss the science and new approaches incutting edge biobank research. The meeting is organised by the BBMRI Steering Committee, WorkPackage Leaders and Chairs, the Executive Management Team from the Medical University Graz andthe University of Turku. The local organiser is Professor Gert-Jan van Ommen from Leiden UniversityMedical Centre (LUMC), NL and scientific director of BBMRI-NL.

Contacts:General queries, registration: [email protected] Poster presentations, programme: [email protected] Sponsoring: [email protected]

www.bbmri.eu

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