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Concept for a European Infrastructure in Nanobiotechnology Final report of the FP7 Support Action EuroNanoBio January 2010

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Page 1: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

Concept for a European Infrastructure in Nanobiotechnology

Final report of the FP7 Support Action EuroNanoBioJanuary 2010

Page 2: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics
Page 3: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

Content

Introduction 4

Recommendations for a European Infrastructure in nanobiotechnology 5

Concept for building a European Capacity in nanobiotechnology 6

WP1:Nanobiotechnologyresearchinfrastructures–potentialsandlimitationsofsingle-sitefacilitiesordistributedresources 13

WP2:Fromproofofconcepttomarket–Analysisofnanobiotechnology-basedindustrialactivitiesinEurope 14

WP3:Educationtowardsaknowledgebasednanobiotechnologyeconomy 15

WP4:Ancillaryfactorsofnanobiotechnology 16

Projectandpartnerdescription 18

Concept for a European Infrastructure in Nanobiotechnology

Final report of the FP7 Support Action EuroNanoBioJanuary 2010

2 3EuroBioNano Final Report|January2010

Page 4: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

IntroductionNanobiotechnologyisessentiallydifferentinmanyaspects

fromotherareasofnanotechnologysuchasnano-elec-

tronicsornano-materials.Itiscertainlythemostcomplex

sub-areaofnanotechnology,becauseitsimultaneouslyin-

volvesverydistantscientificdisciplinessuchasphysicsand

clinicalresearch,biologyandmathematics,orengineering

andimmunology.Fromtheindustrialperspective,nanobio-

technologydoesnotyetrepresentanindustrybyitselforan

existingmarket,butmoreamanifoldofenablingtechnolo-

giestoaidexistingsectors,suchasmedicaltechnologies,

pharma,biotech,food,cosmeticsorwatermanagement

andenvironmentalapplications.Topromotesuccessful

researchandtranslateitefficientlyintoeconomicapplica-

tionsinsuchaninherentlycomplexenvironmentrequires

astructuredandefficientsharingofbothknowledgeand

equipmentamongstakeholdersfrommanyacademicdisci-

plinesandindustries.Thiscallsforanintegrationofpeople

fromdifferentbackgrounds,whohadlittleornoprevious

contactorknowledgeofeachother.Thebestwaytoachieve

thisintegrationandtoaccommodatethecomplexityof

nanobiotechnologyistosetupacoordinateddistributed

Europeaninfrastructureofregionalcompetenceclusters.

Thefollowingrecommendationsaretheresultofintensive

consultationsanddiscussionswithexpertsfromacademia,

industryandlocalandnationalauthorities.Theyprovidea

realisticconceptualframeworkandatoolboxtostructure

theEuropeancapacityinnanobiotechnology.

Page 5: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

Adistributedinfrastructure1. To cover the large range of scientific disciplines in-

volved in nanobiotechnology and the diversity of appli-

cation areas, a European infrastructure has to be built

on regional nanobio clusters, which have world-class

facilities and expertise with high levels of engagement

between industry and academia.

2. The nanobio clusters need to be connected and coordi-

nated to share knowledge and equipment and to cover

the whole value chain in specific application areas of

nanobiotechnology such as environment or medicine,

for example.

3. A dedicated infrastructure management should im-

prove the engagement between academic disciplines,

research centres and companies inside and between

the involved clusters.

4. Clear technical roadmaps for each of the application

areas within nanobio should be defined to provide a

catalyst for collaboration between industry and aca-

demia within the infrastructure.

5. ELSA experts should be encouraged to work collab-

oratively with science departments, research institutes

and industry to help explore ethical, legal and social

aspects (ELSA) of developing nanobiotechnology

thereby enabling early decision making about the prob-

ability of commercialisation in a socially and ethically

responsible manner.

6. Set-up and upgrading of clusters will require local,

national and European political support and funding

supplemented by private investments at a later more

mature stage.

Centralservices7. A European reference centre is needed for characteriza-

tion and toxicology studies of nanoobjects, which can be

accessed by all nanoobject producers and users from

academia and companies similar to the Nanotechnology

Characterization Lab at NCI/USA.

8. A European Centre for Risk and Safety Management

should be established, which provides information and

advice about handling of nanoobjects and protection

measures to SMEs and universities, which cannot af-

ford expensive risk assessment.

9. Clusters should help especially SMEs to articulate

their needs and interests to regulatory and standardi-

sation bodies.

Communicationandpublicengagement10. The infrastructure should provide pools of experts

and professional communication tools necessary for

engagement with the public.

11. Promotion of the capabilities of nanobiotechnology to

SMEs and clinicians should be facilitated by showcas-

ing examples of successful exploitation of nanobio-

technology.

12. Engagement of the European infrastructure with

nanobio clusters and research centres outside Europe

should be encouraged.

Educationandtraining13. The highly interdisciplinary nature of nanobiotech-

nology requires the integration of dedicated nanobio

modules preferably at the MSc or PhD level.

14. Because nanobiotechnology touches on many impor-

tant wider issues, teaching an understanding of ethical

and social aspects and training in science communica-

tion and public engagement should be included at the

MSc and PhD level.

15. Due to the rapid development in nanobiotechnology,

targeted education and training programmes for in-

career training need to be developed.

RecommendationsforaEuropeanInfrastructureinnanobiotechnology

4 5EuroBioNano Final Report|January2010

Page 6: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

Theprojecthasexaminedthestateoftheartandfuturerequirementsofthe

nanobiotechnologycapacityinEuropewithregardtoinfrastructureneeds,communication

management,educationandtraining,andthepoliticalandsocialenvironment.Infourwork

packagestheconceptofadecentralizedinfrastructurebasedondistributedEuropean

competenceclusterswasevaluatedbyexpertinterviews,analysisofexistingoremerging

clustersandintensivediscussionsattwostakeholdersmeetings.Theresultshave

corroboratedtheconceptofadistributedinfrastructureandsubstantiatedtheidealconditions

forefficientcommunication,educationandtechnologytransferinnanobiotechnology.

ConceptforbuildingaEuropeanCapacityinnanobiotechnology

Page 7: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

AdistributedinfrastructureTheapplicationofnanotechnologiestodifferentbiologi-

calormedicalapplicationsdoesnotrequirethecreation

oflargefacilitieslikesynchrotronsorheavyandexpensive

equipmentsuchassupercomputers.Instead,itwillcom-

pletelydependonthegenerationandefficientexchangeof

knowledgebetweenscientificdisciplines,andtransferof

knowledgebetweenacademia,SMEsandlargecompanies,

becauseitisaknowledgedrivendevelopment.Therefore,

thebiggestchallengeisthecreationofanenvironment,

wherepeoplewithdifferentbackgroundcanmeetand

worktogethertodevelopacommonunderstandingofeach

other’sexpertiseandhowtouseittodevelopnewproducts

fornanobiologicalapplications.Forexample,todevelop

newnanoparticlesformolecularimagingoneneedsatleast

chemiststoproducethem,physiciststodevelopthedetec-

tors,toxicologiststoanalysetheirsafety,andcliniciansto

validateandimplementtheminclinicaluse.Furthermore,

thisprocessneedsacademiclabsforbasicresearch,SMEs

fordevelopmentofprototypesandtransfertolargecompa-

nies,whichvalidate,distributeandcommercializethewhole

systemconsistingofnanoparticlesanddetectors.

Itisobviousthatefficienttransferofknowledgerequired

forsuchcomplexvaluechainsneedsaclosecooperation

betweenexperts.Thisstudyhasconfirmedthatthespeed

ofdevelopmentisbestachievedbyclustershavingall

necessaryexpertsandfacilitiesinclosevicinity.Existing

clustersareoftenlocatedaroundleadingresearchcentres

withcorenanotechnologyfacilities,plusspinoffventures.

Theyhaveasufficientcriticalmassofscientistsoriginally

comingfromdiversedisciplineswithongoingcollaborations

withindustryandhospitals.

TheseNanobioclustersoffergreateropportunitiesfor

SMEsandmultinationalcompanies(MNCs)toengagein

mutuallybeneficialcollaborationsandtomaximisethe

synergyfrominteractionsofMNCs,SMEsandacademic

researchers.TheSMEscanleverageIPopportunitiesfrom

theMNCaswellasgaininginsightsintonewR&Dopportu-

nities,managementpractices,innovationimplementation

andgreateraccesstoexternalknowledgeandadvice.

ThroughtheaddedvalueofcloselinksofMNCswithlocal

companiesandthefacilitiesandexpertisefromacademic

researchinfrastructures,abasiscanbeformedforMNCs

toleveragenewinvestmentfromparentcompanies,andit

canalsoleadtomorecommerciallyfocussedresearchers.

ThisinturncreatesanenvironmentwithpotentialforMNCs

tobecomemoreembeddedinECcountriesthroughlocal

interactionswithnanobiotechsupplychainandmultidis-

ciplinaryR&Dcollaborations.Whilesuchclustersalready

exist,theabovedefinitionprovidesfortheinclusionofany

newnanobioclustersfromanyEUregionwhichfulfilsthe

criteria.

Recommendation 1:

To cover the large range of scientific disciplines involved in

nanobiotechnology and the diversity of application areas, a

European infrastructure has to be built on regional nanobio

clusters, which have world-class facilities and expertise

with high levels of engagement between industry and

academia.

Theanalysisofexistingclustersinthisstudyhasshown

thatnoneofthemcoverssofarthewholedevelopment

processinagivennanobioapplicationarea.Instead,allof

themfocusonacertainsub-areabasedontheirhistorical

scientificstrengthanddevelopment.Furthermore,asanex-

ample,nanoobjectssuchasnanoparticlesmightnotonlybe

usedasimagingprobesbutalsofortargeteddrugdelivery.

Thiswouldinvolvetwoverydifferentindustriesnamelydi-

agnosticsandpharmaceuticalcompanieswithverydifferent

regulatoryframeworksandvaluechains.Asinglecluster

wouldnothavethehumanandfinancialresourcesand

facilitiestocoverbothdevelopmentprocesses.

Opportunitiesforleveragingcross-disciplinaryIPopportu-

nitiescanbeoptimisedbyfacilitatingcloserlinksbetween

wellorganizedclustersandEuropeancompaniesaswellas

existingnationalandEUprojectsandframeworksinvolved

inNanobioresearch.Furthermore,exchangeofinsights

amongpharma,biotech,ICTandmedicaldevicesindustries

willleadtonewR&Dopportunities,managementpractices,

andgreateraccesstoexternalknowledgeandadviceinan

openinnovationapproach.

Recommendation 2:

The nanobio clusters need to be connected and coordinated

to share knowledge and equipment and to cover the whole

value chain in specific application areas of nanobiotechnol-

ogy such as environment or medicine, for example.

Thecooperationbetweendifferentdisciplines,academia

andindustry,andlocalauthoritiesandfinancialservicesre-

quiresastructuredanddedicatedinformationandcommu-

nicationplatform.Manyclustersanalysedinthisstudyhad

establishedaclustermanagementteamororganisation,

whichmediatesbetweenstakeholders,organisesstrategic

ConceptforbuildingaEuropeanCapacityinnanobiotechnology

6 7EuroBioNano Final Report|January2010

Page 8: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

meetings,andpromotestheclustertotheoutside.Italso

servesasacentralnodeforgettinginformationaboutall

partners,theirprojects,papersandpatents,andR&Dfund-

inglevels.Anotherimportantobjectiveofthemanagement

agencyisthecommunicationandcoordinationwithother

clustersinsidetheEuropeaninfrastructure.

Theimplementationofmanagingagenciestofacilitate

thecooperationofstakeholdersinsideandbetweenthe

clusterswillgreatlysupporttheinnovationprocessesso

thattranslationofinnovationtomarketandclinicsbecomes

moreefficient.

Recommendation 3:

A dedicated infrastructure management should improve

the engagement between academic disciplines, research

centres and companies inside and between the involved

clusters.

Theoftenquitedivergingagendasbetweendifferentap-

plicationfieldsofthenanobioindustrycallforaclearand

definedroadmapforeachnanobiotechnologyapplication

arealikeenvironment,medicine,lifesciences,agro-food,

andenergy.Incontrasttoroadmapsfortheelectronic

industryforexample,thenanobioroadmapshavetoinclude

fundamentalresearchtargetswhichstillrepresentmajor

roadblocksforanticipatedfutureproductsinthisyoung

technology.Suchroadmapshavebeendefinedforexample

bytheETPNanomedicineforDrugdelivery,Diagnostics

andRegenerativeMedicine.

Duetotheembryonicstageofindustrialmarketsinthe

field,suchroadmapswillfostercollaborationnotonly

amongrelatedcompanieswithinsectorsofthenanobio

industryalongthevaluechain,butbycomplementing

industryrequirementscouldalsofacilitatecollaboration

betweenindustryandacademia.Throughthecreationof

acriticalmassofexpertiseandfacilitieswithinananobio

cluster,industryandacademiacanbemoreefficiently

linkedtoimplementtheroadmapsleadingtodevelopments

ofinnovativeandconvergingtechnologies.Innovationscould

bebroughttothemarketsmuchfasterbysuchconcen-

tratedcentres.

Recommendation 4:

Clear technical roadmaps for each of the application areas

within nanobio should be defined to provide a catalyst for

collaboration between industry and academia within the

infrastructure.

Theapplicationofnanotechnologytobiologicalormedical

applicationswillraisesocialandethicalquestions.Unfortu-

nately,ethicalandsocialthinkingandthefurtherdevelop-

mentoftechnologyandsciencearenotconnectedanymore

becausethecurrentqualificationsystemforscientistsdoes

notleaveroomforsuchconsiderationsinmostcountries.

Therefore,adviceonethical,socialandlegalaspectsof

researchprojectsneedstobemadeavailableforscience

andindustry.

Manyclustersanalysedinthisstudyhavepoolsof

expertsdealingwithethical,orsocialorlegal

questions,butnoneofthemcoversall

areas.Apan-Europeaninfrastructureof

clusterscanprovidetheplatformforre-

searchers,SMEandmultinational

companiestogetadviceonand

involveELSAexpertsinnanobio

developmentsrightfromthe

beginning.

Recommendation 5:

ELSA experts should be

encouraged to work collabora-

tively with science departments,

research institutes and industry to help

explore ethical, legal and social aspects (ELSA)

of developing nanobiotechnology thereby enabling early

decision making about the probability of commercialisation

in a socially and ethically responsible manner.

Page 9: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

Theanalysisofexistingclustersinthisstudynotonly

revealedtheneedforstateoftheartexpertiseandfacilities

innanoandbioresearchinclosevicinitytocompanies,but

alsohighlightedthatmajorregionalpoliticalandfinancial

supportisnecessaryforsetting-upandupgradingacluster.

Thissupportbylocalauthoritiesiscrucialforcreating

thesuitableinfrastructuralandfinancialenvironmentfor

transferofknowledgefromresearchcentrestoindustry.

Theregionalcommitmentalsoprovidesthebasisfora

sustainabledevelopmentanddistinguishesaclusterfrom

alargebutisolatedresearchcentre.Oncetheclusterhas

reachedacriticalsizeandmasstheinitialpublicinvest-

mentiscomplementedbyprivateinvestmentsfromlarge

ormultinationalcompanies,whichwanttoleveragefrom

theR&DpotentialofthelocalresearchcentresandSMEs.

Toattracttheinvestmentofsuchlargecompanies,thecon-

nectionofclustersintoacomplementaryinfrastructurewill

beacrucialstep,becauseitwillfacilitatetherecognitionof

nanobiotechnologyinEuropeattheglobalscale.

Recommendation 6:

Set-up and upgrading of clusters will require local, national

and European political support and funding supplemented

by private investments at a later more mature stage.

CentralservicesNanoobjectsareasubstantialpartinmanynanobio

products.Thereareissuesaboutthereproducibilityand

precisionofthesynthesisprocessesofnanoobjects.There

arealsomajorchallengestobeaddressedwithrespect

tonanoobjecttoxicity.Anotherissueisthephysicaland

chemicalcharacterizationofnanoobjectsaccordingto

commonstandardsandprocedures.Combined,theissues

relatingtonanoobjectsneedamultidisciplinaryapproach

withacriticalmassofexpertiseandfacilitieswhichcanbe

logicallyprovidedinaNanobioreferencecentrewithalarge

functionalinfrastructure.Asanexample,ifstandardisation

ofnanoobjectsynthesisprocessesandcharacterization

couldbeachievedcomparabletothelevelsofsemiconduc-

torthinfilmprocessingandvalidation,thiscouldfacilitate

muchmorereproducibleoutcomesfornanoobjectap-

plications.Thischallengeshouldbesetasthekeygoalof

EuropeanNanobiodevelopment,ascurrentlynanoobject

synthesisandcharacterisationappearstobealimitingstep

forseveralnanobioproducts.

Furthermore,itisimpor-

tantwhenaddressingthe

complianceofnanoobjects

fortherapeuticpurposesorin

vivodiagnosticswiththecurrent

EuropeanregulationstoprepareSOPs

(StandardOperatingProcedures)containing

clearprotocolsofvalidationandmonitoring

ofbiocompatibilityandpotentialtoxicity.These

SOPsshouldbesharedwithinthewholenanobio

communitybetweenresearchcentresandcompaniesin

ordertoworkoncommondocuments.

Recommendation 7:

A European reference centre is needed for characteriza-

tion and toxicology studies of nanoobjects, which can be

accessed by all nanoobject producers and users from

academia and companies similar to the Nanotechnology

Characterisation Lab at NCI/USA.

Nanoproducts,beingasubstantialpartofthenanotech

fieldare“athingwithoutadefinition”becausethekindand

amountof“nano”withinaproductvarieswidely.Tomeet

theupcomingconcernsaboutthesafetyofnanotechnology,

aprecautionaryapproachofallstakeholdersisneededthat

willencouragethegenerationofmoredataandthedefini-

tionofpotentialriskcoveringthewholelifetimeofaprod-

uct.Anothersafetyissueisthecreationofasafeworkplace.

Tobalanceriskandbenefits,safetyofficersincompanies

havetobetrainedandinformedspecificallyaboutthe

propertiesofnanoobjectshandledattheirlocation.Sucha

centrewouldnotonlyprovideacentralinformationplatform

butcouldalsodrivetheharmonizationofnationalsafety

proceduresandprotocols.

8 9EuroBioNano Final Report|January2010

Page 10: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

Recommendation 8:

A European centre for Risk and Safety Management should

be established, which provides information and advice

about handling of nanoobjects and protection measures

to SMEs and universities who cannot afford expensive risk

assessment.

Athirdareawhichneedsacentralapproachcomprises

standardisationandregulationframeworks.Bothhavenot

onlyamajorimpactonthesafetyofnanoproducts,butalso

onmarketaccess.Theyarediscussedanddecidedatthe

Europeanorgloballevelbytheexistingcommitteesand

officialbodiessuchasISO,CENorOECD.Accesstothese

committeesiscrucialforcompanies,becauseitdecides

abouttimetomarketincaseoftheregulatoryframe-

workandmarketaccessinthecaseofproductstandards.

Participationtothecommitteesistimeconsumingand

expensive,whichnormallyexcludesSMEsfromthedecision

making.ClustersshouldhelpespeciallySMEstoarticulate

theirneedsandintereststoregulatoryandstandardisation

bodies.

ThissupportforSMEswillincreasetheirchancetointro-

ducetheirinnovationstothemarket,becauseaccording

totheECNanoActionPlanespecially“standardsprovide

alevelplayingfieldformarketsandinternationaltrade

andareprerequisitesforfaircompetition,comparativerisk

assessmentsandregulatorymeasures.”Thesameistrue

forIPRrulesandagreements,whichshouldalsobeanim-

portantfieldofsupportforSMEsandresearchinstitutions

providedbyclusters.

Recommendation 9:

Clusters should help especially SMEs to articulate their

needs and interests to regulatory and standardisation bodies.

Communicationandpublicengagement

InacomplexareasuchasnanobiotechnologyCommunica-

tionisnotonlyessentialforsuccessfulinvolvementofdis-

ciplinesandstakeholdersinthedevelopmentofnanobio-

technology.Itisalsonecessarytoengagewiththepublicin

atimelymannertoexplainthetechnologyanditsrisksand

benefits,tounderstandhowcitizensseethedevelopments,

includingpotentialconcerns,andtogetacceptanceofthis

newtechnology.Howearlythisshouldbedonewilldepend

onthedevelopmentofthetechnologyandalsothesocial

context.Engagementmaytakemanydifferentforms.Many

toolsareavailable,includingfocusgroupsandcitizens

juriesorInternet-basedapproaches.Sciencecentresalso

haveanimportantroleforexamplewithinteractiveexperi-

mentsorscienceexhibits.

Recommendation 10:

The infrastructure should provide pools of experts and pro-

fessional communication tools necessary for engagement

with the public.

Page 11: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

Uptonow,nanotechnologicaldiscoveriesaremostlymade

inacademiclaboratorieswithoutaclearideaofapossible

application.Inaddition,manynanoobjectscanbeappliedto

severalapplications,butmanypossibleusershavenoclue

aboutnewdevelopmentsinnanotechnologyandhowthey

canutilizethemfornewinnovativeproducts.Toincrease

thetranslationofnanotechnologiesintonewproductsitis

necessarytodevelopmoreefficientmatchingofnanotech-

nologydevelopersandputativeusers.

Recommendation 11:

Promotion of the capabilities of nanobio-technology to

SMEs and clinicians should be facilitated by showcasing

examples of successful exploitation of nanobiotechnology.

AEuropeaninfrastructureconsistingofcomplementary

clusterswillnotrepresentthewholecommunity,because

outsideoftheinfrastructuretherewillbeotherleading

researchcentresinEuropeandaroundtheworld.Further-

more,othernetworksorinitiativesmightexist,whichfocus

onthesameareaofnanobiotechnologyandgatherimpor-

tantstakeholders.Toexploitthefullpotentialofnanobio-

technologyitismandatorytointeractwiththesecentres

andorganisations.

ThisengagementshouldfacilitatebenchmarkingofEUre-

searchinnanobiotechnology,collaborationonthedevelop-

mentofinternationalstandards,recommendedregulatory

requirements,andalsopromoteaccesstoEUexpertise

andinfrastructurefacilitiesforclustersfromdeveloping

countries.

Recommendation 12:

Engagement of the European infrastructure with nanobio

clusters and research centres outside Europe should be

encouraged.

10 11EuroBioNano Final Report|January2010

Page 12: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

EducationandtrainingTheinterdisciplinarynatureofnanobiotechnologyrequires

newapproachesforcrossdisciplinaryeducation.Atpres-

entthereisagreatvarietynotonlyconcerningthetypes

ofcourses,butalsointheconsiderablerangeofcurricula.

Thiscanbeattributedtothefactthatnanobiotechnology

isnotaclearly-bordereddomainbutadiverseandmulti-

disciplinaryfieldwhichcanbeconsideredasasubfieldof

nanotechnologyoranextensionofbiotechnology,aswellas

chemicalorbiologicalengineering.Astrongnecessityfora

morepreciseandcomprehensivedefinitionofthefieldwas

identifiedwhichwillhelptodefineeducationalneedsfor

nanobiotechnology(NBT).

Therequirementsandinterestsofstakeholdersvarywidely.

ThemostproductiveapproachwillbetoincorporateNBT

modulesintoalreadyexistingundergraduateandmaster

leveleducationinscienceandmedicineinsteadoffurther

investingincompleteNBTM.Sc.courses.Thereisfur-

thermoreademandforin-depthtrainingonNBT,which

canbemetbyPhDgraduateschoolprograms,butother

approacheswillalsobeneededincaseswhereaPhDdoes

notnormallyincludeformalteachingmodules.

Recommendation 13:

The highly interdisciplinary nature of nanobio-technology

requires the integration of dedicated nanobio modules pref-

erably at the MSc or PhD level.

Europeansocietiesincreasinglyexpectscientistswhoare

givenpublicmoneytobeaccountableforwhattheydowith

it.Accordingly,scientistsarerequiredtoaddressethical

questionsinresearchproposals,becausefundingagencies

willincreasinglyaskforsuchconsiderations.Especiallyin

nanotechnologyapplicationfieldssuchasmedicineorfood,

awarenessaboutethicalimplicationsiscrucialtomeetcrit-

icalsentimentsaboutthepotentialdangers.Forallthese

reasonsitisessentialtore-integrateethicalthinkinginto

scientificresearchdealingwithapplicationareassuchas

medicineorfoodtoensurearesponsibledevelopment.One

practicalapproachwouldbetoincludecoursesormodules

onethicalandsocialaspectsinengineeringorlifescience

studiesandcoursesofrelevantapplicationareas.

Recommendation 14:

Because nanobiotechnology touches on many important

wider issues, teaching an understanding of ethical and

social aspects together with training in science commu-

nication and public engagement should be included at the

MSc and PhD level.

Nanobiotechnologyisarecentandfastdevelopingarea.

Inaddition,itisanenablingtechnologyformanydifferent

industries.Tocopewiththespeedandtheimplementation

ofitinexistingindustrialprocessesitwillbenecessaryto

continuouslyeducateandtrainthetechnicalandacademic

workforce.SpecifictrainingcoursesonNBTmaybeneeded

forengineers,technicians,scientists,safetyofficersand

otherrelevantpersonnel.

Recommendation 15:

Due to the rapid development in nanobio-technology

targeted education and training programmes for in-career

training need to be developed.

ConclusionThestudyhasshownthatadistributedinfrastructurebased

onacoordinatedpanEuropeanallianceofresearchdriven

clustersisthemostefficientinstrumentforfastandef-

ficienttranslationofnanotechnologicaldiscoveriesintobio-

logicalandmedicalapplications.Thereasonsforproposing

clustersasthebuildingblocksoftheinfrastructurearethat

theyprovide

• thenecessaryclosevicinityofstateoftheartexpertise

andfacilitiesaswellasresearchcentres,SMEsandlarge

companies,

• regionalpoliticalandfinancialsupportforupgradingof

facilitiesandSMEsupport,

• adedicatedcommunicationplatformwithdifferentpools

ofexpertsandtoolsforengagementwithdifferentre-

searchcommunities,industries,investors,mediaandthe

publicatlarge,

• thecriticalmassforimplementationofnewinterdis-

ciplinaryeducationandtrainingconcepts,whichalso

includehorizontaldisciplinessuchasethicsandsocial

sciences,and

• astructuredapproachforbenchmarkingandinteraction

withothercentresorclustersaroundtheworld,espe-

ciallyindevelopingcountries.

Itwillneedaconcertedactionofregional,nationaland

Europeanauthoritiestoprovidethepoliticalandfinancial

supportfortheset-upandupgradeofsuchinfrastructures.

ThismutualinvestmentwillmakesurethatEuropestays

competitiveatthegloballevelinnanobiotechnology.

Page 13: Concept for a European Infrastructure in Nanobiotechnology · Introduction Nanobiotechnology is essentially different in many aspects from other areas of nanotechnology such as nano-elec-tronics

Thecurrentsituationofnanobioresearchclustersin

Europehasbeenanalysedinordertoestablishdefinitions,

identifybestpracticesandsetupevaluationcriteria,in

ordertorecommendthemostsuitablemodelforanEU

nanobioinfrastructureandassessitsimpactonresearch

anddevelopment.

Thisanalysishastakenintoaccountaspectssuchasinte-

grationofresearchactivities,theefficientuseofresources,

regulationofaccesstofacilities,private-publicpartner-

ships,alliances,entrepreneurship,andtheimplementation

ofinterdisciplinaryapproachesforthedevelopmentofap-

plicationsinmedicine,environmentand/orfoodinorderto

understandthereasonsforsuccessforthemostdeveloped

clustersintheEU.

Onechallengewastovalidatetheinput(e.g.research&

development,humanresources,researchequipments,

fundedcommonprojects)andoutput(e.g.papers,patents,

companies)ofdifferentinitiativesbecausereportsare

oftennotspecificandkeypeopleinsideclustersarehardto

identify.Nanobiotechnologyactivitiesarehiddenunderthe

termnanotechnology,becausenanobioornanomedicine

arenotwelldefined.Presently,manyclustersareabottom-

upstructure,yetlooselyorganisedandrarelymanagedby

anagency.Thehaveasufficientcriticalmassofscientists

originallycomingfromdiversedisciplineswithongoing

collaborationswithindustryandhospitals,whicharesofar

mostlyoccasional,notstructuredpartnerships.Existing

clustersareoftenlocatedaroundleadingresearchcentres

withcorenanotechnologyfacilities,plusspinoffventures.

Diversemodelshavebeenobserved,however,depending

onthetraditionandresearchcultureoftheregion(more

centralforelectronics,moredisperseforlifesciences).

Nanobioclustersneedtobemoretightlyconnectedand

organizedattheEUlevelespeciallywithregardtoregula-

toryaffairs,standardisationandaccesstoclinicaltrials.

Suchwellorganisedinterconnectionofhighqualityclusters

or“polesofexcellence”wouldcombinemultidisciplinaryre-

searchcentresthatjoinmodernnanotechnologyfacilitiesin

amultidisciplinaryway.Additionally,theimplementationof

managingagenciestofacilitatetheconnectionofclusters

wouldsupporttheinnovationprocessessothattranslation

ofinnovationtomarketandclinicsbecomesmoreefficient.

Thefirststeptoreachthis“ideal”scenarioistoensurethe

integrationofdifferentdisciplinesatalocallevelwithina

city/district/regionwiththepotentialtobecomeapoleof

excellence.Thesecondstepistheset-upofaclusterman-

agementagencywhichmediatesbetweenstakeholdersand

organisesstrategicmeetingsforacademicinstitutionsand

betweenacademiaandindustry.Acompletedirectoryof

allthepartnersandtheircollaboratorsinexistingprojects

aswellastheirpapersandpatentsandacharacterization

ofresearch&developmentfundinglevelsandoutcomes

wouldberequiredtomoveforwardintothethirdlevel,

theupgradingofindividualclustersandthenetworkasa

wholetobecomeacompetitiveEuropeaninfrastructureof

nanobioclusters.Thisinfrastructurewouldhelptobuilda

knowledgeexchangebasedcommunityandeasetheac-

cesstoothermarketsortoclinicaltrials.Furthermore,the

infrastructureprovidesacomprehensiveinformationpool

neededtoraisepublicacceptanceofnewtechnologies,to

giveadviceforregulationandstandardisationofNanobio

objects,andforastrategicplanforfundingatthenational

andEuropeanlevel.

Definitions of cluster, innovation cluster, research cluster,

and cluster management agency applied in this document:

Cluster:Concentrationingeographicalspaceofallthe

partners(R&Dcentres,universities/departments,hospitals,

industry,entrepreneurs/spinoffcompanies,techtransfer

advisers,technologicalfoundries…)whosecontributionis

requiredforinnovationtohappeninaparticular,interacting

andeffectivefashiontobringnewproducts/servicesintothe

market/hospital.Theseinteractionscanbeledand/orman-

agedbyanagencyoroffice,withdedicatedstaff.

Moreover,ananobioinnovationclusterisbuiltuparounda

nanobioresearchcluster.Thisismostlyduetoitscross-

disciplinaryprofile,characterizedbytheeffectiveinterac-

tionofscientistsandengineersfromverydiverseexper-

tise(materialsscience,microelectronics,photonics,cell

biology,molecularbiology,inorganicandorganicchemistry,

medicine…)amongeachotherandwithhigh-techSMEs

andSpin.offs.

NOTE:Geographicalsizevarieslargelyfromonetoanother.

Roughly,inmostcases,itwillimplyonelargecityanda

suburbanradiusof100kms.

Nanobiotechnologyresearchinfrastructures-Potentialsandlimitationsofsingle-sitefacilitiesordistributedresources

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12 13EuroBioNano Final Report|January2010

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Ourobjectivesweretoestablisharepresentativepanelof

toplevelindustrialmanagerswithexperienceinnanobio-

technologybasedproductandprocesscommercialisation,

andtheanalysisofcasestudiesofsuccessfultechnology

transferorexploitationofnanobiotechnology.Fromthese

studiesthecriticalneedsof,andopportunitiesfor,industry

weretobededuced,especiallyforhigh-techSMEsstrongin

nanobiotechnologyresearch.Anaccomplishedexpertsur-

veyproveddifficulttoevaluateastheincludedcompanies

differedwidelyinsize,targetmarkettypeandtheirlevelof

experienceoractivitywithnanobiotechnology.Therefore,

theresponsesvariedandtoyieldaconsensusopinionad-

ditionalexpertswererecruited.

Itwasfoundthatawell-builtnanobioinfrastructurecould

significantlyeaseaccessforlargeandsmallcompanies

toarangeofexpensiveequipment.Ingeneral,companies

wouldbewillingtopayforinfrastructureaccess,therates

dependingforexampleonwhetherworkwascarriedoutas

co-developmentoraslicensabletechnology.Sharingequip-

mentcanmakesenseespeciallyforSME´sasithelpsthem

tosavemoneyandpotentiallycanyieldnewcollaborators.

Butwhilecollaboratingwithothercompaniesisconsidered

advantageous,animportantpreconditionformostcom-

paniesisthatthesafetyofintellectualpropertyhastobe

guaranteed.

Formultinationalcompanies(MNCs)thesituationisdif-

ferentthanforSMEs.Largecompaniesgenerallypreferto

directlyfundresearch&developmentandsubsequentlyown

resultingintellectualpropertyorshareitwithanacademic

researchprovidingorganisation(RPO).Theirexpertisefor

regulatoryissuesandprotectionofintellectualpropertyis

usuallyin-house.Ontheotherhand,SMEsoftenhaveto

licenseintellectualpropertyrightsfromaresearchorgani-

sationbecauseofhighcostsinvolved,andcouldprofitfrom

theavailabilityofexternalexpertiseprovidedbyananobio

infrastructure.Ithastobementionedthatinnovationin

nanobiomuchmoretakesplaceinhightechSMEstesting

newdevelopmentsonnichemarketsthaninMNCswhichare

usuallymoreconventionalanddoingincrementalinnovation.

Future recommendations:

Therecognizedgapinnanobioexpertisecanbeclosedbya

clearanddefinedroadmapthatwouldincludeeachnano-

biotechnologyapplicationarea.Thisroadmapwouldfoster

collaborationnotonlyamongrelatedcompanieswithin

sectorsofthenanobioindustryalongthevaluechain,butby

complementingindustryrequirementscouldalsofacilitate

collaborationbetweenindustryandacademia.Throughthe

creationofacriticalmassofexpertiseandfacilitieswithin

ananobiocluster,industryandacademiacanbemore

efficientlylinkedtoimplementtheroadmap(s)leadingto

developmentsofinnovativeandconvergingtechnologies.

Innovationscouldbebroughttothemarketsmuchfasterby

suchconcentratedcentres.

Theoftenquitedivergingagendaswithindifferentapplica-

tionfieldsofthenanobioindustrycanbemetbyacollec-

tiveroadmapcomplementedwiththeparalleldevelopment

ofstandardsforexistingandemergingnanobioproducts

andprocesses.Nanoobjectsareasubstantialpartinmany

nanobioproducts.Thereareissuesaboutthereproducibility

andprecisionforthesynthesisprocessesofnanoobjects.

Therearealsomajorchallengestobeaddressedwith

respecttonanoobjecttoxicity.Thepotentialtoimprove

biocompatibilityofsomeformsofnanoobjectsmaybean

optioninsomesituations.Combined,theissuesandoppor-

tunitiesrelatingtonanoobjectneedamultidisciplinaryap-

proachwithacriticalmassofexpertiseandfacilitieswhich

canbelogicallyprovidedinananobioclusterwithalarge

functionalinfrastructure.Asanexample,ifstandardisation

ofnanoobjectsynthesisprocessescouldbeachievedcom-

parabletothelevelsofsemiconductorthinfilmprocessing,

thiscouldfacilitatemuchmorereproducibleoutcomesfor

nanoobjectapplications.Thischallengecouldbesetasthe

keygoalofEuropeannanobiodevelopment,ascurrentlyna-

noobjectsynthesisappearstobealimitingstepforseveral

nanobioproducts.

Furthermore,withthecurrentEuropeanregulations,itis

importantwhenaddressingthecomplianceofnanomateri-

alsfortherapeuticpurposesorforinvivodiagnosticsto

prepareSOPscontainingclearprotocolsofvalidationand

monitoringofbiocompatibilityandpotentialtoxicity.These

SOPsshouldbesharedbetweenresearchcentresandcom-

paniesinordertoworkoncommondocuments.

Tocreatesuchnanobioclusters,alargescaleEuropean

initiativeisrequiredthatisfocussedonselectedregions

wheretherelevantcriticalmassinresearchcapacity

andexpertisehasalreadybeenreached.Collaborations

betweenindustryandacademiashouldbelarge-scaleand

widespreadandresourcesshouldbededicatedtopromote

theseregions.Nanobiotechnologycanprovideatypeof

cementtoenablecollaborationsamongcompaniesspe-

cialisedinICT,medicaldevices,pharmaandbiotechnology.

Fromproofofconcepttomarket–Analysisofnanobiotechnology-basedindustrialactivitiesinEurope

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Withinsuchnanobioclusters,therearegreateropportuni-

tiesforSMEsandMNCstoengageinmutuallybeneficial

collaborationsandtomaximisethesynergyfrominter-

actionsofMNCs,SMEsandacademicresearchers.The

SMEscanleverageIPopportunitiesfromtheMNCaswell

asgaininginsightsintonewR&Dopportunities,manage-

mentpractices,innovationimplementationandgreater

accesstoexternalknowledgeandadvice.Insomecases,

collaborationsmayleadtoopportunitiestorecycleIPfor

newtechnologies/applicationsleadingtoregenerationof

companies.

ThroughtheaddedvalueofcloselinksofMNCswithlocal

companiesandthefacilitiesandexpertisefromacademic

researchinfrastructures,abasiscanbeformedforMNCs

toleveragenewinvestmentfromparentcompanies,andit

canalsoleadtomorecommerciallyfocussedresearchers.

ThisinturncreatesanenvironmentwithpotentialforMNCs

tobecomemoredeeplyembeddedinECcountriesthrough

localinteractionswithnanobiotechsupplychainandmulti-

disciplinaryR&Dcollaborations.

Educationtowardsaknowledgebasednanobiotechnologyeconomy

Ourobjectivewastoidentify(1)theeducationalandtraining

methodsthatarerequiredtodistributeinformationand

awarenessaboutnanobiotechnology(NBT)inthecommu-

nitiesofinterestand(2)howtobuildaknowledge-based

economyandinfrastructure.

Atpresent,therearealreadycourseswithnanobiotechnol-

ogycontentin17Europeancountries.Thereare4master

programsthatfullyfocusonNBTbutalargernumberof

programsinnanotechnologyornanoscienceexistwhere

NBTconstitutesatrackorspecialisation.Finally,thereare

alsomasterprogramsthatteachsubfieldsofNBT(e.g.

MedicalElectronics,CellularBiotechnology,biophysics

and–informatics).Whilethetotalnumberisnothighthere

isagreatvarietynotonlyconcerningthetypesofcourses,

includingmasterdegreeprogramsaswellassummer

schoolsandcontinuingprofessionaldevelopment,butalso

intheconsiderablerangeofcurricula.Thiscanbeattrib-

utedtothefactthatnanobiotechnologyisnotaclearly-

bordereddomainbutadiverseandmultidisciplinaryfield

whichcanbeconsideredasubfieldofnanotechnologyoran

extensionofbiotechnology,aswellaschemicalorbiologi-

calengineering.Astrongnecessityforamorepreciseand

comprehensivedefinitionofthefieldwasidentifiedwhich

willhelptofurtherdefineeducationalneedsforNBT.

Doesthecurrentsituationmeettherequirementsofdiffer-

entgroupsofstakeholdersandhowcanNBTeducationbe

improved?Representativesfromindustry,academiaand

clinicswereaskedinasurveyiftheirinstitutionswouldsee

anaddedvalueeitherbythepossibilitytohireM.Sc.can-

ditatesspecialisedinNBTinsteadofinclassicalsubjects

(chemistry,biology,physics)ortotraincurrentemployees

inNBTspecificshortcourses.

Itwasquicklyevidentthattherequirementsandinterests

varywidely.IndustrystakeholdersoftenhirePhDlevel

employeestrainedinclassicalsubjectswhoareexpected

toadapttonewtechnologicaldevelopmentsandarease.g.

atconferenceswithnoneedforadditionaltraining.Onthe

otherhand,forB.Sc.trainedtechnicalstaff,theprimary

requirementisforcoursesonveryspecifictechniques.

Therefore,completeM.Sc.programsinNBTarenotjudged

tobeofaddedvalue.

Academicstakeholdersagreethatinterdisciplinaryand

theoreticalknowledgeaboutNBTshouldbepartofany

uptodatecurriculumintheclassicalsubjects–butas

amodularpartwithinexistingprogramsandascontinu-

ingprofessionaleducationcourses,notasstandalone

NBTM.Sc.courses.Themostpositiveresponsescame

fromclinicalstakeholders.Addedvalueisexpectedfrom

overviewcoursesaswellasfromspecifictrainingcourses

concentratingontheclinicalneedsthatcanbeaddressed

byNBT.

Future recommendations:

Ourconclusionisthatthemostproductiveapproach

willbetoincorporateNBTmodulesintoalreadyexisting

undergraduateandmasterleveleducationinscienceand

medicineinsteadoffurtherinvestingincompleteNBTM.Sc.

coursesThesemodulesshouldbedesignedinanindividual

waythatsuitsthecontextofthecoursetheyareembedded

in.Differenttechnologicalperspectiveshavetobeconsid-

eredaswellasthebiologicalandclinicalrelevance.

Thereisfurthermoredemandforin-depthtrainingonNBT

whichcanbemetbyPhDgraduateschoolprograms,but

14 15EuroBioNano Final Report|January2010

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otherapproacheswillalsobeneededinmanycaseswhere

aPhDdoesnotnormallyincludeformalteachingmodules.

Forclinicalneeds,partnershipswithinstitutionsstrongin

researchwillbemosthelpfulfortargetededucationpro-

gramsincludingshortcoursesandcontinuousprofessional

education.SpecifictrainingcoursesonNBTmaybeneeded

forsafetyofficersandotherrelevantpersonnel.

Tomeettheeducationalrequirementsofanemergingand

rapidlygrowingfieldsuchasNBTappropriately,aclear

definitionofwhatthetermNBTactuallyencompasses,

anduniversalaccreditationcriteriathatcanbeadaptedto

coursesandmoduleswillbeofhighpriority.Furthermore,

sinceinnovationsforbiologicalormedicalapplications

oftenhaveanimpactonethical,socialandlegalissues,

trainingofstudentsintheseareasshouldbeincludedin

MasterorPhDcourses.

Ancillaryfactorsofnanobiotechnology

Differentancillaryfactorswillsignificantlyinfluencethe

successofananobiotechnologyeconomyinEurope.Impor-

tantprospectiveancillaryfactorswerefoundtobeethical,

legal and social aspects (ELSA), risk management and

safety of products and methods, technology transfer, and

communication.Afteranalysingthecurrentsituationprob-

lemsanddifficultiesconcerningthedifferentaspectswere

identifiedandrecommendationsaremadeoftheactions

necessarytoimplementtheseareasinanEUnanobiotech-

nologyinfrastructure.

Innewtechnologiesethical and social thinkingandthe

furtherdevelopmentoftechnologyandsciencearenot

connectedanymoreastheywereinthelastcenturyduring

theareaofscientistsuchasHumboldtforexample.The

situationvariesindifferentcountries,butinmostcasesthe

currentqualificationsystemforscientistsdoesnotleave

roomforsuchconsiderationsandpresentlyonlyfewnano-

biotechnologyprogramsevenincludeanyELSAactivities.

MostcountriesdonothavedesignatedprogramsforELSA

oftechnologyingeneralornanotechnologyinparticular.

Butwhyaretheseactivitiesstillimportant?

Europeansocietiesincreasinglyexpectscientistswhoare

givenpublicmoneytobeaccountableforwhattheydowith

it.Accordingly,scientistswillberequiredtoaddressethical

questionsinresearchproposals,becausefundingagencies

willincreasinglyaskforsuchconsiderations.Especiallyin

nanotechnologyapplicationfieldssuchasmedicineorfood

awarenessaboutethicalimplicationsiscrucialtomeet

criticalsentimentsaboutthepotentialdangers.Whileno

nanotechnologyspecificissueshavebeenidentified,the

developmentswhichnanotechnologyenableoftenpres-

entnewaspectsofexistingissues,orincreasethescale

oftheirimpact.Forallthesereasonsweconsiderthatit

isessentialtore-integrateethicalthinkingintoscientific

researchdealingwithapplicationareassuchasmedicine

orfoodtoensurearesponsibledevelopment.Onepractical

approachwouldbetoincludecoursesormodulesonethi-

calandsocialaspectsinengineeringorlifesciencestudies

andcoursesofrelevantapplicationareas.Inadditionwe

recommendthatdepartmentsofphilosophy,theologyand

socialsciencesareencouragedtoworkcollaborativelywith

sciencedepartments,researchinstitutesandindustryin

mutualprojects.Inthiswayadviceonethicalandsocial

aspectsofresearchprojectsneedstobemadeavailablefor

scienceandindustry,especiallytoSMEswhichwilloften

havenoinhousecapacity.

InacomplexareasuchasnanobiotechnologyCommunica-

tionisessentialforsuccessfulinvolvementofdisciplines

andstakeholdersinthedevelopmentofthisveryinterdisci-

plinaryfieldandtoengagewiththepublicinatimelyman-

nertogetacceptanceofthisnewtechnology.Engagement

withthepublicisatwo-wayprocessinwhichscientistsand

industrynotonlygiveinformationonunfamiliartechnolo-

gies,butalsolistentovaluableinsightsandperspectives

fromlaypublics.Howearlythisshouldbedonewilldepend

onthedevelopmentofthetechnologyandalsothesocial

context.Ifitisdoneafterthekeytechnologicalchoiceshave

beenmade,publicsareunlikelytoconsidertheirviewswill

betakenintoaccount.Ifitisdonetooearly,thereisarisk

ofanticipatingthewrongapplicationsorethicalquestions.

Engagementmaytakemanydifferentforms.Manytools

areavailable,includingdeliberativemethods(focusgroups

andcitizensjuries),grassrootsinitiatives(e.g.cardgames),

andinternet-basedapproaches.Sciencecentreshavean

importantroleforexamplewithinteractiveexperimentsor

scienceexhibits.Sensitiveandwellplannedeventsareusu-

allywellreceived,andcanhelppromotethedevelopment

andapplicationofnanobiotechnologyinamoretransparent

way,andhelpcreatepublictrustononesideanddevelop-

mentswhicharesensitivetopublicvaluesandattitudeson

thepartofthedevelopers

ANNEX

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Usuallycommunicationbetweenscientistsiswellorganized

butinanewandextremelyinterdisciplinaryfieldsuchas

nanobiotechnologyitshouldbeimprovedamongscientific

disciplines,academiaandindustryattheregional,national

aswellastheEuropeanlevel.Thiscanbeaccomplishedby

regionalclustersthatsupporttheexchangeofideasand

informationnotonlyinsidebutmoreoverbetweenclusters.

Theconnectionofsuchclustersintoacomplementaryalli-

ancewillbeacrucialstepforpromotingtherecognitionof

nanobiotechnologyinEuropeattheglobalscale.Further-

more,suchaclusteralliancecanserveasapoolofprofes-

sionalsprovidinginformationforjournalists,politicians

andthepublic,andwhocancommunicateandengagein

awayunderstandablebynon-scientists.Thetransparency

andaccessibilityofdataandstoriescanalsohelptoattract

fundingandinvestments.

Howcanrisk managementbeimprovedandabettersafety

ofnanoproductsandresearchbeguaranteed?

Nanoproducts,beingasubstantialpartofthenanotech

fieldare“athingwithoutadefinition”becausethekindand

amountof“nano”withinaproductvarieswidely.Today,

thereisanimprovableamountofdatathatdescribesthe

hazardandmaximumlevelsofexposure(risk=hazardx

exposure).Tomeettheupcomingconcernsaboutthesafety

ofnanotechnologyaprecautionaryapproachofallstake-

holdersisneededthatwillencouragethegenerationof

moredataandthedefinitionofpotentialrisk.Tomeetthe

concernsaboutthesafetyofnanotechnology,thereneeds

toabeadynamicapproachwhichseekstodistinguishma-

terialsorapplicationswherespecialrisksareanticipated,

andwhereaprecautionaryapproachofallstakeholders

isappropriate,fromotherareaswherenospecialriskis

involved.

Tocreateasafeworkplaceandtobalanceriskandbenefits

existingsafetyofficersincompanieshavetobetrainedand

informedspecificallyaboutthepropertiesofnanoobjects

suchasnanoparticleshandledattheirlocationasitwas

doneduringtheNanoCareprojectforanumberofrelevant

substances.AEuropeancentreforriskandsafetymanage-

mentinnanobiotechnologyprovidinginformationandadvice

onexistingsafetystandardsandSOPsinEuropewould

bestservetheneedsofSME´sanduniversitieswhocannot

affordexpensiveriskassessment.Suchacentrewouldnot

onlyprovideacentralinformationplatformbutcouldalso

drivetheharmonizationofnationalsafetyproceduresand

protocols.

Tokeepupwiththespeedoftechnologydevelopmentapro-

activeregulatorypartnershipatalllevelsisnecessarycon-

nectingELSA,testing,trainingandcommunicationaspects.

Inthelongtermaclearlegalframeisinevitabledescribing

howtohandlenanoobjects.

Technology transferofnanotechnologyisachallenging

taskasnanotechnologyisatthebeginningofthevalue

chainandadditionally,universitypatentsaremostlyfora

veryearlyphaseofaproduct–ittakesalotoftimetoreach

themarket.Scientistsbecomemoreandmoreinterested

inpatents,becausepatentsarecrucialforcollaborations

ofuniversitieswithindustry,foruniversitymarketing,for

spin-offsastheirmainvalue,andprototypedevelopment.

However,thedevelopmentofprototypesoftentakestoo

muchtimesothatscientistsneededtomonitorandsupport

thedevelopmentsdropoutoftheprocess.Therefore,itisof

strategicimportancetoidentifythescientistwhoiswilling

toleavetheresearchenvironmentandispreparedtofollow

thepotentialproducttomarket.

Oneadequatewaytofacilitatetechnologytransferisto

createprofessionaltransferofficesinsideuniversitiesorre-

searchorganisationswithgoodqualitymanagementskills

andnetworksofscientists,relevantcompaniesormarket

experts.However,theseagenciescanonlybesuccessful,if

thetopmanagementoftheresearchinstitutioncreatesan

entrepreneurialspiritandstudentscanattendcourseson

businessmanagementandentrepreneurship.Thelatteris

alsocrucialforthecreationofspin-offcompanies,which

arestillthemostefficientwaytotransfertechnologyto

industry.Fordevelopmentandgrowthofsuchstart-ups

businessincubatorswithlocalfinancialsupportaremost

important.

Future recommendations:

Connectingthesefindingsitbecomesclearthattheeduca-

tionofscientistsinbothethicalandsocialimplications

ofnanobiotechnologyandalsoinsciencecommunication

andengagementiscrucialtodealwiththeincreasing

complexityofscienceandtheimpactofnanotechnologyin

areassuchasmedicine,food,cosmeticsorenvironment.

Indoingso,itwillbeimportanttodistinguishamongthe

differenttypesofnanobiotechnology,theirapplications,

andtheevaluationoftheirrelevantriskpotential.Clusters

canprovideanorganizedcommunicationplatformforboth

stakeholdersandthegeneralpublictopromoteaholistic

andproactiveapproachfortheresponsibledevelopmentof

nanobiotechnologyinatrustingenvironment

16 17EuroBioNano Final Report|January2010

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Projectandpartnerdescription

ProjectEuroNanoBioisaSupportActionfundedunderthe7th

FrameworkProgrammeoftheEuropeanUnion,whichhas

exploredthedefinition,establishmentandfurtherdevelop-

mentofaEuropeanscaleinfrastructureonnanobiotech-

nologyandtheassociatedrealisticimplementationplan.

Itaimedatdefiningnotonlythekeyfeaturesofapotential

Europeaninfrastructureinnanobiotechnology,butithas

alsoestablishedthewayitshouldbedesigned.

EuroNanoBioproposesthecreationofanetworkofsome

leadingpolesofexcellencethatwillbeabletosupport

industrialactivities,inparticularbenefitinghigh-techSMEs,

education,researchanddevelopment,riskmanagement

andengagementwiththepublic.Tosubstantiatethispro-

posaltheprojectwasdividedintotwophases:

• Ananalyticalphasewheretheexistingdatawerescruti-

nisedandanalysedtoextractsomesuccessfactorstobe

usedfordefiningtheEUinfrastructureinnanobiotech-

nology.

Thisanalysiswasconductedinfourdirections

-existingtopclassinfrastructuresorclustersinsideand

outsideEurope,assessingtheirpositioningwithrespect

totheinternationalscene

-modesoftechnologytransferfromresearchtoindustry

-multidisciplinaryeducationandtraining

-ancillaryaspectsofnanobiotechnology

• Abuildingandconsensusphasewheremanydiverse

stakeholderswereinvitedtojointlydefineandadoptthe

keyfeaturesoftheinfrastructure,andthewaytobuildit.

AsaresultofthisprocessEuroNanoBioproposes15

recommendationsforadistributedEuropeaninfrastruc-

tureinnanobiotechnologyalongthefourdimensionsofthe

Europeaninfrastructure–research,education,technology

transfer,ELSA–targetedatawiderangeofstakeholders

amongwhicharepolicymakers,clustermanagers,univer-

sities,techtransferoffices,andresearchorganisations.

ThemajorexpectedimpactofEuroNanoBioistoinitiatethe

emergenceofaEuropeancapacityinnanobiotechnology,

whichshouldsupportthedevelopmentofnewnanobiotech-

nology-basedproductsandindustrialprocessesandfoster

theirreliability,safetyandfuturecommercialisationonthe

globalmarket.

TheimplementationplanprovidedbyEuroNanoBiomeets

therequirementsoftheEuropeanCommission’sAction

PlanforNanotechnology2005-2009,whichproposes:

“World-class R&D infrastructures and ‘poles of excel-

lence’ are essential for the EU to remain competitive in

N&N. Europe needs an appropriate, diverse but coher-

ent system of infrastructure that comprises both ‘single

sited’ (in one location) and ‘distributed’ (networked)

facilities.”.Furthermore,theconsortiumwasinfrequent

contactandalignmentwithtwoleadingprojectsorinitia-

tivesnamelytheFP7projectNanoMedRoundTable–

www.nanomedroundtable.org–andtheEuropeanTechnolo-

gyPlatformonNanomedicine–www.etp-nanomedicine.eu

toadapttheimplementationplantothespecialrequire-

mentsofnanomedicine,oneofthemostimportantsub-

areasofnanobiotechnology.

PartnersTheEuroNanoBiopartnersarehighlyexperiencedinEUin-

tegrationinnanobiotechnologyingeneralaswellasinspe-

cificaspectsstudiedinthisSupportActionbybeinginvolved

inprojectssuchastwolargeFP6networksofexcellencein

nanobiotechnology-Nano2LifeandFrontiers–theEuro-

peanTechnologyPlatformonNanomedicineandsimilar

nationalPlatformsinNanomedicineinSpain,Franceand

Romania,andtheFP7SupportActionNanomedRound

Table,whichfocusesontheancillaryfactorsofnanomedi-

cinesuchasELSA,economicsandpatient’sinterest.They

usetheirunrivalledaccesstoawidepanelofstakeholders

ingovernments,industry,andacademiatocreatearealistic

implementationplanfortheconstructionofaEuropean

infrastructureinnanobiotechnology.

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CEAwww.leti.fr

Bioanalytik-muensterwww.bioanalytik-muenster.de

Tyndall National Institutewww.tyndall.ie

MESA+ Institute for Nanotechnologywww.mesaplus.utwente.nl

Fondazione Don Gnocchiwww.dongnocchi.it

Institute for Bioengineering of Cataloniawww.ibecbarcelona.eu

National Institute of Microtechnologywww.imt.ro

3

1

24

5

6

7

1

2

3

4

5

6

7

18 19EuroBioNano Final Report|January2010

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SupportedbyFP7oftheEuropeanCommission

Publisher: EuroNanoBio Editors: Dr. Klaus-Michael Weltring Design: conImago, Münster, Germany Pictures: iStockphoto, CEA Print: Thiekötter Druck, Münster, Germanywww.euronanobio.eu