academic-nhs-industry collaboration in experimental medicine
TRANSCRIPT
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Academic NHS Industry Collaborationin Experimental Medicine
Innovative partnering
Office for Clinical Research Infrastructure
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Contents
3 Foreword
5 Benetsofcollaboration
6 Collaboration1:NIHRNationalCancerResearchNetwork-AstraZeneca Early-stagedrugdevelopment
8 Collaboration2:TheUniversityofCambridge-GlaxoSmithKline AnAcademicDiscoveryPerformanceUnit
10 Collaboration3:NIHRBiomedicalResearchCentre,MooreldsEyeHospitalNHSTrust- UniversityCollegeLondon-TheAutomationPartnership
Regenerativemedicineapplicationsinophthalmology
12 Collaboration4:NIHRBiomedicalResearchCentre,NewcastleUniversity-Multiple IndustryPartners
Acollaborativetrainingprogrammeintranslationalresearch
14 Collaboration5:TheUniversityofBrighton-TheBrightonandSussexUniversityHospitals NHSTrust-NeaterSolutions
Improvedassistedlivingtechnology
16 Collaboration6:TheUniversityofEdinburgh-NHSLothian-Pzer Generationofawell-characterisedpatientcohort
18 Appendix
19 PostscriptfromtheManagingDirectoroftheNIHROfceforClinicalResearch Infrastructure(NOCRI)
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3
Foreword
Innovativepartneringcanacceleratethe
developmentofnewtreatments,devices
anddiagnosticstotacklecomplex
healthcareneeds.Creativeengagement
betweentheNHS,universitiesand
industryformsapowerfulalliancetodrive
translationalmedicineintheUK.This
allianceisvital.Itensuresthatadvancesin
basicscienceprogressswiftlyintobenets
forpatientsandtheeconomy.
TheNationalInstituteforHealthResearch
andMedicalResearchCouncilhave
compiledthisbookletinordertosharesix
examplesofinnovativeresearchthatinvolve
successfulpartneringbetweentheNHS,
universitiesandindustry.Theseexamples
showdifferentsortsofcollaboration,
supportedbyarangeoffunders.
Avarietyofapproacheshavebrought
aboutsuccessfulcollaborations.Many
involveacommitmentofmaterial,funding
orexpertise.Industryhasbeenwillingto
shareuniquecompoundlibraries.Shared
risk-rewardmodelshavebeencreatedto
fundprogrammesofwork.Training
programmes,secondmentsandjointposts
havehelpedshareexpertiseandbestpractice.
Wehopethatreadingtheseexampleswill
inspireyoutoexploreideasforcollaboration
adaptedtoyourownareaofinterest.
Professor Dame
Sally C. DaviesDirectorGeneralofR&D,
DepartmentofHealth
Professor Sir
John SavillChiefExecutiveof
theMRC
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Benetsofcollaboration
Theabilityofacademia,theNHSand
industrytocollaborateinmoreproductive
wayswillspeedtranslationofscienticideas
andobservationsintotherapeuticsand
benetsforpatients.
Collaborationiseffectivewhenitteams
complementaryscienticskills,knowledge
andtechnologiestotackleacomplex
researchissue.Itismostpertinentwhen
undertakingtheearlyclinicalphaseinthe
developmentofanewhealthcareproduct.
Atarecentworkshopinvolvingthedirectors
ofacademicexperimentalmedicinecentres
andindustryscientists,anumberof
complementarystrengthsandresources
werehighlighted:
Thepharmaceutical,biotechnologyand
medicaltechnologyindustriescould
adoptmoreinformedapproachesto
drug,deviceanddiagnosticdesignand
developmentthroughcollaboration.UK
academiahostsastrongcohortof
investigatorswithinnovativediscoveries
andideasarisingfromdetailed
explorationsofspecicdiseases.
Accuratediseasebiomarkersdeveloped
andvalidatedbyacademiacanimprove studyprotocols,stratifypatient
populationsandultimatelyensure
therapydevelopmentismoretargeted
andefcient.
PartneringwiththeUKsworldclassNHS,
includingitsclinicians,healthcare
professionalsanddedicatedexperimental
medicineresearchinfrastructure,fosters
engagementwithpatientsandtheir
carers.Operatinginthecontextofa
uniedcaresystemensuresproduct
designisbetterinformedandpotentially
stratiedbypatientdisease.
Earlyaccesstoindustrycompoundsand
technologiespresentsacademicsand
clinicianswiththeopportunityforunique
rst-in-humanclinicalresearchstudies.
Theseprovideaplatformforfurther
researchanddevelopment,aswellas
expandtheknowledgebaseand
publicationrecord.Industrycanalso
shareitswealthofexperiencein
negotiatingtheregulatorypathwaysto
rst-in-humanstudies.
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Withintranslationalmedicine,stronger
collaborationbetweenuniversities,the
NHSandindustrywillbecomeapowerful
platformforengagingandinuencingother
importantstakeholders,suchasnationaland
internationalregulatoryauthorities.
Personalcontacts,showcases,workshops
andconferencesremainfertilegroundfor
initiatingcollaboration.Researchfunders
providearangeofsupportbothforevents
tokick-startpartneringandthrougha
varietyoffundingstreamstosupport
collaborationsatalllevels,fromindividual
projectstolargescaleconsortia.Themodel
IndustryCollaborativeResearchAgreement
(mICRA),streamlinedregulatoryapprovals
andguidancewithroutemapsfor
intellectualpropertyagreementsallaimtosimplifypartnering.
AgainstabackdropofhighratesofphaseII
candidatecompoundattrition,andan
increasingemphasisonopeninnovation
bythelifesciencesindustries,thetimeis
ripetoencourageearlystagecollaboration
betweenindustry,academiaandtheNHS.
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InitiatedbyachancediscussionbetweenProfessorDavidCameronoftheNIHRNationalCancer
ResearchNetwork(NCRN)andProfessorAndrewHughesofAstraZeneca(AZ),thiscollaboration
offeredmutualbenets.AZwerelookingtoevaluatetheircompoundsinabroaderrangeofcancers,
andtheNetwork(comprisingmultipleclinicalinvestigators)wouldgainaccesstonovelmolecules
forimprovedoncologyresearchandpatientbenet.
Offer
Collaborative functions
Outcome
6
R&Dofdrugsforcancersoutsidecompanyscoreprogramme
Earlierpatientaccesstonewandmoreinnovativedrugs
14PhaseIIClinicalStudies
Anestablishedmodelofcollaborativeworkingthatcouldbe
rolledoutinotherdiseaseareasandwithother industrypartners
Jointprotocolsign-off
Early-stagedatasharing
Collaborativechoiceofleadcandidatemolecules
Systematiccollaborativesupportincludingmodelagreements
Combinationaltherapeuticapproaches
Researchinfrastructure
NHSpatientaccess
Novelprotocoldevelopment Objectivemoleculeevaluation
Integrateddiseaseknowledge
Denedcollaborationbudget
Portfolioofnovelmolecules
Patientsupportcosts Drugdevelopmentexpertise
ProfessorsRickKaplan&DavidCameron
(NCRN)broughtpreviousexperienceofindustry
engagementfromtheNationalCancer
Institute,USA.
ProfessorAndrewHughes,aseniorVPatAZ,
heldajointpositionasChairofTranslational
MedicineattheUniversityofManchesterand
hadenthusiasmforworkingwithacademia.
InitiationAcademia Industry
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Keysuccessfactors
Accesstoandengagementof
AstraZenecadecisionmakersin
thecompanysUKCancerDivision
Headquarters
Effectiveworkshopsinvolvingindustry
product&diseaseteamsandacademic
studygroupsgeneratedideasand
opportunitiesforthedevelopmentof
drugcandidates
Long-termsupportforthecollaboration
wasestablishedintheformofmodel
contracts,clearrolesandresponsibilities, activemanagementandorganisational
understanding
Youneedtosimplysitdownwithcompanies
andndcommonareas.Perhapslookat1or2
moleculesanddiseaseareaswhereacompany
maywishtobroadentheiractivity.Emphasise
theneedforlong-termcollaborationandestablishthesystemstoensurethis.
Thisreallyisawin-winsituation.Wecan
providedataaboutourdevelopmentpipeline
andcompoundsthatallowacademicresearchers
topursueinterestingareasofscience,whilstwe
gainavitalexternalperspective,andresearchdatathatmaypointtowardsnewindicationsfor
aparticulardrug.
Professor Rick Kaplan
AssociateDirectorof
theNationalCancer
ResearchNetwork
Chris Wilks
CoordinationDirector
&HeadofPartnerships,
AstraZeneca
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CambridgeUniversity,CambridgeUniversityHospitalsNHSTrustandGlaxoSmithKlinehavebuilt
uponastronghistoryofcollaboration.AsaGSKAcademicDiscoveryPerformanceUnit,Cambridge
academicsworkasstakeholdersontheclinicaldevelopmentofproprietaryGSKdrugcandidates,while
GSKgainthecross-themedexpertiseofinternationalexperts.
Initiation
Offer
Collaborative functions
Outcome
Academia Industry
Onecandidatedrugforobesitysuccessfullyprogressedthrougha
phaseIprogrammeandisnowundergoingphaseIItrials.
Preclinicalstudiesonacandidatedrugbeinganalysedprimarilyfor
obesityhaveidentiedanadditionaltherapeuticactivityforaddiction
Agreaterappreciationoftheissuesfacingthetwopartnershas
broughtacademiaandindustrycloserinthissetting
Embeddedacademicteams
Programme-levelagreementstocoverIP,publicationrights,
andotherrulesofengagement
Asharedrisk-rewardstructure
Projectmanagementfocusedon
delivery
Structuralandstrategicmodelof
aGSKprojectteam
Specialistdrug-development knowledge
Commercialanalysis
Non-compartmentalisedand
imaginativethoughttoaresearch
questionthatcutacrosstwoGSK
diseaseteams,neuroscienceand
metabolism
Objectivejudgementofacandidate
drugspotential
ThesecondmentofProfessorEdBullmorefromCambridgetoworkhalf-timeasheadoftheGSK
CambridgeClinicalUnit,basedinAddenbrookesHospital,greatlyfacilitatedthiscollaboration.BuildingonafoundationofpreviousCambridge-GSKpre-competitivecollaboration,therewasa
mutualdesireforgreateracademicinputintheclinicaldevelopmentactivitiesofGSK.
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Keysuccessfactors
Anapproachthatprioritisedscientic
engagementasanincentiveforindividual
academics
Financialrisk-sharingmodel
TheonsiteGSKclinicalunitin
Cambridgehelpedtobuildbridgesand
enablethepartnerstorealiseeach
othersvaluetothecollaboration
Cambridgeacademicssuccessfully
presentedanorganised,coherentand
compellingoffertoGSKinatherapeutic
areainwhichtheyexcelledinan
internationalcontext
Adrivingforcebehindthiscollaborationwas
therealisationthattheexistingGSKunitonthe
Cambridgecampuswasnotinitselfenoughto
establishstrongcollaborations.Therehadtobe
anarrangementthatallowedacademicstobeincontrolofthedrugdevelopmentworkinorder
tomotivatethemonascienticlevel.
Professor Ed BullmoreCambridgeUniversity/
GSK
ThiscollaborationwithCambridgehashad
averypositiveeffectonGSKscientists.The
innovativenatureofthecollaborationhas
stimulatedmoreinnovativethinkingfromour
teamsandliberatedtheiracademicwithin.
Dr Pauline Williams
HeadofGSKsAcademic
DiscoveryPerformance
Unit,Cambridge
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Amethodforgrowingtransparenttissue,developedbyacademicsatUniversityCollegeLondon(UCL),
waslicensedtoTheAutomationPartnership.CollaborationwiththeNIHRBiomedicalResearchCentre
(BRC)atMooreldsEyeHospitalbroughttherapeuticapplicationstocureblindnessthroughtheproposed
generationofacompleteocularsurface.Thetechnologyultimatelyhasapplicationsinmanyareasof
regenerativemedicine.
Initiation
Offer
Collaborative functions
Outcome
Academia Industry
10
ProfessorRobertBrownofUCLpatentedtechnologies
formembranessupportingcellgrowth.DrJulieDanielsoftheNIHRBRCatMooreldsjoinedthe
TechnologyStrategyBoard-fundedcollaboration
todevelopclinicalapplicationsforthetechnology
inoculartherapy.
TheAutomationPartnershipwereinterested
inlicensingthistechnologyforcommercialdevelopment,andwereawardedagranttothis
endfromtheTechnologyStrategyBoard(TSB).
Experienceinautomatedcell
culturesystems
Robustprotocolsandtechnique
standardisation
Funding
LeadapplicantontheTechnology
StrategyBoardgrant
Translationalresearchexpertise
intheeldofoculartherapy
Patentedtechnologies
Academiccontactsinfurther therapeuticareas
NIHR-fundedresearchinfrastructure
TheAutomationPartnershipwonacollaborativegrant
fromtheTechnologyStrategyBoard
Appropriatepatentsareledinopennegotiationbetween
thepartners
Twentyindividualsfrombothacademiaandindustryare
involvedintheproject
Apatentedautomatedworkstationcapableofproducing
consistent3Dtissuestructures
Publicationsandconferencepresentationsfromboth
academicandindustrypartners
Grantapplicationssubmittedforspin-offprojectsinfurther
areasofregenerativemedicine
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Keysuccessfactors
Enthusiasmandcommitmentofthe
partnerstowardsacommongoal
Availabilityofcollaborativefunding
tokickstartdevelopmentofa
commerciallyhigher-risktechnology
Aprotectedacademicideadeveloped
bycommercially-awarescientists
ACollaborationSteeringCommittee
toquicklyescalateissuesandkeepthe
projectontrack
ThecelltherapyunithostedbytheNIHR BiomedicalResearchCentreatMoorelds
Adeeprelationshiphasdevelopedbetweenthe
collaboratorsandmuchhasbeenlearntinthe
eldoftissueengineeringfromworkingwith
world-classresearchers.Thesuccessesalready
realisedinthisprojectwouldsimplynothavebeenseenoutsideofthiscollaborativemodel.
Dr Rosemary Drake
ChiefScienticOfcer,
TheAutomation
Partnership
Theestablishmentofcoreinfrastructureinthe
formoftheNIHRBRCscelltherapyunitwas
crucialinattractingTheAutomationPartnership
tospecicallyentertheareaofcorneal
regeneration.Theprojecthasreallybenetedfromtheexpertiseoftheindividualsinthisunit.
Dr Julie DanielsReader,NIHRBRC,
MooreldsEyeHospital
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TheWellcomeTrusthassupportedatrainingprogrammedevelopedcollaboratively
betweenNewcastleUniversityandseveralindustrypartners.Ithasprovenverypopularwith
bothclinicalfellowsandindustry,andactedasacatalystforgreaterindustryengagement
atNewcastle.
Initiation
Offer
Collaborative functions
Outcome
Academia Industry
Therewasamutualrealisationbetweenindustryandacademiathat,althoughmanypeople
discussedthetopicoftranslationalresearch,fewwithinacademiaactuallyunderstoodhow
toeffectivelydeveloptheresultsofresearchintotherapiesandtechnologiesforpatientbenet.
UpdatedRealWorldcourse
content
PhDprogrammesintranslational
researchhostedatindustrysites
Expertexperienceintherapy
development
NIHRBiomedicalResearchCentre
withdedicatedinfrastructure
fundingtosupportresearch
translation
Anexperiencedgroupofclinical
academics
NewcastleUniversityengagedmultipleindustrypartners
CollaborativedevelopmentofarstyearMasterscourse
entitledMResinMedicalandMolecularBiosciences
Partnersagreedtouserealexperimentaldatatoenrichthecoursecontent
University,NHSandindustrypartnersfoundthemselveson
thesamesideofthetablewhendesigninganddelivering
thetrainingprogramme
University-NHS-industryinteractionsinNewcastlearemore
common,richanddiverseasaresultofthiscollaboration
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Key success factors
Seniorindustryguresfromthepartner
companiesworkalongsideacademicsto
delivertheMastersprogramme
Astrongtranslationalresearch
environmentwithintheNewcastle
NIHRBiomedicalResearchCentre
Thecoursetacklesaveryrealgapin
translationalknowledgewithinthe
clinicalacademiccommunity
Broadprolesofthecompaniesinvolved,
whichincludeSano-aventis,Roche,
AstraZeneca,PTCTherapeutics,Sirtris
andGSK
Thesuccessofthecoursehasmeantthatwe
areontargetforittobeself-fundingwithinthe
planned5yeartimescale.Therearebigplansto
rollmodulesoutnationwideinspecicdisease
areas,ortoaidincontinuingprofessionaldevelopmentforindustryproles.
Professor David Jones
NewcastleNIHR
BiomedicalResearch
Centre
13
Collaborativetranslationalmedicineprogrammes
provideauniqueopportunityforearlystage
researchtoprogressandtransitionintoadvanced
development.Inthenearterm,programmesin
translationalmedicinewillbenetbothacademiaandindustry.Lookingtothefuture,
globalhealthcareandoverallqualityoflifewill
bethebeneciaries.
Dr Zvi LoewyVicePresidentof
ResearchforDentalCare
atGlaxoSmithKline
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Thecollaborativedevelopmentofthiswheelchair,involvingacademicsatBrightonUniversity,NHS
cliniciansandtheirpatientsandengineersatNeaterSolutionsofferspatientsmorefreedomthanthe
standardNHSwheelchair.AcrucialgrantwasawardedfromtheNationalInstituteforHealthResearch
(NIHR)HealthTechnologyDevicesProgramme.
Collaborative functions
Outcome
Offer
InitiationAcademia Industry
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Commercialacumen
Engineeringdesignexperience
Productionfeasibility
IPownershipandpublicationissueswereaddressedatthe
beginningofthecollaboration
ThetriallingofprototypesinNHSpatientshomeswascrucial
toresolveearly-stagedesignproblems
Openchannelsofcommunicationweremaintainedand quarterlymeetingsheldbetweenthecollaborators
EngineerSamuelLesleybegandevelopingthe
foot-steeredwheelchairduringastudentproject.In2002heapproachedDrAnneMandyatthe
UniversityofBrightonwiththeidea.
JonMichaelis,ManagingDirectorofNeater
Solutions,signeduptodevelopthetechnologyinacollaborativedealwiththeacademicpartners.
Theinvolvementofrehabilitation
teams,carehometeamsandstroke
professionals
Effectivepatientengagement
Grantapplicationexpertise Trialprotocoldesign
Theproducthasbeenshowcasedatinternational
conferencesandexhibitions
Thereputationsofallpartnersbenettedfromanumber
ofpublications
NeaterSolutionsarelookingtoengagewithotheracademic
partnersinotherdeviceareasasaresultofthiswork
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Keysuccessfactors
Datawerepublishedfromwelldesigned
trialsthatdemonstratedthebenetsof
thedesignoverstandardwheelchairs.
Thiswaskeytosecuringfurthergrant fundingfortheproject
Extensivepatientandcarerinvolvement
foreachtrialandfurtherengagementvia
newsletters
Strongcoverageofprogressthrough
scienticpublications,conference
presentations,localpresscoverage
andpatientcomment
Clearareasofleadershipand
responsibilitywereestablishedin
thecollaboration
Followingtrialsoftheprototype,itwasvital
thatacommercialpartnerwasengagedinorder
toattractfurtherfunding.TheNIHRHealth
TechnologyDevicesprogrammebecame
availabletousandlaunchedthenextphaseofdevelopment.
Dr Anne MandyUniversityofBrighton
Workingwithacademiawascrucialtosecure
grantsforthedevelopmentwork.Italsoensured
ourdesignoptimallymettheneedsofboth
patientsandcarers.Forinstance,trialsinpatients
homestriggeredadesignchangeinthesteeringsystemthatwasnotpredictedatthestartofthe
project.Futurestudiesintotheimpactonpatient
healthandcarewillbeimportanttosecurefunding
oftheequipmentfortheindividualswhoneedit.
Jon Michaelis
ManagingDirector,
NeaterSolutions
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Thiscollaborationevolvedfromanacademically-ledcohortstudyinvestigatingthecomplicationsof
diabetesinolderpatients.Pzersinvolvementsignicantlyexpandedtherangeofbaselineinformation
collectedontheparticipants,exploredbiomarkersandprovidedaplatformforbroaderstudies.
Initiation
Offer
Collaborative functions
Outcome
Academia Industry
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AnMRC-fundedstudywascollectingclinicaldataoninammationandmicrovasculardiseaseinolder
diabetespatientswithafocusonthedevelopmentandprogressionofcognitiveimpairment.Achancediscussionbyoneoftheclinicalco-investigatorswithhislocalareadrugrepresentativestirredinterest.
Pzerwereinterestedinopportunitiesforcomplementaryinvestigationsonliverdysfunction,another
complicationofdiabetes.
Interestinliverfunctionindiabetes
Funding
Specialistbiomarkermethodologies
Multidisciplinaryteam
Protocoldesign
Cohortof1000seniordiabetic
patients Dedicatedresearchinfrastructure
Expandedbiomarkerinvestigationsonparticipantsallowinga
morecomprehensiveunderstandingofdiabeticcomplications
Comparisonofdifferentmeasurementtechniques
Crossvalidationofnovelbiomarkers
Anintensivelyphenotypedcohort
Expandeddatasetsgivingastrongplatformforfuturestudies
onasuiteofdiabeticcomplications
Publicationsandconferencepresentations
Validatedtechniquestobeusedforfuturedatacollection
Asolidplatformforfuturegrantsubmissions
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Keysuccessfactors
Amultidisciplinaryacademicteam
Topclassresearchinfrastructure
UK-basedleadscientistatPzer
Alignmentofourinterestswiththatof
Industrialpartnerswasvaluable.Italsohelped
havingakeypersonhereintheUKtotalkto
andbuildamorepersonalworkingrelationship,
assometimescollaborationatadistancecanbedifcult.
Dr Jackie Price
ClinicalSeniorLecturer
inEpidemiologyand
PublicHealth,The
UniversityofEdinburgh
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FromaPzerperspective,accesstoawell
phenotypedpatientcohortwaskey.Itisoften
verydifculttobeabletoaccesslongitudinal
dataandclinicalsamplesthatwillallowa
betterunderstandingofdiseaseemergenceandprogression.
Dr Geoff Johnston
DirectorofMolecular
Medicine,Pzer
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Appendix
Usefullinks:
Medical Research Council (MRC)
IndustryCollaborationAward(MICA)
www.mrc.ac.uk/Fundingopportunities/Grants/MICA/Specication/index.htm
National Institute for Health Research (NIHR)
InventionforInnovationProgramme(i4i)
www.nihr-ccf.org.uk/site/programmes/i4i/
Technology Strategy Board (TSB)
CollaborativeResearchandDevelopment
www.innovateuk.org/deliveringinnovation/collaborativeresearchanddevelopment.ashx
The Wellcome Trust
Collaborativetranslationalfundingstreams
www.wellcome.ac.uk/Funding/index.htm
UKCRC Experimental Medicine Resources Website
OnlinedatabaseoftheUKsexperimentalmedicineinfrastructureandexpertise
www.ukcrcexpmed.org.uk
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Thisbooklethighlightssixinnovativemodels
ofearlyphasepartnershipsbetweenindustry,
theNHSanduniversities.Theseshowa
varietyofwaysbywhichcollaborations
canarisetobenetallparties.
Anumberofthecollaborationsbuildupon
previouslyestablishedrelationships.Others
beganfromchanceinteractionsorpersonal
relationships.TheNIHROfceforClinical
ResearchInfrastructure(NOCRI)aimsto
makethisprocessmorestreamlinedby
linkingindustrywiththecountrysleading
academicexperimentalmedicineexpertsin
acoordinatedway,aswellasbyprovidinga
forumforearlycollaborativediscussions.
Additionally,NOCRIisprovidingthetools
tosupporttheseinteractions.Forexample,
therecentlydevelopedmodelIndustry
CollaborativeResearchAgreement(mICRA)
canshortenthecontractingprocessfor
collaborativerelationships.Ifyouwouldlike
toknowmoreabouthowNOCRIcanhelp
youtoestablishacademic-NHS-industry
collaborations,pleasecontactusat:[email protected].
19
PostscriptfromtheManagingDirectoroftheNIHROfce
forClinicalResearchInfrastructure(NOCRI)
Forfurtherinformationorsupportwithresearch
collaborations,contact:[email protected]
MarkSamuels,
ManagingDirector,NOCRI
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NIHROfceforClinicalResearchInfrastructure(NOCRI)
132RichmondHouse
79Whitehall
London
SW1A2NS
www.nihr.ac.uk/nocri
Tel: +44 (020) 7210 6217
MRCHeadOfce(London)
14thFloor
OneKembleStreet
London
WC2B4AN
www.mrc.ac.uk
Tel: +44 (0)1793 416 200