ANTICIPATING THE CLINICAL DELIVERY OF ......ANTICIPATING THE CLINICAL DELIVERY OF REGENERATIVE...
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ANTICIPATINGTHECLINICALDELIVERYOFREGENERATIVEMEDICINESCHALLENGES,TENSIONS&OPPORTUNITIES
23rdMay,2017
JohnGardnerSchoolofSocialSciencesMonashUniversityMelbourne,Australia
ORTHEPROBLEMOFTECHNOLOGYADOPTION
Overview
1. ThegeneralproblemoftechnologyadopKoninhealthcare2. TechnologyadopKoninRegeneraKveMedicine–
innovaEonniche3. ProposedCentresforCellandGeneTherapy4. PrecedentsandaffordancesforRMtreatmentcentres5. Insightsfromthesocialsciences• InsKtuKonalReadiness
ESRCGrantRef:ES/L002779/1
TechnologyadopEoninhealthcareAdopKonprocesseshavebeenoverlookedinthepast…• e.glinearconceptualisaKonsofinnovaKon(TRLs)
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Nowrecognisedasanimportant&problemaEcaspectofinnovaEon• High-profileadopKonfailurese.gNaKonalNHSITprogramme• EmphasisontranslaKonalmedicine(benchtobedside,bedsidetobench)• RecentHoCScienceandTechnologyCommi]eeReportonRegenMed.
SomecasestudiesoftechnologyadopEoninhealthcare:• IntraoperaKveBreastLymphNodeAssay(BLNA)(Llewellynetal
2014)• ThedaVincirobotforprostatectomy(Ulucanlaretal2013)• E-healthpaKentrecords(Greenhalghetal2010;2013)• Chronicwoundcaretechnologies(Madden2012)• CytoriCeluKon®System(Gardneretal2017)• PaediatricdeepbrainsKmulaKon(Gardner2016;2017)
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Generalfindings:complexity&heterogeneity• NewtechnologiesmustalignwithinsKtuKonal&professional
interests• DisKncKonbetweencosteffecKveness&affordabilityishighly
relevant• Agoodbusinesscase!• Whatcountsas‘evidence’isnotalwaysclear.Professional
differences,relianceoninformalnetworks…
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SpecificchallengesforregeneraEvemedicines
• LiveKssues/cellsrequirespecialistinfrastructure&skillsfortransportaEonandpreparaKonattheclinic
• Newmanufacturing&logisKcsarrangements.ClinicassiteofparEal
orfullmanufacturing.• Onsitemanufacturingwillrequireexpensivebioprocessing
equipmentsuchascellseparaKon&expansionsystems,systemsfortransfecKonetc.
• Hospitalsmayneedtoactasprocurementserviceforthirdparty.Contractarrangementsforthiscanbecomplex.HowmightQAandliabiliKesbedistributedamongparKes?
• Someproposedrisk-sharingcommissioningschemesneedcoordinateddata-collecEoninfrastructures.
• EmergingtherapiesarediverseandwillpresentvaryinglevelsofdistribuKon.
seeGardneretal2015
flexibleGMPfaciliKes
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ThedeliveryofregeneraEvemedicineswillrequiresignificantorganisaEonal/insEtuEonaladjustmentsConstrucKngan‘innovaEonniche’fornewtechnologies/techniques
Gardner,J.&Webster,A.(2016).TheSocialManagementofBiomedicalNovelty:FacilitaKngtranslaKoninregeneraKvemedicine.SocialScience&Medicine.156:90-7
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ProposedCentresforCellandGeneTherapyTreatmentRecommendedbyRMEGandATMTaskforce
Providestability,enablingconsolidaKonofsupplychains,datacollecKoninfrastructures&trailingandconsolidaKonofbusinessmodels.
• Consolidateresourcesatseveralcoordinatedclinicalsites
• ATMTrecommends£30MillionadministeredbyInnovateUK
• RepresentpartnershipsbetweenNHS&industry
Clinicofthefuture.CentreforProcessEngineering
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Precedents&affordancesfortreatmentcentres
1. Haematologicalservices,NHSBT,SNBTS• Reservoirofinfrastructure&experKse(seeLowdell&Thomas2017)
• Procurement,transportaKon,administering,paKentpreparaKon
• FamiliaritywithHTA,MHRA,GMPetc
• NHSBT&SNBTSalreadypartneredinRMinnovaKonalliances
2. ExisEngrisk-sharingcommissioningarrangements• ProvisionofsomehighcostcancerdrugsinScotland,enabledby
integratedEPRinfrastructure
• ElsewhereinEurope,egItaly.GSK‘money-backguarantee’onStrimvelisforADA-SCID
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Precedents&affordancesfortreatmentcentres3. EstablishmentofaUKProtonBeamTherapyService
• Highcost,requiringnewinfrastructures,paKent-pathways,&associatedskillsandtrainingwww.england.nhs.uk/• Considerableinvestmentrequired:£250million• CoordinatedacKonfromvariousagencies–NHSEngland,FoundaKonTrusts,HealthEducaKonEngland,etc
Similarlevelofinvestment&coordinaEonmayberequiredforimplemenEngsomehighlydisrupEveregenmeds
Fromh]ps://www.england.nhs.uk/commissioning/spec-services/highly-spec-services/pbt/
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Also…meaningfulpaKentengagementinservicedesign
• RegionaldistribuKonofRegeneraKvemedicinetreatmentcentres
• AreoutcomemeasuresrelevanttopaKentsandtheirfamilies?Infrastructureforthesemeasures?
• Psycho-socialdimensions–appropriatesupport?Appropriatelinkswithcommunityservices?
RMtechnologies/techniquesshouldnotbeseenasatechnologicalfix–theyshouldbeapproachedaspartofanongoingregimeofcare
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InsEtuEonalReadiness(IR)InparallelwithTechnologyReadiness
thedegreetowhichorganisa7onsorgroupsarewillingtodeploy,andarecapableofimplemen7ng,anoveltechnologyorprac7ce.
• A(novel)technologyisarelaKonalproduct,embeddedinamaterial-semioKcnetwork.
• AdopKonistheresultofacKve,ongoingworkbycreaKveagentswithboundedraKonalityandlimitedresources.
• DiverseagentsneedtobeacKvelyenrolledintheembeddingprocess-alignworkloadsandexpectaKons.
• RequiresregularopportuniKesforreflexiveevaluaKon,monitoringSeealsoMay2013
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InsEtuEonalReadiness&RegeneraEveMedicineWhatparametersmightberelevant?
RMTechnology/Technique Context(ClinicalSebng)
PrevalenceofindicaKon Appropriatecapacity
OpportuniKesformeaningfulpaKent/publicinvolvement&collaboraKon?
Place&modeofmanufacturing(e.gcentralised?on-site?)
GMPcleanroomaccess;Bioprocessingcapacity
PreparaKonrequired(product,paKent…) AppropriatelytrainedQP?InfrastructureforQA
Clinicalskillrequiredforadministering Appropriatereservoirofskills,opportuniKesfortraining
Monitorable Infrastructuresforassessment&monitoring
Timeformonitoring&collecKveevaluaKon
QualityofsupporKngevidence InsKtuKonalStrategy/PrioriKes
Stakeholderalignment(e.gmanagers,frontlinestaff,paKents&families)
Affordability Paymentstructures(e.g.tariffs),otherrevenuesources(e.gcharitablegrants).
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IR-L InsEtuEonalReadinessCategoriesinhealthcare1 InsKtuKonshaveoperaKonalgroupstaskedwithengagingandidenKfyingnew
technologies
2 InsKtuKonhasidenKfiedpotenKalnewtherapeuKctechnologies.
3 InsKtuKonhasanoperaKonalgrouptaskedwithassessinginsKtuKonalcapacity/readinessfornewtherapeuKctechnologies
4 AssessmentsofcurrentinsKtuKonalarrangementsfornewtechnologyhavebeenmade
Formalguidelinesexistfor‘readying’thoseinsKtuKonalstructuresinwhichthetechnologywillbeused/produced/assessed
5 Keyindividuals/groupstaskedwithreadyinginsKtuKons(inwhichtechnologywillbeused/produced,assessed)accordingtoguidelines.
6 NovelinsKtuKonalstructuresexist,inanKcipaKonofexpectedchallenges/affordancespresentedbynoveltechnology.Thesestructuresresultfromretrainingofstaff,construcKonofnewspacesetc
7 Noveltechnologyisbeingproduced/used/assessedwithininsKtuKon.TeethingproblemsandunanKcipatedchallenges/affordancesarenoted.
8 NoveltechnologyisrouKnelyproduced/used/assessedwithininsKtuKon.CurrentinsKtuKonalarrangementsaresufficientforrouKneproducKon/assessment/deployment.
InsEtuEonalReadinessLevels…
(Moreworktobedoneonthis…watchthisspace)
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InsEtuEonalReadinessLevels ExamplesClinicalinsKtuKonalcontext GovernanceinsKtuKonalcontext CommercialinsKtuKonalcontext
1 InsKtuKonshaveoperaKonalgroupstaskedwithengagingandidenKfyingnewtechnologies
Clinician(s)constantlylookingfornovelintervenKonsforexisKngcondiKons/illnesses.
Governmentbodies/policymakersconcernedwithcostofhealthcareandnaKonaleconomicperformance.Thesebodies/policymakersacKvelypromoteinnovaKoninhealthcare.
EmployeesorR&Ddivisionofcompanies/academicgroupsacKvelylookingfornewproducts.Or,individuals/groupswithincompaniesacKvelyscouKngforsmallcompanieswithnovelproductstoalignwith.
2 InsKtuKonhasidenKfiedpotenKalnewtherapeuKctechnologies.
Clinician(s)becomeawareofnewintervenKon–perhapsindevelopmentalstageand/orusedinotherhealthcareserngs
Governmentbody/policymakersidenKfyandpromoteparKculartechnologies–suchasRM-aspartoftheirpushforinnovaKon.
PotenKalnewtechnologyidenKfiedandisbeingdevelopedwithincompany,oronecompanyhasidenKfiedpotenKaltechnologyproducedbyanother,andthusestablishesanalliance.
3 InsKtuKonhasanoperaKonalgrouptaskedwithassessinginsKtuKonalcapacity/readinessfornewtherapeuKctechnologies
FormulaKonofspecialistgroup(whichmayonlyinclude‘pioneering’clinicianandclinicaldirector)taskedwithexamininghowwellexisKngNHShospitalworkflows/structureswillaccommodatenewtechnology.Inevitablythiswillinvolveassessingwhethersuchaclinicalservicewouldbefinanciallyself-sustainingwithinthetariffsystem.
Government-appointedgrouptaskedwithassessingthesuitabilityofcurrenthealthcaresystemarrangementsforfacilitaKngofnewtechnologies.Thismayincludeanassessmentofcurrentgovernancestructures(regulatoryagenciesandappraisalbodies).
Groupwithincompanyassessescurrentcapacityoffurtherdevelopment/producKonofnoveltechnology.Thisincludesassessingcurrentmanufacturingplasorms,experKse,componentsuppliers,possiblemarketetc.
4 AssessmentsofcurrentinsKtuKonalarrangementsfornewtechnologyhavebeenmade
Formalguidelinesexistfor‘readying’thoseinsKtuKonalstructuresinwhichthetechnologywillbeused/produced/assessed
EstablishmentofproposalforadjusKngNHSclinicalsitessothatthenewtechnologycanbeintegratedintoanew/exisKngclinicalservice.Suchproposalswilloutlinethevariousresourcesrequired:staff,supporKngtechnologies,clinicalarchitectureetc
Governmentappointedgroupproposesformalchangestocurrentgovernancestructures.SuchproposalsmayincludenewregulatoryclassificaKonsystem,newformsofcost-effecKvenessanalysis,theappointmentofindividuals/groupswithparKcularexperKsetoregulatoryagenciesandappraisalbodies.
Companyhasbusinessplan/viableeconomicmodelfordevelopingandproducingnewtechnology.
5 Keyindividuals/groupstaskedwithreadyinginsKtuKons(inwhichtechnologywillbeused/produced,assessed)accordingtoguidelines.
Pioneeringclinician(orclinicalleadsareappointed)and/ormanagertaskedwithbringingtheseresourcestogether.
Individuals/groupswithingovernancestructures(suchasEMA,NICE,MHRA)aretaskedwithbringingaboutrequiredchanges.Theseindividuals/groupsmayengageinpublicconsultaKonaspartoftheir‘readyingacKviKes’.
Keymanager(s)aretaskedwithenacKngbusinessplan.ThismayincludesecuringaddiKonalcapital.
6 NovelinsKtuKonalstructuresexist,inanKcipaKonofexpectedchallenges/affordancespresentedbynoveltechnology.Thesestructuresresultfromretrainingofstaff,construcKonofnewspacesetc
Appropriateclinicalspace/nicheiscreatedforthenoveltechnology,accordingtothespecialistgroupproposal.ThisclinicalspacemaybeparKcularlynovel(suchastheformulaKonofanewmulKdisciplinaryteam,ortheconstrucKonofanewmaterialenvironmenttohousethetechnology),orerelaKvelyminor(retrainingone/severalstaffmembersofexisKngclinicalteam).
Newgovernancearrangementsareformallyestablished.Thismayincludetheestablishmentofnewclassificatorysystemfornoveltechnologiesoranewcommi]eewithspecificexperKse.
Sufficientinvestmentissecuredandbusinessplanisenacted-thisinvolvessecuringappropriatesuppliersofcGMP-compliantsupplies,construcKngmaterialinfrastructurefortechnologyproducKon,hiring&trainingstaff.
7 Noveltechnologyisbeingproduced/used/assessedwithininsKtuKon.TeethingproblemsandunanKcipatedchallenges/affordancesarenoted.
Newtechnologyisdeployedinanactualclinicalserng.Whileworkingwiththetechnology,cliniciansbecomeawareof(inevitable)problems/affordancesrequiringsmall-scale,ad-hocalteraKonstoexisKngstructures/rouKnesetc.
Thegovernancestructuresare‘processing’thenewtechnology:regulatoryagenciesandappraisalbodiesareassessingthenew‘class’oftechnologies.However,keyindividuals/groupshavenotedthatfurtherminoradjustmentsmaybenecessary.Forexample,itmightbenotedthattheclassificatorysystemisunclearandrequiresfurther‘tweaking’.
Noveltechnologyisproducedbythecompany.Furtherad-hocadjustmentsarenecessarybeforeefficientproducKoncanberouKnized.
8 NoveltechnologyisrouKnelyproduced/used/assessedwithininsKtuKon.CurrentinsKtuKonalarrangementsaresufficientforrouKneproducKon/assessment/deployment.
NewtechnologyisrouKnelydeployed.StaffhaveappropriateexperKse,trainingandtacit/embodiedknowledgerequiredtooperaKonalisenewtechnology.
GovernancestructuresrouKnely‘process’thenewclassoftechnology.Whiletheremaybesomeindividualsorgroups(suchasindustry)thatbelievesthecurrentstructuresareinadequate,suchviewpointsdonotcarrysufficientweighttopromptchangewithingovernancestructures.
NoveltechnologyisrouKnelyproducedbythecompany.Companyhasaprovenmanufacturingplasormandaviable,proveneconomicmodel.
(Moreworktobedoneonthis…watchthisspace)
THANKYOU
JohnGardnerSchoolofSocialStudiesMonashUniversityMelbourne,Australia
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