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TranslationalMedicine

&

PersonalizedMedicine转化医学和个体化医学TranslationalMedicine

&

PerEBPModelsTraditionalpracticeModel(×)Model1:UsethehighestqualityinformationtoguideclinicaldecisionsModel2:Search,evaluate,andmakeavailablespecialtyspecificLevel1informationModel3:CreateoriginalresearchorsystematicreviewsModel4:Translationalresearch……EBPModelsTraditionalpracticeBackgroundInthepast30years，NCI$200BillionsResults：1.56millionarticles80％onmice,fruitflyandroundworm。NochangeoncancerrelatedmortalityrateBackgroundInthepast30yearsBackgroundBackgroundBackgroundNewbiotechnologyGenomics(基因组),Proteomics(蛋白质组)Bioinformatics(生物信息学)IncreasingcomplexityofclinicalresearchBackgroundNewbiotechnologyDefinitionTranslationalresearch,“transformsscientificdiscoveriesarisingfromthelaboratory,clinical,orpopulationstudiesintoclinicalapplications…”Include：benchtobedside(基础研究到临床应用)bedsidetobench(临床治疗结果促进基础研究)Source:NationalCancerInstitute,NationalInstitutesofHealthDefinitionTranslationalresearDefinition

ClinicLabPopulationT1T2T1:applyingbasicsciencefindingsfromlabresearchinclinicalstudiesofpatientsT2:applyingthefindingsofclinicalstudiestoalterhealthpracticesinthecommunityEBMTranaslationalMedicinePersonalizedMedicineDefinitionClinicLabPopulationGoals/PurposeT1:Theproductionofapromisingnewtreatment/methodthatcanbeusedclinicallyorcommercialized.T2:EnsurethatnewtreatmentsandresearchknowledgeactuallyreachthepatientsorpopulationsforwhomtheyareintendedandareimplementedcorrectlyGoals/PurposeT1:T2:ResearchcontentT1:totest,inhumans,thenoveltherapeuticstrategiesdevelopedthroughexperimentation(exvivoorfrom-bench-to-bedside)

T2:totesthowcanefficientlyuseclinicalresultstooptimizehealthpracticesandimproveguidelinesandhealthpolicy(from-bedside-to-population)ResearchcontentT1:T2:Settings/knowledgebackgroundT1:requiresmasteryofmolecularbiology,genetics,andotherbasicsciences;clinicalscientistsworkinginstronglaboratoriesandwithcutting-edgetechnology;asupportiveinfrastructurewithintheinstitution.T2:the“laboratory”forT2researchisthecommunityandambulatorycaresettingsmasteryofthe“implementationscience”offieldingandevaluatinginterventionsinrealworldsettingsmasteryofthedisciplinessuchasclinicalepidemiologyandevidencesynthesis,communicationtheory,behavioralscience,publicpolicy,financing,organizationaltheory,informatics,andmixedmethods/qualitativeresearch.Settings/knowledgebackgroundTChallengesT1:strugglesmorewithbiologicalandtechnologicalmysteries,trialrecruitment,andregulatoryconcernsT2:strugglesmorewithhumanbehaviorandorganizationalinertia,infrastructureandresourceconstraints,andthemessinessofprovingtheeffectivenessof“movingtargets”underconditionsthatinvestigatorscannotfullycontrolChallengesT1:T2:InvestigatorsT1:BasicscientistscooperatewithclinicaldoctorsT2:Population-basedinvestigatorsandepidemiologistsandhealthpolicymakers,etc...MoreeffectivecollaborationbetweenlabscientistsandclinicaldoctorsInvestigatorsT1:T2:MoreeffeTranslationalMedicineDisseminationoftheinnovationAdoptionoftheinnovationMaintainingtheinnovationRefiningandevolvingasbodyofknowledgeexpandsTranslationalMedicineDisseminTheTranslationContinuumBasicScientificDiscoveryEarlyTranslationLateTranslationDisseminationAdoptionPromisinggeneBasicepidemiologicalfindingPartnershipsInterventiondevelopmentPhaseIIItrialsRegulatoryapprovalPartnershipsHealthservicesresearchtosupportdisseminationandadoptionTocommunityprovidersTopatientsandpublicAdoptionofadvancebyproviders,patients,andpublicPaymentmechanismstoenableadoptionSource:NationalCancerInstituteTheTranslationContinuumBasicTranslationalMedicineTranslatethesuccessingenomicmedicineintoclinicalapplicationsEvidence-basedmedicinedeveloprationaleandtheoryfordrugdesignandtherapeuticinterventionDeveloppersonalmedicineandpreventivemedicineTranslationalMedicineTranslatTranslationalMedicineTranslationalResearch-hotspotGenomicandgenediagnosisandtreatment基因组研究及基因诊断治疗PhaseItrialfordrugs药物一期临床试验GenomicPharmocologyandpersonalizedmedicine基因组药理学与个体化医学Biomarks生物标记物Signaltransductingpathwayandclinicalapplications信号传导通路的研究及其临床应用Stemcell干细胞TranslationalMedicineTranslatTranslationalMedicineTheheartoftranslationalresearchresidesinPhaseItrialswherenoveltreatmentsare：testedforfeasibilityandtoxicitypreparationforaPhaseIItrialinwhichtherapeuticeffectivenessistestedMarincola,FMTranslationalMedicine:Atwo-wayroad,JTM,2006TranslationalMedicineThehearClinicalResearchTrainingProgramComputerSkillsClinicalResearchMethodsBiostatistics:StatisticalApproachinClinicalResearchMeasurementsinClinicalResearchEthicsandRegulationsofClinicalResearchResearchDesignandDevelopmentCost-effectivenessAnalysisRegressionandANOVALogisticRegressionClinicalTrialsClinicalResearchTrainingProTheprocessofTranslationChoosearesearchtopicrelatedtoyourclinicalpracticeTheprocessofTranslationChooEarlystudyonnitricoxideSynthaseEarlystudyonnitricoxideSyUsesforaclonedgeneHomologycomparisonQuantitategeneexpressionChromosomalmappingDeterminetranscriptionalregulationPreparerecombinantproteinAntibodydevelopmentTissuelocalizationDeveloptransgenic/knockoutanimalsGenetransfer/genetherapystudiesIntellectualproperty/technologytransferUsesforaclonedgeneHomology转化医学和个体化医学课件ExploreGeneandDiseasesExploreGeneandDiseases转化医学和个体化医学课件PhysiopathologicalStudyBench:VasoprotectivePropertiesofNitricOxideInhibitsplateletaggregationInhibitsleukocytechemotaxisInhibitsVSMCproliferationInhibitsVSMCmigrationPromotesECgrowthInhibitsECapoptosisPotentvasodilatorPhysiopathologicalStudyBench:CellandAnimalAdenoviralVector(type5,E1-,E3-)腺病毒载体CellandAnimalAdenoviralVectSmallAnimalsSmallAnimalsBiggerAnimalsBiggerAnimalsAnimalExperiment2005年AnimalExperiment2005年转化医学和个体化医学课件PhaseⅠClinicalTrialClinicalTrial:AdiNOSgenetherapytoblockAVfistulaneointimalhyperplasiainhemodialysispatients2006PhaseⅠClinicalTrialClinicalTCurrentStateofTranslationalMedicine17yearinnovationadoptioncurvefromdiscoveryintoacceptedstandardsofpracticeEvenifastandardisaccepted,patientshavea50:50chanceofreceivingappropriatecare,a5-10%probabilityofincurringapreventable,anticipatableadverseeventThemarketisbalkingathealthcareinflation,newdiagnosticsandtherapeuticswillfindincreasingresistanceforreimbursementCurrentStateofTranslationalPersonalizedMedicine

ClinicLabPopulationT1T2T1:applyingbasicsciencefindingsfromlabresearchinclinicalstudiesofpatientsT2:applyingthefindingsofclinicalstudiestoalterhealthpracticesinthecommunityEBMTranaslationalMedicinePersonalizedMedicinePersonalizedMedicineClinicLaPersonalizedmedicinetheapplicationofgenomicandmoleculardatatobettertargetthedeliveryofhealthcare,facilitatethediscoveryandclinicaltestingofnewproducts,andhelpdetermineaperson'spredispositiontoaparticulardiseaseorconditionapatient'sprotein,geneormetaboliteprofilecouldbeusedtotailormedicalcaretothatindividual'sneedsPersonalizedmedicinetheapplImatinibforGISTGIST

genesisKeyprocess：c-kitmutation---KITTKactivationPDGFRmutation86%

GIST

kitmutation，prognosisfactorImatinibOralsmallmoleculeTKIInhibitTKactivation抑制酪氨酸激酶活化Designforchronicmyeloidleukemia(CML)ImatinibforGISTGISTgenesisImatinibforGISTImatinibforGISTImatinibforGISTJoensuuH，etal.2001ImatinibforGISTJoensuuH，etPretreatmentOnemonthoftherapyH&E(atdiagnosis)H&EKi67CD117JoensuuHetal.NEnglJMed.2001;344:1052-1056.TheFirstGISTPatient:HistologyImatinibforGISTPretreatmentOnemonthH&E(atImatinibforGISTJoensuuH，etal.2001Theory：ImatinibcouldtargetGISTEasyDetectedtumormarker：CD117TissuefromthepatientResponseconfirmedbypathologyDynamicmonitoredbytumormarkerEthics：IRBImatinibforGISTJoensuuH，etImatinib治疗GIST2000.3：JoensuuH.firstcase2000.7：

phaseIIstudy(B2222)

2001autumn：phaseIIstudy(S0033,EORTC)2002.2：FDAImatinib治疗GIST2000.3：Joensu转化医学和个体化医学课件ImatinibforGIST5-yearsurvivalKit

mutationpredictImatinibresponseImatinibforGIST5-yearsurvivImatinibforGISTImatinibforGISTImatinibforGISTImatinib

resistanceclinic→labOvercomeImatinib

resistance

lab→

clinicMechanismofImatinib

resistance

clinic→labImatinibforGISTImatinibresiImatinibforGISTSurgeryinadvanceGISTWhentostop?ImatinibforGISTSurgeryinadChoi’sImatinibforGISTChoietal,JClinOncology,2007;25:1753-1759Choi’sImatinibforGISTChoieImatinibforGISTC-kitactivationnormallyassociatedwithKITmutationsC-kitactivationsometimeswithoutKITmutationsSomec-kitnegativetumorshaveKITmutationsSomec-kitnegativeGISTshaveactivatingmutationsinadifferentTK(tyrosinekinase),PDGFRa……ImatinibforGISTC-kitactivatSummaryClinicalexpertiseisimportantEBM:improveclinicalpracticeandresearchTranslationalMedicine&PersonalizedMedicine:newtrendIntegrationofEBMandTranslationalMedicineSummaryClinicalexpertiseisiTranslationalMedicine

&

PersonalizedMedicine转化医学和个体化医学TranslationalMedicine

&

PerEBPModelsTraditionalpracticeModel(×)Model1:UsethehighestqualityinformationtoguideclinicaldecisionsModel2:Search,evaluate,andmakeavailablespecialtyspecificLevel1informationModel3:CreateoriginalresearchorsystematicreviewsModel4:Translationalresearch……EBPModelsTraditionalpracticeBackgroundInthepast30years，NCI$200BillionsResults：1.56millionarticles80％onmice,fruitflyandroundworm。NochangeoncancerrelatedmortalityrateBackgroundInthepast30yearsBackgroundBackgroundBackgroundNewbiotechnologyGenomics(基因组),Proteomics(蛋白质组)Bioinformatics(生物信息学)IncreasingcomplexityofclinicalresearchBackgroundNewbiotechnologyDefinitionTranslationalresearch,“transformsscientificdiscoveriesarisingfromthelaboratory,clinical,orpopulationstudiesintoclinicalapplications…”Include：benchtobedside(基础研究到临床应用)bedsidetobench(临床治疗结果促进基础研究)Source:NationalCancerInstitute,NationalInstitutesofHealthDefinitionTranslationalresearDefinition

ClinicLabPopulationT1T2T1:applyingbasicsciencefindingsfromlabresearchinclinicalstudiesofpatientsT2:applyingthefindingsofclinicalstudiestoalterhealthpracticesinthecommunityEBMTranaslationalMedicinePersonalizedMedicineDefinitionClinicLabPopulationGoals/PurposeT1:Theproductionofapromisingnewtreatment/methodthatcanbeusedclinicallyorcommercialized.T2:EnsurethatnewtreatmentsandresearchknowledgeactuallyreachthepatientsorpopulationsforwhomtheyareintendedandareimplementedcorrectlyGoals/PurposeT1:T2:ResearchcontentT1:totest,inhumans,thenoveltherapeuticstrategiesdevelopedthroughexperimentation(exvivoorfrom-bench-to-bedside)

T2:totesthowcanefficientlyuseclinicalresultstooptimizehealthpracticesandimproveguidelinesandhealthpolicy(from-bedside-to-population)ResearchcontentT1:T2:Settings/knowledgebackgroundT1:requiresmasteryofmolecularbiology,genetics,andotherbasicsciences;clinicalscientistsworkinginstronglaboratoriesandwithcutting-edgetechnology;asupportiveinfrastructurewithintheinstitution.T2:the“laboratory”forT2researchisthecommunityandambulatorycaresettingsmasteryofthe“implementationscience”offieldingandevaluatinginterventionsinrealworldsettingsmasteryofthedisciplinessuchasclinicalepidemiologyandevidencesynthesis,communicationtheory,behavioralscience,publicpolicy,financing,organizationaltheory,informatics,andmixedmethods/qualitativeresearch.Settings/knowledgebackgroundTChallengesT1:strugglesmorewithbiologicalandtechnologicalmysteries,trialrecruitment,andregulatoryconcernsT2:strugglesmorewithhumanbehaviorandorganizationalinertia,infrastructureandresourceconstraints,andthemessinessofprovingtheeffectivenessof“movingtargets”underconditionsthatinvestigatorscannotfullycontrolChallengesT1:T2:InvestigatorsT1:BasicscientistscooperatewithclinicaldoctorsT2:Population-basedinvestigatorsandepidemiologistsandhealthpolicymakers,etc...MoreeffectivecollaborationbetweenlabscientistsandclinicaldoctorsInvestigatorsT1:T2:MoreeffeTranslationalMedicineDisseminationoftheinnovationAdoptionoftheinnovationMaintainingtheinnovationRefiningandevolvingasbodyofknowledgeexpandsTranslationalMedicineDisseminTheTranslationContinuumBasicScientificDiscoveryEarlyTranslationLateTranslationDisseminationAdoptionPromisinggeneBasicepidemiologicalfindingPartnershipsInterventiondevelopmentPhaseIIItrialsRegulatoryapprovalPartnershipsHealthservicesresearchtosupportdisseminationandadoptionTocommunityprovidersTopatientsandpublicAdoptionofadvancebyproviders,patients,andpublicPaymentmechanismstoenableadoptionSource:NationalCancerInstituteTheTranslationContinuumBasicTranslationalMedicineTranslatethesuccessingenomicmedicineintoclinicalapplicationsEvidence-basedmedicinedeveloprationaleandtheoryfordrugdesignandtherapeuticinterventionDeveloppersonalmedicineandpreventivemedicineTranslationalMedicineTranslatTranslationalMedicineTranslationalResearch-hotspotGenomicandgenediagnosisandtreatment基因组研究及基因诊断治疗PhaseItrialfordrugs药物一期临床试验GenomicPharmocologyandpersonalizedmedicine基因组药理学与个体化医学Biomarks生物标记物Signaltransductingpathwayandclinicalapplications信号传导通路的研究及其临床应用Stemcell干细胞TranslationalMedicineTranslatTranslationalMedicineTheheartoftranslationalresearchresidesinPhaseItrialswherenoveltreatmentsare：testedforfeasibilityandtoxicitypreparationforaPhaseIItrialinwhichtherapeuticeffectivenessistestedMarincola,FMTranslationalMedicine:Atwo-wayroad,JTM,2006TranslationalMedicineThehearClinicalResearchTrainingProgramComputerSkillsClinicalResearchMethodsBiostatistics:StatisticalApproachinClinicalResearchMeasurementsinClinicalResearchEthicsandRegulationsofClinicalResearchResearchDesignandDevelopmentCost-effectivenessAnalysisRegressionandANOVALogisticRegressionClinicalTrialsClinicalResearchTrainingProTheprocessofTranslationChoosearesearchtopicrelatedtoyourclinicalpracticeTheprocessofTranslationChooEarlystudyonnitricoxideSynthaseEarlystudyonnitricoxideSyUsesforaclonedgeneHomologycomparisonQuantitategeneexpressionChromosomalmappingDeterminetranscriptionalregulationPreparerecombinantproteinAntibodydevelopmentTissuelocalizationDeveloptransgenic/knockoutanimalsGenetransfer/genetherapystudiesIntellectualproperty/technologytransferUsesforaclonedgeneHomology转化医学和个体化医学课件ExploreGeneandDiseasesExploreGeneandDiseases转化医学和个体化医学课件PhysiopathologicalStudyBench:VasoprotectivePropertiesofNitricOxideInhibitsplateletaggregationInhibitsleukocytechemotaxisInhibitsVSMCproliferationInhibitsVSMCmigrationPromotesECgrowthInhibitsECapoptosisPotentvasodilatorPhysiopathologicalStudyBench:CellandAnimalAdenoviralVector(type5,E1-,E3-)腺病毒载体CellandAnimalAdenoviralVectSmallAnimalsSmallAnimalsBiggerAnimalsBiggerAnimalsAnimalExperiment2005年AnimalExperiment2005年转化医学和个体化医学课件PhaseⅠClinicalTrialClinicalTrial:AdiNOSgenetherapytoblockAVfistulaneointimalhyperplasiainhemodialysispatients2006PhaseⅠClinicalTrialClinicalTCurrentStateofTranslationalMedicine17yearinnovationadoptioncurvefromdiscoveryintoacceptedstandardsofpracticeEvenifastandardisaccepted,patientshavea50:50chanceofreceivingappropriatecare,a5-10%probabilityofincurringapreventable,anticipatableadverseeventThemarketisbalkingathealthcareinflation,newdiagnosticsandtherapeuticswillfindincreasingresistanceforreimbursementCurrentStateofTranslationalPersonalizedMedicine

ClinicLabPopulationT1T2T1:applyingbasicsciencefindingsfromlabresearchinclinicalstudiesofpatientsT2:applyingthefindingsofclinicalstudiestoalterhealthpracticesinthecommunityEBMTranaslationalMedicinePersonalizedMedicinePersonalizedMedicineClinicLaPersonalizedmedicinetheapplicationofgenomicandmoleculardatatobettertargetthedeliveryofhealthcare,facilitatethediscoveryandclinicaltestingofnewproducts,andhelpdetermineaperson'spredispositiontoaparticulardiseaseorconditionapatient'sprotein,geneormetaboliteprofilecouldbeusedtotailormedicalcaretothatindividual'sneedsPersonalizedmedicinetheapplImatinibforGISTGIST

genesisKeyprocess：c-kitmutation---KITTKactivationPDGFRmutation8

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