創(chuàng)新藥物研發(fā)-北京到新澤西的路程有多遠(yuǎn)課件

創(chuàng)新藥物研發(fā)—北京到新澤西的路程有多遠(yuǎn)？

2011年3月23日孟凡強(qiáng)博士，總裁北京翰博瑞強(qiáng)醫(yī)藥科技有限公司H&JCROInternational,Inc.2022/11/221創(chuàng)新藥物研發(fā)—北京到新澤西的路程有多遠(yuǎn)？2011年3月23內(nèi)容提要中國(guó)是藥品消費(fèi)大國(guó)，但在國(guó)際上是創(chuàng)新藥品研發(fā)小國(guó)。知恥近乎勇。我們與美國(guó)新澤西的藥物研發(fā)中心有較大差距，具體表現(xiàn)在以下幾個(gè)方面：藥品研發(fā)技術(shù)和CRO公司的整體水平低下v.s.十分成熟的研發(fā)技術(shù)和CRO公司IT技術(shù)整體低下，不足以支撐創(chuàng)新藥物研發(fā)v.s.LinuxVersionControl等IT技術(shù)，使得所有研究數(shù)據(jù)可以溯源臨床試驗(yàn)操作不規(guī)范，關(guān)鍵證據(jù)(TMF)漏洞百出v.s.臨床試驗(yàn)各環(huán)節(jié)認(rèn)真負(fù)責(zé)，臨床醫(yī)生自我約束力高，文件管理嚴(yán)謹(jǐn)，數(shù)據(jù)證據(jù)鏈完整數(shù)據(jù)管理和統(tǒng)計(jì)分析技術(shù)低下，專業(yè)人才缺乏v.s.專業(yè)的、高度職業(yè)化的DM和SA研發(fā)企業(yè)與CRO未形成風(fēng)險(xiǎn)共擔(dān)的系統(tǒng)，兩者是簡(jiǎn)單的雇傭關(guān)系v.s.伙伴關(guān)系新藥研發(fā)法規(guī)滯后v.s.對(duì)研發(fā)的政策法規(guī)支持大眾對(duì)知識(shí)產(chǎn)權(quán)保護(hù)普遍缺乏v.s.對(duì)知識(shí)產(chǎn)權(quán)的尊重研發(fā)者急于求成的態(tài)度偏差v.s.極力證明“可能不行”我們有學(xué)習(xí)的目標(biāo)，努力的方向，國(guó)家的大力支持，研發(fā)企業(yè)的努力，大量“海歸”人才，相信在不遠(yuǎn)的將來，達(dá)到世界先進(jìn)水平！2022/11/222內(nèi)容提要中國(guó)是藥品消費(fèi)大國(guó)，但在國(guó)際上是創(chuàng)新藥品研發(fā)小國(guó)。2China:NewSiliconValleyofR&D?Pharmaceuticalsales:2010+27%,2011+24%(938.8BillionRMB)OTC2009,WorldNumber2,2ndtoUSAR&DInvestmentChinainvested6BillionRMB2009R&DChinainvested7BillionShandong:1.2BillionR&DPlatformChengdu:Bio-valleyWuxi:HuishanLife-parkTianjin:……2022/11/223China:NewSiliconValleyofR3OurR&DAchievementThousandsof“MimicDrug”not“Generic”Socalled“NewDrug”,actuallynotGenericsapplymarketinginUS,thegameplayedbyIndiacompanyformorethan10yearsNDAwithinternationalpatent=02022/11/224OurR&DAchievementThousandso4HowfarfromBJtoNJ2022/11/225HowfarfromBJtoNJ2022/11/25HowfarfromBJtoNJR&DTechnology&CROProfessionalLevelInformationTechnologyClinicalTrialOperation(TMF)DataManagementandStatisticsMutualsupportbetweenSponsorandCROR&DPolicy&RegulationsPublicConsciousofIPprotectionR&DConception2022/11/226HowfarfromBJtoNJR&DTechn6InformationTechnologyItemsChinaUSAServerOperatingSystemWindowsUnixorLinuxOperationPlatformLocalcomputersCentralServerServerManagementMostcompaniesdelegatetheirserverstoprofessionalITcompanyformanagementHaveanindependentdepartmentforITserviceandservermanagementNetworkSpeed2Mbps15MbpsDataBackupBackupdatainITvendororbackupdatainlocaldiskMostcompaniesuseRAIDITSpecialistcollocation1~3ITspecialist(s)inacompanyUsuallyevery10employeeshave2ITspecialists2022/11/227InformationTechnologyItemsChi7ITInfrastructureFirstDomesticCROwithqualifiedITsupport

5ITstaff(1EDC,1DM,1Web/Mail,2Security)DisasterBackupinNJDM/SASonserverVersioncontrolVPNremotedesktopLinuxOperationSystem2022/11/228ITInfrastructureFirstDomesti8ClinicalTrialOperationSponsorItemsChinaUSAVendorSelectionPrefercheapervendorsPrefervendorswithgoodhistoryoncooperationandqualityBudget<$500,000commonlyDifferentbudgetondifferenttrialphaseInvestigationalProductFocusonGenericDrugsandListingDrugsNewDrugs,alsohaveListingDrugsTrialsTypeMostofPhaseIVtrialsorPost-marketingstudiesMostofPhaseItoIIIforRegistrationExpectationonResultHaveagoodresultontrialobjectsResultpresentedontruedata2022/11/229ClinicalTrialOperationSponso9CompareonClinicalTrialOperation2InvestigatorItemsChinaUSASiteScaleHospitalsinMedicalCenterLevelPrivateclinicsorRegionalHospitalsAttitudeforTrialsMostofInvestigatorsdon’tcaretheirtrialsPaymoreattentiontothetrialshe/sheparticipatesPerformanceonTrialsProtocolorSOPsDeviations/ViolationsappearcommonlyGoodcompliancewithProtocolandSOPsCooperationwithCRAHaveanarrogantattitudetoCRAsTakeagoodcooperationwithCRACorrespondencesbetweenInvestigatorsandCRAsAfewofInvestigatorsanswertheEmails/FaxfromCRAMostofInvestigatorsanswertheEmails/FaxfromCRAifCRArequires2022/11/2210CompareonClinicalTrialOper10CompareonClinicalTrialOperation3ContractResearchOrganization(CRO)1ItemsChinaUSACROScale10~100employeecommonly50~1000employeeDescriptionProvideafullservicesontrialDividethetrialfordifferentstepsandprovidesaveryprofessionalserviceononestepamongthose,e.g.justforDataManagementCRAQualificationMostofCRAsaretrainedbyGCPandSOPsbuthavelittleexperienceonmonitoringWell-trainedandalsohaveabundantexperience2022/11/2211CompareonClinicalTrialOper11CompareonClinicalTrialOperation4ContractResearchOrganization(CRO)2ItemsChinaUSASOPSystemHaveSOPframeworkandhaveSOPsoncriticaltrialstepsHaveverydetailedandsystemicSOPsoneverystepsonthetrialsSOPOperationCanfollowSOPsbutSOPDeviations/ViolationsappearusuallyFollowSOPsstrictlyandeverySOPDeviations/ViolationscanberecordcarefullyTrialDataQualityMostofdataonCRFscanbeSDVedbyCRAs,buttherealsohavesomefraudontrialsCROandInvestigatorstakeanhonestperformanceontrials,andalsocollectdatabyprotocol/SOPsrequires2022/11/2212CompareonClinicalTrialOper12CompareonClinicalTrialOperation5ContractResearchOrganization(CRO)3ItemsChinaUSASubjectsProtectiononTrailsTakeinformedconsentactionandgetsignedICF.AfewoftrialscanprovideindemnificationTakeinformedconsentactionstrictlyandgetsignedICF.Mostoftrialscanprovideindemnification2022/11/2213CompareonClinicalTrialOper13CompareonDataManagementandStatistics1DataManagement1ItemsChinaUSADataManagementSOPsAfewcompanieshaveSOPsonthissection,alsowithpoorcomplianceHaveprofessionalcompaniesinthissectionandthosecompanieshavesystemicSOPsDatabaseFormatoneOBSisinoneline.AndwithoutuniformformatforsubmissiontoSFDARawDataissavedasSDTM-Like.AndshouldbesubmittedtoFDAbySDTMformatStandardforDatabaseDesignandCRFDesignNoCDASH2022/11/2214CompareonDataManagementand14CompareonDataManagementandStatistics2DataManagement2ItemsChinaUSAElectronicDataStorageLocalcomputersDatacanbestoredinCentralServersandhavemorethantwobackupserversindifferentareasDataTransmittalByEmailorflashdiskByCentralServerDocument(Paperversion)StorageStoredincabinetwithlockHaveanindividualroomtostoredocumentandtheroommusthavefunctiononfire-proofandsoon2022/11/2215CompareonDataManagementand15CompareonDataManagementandStatistics3Statistics1ItemsChinaUSADataFormatWithoutuniformformatCDisc(SDTM/ADAM)ProgrammingQCProgressNoIndependentdoubleprogramming(IDP)AnalysisProcessGetresultdirectlyFirstgiveanAnalysisDatasetandthangettheTFLDocumentsNorecordAllrecordforwholeprogressReportGenerationCopyandpasteresultsintoreportGenerateTFLdirectlyfromSASprogramintoawordfile2022/11/2216CompareonDataManagementand16HowfarfromBJtoNJR&DTechnology&CROProfessionalLevelInformationTechnologyClinicalTrialOperation(TMF)DataManagementandStatisticsMutualsupportbetweenSponsorandCROR&DPolicy&RegulationsPublicConsciousofIPprotectionR&DConception2022/11/2217HowfarfromBJtoNJR&DTechn17DifferenceonRegulationsandLawsChinaUSADrugAdministrationLawofthePeople'sRepublicofChinaCodeofFederalRegulations（CFR）Title21―FoodandDrugsRegulationsfortheImplementationofDrugAdministrationLawofthePRCChineseGoodClinicalPracticeICH-GCPComparingtoChineseGCP,USregulationsgivemoredetailedandmorehumanizedguidanceontrialperformance.Insomespecialsituations,theChinesegovernmentwouldinterveneintheprogressofnewdrugclinicaltrials2022/11/2218DifferenceonRegulationsand18HowfarfromBJtoNJR&DTechnology&CROProfessionalLevelInformationTechnologyClinicalTrialOperation(TMF)DataManagementandStatisticsMutualsupportbetweenSponsorandCROR&DPolicy&RegulationsPublicConsciousofIPprotectionR&DConception2022/11/2219HowfarfromBJtoNJR&DTechn19HowfarfromBJtoNJR&DTechnology&CROProfessionalLevelInformationTechnologyClinicalTrialOperation(TMF)DataManagementandStatisticsMutualsupportbetweenSponsorandCROR&DPolicy&RegulationsPublicConsciousofIPprotectionR&DConception2022/11/2220HowfarfromBJtoNJR&DTechn20GaponConceptionItemsChinaUSAConceptionofSponsorMeansformarketingorpromotion,justafewforresearchMostoftrialsareheldonpurposeofresearchConceptionofInvestigatorBurdenofleadersdelegatedormeanstoincreaserevenueAlsoawaytoincreaserevenuebutit’savoluntarychoiceConceptionofCROVulnerablegroupsintrials,havelowerstatusthanSponsorsandInvestigators.HaveharshcompetitionintheindustrywithlowprofitEqualstatuswithSponsorsandInvestigators.AlsohavemorechoicetoselectInvestigatorstofinishthetrial2022/11/2221GaponConceptionItemsChinaUSA21HowfarfromBeijingtoNewJersey?

2022/11/2222HowfarfromBeijingtoNewJe22Thankyouforyouattention2022/11/2223Thankyouforyouattention20223創(chuàng)新藥物研發(fā)—北京到新澤西的路程有多遠(yuǎn)？

2011年3月23日孟凡強(qiáng)博士，總裁北京翰博瑞強(qiáng)醫(yī)藥科技有限公司H&JCROInternational,Inc.2022/11/2224創(chuàng)新藥物研發(fā)—北京到新澤西的路程有多遠(yuǎn)？2011年3月23內(nèi)容提要中國(guó)是藥品消費(fèi)大國(guó)，但在國(guó)際上是創(chuàng)新藥品研發(fā)小國(guó)。知恥近乎勇。我們與美國(guó)新澤西的藥物研發(fā)中心有較大差距，具體表現(xiàn)在以下幾個(gè)方面：藥品研發(fā)技術(shù)和CRO公司的整體水平低下v.s.十分成熟的研發(fā)技術(shù)和CRO公司IT技術(shù)整體低下，不足以支撐創(chuàng)新藥物研發(fā)v.s.LinuxVersionControl等IT技術(shù)，使得所有研究數(shù)據(jù)可以溯源臨床試驗(yàn)操作不規(guī)范，關(guān)鍵證據(jù)(TMF)漏洞百出v.s.臨床試驗(yàn)各環(huán)節(jié)認(rèn)真負(fù)責(zé)，臨床醫(yī)生自我約束力高，文件管理嚴(yán)謹(jǐn)，數(shù)據(jù)證據(jù)鏈完整數(shù)據(jù)管理和統(tǒng)計(jì)分析技術(shù)低下，專業(yè)人才缺乏v.s.專業(yè)的、高度職業(yè)化的DM和SA研發(fā)企業(yè)與CRO未形成風(fēng)險(xiǎn)共擔(dān)的系統(tǒng)，兩者是簡(jiǎn)單的雇傭關(guān)系v.s.伙伴關(guān)系新藥研發(fā)法規(guī)滯后v.s.對(duì)研發(fā)的政策法規(guī)支持大眾對(duì)知識(shí)產(chǎn)權(quán)保護(hù)普遍缺乏v.s.對(duì)知識(shí)產(chǎn)權(quán)的尊重研發(fā)者急于求成的態(tài)度偏差v.s.極力證明“可能不行”我們有學(xué)習(xí)的目標(biāo)，努力的方向，國(guó)家的大力支持，研發(fā)企業(yè)的努力，大量“海歸”人才，相信在不遠(yuǎn)的將來，達(dá)到世界先進(jìn)水平！2022/11/2225內(nèi)容提要中國(guó)是藥品消費(fèi)大國(guó)，但在國(guó)際上是創(chuàng)新藥品研發(fā)小國(guó)。2China:NewSiliconValleyofR&D?Pharmaceuticalsales:2010+27%,2011+24%(938.8BillionRMB)OTC2009,WorldNumber2,2ndtoUSAR&DInvestmentChinainvested6BillionRMB2009R&DChinainvested7BillionShandong:1.2BillionR&DPlatformChengdu:Bio-valleyWuxi:HuishanLife-parkTianjin:……2022/11/2226China:NewSiliconValleyofR26OurR&DAchievementThousandsof“MimicDrug”not“Generic”Socalled“NewDrug”,actuallynotGenericsapplymarketinginUS,thegameplayedbyIndiacompanyformorethan10yearsNDAwithinternationalpatent=02022/11/2227OurR&DAchievementThousandso27HowfarfromBJtoNJ2022/11/2228HowfarfromBJtoNJ2022/11/228HowfarfromBJtoNJR&DTechnology&CROProfessionalLevelInformationTechnologyClinicalTrialOperation(TMF)DataManagementandStatisticsMutualsupportbetweenSponsorandCROR&DPolicy&RegulationsPublicConsciousofIPprotectionR&DConception2022/11/2229HowfarfromBJtoNJR&DTechn29InformationTechnologyItemsChinaUSAServerOperatingSystemWindowsUnixorLinuxOperationPlatformLocalcomputersCentralServerServerManagementMostcompaniesdelegatetheirserverstoprofessionalITcompanyformanagementHaveanindependentdepartmentforITserviceandservermanagementNetworkSpeed2Mbps15MbpsDataBackupBackupdatainITvendororbackupdatainlocaldiskMostcompaniesuseRAIDITSpecialistcollocation1~3ITspecialist(s)inacompanyUsuallyevery10employeeshave2ITspecialists2022/11/2230InformationTechnologyItemsChi30ITInfrastructureFirstDomesticCROwithqualifiedITsupport

5ITstaff(1EDC,1DM,1Web/Mail,2Security)DisasterBackupinNJDM/SASonserverVersioncontrolVPNremotedesktopLinuxOperationSystem2022/11/2231ITInfrastructureFirstDomesti31ClinicalTrialOperationSponsorItemsChinaUSAVendorSelectionPrefercheapervendorsPrefervendorswithgoodhistoryoncooperationandqualityBudget<$500,000commonlyDifferentbudgetondifferenttrialphaseInvestigationalProductFocusonGenericDrugsandListingDrugsNewDrugs,alsohaveListingDrugsTrialsTypeMostofPhaseIVtrialsorPost-marketingstudiesMostofPhaseItoIIIforRegistrationExpectationonResultHaveagoodresultontrialobjectsResultpresentedontruedata2022/11/2232ClinicalTrialOperationSponso32CompareonClinicalTrialOperation2InvestigatorItemsChinaUSASiteScaleHospitalsinMedicalCenterLevelPrivateclinicsorRegionalHospitalsAttitudeforTrialsMostofInvestigatorsdon’tcaretheirtrialsPaymoreattentiontothetrialshe/sheparticipatesPerformanceonTrialsProtocolorSOPsDeviations/ViolationsappearcommonlyGoodcompliancewithProtocolandSOPsCooperationwithCRAHaveanarrogantattitudetoCRAsTakeagoodcooperationwithCRACorrespondencesbetweenInvestigatorsandCRAsAfewofInvestigatorsanswertheEmails/FaxfromCRAMostofInvestigatorsanswertheEmails/FaxfromCRAifCRArequires2022/11/2233CompareonClinicalTrialOper33CompareonClinicalTrialOperation3ContractResearchOrganization(CRO)1ItemsChinaUSACROScale10~100employeecommonly50~1000employeeDescriptionProvideafullservicesontrialDividethetrialfordifferentstepsandprovidesaveryprofessionalserviceononestepamongthose,e.g.justforDataManagementCRAQualificationMostofCRAsaretrainedbyGCPandSOPsbuthavelittleexperienceonmonitoringWell-trainedandalsohaveabundantexperience2022/11/2234CompareonClinicalTrialOper34CompareonClinicalTrialOperation4ContractResearchOrganization(CRO)2ItemsChinaUSASOPSystemHaveSOPframeworkandhaveSOPsoncriticaltrialstepsHaveverydetailedandsystemicSOPsoneverystepsonthetrialsSOPOperationCanfollowSOPsbutSOPDeviations/ViolationsappearusuallyFollowSOPsstrictlyandeverySOPDeviations/ViolationscanberecordcarefullyTrialDataQualityMostofdataonCRFscanbeSDVedbyCRAs,buttherealsohavesomefraudontrialsCROandInvestigatorstakeanhonestperformanceontrials,andalsocollectdatabyprotocol/SOPsrequires2022/11/2235CompareonClinicalTrialOper35CompareonClinicalTrialOperation5ContractResearchOrganization(CRO)3ItemsChinaUSASubjectsProtectiononTrailsTakeinformedconsentactionandgetsignedICF.AfewoftrialscanprovideindemnificationTakeinformedconsentactionstrictlyandgetsignedICF.Mostoftrialscanprovideindemnification2022/11/2236CompareonClinicalTrialOper36CompareonDataManagementandStatistics1DataManagement1ItemsChinaUSADataManagementSOPsAfewcompanieshaveSOPsonthissection,alsowithpoorcomplianceHaveprofessionalcompaniesinthissectionandthosecompanieshavesystemicSOPsDatabaseFormatoneOBSisinoneline.AndwithoutuniformformatforsubmissiontoSFDARawDataissavedasSDTM-Like.AndshouldbesubmittedtoFDAbySDTMformatStandardforDatabaseDesignandCRFDesignNoCDASH2022/11/2237CompareonDataManagementand37CompareonDataManagementandStatistics2DataManagement2ItemsChinaUSAElectronicDataStorageLocalcomputersDatacanbestoredinCentralServersandhavemorethantwobackupserversindifferentareasDataTransmittalByEmailorflashdiskByCentralServerDocument(Paperversion)StorageStoredincabinetwithlockHaveanindividualroomtostoredocumentandtheroommusthavefunctiononfire-proofandsoon2022/11/2238CompareonDataManagementand38CompareonDataManagementandStatistics3Statistics1ItemsChinaUSADataFormatWithoutuniformformatCDisc(SDTM/ADAM)ProgrammingQCProgressNoIndependentdoubleprogramming(IDP)AnalysisProcessGetresultdirectlyFirstgiveanAnalysisDatasetandthangettheTFLDocumentsNorecordAllrecordforwholeprogressReportGenerationCopyandpasteresultsintoreportGenerateTFLdirectlyfromSASprogramintoawordfile2022/11/2239CompareonDataManagementand39HowfarfromBJtoNJR&DTechnology&CROProfessionalLevelInformationTechnologyClinicalTrialOperation(TMF)DataManagementandStatisticsMutualsupportbetweenSponsorandCROR&DPolicy&RegulationsPublicConsciousofIPprotectionR&DConception2022/11/2240HowfarfromBJtoNJR&DTechn40DifferenceonRegulationsandLawsChinaUSADrugAdministrationLawofthePeople'sRepublicofChinaCodeofFederalRegulations（CFR