创新药物研发-北京到新泽西的路程有多远课件

创新药物研发—北京到新泽西的路程有多远？

2011年3月23日孟凡强博士，总裁北京翰博瑞强医药科技有限公司H&JCROInternational,Inc.2022/11/221创新药物研发—北京到新泽西的路程有多远？2011年3月23内容提要中国是药品消费大国，但在国际上是创新药品研发小国。知耻近乎勇。我们与美国新泽西的药物研发中心有较大差距，具体表现在以下几个方面：药品研发技术和CRO公司的整体水平低下v.s.十分成熟的研发技术和CRO公司IT技术整体低下，不足以支撑创新药物研发v.s.LinuxVersionControl等IT技术，使得所有研究数据可以溯源临床试验操作不规范，关键证据(TMF)漏洞百出v.s.临床试验各环节认真负责，临床医生自我约束力高，文件管理严谨，数据证据链完整数据管理和统计分析技术低下，专业人才缺乏v.s.专业的、高度职业化的DM和SA研发企业与CRO未形成风险共担的系统，两者是简单的雇佣关系v.s.伙伴关系新药研发法规滞后v.s.对研发的政策法规支持大众对知识产权保护普遍缺乏v.s.对知识产权的尊重研发者急于求成的态度偏差v.s.极力证明“可能不行”我们有学习的目标，努力的方向，国家的大力支持，研发企业的努力，大量“海归”人才，相信在不远的将来，达到世界先进水平！2022/11/222内容提要中国是药品消费大国，但在国际上是创新药品研发小国。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创新药物研发—北京到新泽西的路程有多远？

2011年3月23日孟凡强博士，总裁北京翰博瑞强医药科技有限公司H&JCROInternational,Inc.2022/11/2224创新药物研发—北京到新泽西的路程有多远？2011年3月23内容提要中国是药品消费大国，但在国际上是创新药品研发小国。知耻近乎勇。我们与美国新泽西的药物研发中心有较大差距，具体表现在以下几个方面：药品研发技术和CRO公司的整体水平低下v.s.十分成熟的研发技术和CRO公司IT技术整体低下，不足以支撑创新药物研发v.s.LinuxVersionControl等IT技术，使得所有研究数据可以溯源临床试验操作不规范，关键证据(TMF)漏洞百出v.s.临床试验各环节认真负责，临床医生自我约束力高，文件管理严谨，数据证据链完整数据管理和统计分析技术低下，专业人才缺乏v.s.专业的、高度职业化的DM和SA研发企业与CRO未形成风险共担的系统，两者是简单的雇佣关系v.s.伙伴关系新药研发法规滞后v.s.对研发的政策法规支持大众对知识产权保护普遍缺乏v.s.对知识产权的尊重研发者急于求成的态度偏差v.s.极力证明“可能不行”我们有学习的目标，努力的方向，国家的大力支持，研发企业的努力，大量“海归”人才，相信在不远的将来，达到世界先进水平！2022/11/2225内容提要中国是药品消费大国，但在国际上是创新药品研发小国。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