trens in medicinal plant research

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1、TRENSINMEDICINALPLANTRESEARCH工研院生醫所報告人李連滋中華民國九十六年十二月二十六日CostandTimeperDrugtoMarketIdeaMarket10-15YearsClinicalPost-MarketingPhaseIPhaseIIPhaseIIIPre-ClinicalExploratoryLeadOptimizationDevelopmentCandidatePre-clinical&PhaseIDevelopmentDemonstrateSafetyandEfficacyinPatientsPhasell&lll

2、ClinicalTrialDrugDiscovery&DevelopmentProcessDiscoveryPreclinicalTestingPhaseIPhaseIIPhaseIIINDA&ApprovalPost-Marketing(Efficacy,Safety,DMPK,Tox)(20-80volunteersforsafetyanddosage)(100-300patientforefficacyandsideeffects)(1,000-5,000patientforadversereactionsandefficacy)(Additionalt

3、estingforotherindicationsand/orlong-termsafetymonitoring)10-15Years(~$800M)SuccessRate>10,000Screened200enterpreclinicaltest3-5enterclinicaltest1approvedbyFDA60%60%*inlatestage*survivalrate50%80%90%(HTS,Selectivity,Potency)FromDrugDiscoverytoMarketPhRMA,1998Toxicity17%AdverseEffe

4、cts16%Commercial7%Efficacy46%Miscellaneous7%Pharmacokinetics17%CausesofNewDrugFailureTargetIdentificationValidationLeadOptimizationLeadPrioritizationPreclinicalDevelopmentClinicalDevelopmentPostApprovalALINEARPROCESSDiscoveryTechnologies/DevelopmentServicesPartnershipsandCollaborati

5、onsNEWDRUGDISCOVERY&DEVELOPMENTPORCESSB:生技藥物N:天然物成分.ND天然物成分衍生物:S:純合成化合物.S*:由天然物成分發展之合成化合物.資料來源：TRENDSINMEDICINALPLANTRESEARCH:SCREENING,BIOTECHNOLOGYANDRATIONALPHYTOTHERAPY處方藥之來源Materiamedicaextraction&separationbiologicalactivityPreclinicalClinicaltestidentifiedwithgenepatternnewre

6、sourceextractionMembraneseparationInvitrotestInvivotestEnzymeactivity　signaltransductionproteinexpressionbiochemicalassayAcuteresponseCellmembranevoltageintracellCa2+changesignaltransductioncell-basedphysiologicalresponseassaymRNAcDNAvariationPCRproliferateDNADNAArraysSurveyDisplayg

7、eneAnalysisgenepattern&comparewithactivecomponentsAcuteresponseChronicresponseAcuteresponseRAPDAFLPSSLPRFLPAffinitymembraneartificialmembraneultrafiltrationSupercriticalextractionTwophaseaquousextrationReversedmicellarextractionaffinityextractionPathologyTransgeneanimalAnimalmodelBi

8、oavailabilityPharma