礼来公司在FDA的演讲：择思达与PG

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1、RichardD.Hockett,Jr.M.D.Sr.ClinicalResearchPhysicianGroupLeader,GenomicMedicineFDAClinicalPharmacologyAdvisoryCommitteeIntegratingPharmacogenomicsintoDrugDevelopmentStratteraCaseStudyEMEA1definition:Pharmacogenomicsappliesgenomicinformationtodrugdesign,discoveryandclinicaldevel

2、opment,reflectingthestateorresponsesatcellular,tissue,individualorpopulationlevels.Pharmacogenetics&PharmacogenomicsPWGdefinition:Pharmacogenetics:thestudyofDNAsequencevariationasitrelatestodifferentialdrugresponse.Pharmacogenomics:thestudyofthegenomeanditsproducts(includingRNAa

3、ndprotein)asitrelatestodrugdiscoveryanddevelopment.1-TheEuropeanAgencyfortheEvaluationofMedicinalProductsLillyDefinitions:DiscoveryGeneticsutilizesgeneticinformationtoimprovetargetidentification/verificationandMOAtesting.Pharmacogenomicsutilizesgenebasedinformationtopredict,asse

4、ssandevaluatedrugresponse.ThePromiseofPharmacogenomics"Pharmacogenomicswillradicallychangethemannerinwhichwedevelopdrugs.""Soon,wewillbeabletogettherightdrugintotherightpatient.""Applyingpharmacogenomicstodrugdevelopmentwillcutcycletimesto1.5-2years.""Pharmacogenomicswillbeablet

5、obringremoveddrugsbackonthemarket,bypredictingwhoissusceptibletoadverseevents."HowCloseAreWe?IntegratingEmergingTechnologyPharmacogenomics:applicationsandkeyactivitiesThreebroadapplicationsDiscoveryTargetIdentificationMechanismofActionTargetDifferentiationBiomarkerIdentification

6、Pre-clinicalToxicologyToxicogenomicsInvivoMechanismofActionBiomarkerIdentificationClinicalInvivoMechanismofActionBiomarkerDevelopment&ValidationTwokeyactivitiesIdentify&UnderstandTargetsDevelopHumanBiomarkersGeneticsinDrugDevelopmentGeneticChangesasBiomarkersDiseaseSusceptibilit

7、yBiomarkersSingleDiseaseGenes(MendelianInheritance)GeneticAssociationsinComplexDiseasesGeneticChangesAssociatedwithTumorogenesisInheritedMutationsSpontaneousMutationsintheTumorMultipleTranscriptChangesLeadingtoReclassificationDrugActivityBiomarkersGeneticPolymorphismsPredictingD

8、rugMetabolismDNAVariationsPredictingDrugRespons