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1、Pharmacogenomics,PersonalizedPharmacogenomics,PersonalizedMedicineandtheRoleofFDAMedicineandtheRoleofFDABio-ITWorldConferenceHynesConventionCenterBoston,MassachusettsMay18,2004LawrenceJ.Lesko,Ph.D.,FCPDirector,OfficeofClinicalPharmacologyandBiopharmaceuticsCenterforDrugEvaluationandResearchFoodand
2、DrugAdministrationRockville,MarylandOutlineofPresentationOutlineofPresentation¢Problemofheterogeneityindiseaseandvariabilityindrugresponse¢FDAinitiativestofacilitateinnovationincludingpharmacogenomics(PGx)¢Currentstatuswithexamplesofsuccessesandfailures¢OutlookonfuturechallengesandbarriersTheBigPi
3、ctureTheBigPictureMostpopularGooglesatellitemaps…..BillGates’house,MichaelJacksons’NeverlandRanchandBostons’HynesConventionCenter……….BoylstonStreethttp://www.aaccessmaps.comHowAdvancesinTechnologyWillHowAdvancesinTechnologyWillImpactHealthCareSystems?ImpactHealthCareSystems?“Menareonlysogoodasthei
4、rtechnicaldevelopmentsallowthemtobe”GeorgeOrwell,1903-1950Essayist,NovelistandSatiristNovember28,1983I.PatientDigitizedHealthRecordsUsingI.PatientDigitizedHealthRecordsUsingaWebaWeb--BasedProgramBasedProgram¢Patientsfillintheirmedicalhistory,includingdrugsandallergies,online¢Patientsdecidewhenandw
5、heretoshareitwithdoctorsandhospitals¢Patientschoosetotransfertheirrecordstonewdoctors¢PatientsreceiveemailsaboutdrugrecallsandrelatedhealthinformationMedem’siHealthRecord,WallStreetJournal,May9,2005II.PatientMedicalRecordInformationII.PatientMedicalRecordInformationonImplantableMicrochipsonImplant
6、ableMicrochips¾16-digitnumberonchipretrievedbyhandheldradioscanner¾AccesstorecordsonchipauthorizedbypatientShiftinBalanceofPowerfromShiftinBalanceofPowerfromPhysicianstoPatientsPhysicianstoPatientsInformationDoctorPatientSmarterPatientsMorePatient-FocusedDoctorDeliveringHealthCarewithGreaterPrecis
7、ionPersonalizedMedicineTechnologyAffectsSocietyinGeneral:TechnologyAffectsSocietyinGeneral:FromSmartFromSmartCamerasCamerastoSmarttoSmartDrugsDrugsYournamehereStorrowandMemorialDrivesPersonalizedMedicine~So,WhatI
