药物发现和发展.ppt

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2025-05-08 发布于浙江
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药物发现和发展.ppt

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IntroductionInthepastmostdrugshavebeendiscoveredeitherbyidentifyingtheactiveingredientfromtraditionalremediesorbyserendipitousdiscovery.Butnowweknowdiseasesarecontrolledatmolecularandphysiologicallevel.Alsoshapeofanmoleculeatatomicleveliswellunderstood.InformationofHumanGenome

HistoryofDrugDiscovery:

Registration:TheMinistryofhealthFamilyWelfareandtheMinistryofChemicalsFertilizershavemajorroleinregulationofIPM.NDAmustbesubmittedtoDCGIPhaseIIIstudyreportedtoCDL,KolkataPackageinsertedapprovedbyDCIMarketingapprovalfromFDA

~$800Mspenttobringanewdrugtomarket.$127BillionspentonPharmaRDin2010ShareofCROsinresearchoperationsis27%WorldCROmarketis16.3B(Indianshare$500M)MarketScenerio:

TopCROs(ByRevenue)ContractResearchOrganizationsRevenueQuintiles$2.5BillionPharmaceuticalProductDevelopment$1.8BillionCovance$1.4BillionCharlesRiverLaboratories$1.2BillionParexel$930MillionIcon$887MillionKendle$590MillionPharmanet$470MillionPRAInternational$410Million4GPharmacovigilance$391Million

TopCROs(India)ContractResearchOrganizationsLocationActimusBiosciencesHyderabadAdvinusTherapeuticsBangaloreAurigeneDiscoverytechnologiesBangaloreChembiotekKolkataGVKBiosciencesHyderabadJubilantOrganosysBangaloreRanbaxyLifeSciencesMumbaiRelianceLifeSciencesMumbaiSuvenLifeSciencesHyderabadSyngeneBangalore

MostvaluableRDProjectsRankProductCompanyPhasePharmacologicalclassTodaysNPV($mn)1DegludecNovoNordiskPhaseIIIInsulin5,8072TofacitinibPfizerPhaseIIIJAK-3inhibitor4,9533BG-12BiogenIdecPhaseIIIFumarate4,6664IncivekJJPhaseIVHepCproteaseinhibitor4,3325RelovairTheravancePhaseIIICorticosteroid4,2416DRCysteamineUndisclosedPhaseIIILysosomaltransportmodulator4,1557AMR101UndisclosedPhaseIIIOmega-3fattyacid4,0528EliquisBristolMyersSquibbPhaseIVFactorXainhibitor3,8369EliquisPfizerPhaseIVFactorXainhibitor3,59210BexsseroNovartisPhase