Clinical Development | CHUGAI PHARMACEUTICAL CO., LTD.

Chugai Pharmaceutical's own in-house development pipeline has one of the strongest line-ups in Japan. By adding Roche and Genentech products based on ... Home AboutChugai R&D ClinicalDevelopment Tobringinnovativepharmaceuticalstopatientsasquicklyaspossible,Chugaihasestablishedalifecyclemanagement*systemforproject-levelintegratedmanagementofresearch,regulatoryaffairs,drugsafety,manufacturingandotherfunctions,andcooperateswithnumerousmedicalinstitutionsandclinicalresearchcenters.Inthisway,weworktoimplementclinicaltrialsdistinguishedbyexceptionalspeed,efficiencyandscientificrigor. * Thevariousmeasurestakentomaximizethepotentialvalueofadrug,includingshorteningdevelopmenttime,expandingsales,extendingtheproduct’slife,andconductingappropriatecostcontrol.Competitivenesscanbestrengthenedfurtherbyusingearningsfromsalesofestablisheddrugstostrategicallyreinvestinnewdrugdevelopment,marketingorotherareas. ChugaiPharmaceutical’sownin-housedevelopmentpipelinehasoneofthestrongestline-upsinJapan.ByaddingRocheandGenentechproductsbasedonlicenseagreementswiththosecompanies,ChugaiPharmaceuticalhasbenefitedfromadevelopmentsynergyeffect*1andassembledatop-class,innovativedomesticdevelopmentpipeline*2. *1 Thisreferstothesynergisticeffectthatenableseachpharmaceuticalcompanytosavelargeamountsofmoneyandtimeinthenew-drugdevelopmentprocessbysharingknow-how,R&Dresults,anddatafromresearchinprogress. *2 Thesetofproductscurrentlyunderdevelopmentatapharmaceuticalcompany,fromtheinitialdevelopmentstageofeachdruguntilthestartofsales,iscalledthe"developmentpipeline".Theterms"productpipeline"and"new-drugpipeline"arealsoused. EvolutionofClinicalDevelopmentUsingDigitalTechnology Co-DevelopmentandJointPromotionwithRoche EvolutionofClinicalDevelopmentUsingDigitalTechnology Intheearly-stageclinicaldevelopmentuptoproofofconcept(PoC)*1,weareworkingtodevelopanintricateunderstandingofbiologicalresponsesutilizinginnovativetechnologiessuchasM&S*2andhumanorganoidconstruction*3,fromthepreclinicalstages.Thesewillbecombinedwiththefulluseofreal-worlddata(RWD)andawealthofdataondiseasesandtreatmentsthatwehaveaccumulatedtoimprovethepredictabilityofdosageandadministration,efficacy,andsafety,andtoincreasethesuccessratesofclinicaltrials. Inthepast,additionalindicationsweredevelopedinstages,butbyusingM&Sandotherscientificevidence,wenowaimtoidentifytargetdiseasesatanearlypointanddevelopindicationsformultiplediseasessimultaneously.Combiningthiswithanunderstandingandanalysisofbiologicalresponses,wewillfocusonthedevelopmentofdigitalbiomarkers(dBMs)anddigitaldeviceswhileidentifyinghealthcareissuesforeachdiseaseandlinkingtheresultsfromthisworktoappropriatediagnosisandtreatment.Furthermore,bycombiningthedataobtainedinthiswaywithRWD,wewilldemonstratetheTrueEndpointsthatcanhelptoimprovepatientQoLattheearlystages,therebymaximizingthevaluedeliveredtopatients. Inlate-stagedevelopment,wewillactivelyusedigitaltechnologiesformonitoringandmanagementtasks,andatthesametime,wewillpromotereductionsinthesizeanddurationofstudiesthroughtheuseofRWD.Inthisway,weaimtodeliverproductstothemarketfasterandreducetheburdenonpatients. *1Proofofconcept:Confirmationthatthetherapeuticeffectconceivedintheresearchstageiseffectiveinhumans *2Technologythatintegratescomputer-basedmathematicalsimulationswithbiologicalsciences.Supportskeydecision-makingduringpharmaceuticaldevelopment. *3Tissuestructuresdesignedtohavesimilaritiestoorgansinthehumanbody Forcasestudiesusingdigitaltechnology,pleaseaccesstotheURLbelow. Digitalbiomarkers(dBM)initiatives Bycollectingandanalyzingpatientdatausingwearabledevices,Chugaiwillcreatenewhealthindicatorsandprovidenewvaluetopatients. Utilizationofreal-worlddata(RWD) Byutilizingreal-worlddata(RWD),wepromotetheefficiencyandsophisticationoftheclinicaldevelopmentprocessofnewdrugs,theverificationofdrugvalues,andunderstandingofdiseases,toprovideanoptimaltreatmentforeachpatient. Co-DevelopmentandJointPromotionwithRoche Byconcludingco-development/jointpromotionagreementswithRoche,ChugaiPharmaceuticalhasestablishedabusinessmodelthatenablesittodevelopandmarketitsownproductsoverseasaswellasinJapan,andenablesittoutiliseRoche'sglobalnetwork.Asaresultofcoordinationofco-developmentwithRocheinEuropeandtheUnitedStates,ChugaiPharmaceutical'sdevelopmentisproceedingmoreeffectivelyandefficiently.Furthermore,ChugaiPharmaceutical'sproductscannowbesoldthroughRoche'soverseassalesnetwork,sothealliancecanbeexpectedincreasesales. 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