




版權(quán)說明:本文檔由用戶提供并上傳,收益歸屬內(nèi)容提供方,若內(nèi)容存在侵權(quán),請進(jìn)行舉報(bào)或認(rèn)領(lǐng)
文檔簡介
CONFIDENTIALPharmaceuticalLife
CycleManagement(LCM)ClientworkshopJune2001Today′sdiscussion * FootnoteSource: SourceKeyelementsofLifeCycleManagementThoughtsonhowtoorganizeforLCMKeyissues1LifeCycleManagementLifeCycleManagementislargely
aboutbuildingbrandsovertime–
byincrementalinvestmentsinvaluecreatingactivitiestomaximize
thevalueofacompoundObjectiveBuildingabusinessbasedonagreatproductidea/brand–notjustlaunchaninnovationMindset2LCMrequiresacommercialmindsetSettingambitionlevelShape
theproductShape
themarketShapethecompany3LCMrequiresacommercialmindsetSettingambitionlevelShape
theproductEarlycrossfunctionalagreementonvisionfortheproduct(targetlabel)InvestwithaventurecapitalistmindsetDeliveragainsttimelineFocusonwhatisimportantContinuouslyenhancecompetitivedifferentiationClinicaldevelopmententirelyfocusedonvaluecreation
(e.g.,mostimportantindications)4LCMrequiresacommercialmindsetSettingambitionlevelShape
themarketShapethemarketearly
andactivelyClearandconsistentmessagesincommunication/PRstrategiesRecognizeregionaldifferencesinkeymarketsClearandbroadperspectiveonresourcesrequiredtoshapethemarketEnsuretightlinkbetweenR&Dstrategyandmarketstrategy5LCMrequiresacommercialmindsetSettingambitionlevelShapethecompanyHaveaconsistentandtransparentcommercializationprocessMarketleadingwhereitreallymattersStrongmotivationamongemployees
tobringproducttomarketPartnership/
communicationsacrossfunctions/teams/MCsTimelytrainingofallrelevantemployees6LCMrequiresacommercialmindsetSettingambitionlevelEarlycrossfunctionalagreementonvisionfortheproduct(targetlabel)InvestwithaventurecapitalistmindsetDeliveragainsttimelineFocusonwhatisimportantContinuouslyenhancecompetitivedifferentiationClinicaldevelopmententirelyfocusedonvaluecreation(e.g.,mostimportantindications)HaveaconsistentandtransparentcommercializationprocessMarketleadingwhereitreallymattersStrongmotivationamongemployeestobringproducttomarketPartnership/
communicationsacrossfunctions/teams/MCsTimelytrainingofallrelevantemployeesShapetheproductShapethemarketearly
andactivelyClearandconsistentmessagesincommunication/PRstrategiesRecognizeregionaldifferencesinkeymarketsClearandbroadperspectiveonresourcesrequiredtoshapethemarketEnsuretightlinkbetweenR&DstrategyandmarketstrategyShape
themarketShapethecompany7ThelifecyclecanbedividedintothreephasesActionsoftentakenyearsearlier!YearOverallambitions0–4GainmarketshareEstablishmarketRapidsalesramp-up5–10ExpandmarketGainmarketshare11+MinimizeimpactofgenericsDevelopandlaunchline-extensionsTypicalindustrycurvePotentialcurvewithactiveLCMPhaseLaunchExtendSustain8Bestpracticetargetsfor”launch”phaseAmbitionsRapidgrowthinmarketshare(x%byyear4)Establishoverallmarket(fromytozbillionUSD)Rapidsalesrampup(a%ofyear4salesinyear2)AlignandanchortargetswithentireorganizationShapetheproductRapidlaunchacrossallmarketsProductlabel/positioning/brandingisconsistentanddifferentiatedCompetitormovesandstrategiesassessedandimplicationstaken–
inadvanceLCMstrategy/positioningovertimeisclearlyidentifiedShapethemarketEstablishKOLnetworkandbuildbaseforongoingrelationshipPricingstrategybalancesneedforquickapproval/penetrationandestablishingfavorablelong-termpositionMarketingmixandfocusonkeyinfluencerstoreachambitionClinical“shareofvoice”andpublicationlevelsofsufficientmagnitudeandqualityShapethecompanyCompetitiveinvestmentlevelacrossmarkets(e.g.,xperpatient)Transitionglobalteamroleandcomposition;Educate,exciteandalignlocalteamsandsalesforceCreateandmaintainmasterplanningchartoflaunchactivitiesNegotiatepossiblealliances/co-promotionarrangementtooptimizegeographicalcoverage9SelectingtherightlabelrequiresaclearambitionExampleofambitionlevelstaircaseKeyinputintolabelWhatlabelisneededtogettothenextstep?Productname,
projectnameProductvisionCompetitiveenvironmentMainpatientandcustomergroupsandtheirkeyunmetneedsPricingstrategyKeyclaimsforlaunchGo/nogoRelativevalueRouteofadministrationDosingregimenLabelindication(s)LaunchdateKeyissuesNogoMinimallyacceptedlevelGet“fairshare””ClassleaderExpandthemarket10Trendtowardscompressedlaunchschedules–caseexample:Pfizer* Numberinparenthesesdenotesfirstlaunchdateworldwide** Includesforecastsbecausetimehorizonextendspast1998Source: FDA;pinksheets;10-K;MorganStanleyanalystreport(7/98);McKinseyanalysisWorldwidesalesUSDbillionsLipitor**(withWL)ZoloftViagra**NorvascYearsafterlaunchLipitor(97)Norvasc(90)Viagra(98)Zoloft(90)YearsafterlaunchNumberofcountries*11MarketinginvestmentbecomingmoreaggressiveLipitorPravacholCumulativeUSdetailsThousandsYearsfromlaunchYearsfromlaunchSource: SalesanddetailsfromScottLevinUSCumulativeUSsalesUSDmillionsLipitor(1997)Pravachol(1991)Projected12TrackresultsagainstsegmentbottlenecksDevelopscorecardtoevaluate
resultsfrommarketingsolutionsFocusmessageandspend
oneliminatingbottlenecksDevelopmarketingsolutionsandevaluate
eachbasedonabilitytoresolvebottleneck,easeofimplementationandcostIdentifywhichdriverscanresolve
thebottleneck(s)Howtoincreaseawareness,inducetrial,retainpatientsandphysicians,etc.?Identifykeybottlenecksformostattractiveconsumer/prescribersegments
Evaluatewhereinthepurchasefunnelmajorbottle-necksexistforhigh-valuepatientsandphysiciansManylargepharmaco’sarestillintheprocessofadoptingthistoolDynamicmarketingmodel123413PhysicianisawareofnewdrugPhysicianconsidersnewdrugPhysiciandifferen-tiatesnewdrugfromolddrugPhysiciantriesnewdrugPhysicianendorsesnewdrugsforpatientswithunresolvedsymptomsPhysicianendorsesnewdrugforallolddrugusersFew,ifany,
unmetneedsNolong-term
safetyprofileBelievesthatnewdrugefficacyisnotsignificantlysuperiortothatofolddrugLackofsamplesLackofexperiencewithnewdrug;prefertrueandtesteddrugNewdrugisnotonmanyformularies/physiciandoesnotwanttodealwithMCOcallbacksPhysiciandoesnotwanttoswitchpatientwhoisstableonolddrugNotallpatientsrespondwelltonewdrugNewdrugisnotonmanyformulariesNewdrugdoesnothavefullrangeofindicationsExampleofphysiciandecisionfunnelBottle-necksILLUSTRATIVEEXAMPLE14PublicationvolumeisimportantindifferentiatingdrugproductsSource: Citedreferencesciencedatabase,variousmarketing/salesdatabaseandpublicationsDiovan(Novartis)launchedin1994oneyearafterCozaar(Merck)withahigherefficacyandbettertolerateddrug;however,Cozaarwasabletoleveragea5––32xgreaterpublicationvolumetobeatDiovanSalesUSDmillionsCozaarDiovan0250500750100019929394959697982Q99Cozaar202204206201992939495969798DiovanNumberofcitationsCorrelationbetweendrugsalesandpublications15MasterplanningchartToplevelmilestonesEXAMPLEProcessDiseaseorientatedUpdateddiseaseorientatedFinaldiseaseorientatedInitialprojectspecific––staircaseRefinedbasedonmarketresearchandtrialresults––staircaseFinalpre-launchOnlyifissues/LCM*MS1MS2TG1MS4TG2TG3TG4MS8GlobalmarketingTargetlabelPositioningBranding*UpdatedannuallyBroadinitialUpdatedasCDiselectedUpdatedbasedondevelop-mentstudiesandfocusgroupswithKOLsFinalpre-launchbasedonmarketresearchandclinicaltrialsRepositionifnecessaryInitialverypreliminaryUpdatedbasedonmarketresearchandfocusgroupsFinalpre-launchbasedoninputfrommarketsandtrialsRebrandedonlyinunusualsituationsCoverskeydimensionsProductdevelopmentGlobalmarketingProductsupplyPatentsEtc.Toplevelmilestonesandmoredetailedactivities16Bestpracticetargetsfor””extend”phaseAmbitionsMaximizegrowthoffranchiseovertimethroughshareandmarketgrowthShapetheproductDeliverstudiestoevolveproductpositioningandrespondtocompetitiveandmarketshifts–focusonincrementalsalesEvolvetheproduct(e.g.,drugdeliverymethods)andaddvalue-addedofferings(e.g.,diagnosissupport)Pursuelocalclinicalstudiesbalancingneed/demandsoflocalmarketswithdiminishingreturnsofglobalpositioningShapethemarketEvolvemarketingmixandfocusovertimeAppropriatelyfocusKOLactivitiestomaintainnetworkandrespondtonewcompetitorsIncreasethesizeofthemarketthroughinvestmentstobroadenusageandenhancediagnosisSecureoptimalgeographicalcoveragebyalliances/co-promotionShapethecompanyDevelopandretainproductteamsonglobalandlocallevelEnsuresalesforceincentivesdriveevolutionofexistingprescribersandconversionofnewprescribers17ExamplesofproductextensionsPatientbasedinnovationSafety/tolerabilityprofileLineextensionsPharmaco––economicFurther/expandedindicationsNewindication18ExamplesofproductextensionsWaystocreateproductextensionDescriptionExamplesNewindicationIdentifyingdiseases/symptomcurrentlypoorly/nottreatedanddevelopingnovelproductsProscar(Merck)Captopril(BMS)Reo-Pro(Centocor)Acculane(Roche)LineextensionsAdaptingproducttoavoid/delaygenericcompetitionVoltarol(Geigy)Amoxil(SB)ProcardiaXL(Pfizer)Safety/tolerability
profileFocusingproductdevelopment/marketingonaddressingsafelyissueswithincumbenttherapiesIstin/Norvasc(Pfizer)Cardizem(HMR)Zantac(GW)PharmacoeconomicDefiningp-economicprofilebye.g.,redefiningclinicalendpointsforcompetitiveadvantageRocephin(Roche)IPA/GUSTO(Genentech)Dipravan(AstraZeneca)Patient-basedInnovatingaroundthespecificneedofpatientsEasi-Breathe(3M)Novopen(NovoNordisk)Menorest(RPR)Further/expandedindicationsExpandingrelevantpatientpopulationbyredefiningdiseasesofbytreatingadditionaldiseases(formulationcombinations)Fosamax(Merck)Mevacor(Merck)Coreg(BM)Wellbutrin/Zyban(GW)19CapturingbenefitsofcontinuedresearchSource:UKofficeofHealthEconomics/MarketletterJune13,200125-40%ofsalesoftopsellingdrugsinUK/USAareforindicationsdiscoveredonlyafterthedrugswerelaunched20ImpactofnewindicationsExperienceshowsSubstantialspillovereffectsfrombeingfirstcompanytolaunchindicationFirstmovercangetupto10%moremarketshareevenwhereoff-labelexistsThefollower––runningthesameindications–usuallyisnotabletoimprovehismarketpositionExampleofpossibleindicationsforSSRIsMajordepressionPreventionofrelapseofdepressionPremenstrualdysphoricdisorderAnxiety–generalandpanicattacksObsessivecompulsivedisordersEatingdisorders–anorexiaandbulimiaSubstanceabuseSocialphobiaWherecancompanygainsharebypioneeringindications?Wherecancompanyleverageclasseffect?DISGUISEDEXAMPLE21SustainedresultswithproactiveLifeCycleManagement–exampleVoltarenSource:IMS"Patentlife"extended10yearsafterexpirythroughproactiveproductre-launchesUSD1billionglobalsalesin1997SalesinGermanyDEMMillionsPatentexpiryGelSustainedreleaseSuppositoryPlainGlobalmarketsharePercent199394959697198283848586878889909192930408012016022IncreasingchallengetomaintainKOLnetworkdemandsfocusSponsoredSupportedCharacterization“Thoughtleaders””ProvidecriticaldataPrescribersMarketingmeasuresScientificeventsinitiatedbycompanyInvolvementinsalesforcetraining“Influencers””Heavilyinvolvedinteaching“Followers”Commandvastmajority
ofprescriptionsVeryheterogeneousandvolatilelimitedunderstanding“Laggards””LagbehindnewtherapydevelopmentsSpecialcompanyeventstoleverageOPLs,e.g.,““Semi-Annualupdate””forheavyprescribersSalesforcevisitsInformationusingmarketingmeasuresotherthansalesforcecontactOPLHighprescribersLowprescribers23RetainingandmotivatingtoptalentoveryearsrequiresmorethanmoneyGreattasksDifferentiatedcompensationHightotalcompensationFreedomandautonomyJobhasexcitingchallengesCareeradvancementandgrowthGreatproductCompensationValuesandcultureWellmanagedproductCompanyhasexcitingchallengesStrongperformance24Bestpracticetargetsfor””sustain”phaseAmbitionsMaintainmarketshareandprofitlevelsaslongaspossibleShapetheproductIdentifyandinvestinleverstoextendlifecycleShapethemarketReviewpricingasakeylevertomeasureproductvalueExtendsalesandmarketingactivityShapethecompanyRampupexcitementandonlocalteamstoextendthefranchiseShiftcompositionofglobalteamtomeetdemandsofsustaininglifecycleAddressinternalbarrierstosustainingfranchise255keycompetitiveleverstomaximizelatelifecycleNPVMaximize
remainingsalesIncreasesalesspendingImprovesaleseffectivenessIncreasemarketspendingImprovemarketingeffectivenessAttainadditionalindicationsCreateproductextensionsMigratetonewproprietaryproductsExclusiveproductenhancements/extensions”New”versionsofproductParsethemarketDefendsalesexclusivityLitigateManageregulatoryaffairsTakecompetitiveactionsCompetein
genericmarketProduceowngenericPartnerwithgenericsMaximizecontributionMigratetoOTCTransferownershipLicenseTradeSellKeyleversPossibleactions26InternalbarrierstoaddresslifecycleextensionsPossibleresponseDeterminewhichgenericcompetitorsarelikely
toenterStudycaseexamplesUsescenariomodelingtoquantifyimpactandassesspotentialopportunityRecognitionofthe
threatandopportunityNewproductbiasResourcecapacityconstraintsEstablishmoresophisticatedrisk/rewardmeasuresFocusontotalproductopportunityratherthanannualbudgetingforin-lineproductsLCMrevenuesimportanttosustainingperformancethrough”droughts”O(jiān)utsourcetheLCMworktoconservein-houseresources,e.g.,transferringownership27Non-traditionalskillsneededinlateLifeCycleManagementTraditionalFocus:Thisyear’sprofitplanRequiredFocus:NPVofassetClinicaldevelopmentRegulatoryaffairsSales/marketingClinicaldevelopmentRegulatoryaffairsSaleseffectivenessLicensingandacquisitioning/partneringDealstructure,negotiation
andalliancemanage-
mentLitigationstrategyandtacticsProductteamProductteam28Today′′sdiscussionKeyelementsofLifeCycleManagementThoughtsonhowtoorganizeforLCMKeyissues29DesignprinciplesDrivelifecyclemanagementaroundthemajorplanningevents(earlyonmilestonesandlaterinannualplanningcycle)CreateclearrolesandresponsibilitiesbetweenglobalandmarketsDocumentlifecyclemanagementthinkinginasimpledocumentthatpotentiallyisbroaderthanthebusinessplandocument30FocusareasandearlyrecommendationsClarifydecision-makingaroundLCMMakeLCM-plananintegralpartoftollgatedecisionsMakeLCMplanningpartofannualportfoliomanagementprocessDefinerolesandresponsibilitiesDefinewhohaswhatresponsibilitiesDefinethecompanylifecycleplanUpgradetheLCM-plantoarealannualstrategydocumentforpostlaunchDefinethecompanyLCM-plan(alignedwithmarkets)OrganizeforcreationandmanagementoftheLCM-planClarifyleadership–commercialversustechnicalCreateastanding/recurringLCMsub-teamincludingkeymarketsMakeLCMapriorityinannualplanningDefinetheroleinannualplanningDefinethecompanyminimumstandardLinkbudgetstoLCMplanning31LifecyclethinkingshouldbepartoftheearlydevelopmenttollgatedecisionsChoiceoffirstindicationTargetlabelassessmentPreliminarytargetTargetlabelevolutionovertimePatent/IPstrategyChoiceofCDandbackupRoughlifecyclevisionFuturedevelopmentactivitiesEvolutionofpositioningUpdatedtargetlabelassessmentStaircaseDevelopmentprojectplanforproposedscenarioScopeScaleInvestmentforspeedUpdatedLCMplanAgreedvisionwithmarketsFuturedevelopmentinitiativesEvolutionofpositioningFuturemarketinginitiativesUpdateddevelopmentprojectplanforproposedscenarioEnsuresupplyUpdatedtargetlabelassessmentFinal“l(fā)aunch”targetlabelUpdatedLCMplanILLUSTRATIVEPre-CDCDnominationProofofconceptApprovaltolaunch32AgoodLCMplanconsidersabroadrangeofstrategicinitiativesWhatisrequiredtoreachvision/objectives?Marketing
andsalesClinicaldevelopmentOtherMarketpenetrationprogramsGlobalpositioningandcoordinationprogramsNewmarketing/salesapproachesNewclaims/indicationsLineextensionsRepositioningofotherclassesProductionandlogisticsimprovementprogramRenegotiateallianceagreementEXAMPLE33CreatequalitystandardoverallandwithintheLCMplanExamplesDecisionsshouldbebasedonadeeperlevelofinsightintooverallmarketsituationthanwhatresidesinanysinglemarketAvoiddoing““alittleofeverything””Avoidmismatchbetweenglobalandlocalambition.BeclearonoverallstrategicdirectionEachplanshouldincreasethefuturevalueofproductbasedondefiningessentialactivitiesforproductgrowthEnsurethatinitiativesfocusonbothdevelopmentandmarketingleversacrosstimeUseinnovativetoolsandframeworktopushthinking
(e.g.,““wargames””,strategicstaircasesetc)ILLUSTRATIVE34Lifecycleplan––annualportfolioreviewpostlaunchChapterContentQualityguideline1.ExecutivesummaryOutlineplanforthebrandExplaintheoverallLCMstrategyandperformanceobjectivesDescribethe3–5mainissuesthatmaysignificantlyaffecttheproductsuccessLayoutactionstoresolveissuesDoestheexecutivesummaryclearlyandconciselyarticulatehowtheproductwillwininthemarketplaceandovercomeanysignificantchallenges?2.Deci
溫馨提示
- 1. 本站所有資源如無特殊說明,都需要本地電腦安裝OFFICE2007和PDF閱讀器。圖紙軟件為CAD,CAXA,PROE,UG,SolidWorks等.壓縮文件請下載最新的WinRAR軟件解壓。
- 2. 本站的文檔不包含任何第三方提供的附件圖紙等,如果需要附件,請聯(lián)系上傳者。文件的所有權(quán)益歸上傳用戶所有。
- 3. 本站RAR壓縮包中若帶圖紙,網(wǎng)頁內(nèi)容里面會有圖紙預(yù)覽,若沒有圖紙預(yù)覽就沒有圖紙。
- 4. 未經(jīng)權(quán)益所有人同意不得將文件中的內(nèi)容挪作商業(yè)或盈利用途。
- 5. 人人文庫網(wǎng)僅提供信息存儲空間,僅對用戶上傳內(nèi)容的表現(xiàn)方式做保護(hù)處理,對用戶上傳分享的文檔內(nèi)容本身不做任何修改或編輯,并不能對任何下載內(nèi)容負(fù)責(zé)。
- 6. 下載文件中如有侵權(quán)或不適當(dāng)內(nèi)容,請與我們聯(lián)系,我們立即糾正。
- 7. 本站不保證下載資源的準(zhǔn)確性、安全性和完整性, 同時(shí)也不承擔(dān)用戶因使用這些下載資源對自己和他人造成任何形式的傷害或損失。
最新文檔
- 困難救助協(xié)議書范本
- 私人修房協(xié)議書樣本
- 傭金結(jié)算協(xié)議書范本
- 木工吊頂裝修協(xié)議書
- 貨款糾紛簽了協(xié)議書
- 中轉(zhuǎn)委托協(xié)議書范本
- 女性婚前保護(hù)協(xié)議書
- 養(yǎng)殖種植協(xié)議書模板
- 自愿截肢協(xié)議書范本
- 物業(yè)保潔聘用協(xié)議書
- 山東省青島市各縣區(qū)鄉(xiāng)鎮(zhèn)行政村村莊村名居民村民委員會明細(xì)
- 接觸網(wǎng)工程施工方法及技術(shù)措施
- 質(zhì)量獎勵(罰款)通知單
- HIS系統(tǒng)現(xiàn)場整體需求調(diào)研
- DB11-T1448-2017城市軌道交通工程資料管理規(guī)程
- 2022年《國民經(jīng)濟(jì)行業(yè)分類》
- OTN傳輸項(xiàng)目交付實(shí)施計(jì)劃方案
- 固定頂、外浮頂和內(nèi)浮頂儲罐
- 千牛工作臺操作圖解PPT課件
- IH型化工離心泵設(shè)計(jì)
- 教師問責(zé)制度
評論
0/150
提交評論