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CONFIDENTIALPharmaceuticalLife
CycleManagement(LCM)Today´sdiscussion * FootnoteSource: SourceKeyelementsofLifeCycleManagementThoughtsonhowtoorganizeforLCMKeyissuesLifeCycleManagementLifeCycleManagementislargely
aboutbuildingbrandsovertime–
byincrementalinvestmentsinvaluecreatingactivitiestomaximize
thevalueofacompoundObjectiveBuildingabusinessbasedonagreatproductidea/brand–notjustlaunchaninnovationMindsetLCMrequiresacommercialmindsetSettingambitionlevelShape
theproductShape
themarketShapethecompanyLCMrequiresacommercialmindsetSettingambitionlevelShape
theproductEarlycrossfunctionalagreementonvisionfortheproduct(targetlabel)InvestwithaventurecapitalistmindsetDeliveragainsttimelineFocusonwhatisimportantContinuouslyenhancecompetitivedifferentiationClinicaldevelopmententirelyfocusedonvaluecreation
(e.g.,mostimportantindications)LCMrequiresacommercialmindsetSettingambitionlevelShape
themarketShapethemarketearly
andactivelyClearandconsistentmessagesincommunication/PRstrategiesRecognizeregionaldifferencesinkeymarketsClearandbroadperspectiveonresourcesrequiredtoshapethemarketEnsuretightlinkbetweenR&DstrategyandmarketstrategyLCMrequiresacommercialmindsetSettingambitionlevelShapethecompanyHaveaconsistentandtransparentcommercializationprocessMarketleadingwhereitreallymattersStrongmotivationamongemployees
tobringproducttomarketPartnership/
communicationsacrossfunctions/teams/MCsTimelytrainingofallrelevantemployeesLCMrequiresacommercialmindsetSettingambitionlevelEarlycrossfunctionalagreementonvisionfortheproduct(targetlabel)InvestwithaventurecapitalistmindsetDeliveragainsttimelineFocusonwhatisimportantContinuouslyenhancecompetitivedifferentiationClinicaldevelopmententirelyfocusedonvaluecreation(e.g.,mostimportantindications)HaveaconsistentandtransparentcommercializationprocessMarketleadingwhereitreallymattersStrongmotivationamongemployeestobringproducttomarketPartnership/
communicationsacrossfunctions/teams/MCsTimelytrainingofallrelevantemployeesShapetheproductShapethemarketearly
andactivelyClearandconsistentmessagesincommunication/PRstrategiesRecognizeregionaldifferencesinkeymarketsClearandbroadperspectiveonresourcesrequiredtoshapethemarketEnsuretightlinkbetweenR&DstrategyandmarketstrategyShape
themarketShapethecompanyThelifecyclecanbedividedintothreephasesActionsoftentakenyearsearlier!YearOverallambitions0–4GainmarketshareEstablishmarketRapidsalesramp-up5–10ExpandmarketGainmarketshare11+MinimizeimpactofgenericsDevelopandlaunchline-extensionsTypicalindustrycurvePotentialcurvewithactiveLCMPhaseLaunchExtendSustainBestpracticetargetsfor”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-promotionarrangementtooptimizegeographicalcoverageSelectingtherightlabelrequiresaclearambitionExampleofambitionlevelstaircaseKeyinputintolabelWhatlabelisneededtogettothenextstep?Productname,projectnameProductvisionCompetitiveenvironmentMainpatientandcustomergroupsandtheirkeyunmetneedsPricingstrategyKeyclaimsforlaunchGo/nogoRelativevalueRouteofadministrationDosingregimenLabelindication(s)LaunchdateKeyissuesNogoMinimallyacceptedlevelGet““fairshare””ClassleaderExpandthemarketTrendtowardscompressedlaunchschedules––caseexample:Pfizer*Numberinparenthesesdenotesfirstlaunchdateworldwide**Includesforecastsbecausetimehorizonextendspast1998Source: FDA;pinksheets;10-K;MorganStanleyanalystreport(7/98);McKinseyanalysisWorldwidesalesUSDbillionsLipitor**(withWL)ZoloftViagra**NorvascYearsafterlaunchLipitor(97)Norvasc(90)Viagra(98)Zoloft(90)YearsafterlaunchNumberofcountries*MarketinginvestmentbecomingmoreaggressiveLipitorPravacholCumulativeUSdetailsThousandsYearsfromlaunchYearsfromlaunchSource: SalesanddetailsfromScottLevinUSCumulativeUSsalesUSDmillionsLipitor(1997)Pravachol(1991)ProjectedTrackresultsagainstsegmentbottlenecksDevelopscorecardtoevaluate
resultsfrommarketingsolutionsFocusmessageandspend
oneliminatingbottlenecksDevelopmarketingsolutionsandevaluate
eachbasedonabilitytoresolvebottleneck,easeofimplementationandcostIdentifywhichdriverscanresolve
thebottleneck(s)Howtoincreaseawareness,inducetrial,retainpatientsandphysicians,etc.?Identifykeybottlenecksformostattractiveconsumer/prescribersegments
Evaluatewhereinthepurchasefunnelmajorbottle-necksexistforhigh-valuepatientsandphysiciansManylargepharmaco’sarestillintheprocessofadoptingthistoolDynamicmarketingmodel1234PhysicianisawareofnewdrugPhysicianconsidersnewdrugPhysiciandifferen-tiatesnewdrugfromolddrugPhysiciantriesnewdrugPhysicianendorsesnewdrugsforpatientswithunresolvedsymptomsPhysicianendorsesnewdrugforallolddrugusersFew,ifany,unmetneedsNolong-termsafetyprofileBelievesthatnewdrugefficacyisnotsignificantlysuperiortothatofolddrugLackofsamplesLackofexperiencewithnewdrug;prefertrueandtesteddrugNewdrugisnotonmanyformularies/physiciandoesnotwanttodealwithMCOcallbacksPhysiciandoesnotwanttoswitchpatientwhoisstableonolddrugNotallpatientsrespondwelltonewdrugNewdrugisnotonmanyformulariesNewdrugdoesnothavefullrangeofindicationsExampleofphysiciandecisionfunnelBottle-necksILLUSTRATIVEEXAMPLEPublicationvolumeisimportantindifferentiatingdrugproductsSource: Citedreferencesciencedatabase,variousmarketing/salesdatabaseandpublicationsDiovan(Novartis)launchedin1994oneyearafterCozaar(Merck)withahigherefficacyandbettertolerateddrug;however,Cozaarwasabletoleveragea5––32xgreaterpublicationvolumetobeatDiovanSalesUSDmillionsCozaarDiovan0250500750100019929394959697982Q99Cozaar202204206201992939495969798DiovanNumberofcitationsCorrelationbetweendrugsalesandpublicationsMasterplanningchartToplevelmilestonesEXAMPLEProcessDiseaseorientatedUpdateddiseaseorientatedFinaldiseaseorientatedInitialprojectspecific––staircaseRefinedbasedonmarketresearchandtrialresults––staircaseFinalpre-launchOnlyifissues/LCM*MS1MS2TG1MS4TG2TG3TG4MS8GlobalmarketingTargetlabelPositioningBranding*UpdatedannuallyBroadinitialUpdatedasCDiselectedUpdatedbasedondevelop-mentstudiesandfocusgroupswithKOLsFinalpre-launchbasedonmarketresearchandclinicaltrialsRepositionifnecessaryInitialverypreliminaryUpdatedbasedonmarketresearchandfocusgroupsFinalpre-launchbasedoninputfrommarketsandtrialsRebrandedonlyinunusualsituationsCoverskeydimensionsProductdevelopmentGlobalmarketingProductsupplyPatentsEtc.ToplevelmilestonesandmoredetailedactivitiesBestpracticetargetsfor”extend””phaseAmbitionsMaximizegrowthoffranchiseovertimethroughshareandmarketgrowthShapetheproductDeliverstudiestoevolveproductpositioningandrespondtocompetitiveandmarketshifts–focusonincrementalsalesEvolvetheproduct(e.g.,drugdeliverymethods)andaddvalue-addedofferings(e.g.,diagnosissupport)Pursuelocalclinicalstudiesbalancingneed/demandsoflocalmarketswithdiminishingreturnsofglobalpositioningShapethemarketEvolvemarketingmixandfocusovertimeAppropriatelyfocusKOLactivitiestomaintainnetworkandrespondtonewcompetitorsIncreasethesizeofthemarketthroughinvestmentstobroadenusageandenhancediagnosisSecureoptimalgeographicalcoveragebyalliances/co-promotionShapethecompanyDevelopandretainproductteamsonglobalandlocallevelEnsuresalesforceincentivesdriveevolutionofexistingprescribersandconversionofnewprescribersExamplesofproductextensionsPatientbasedinnovationSafety/
tolerabilityprofileLineextensionsPharmaco–economicFurther/expandedindicationsNewindicationExamplesofproductextensionsWaystocreateproductextensionDescriptionExamplesNewindicationIdentifyingdiseases/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)CapturingbenefitsofcontinuedresearchSource:UKofficeofHealthEconomics/MarketletterJune13,200125-40%ofsalesoftopsellingdrugsinUK/USAareforindicationsdiscoveredonlyafterthedrugswerelaunchedImpactofnewindicationsExperienceshowsSubstantialspillovereffectsfrombeingfirstcompanytolaunchindicationFirstmovercangetupto10%moremarketshareevenwhereoff-labelexistsThefollower––runningthesameindications–usuallyisnotabletoimprovehismarketpositionExampleofpossibleindicationsforSSRIsMajordepressionPreventionofrelapseofdepressionPremenstrualdysphoricdisorderAnxiety–generalandpanicattacksObsessivecompulsivedisordersEatingdisorders–anorexiaandbulimiaSubstanceabuseSocialphobiaWherecancompanygainsharebypioneeringindications?Wherecancompanyleverageclasseffect?DISGUISEDEXAMPLESustainedresultswithproactiveLifeCycleManagement––
exampleVoltarenSource: IMS"Patentlife"extended10yearsafterexpirythroughproactiveproductre-launchesUSD1billionglobalsalesin1997SalesinGermanyDEMMillionsPatentexpiryGelSustainedreleaseSuppositoryPlainGlobalmarketsharePercent1993949596971982838485868788899091929304080120160IncreasingchallengetomaintainKOLnetworkdemandsfocusSponsoredSupportedCharacterization“Thoughtleaders”ProvidecriticaldataPrescribersMarketingmeasuresScientificeventsinitiatedbycompanyInvolvementinsalesforcetraining“Influencers”Heavilyinvolvedinteaching“Followers”Commandvastmajority
ofprescriptionsVeryheterogeneousandvolatilelimitedunderstanding“Laggards”LagbehindnewtherapydevelopmentsSpecialcompanyevents
toleverageOPLs,e.g.,“Semi-Annualupdate”forheavyprescribersSalesforcevisitsInformationusingmarketingmeasuresotherthansalesforcecontactOPLHighprescribersLowprescribersRetainingandmotivatingtoptalentoveryearsrequiresmorethanmoneyGreattasksDifferentiatedcompensationHightotalcompensationFreedomandautonomyJobhasexcitingchallengesCareeradvancementandgrowthGreatproductCompensationValuesandcultureWellmanagedproductCompanyhasexcitingchallengesStrongperformanceBestpracticetargetsfor””sustain”phaseAmbitionsMaintainmarketshareandprofitlevelsaslongaspossibleShapetheproductIdentifyandinvestinleverstoextendlifecycleShapethemarketReviewpricingasakeylevertomeasureproductvalueExtendsalesandmarketingactivityShapethecompanyRampupexcitementandonlocalteamstoextendthefranchiseShiftcompositionofglobalteamtomeetdemandsofsustaininglifecycleAddressinternalbarrierstosustainingfranchise5keycompetitiveleverstomaximizelatelifecycleNPVMaximize
remainingsalesIncreasesalesspendingImprovesaleseffectivenessIncreasemarketspendingImprovemarketingeffectivenessAttainadditionalindicationsCreateproductextensionsMigratetonewproprietaryproductsExclusiveproductenhancements/extensions”New”versionsofproductParsethemarketDefendsalesexclusivityLitigateManageregulatoryaffairsTakecompetitiveactionsCompetein
genericmarketProduceowngenericPartnerwithgenericsMaximizecontributionMigratetoOTCTransferownershipLicenseTradeSellKeyleversPossibleactionsInternalbarrierstoaddresslifecycleextensionsPossibleresponseDeterminewhichgenericcompetitorsarelikely
toenterStudycaseexamplesUsescenariomodelingtoquantifyimpactandassesspotentialopportunityRecognitionofthe
threatandopportunityNewproductbiasResourcecapacityconstraintsEstablishmoresophisticatedrisk/rewardmeasuresFocusontotalproductopportunityratherthanannualbudgetingforin-lineproductsLCMrevenuesimportanttosustainingperformancethrough”droughts”OutsourcetheLCMworktoconservein-houseresources,e.g.,transferringownershipNon-traditionalskillsneededinlateLifeCycleManagementTraditionalFocus:Thisyear’sprofitplanRequiredFocus:NPVofassetClinicaldevelopmentRegulatoryaffairsSales/marketingClinicaldevelopmentRegulatoryaffairsSaleseffectivenessLicensingandacquisitioning/partneringDealstructure,negotiation
andalliancemanage-
mentLitigationstrategyandtacticsProductteamProductteamToday´´sdiscussionKeyelementsofLifeCycleManagementThoughtsonhowtoorganizeforLCMKeyissuesDesignprinciplesDrivelifecyclemanagementaroundthemajorplanningevents(earlyonmilestonesandlaterinannualplanningcycle)CreateclearrolesandresponsibilitiesbetweenglobalandmarketsDocumentlifecyclemanagementthinkinginasimpledocumentthatpotentiallyisbroaderthanthebusinessplandocumentFocusareasandearlyrecommendationsClarifydecision-makingaroundLCMMakeLCM-plananintegralpartoftollgatedecisionsMakeLCMplanningpartofannualportfoliomanagementprocessDefinerolesandresponsibilitiesDefinewhohaswhatresponsibilitiesDefinethecompanylifecycleplanUpgradetheLCM-plantoarealannualstrategydocumentforpostlaunchDefinethecompanyLCM-plan(alignedwithmarkets)OrganizeforcreationandmanagementoftheLCM-planClarifyleadership–commercialversustechnicalCreateastanding/recurringLCMsub-teamincludingkeymarketsMakeLCMapriorityinannualplanningDefinetheroleinannualplanningDefinethecompanyminimumstandardLinkbudgetstoLCMplanningLifecyclethinkingshouldbepartoftheearlydevelopmenttollgatedecisionsChoiceoffirstindicationTargetlabelassessmentPreliminarytargetTargetlabelevolutionovertimePatent/IPstrategyChoiceofCDandbackupRoughlifecyclevisionFuturedevelopmentactivitiesEvolutionofpositioningUpdatedtargetlabelassessmentStaircaseDevelopmentprojectplanforproposedscenarioScopeScaleInvestmentforspeedUpdatedLCMplanAgreedvisionwithmarketsFuturedevelopmentinitiativesEvolutionofpositioningFuturemarketinginitiativesUpdateddevelopmentprojectplanforproposedscenarioEnsuresupplyUpdatedtargetlabelassessmentFinal““launch”targetlabelUpdatedLCMplanILLUSTRATIVEPre-CDCDnominationProofofconceptApprovaltolaunchAgoodLCMplanconsidersabroadrangeofstrategicinitiativesWhatisrequired
toreachvision/objectives?MarketingandsalesClinicaldevelopmentOtherMarketpenetrationprogramsGlobalpositioningandcoordinationprogramsNewmarketing/salesapproachesNewclaims/indicationsLineextensionsRepositioningofotherclassesProductionandlogisticsimprovementprogramRenegotiateallianceagreementEXAMPLECreatequalitystandardoverallandwithintheLCMplanExamplesDecisionsshouldbebasedonadeeperlevelofinsightintooverallmarketsituationthanwhatresidesinanysinglemarketAvoiddoing“alittleofeverything””Avoidmismatchbetweenglobalandlocalambition.BeclearonoverallstrategicdirectionEachplanshouldincreasethefuturevalueofproductbasedondefiningessentialactivitiesforproductgrowthEnsurethatinitiativesfocusonbothdevelopmentandmarketingleversacrosstimeUseinnovativetoolsandframeworktopushthinking
(e.g.,““wargames””,strategicstaircasesetc)ILLUSTRATIVELifecycleplan––annualportfolioreviewpostlaunchChapterContentQualityguideline1.ExecutivesummaryOutlineplanforthebrandExplaintheoverallLCMstrategyandperformanceobjectivesDescribethe3–5mainissuesthatmaysignificantlyaffecttheproductsuccessLayoutactionstoresolveissuesDoestheexecutivesummaryclearlyandconciselyarticulatehowtheproductwillwininthemarketplaceandovercomeanysignificantchallenges?2.DecisionrequiredExplainwha
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