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CONFIDENTIAL PharmaceuticalLifeCycleManagement LCM Today sdiscussion FootnoteSource Source KeyelementsofLifeCycleManagement ThoughtsonhowtoorganizeforLCM Keyissues LifeCycleManagement LifeCycleManagementislargelyaboutbuildingbrandsovertime byincrementalinvestmentsinvaluecreatingactivitiestomaximizethevalueofacompound Objective Buildingabusinessbasedonagreatproductidea brand notjustlaunchaninnovation Mindset LCMrequiresacommercialmindset Settingambitionlevel Shapetheproduct Shapethemarket Shapethecompany LCMrequiresacommercialmindset Settingambitionlevel Earlycrossfunctionalagreementonvisionfortheproduct targetlabel InvestwithaventurecapitalistmindsetDeliveragainsttimelineFocusonwhatisimportantContinuouslyenhancecompetitivedifferentiationClinicaldevelopmententirelyfocusedonvaluecreation e g mostimportantindications LCMrequiresacommercialmindset Settingambitionlevel ShapethemarketearlyandactivelyClearandconsistentmessagesincommunication PRstrategiesRecognizeregionaldifferencesinkeymarketsClearandbroadperspectiveonresourcesrequiredtoshapethemarketEnsuretightlinkbetweenR Dstrategyandmarketstrategy LCMrequiresacommercialmindset Settingambitionlevel HaveaconsistentandtransparentcommercializationprocessMarketleadingwhereitreallymattersStrongmotivationamongemployeestobringproducttomarketPartnership communicationsacrossfunctions teams MCsTimelytrainingofallrelevantemployees LCMrequiresacommercialmindset Settingambitionlevel Earlycrossfunctionalagreementonvisionfortheproduct targetlabel InvestwithaventurecapitalistmindsetDeliveragainsttimelineFocusonwhatisimportantContinuouslyenhancecompetitivedifferentiationClinicaldevelopmententirelyfocusedonvaluecreation e g mostimportantindications HaveaconsistentandtransparentcommercializationprocessMarketleadingwhereitreallymattersStrongmotivationamongemployeestobringproducttomarketPartnership communicationsacrossfunctions teams MCsTimelytrainingofallrelevantemployees Shapetheproduct ShapethemarketearlyandactivelyClearandconsistentmessagesincommunication PRstrategiesRecognizeregionaldifferencesinkeymarketsClearandbroadperspectiveonresourcesrequiredtoshapethemarketEnsuretightlinkbetweenR Dstrategyandmarketstrategy Shapethemarket Shapethecompany Thelifecyclecanbedividedintothreephases Year Overallambitions 0 4 GainmarketshareEstablishmarketRapidsalesramp up 5 10 ExpandmarketGainmarketshare 11 MinimizeimpactofgenericsDevelopandlaunchline extensions TypicalindustrycurvePotentialcurvewithactiveLCM Phase Launch Extend Sustain Bestpracticetargetsfor launch phase Selectingtherightlabelrequiresaclearambition Exampleofambitionlevelstaircase Keyinputintolabel Whatlabelisneededtogettothenextstep Productname projectnameProductvisionCompetitiveenvironmentMainpatientandcustomergroupsandtheirkeyunmetneedsPricingstrategyKeyclaimsforlaunchGo nogoRelativevalueRouteofadministrationDosingregimenLabelindication s LaunchdateKeyissues Nogo Minimallyacceptedlevel Get fairshare Classleader Expandthemarket Trendtowardscompressedlaunchschedules caseexample Pfizer Numberinparenthesesdenotesfirstlaunchdateworldwide Includesforecastsbecausetimehorizonextendspast1998Source FDA pinksheets 10 K MorganStanleyanalystreport 7 98 McKinseyanalysis WorldwidesalesUSDbillions Lipitor withWL Zoloft Viagra Norvasc Yearsafterlaunch Lipitor 97 Norvasc 90 Viagra 98 Zoloft 90 Yearsafterlaunch Numberofcountries Marketinginvestmentbecomingmoreaggressive Lipitor Pravachol CumulativeUSdetailsThousands Yearsfromlaunch Yearsfromlaunch Source SalesanddetailsfromScottLevinUS CumulativeUSsalesUSDmillions Lipitor 1997 Pravachol 1991 Projected Manylargepharmaco sarestillintheprocessofadoptingthistool Dynamicmarketingmodel Physicianisawareofnewdrug Physicianconsidersnewdrug Physiciandifferen tiatesnewdrugfromolddrug Physiciantriesnewdrug Physicianendorsesnewdrugsforpatientswithunresolvedsymptoms Physicianendorsesnewdrugforallolddrugusers Few ifany unmetneedsNolong termsafetyprofile Believesthatnewdrugefficacyisnotsignificantlysuperiortothatofolddrug Lackofsamples Lackofexperiencewithnewdrug prefertrueandtesteddrugNewdrugisnotonmanyformularies physiciandoesnotwanttodealwithMCOcallbacks PhysiciandoesnotwanttoswitchpatientwhoisstableonolddrugNotallpatientsrespondwelltonewdrugNewdrugisnotonmanyformulariesNewdrugdoesnothavefullrangeofindications Exampleofphysiciandecisionfunnel Bottle necks Publicationvolumeisimportantindifferentiatingdrugproducts Source Citedreferencesciencedatabase variousmarketing salesdatabaseandpublications Diovan Novartis launchedin1994oneyearafterCozaar Merck withahigherefficacyandbettertolerateddrug however Cozaarwasabletoleveragea5 32xgreaterpublicationvolumetobeatDiovan Sales USDmillions Cozaar Diovan 0 250 500 750 1000 1992 93 94 95 96 97 98 2Q99 Cozaar 20 220 420 620 1992 93 94 95 96 97 98 Diovan Numberofcitations Correlationbetweendrugsalesandpublications Masterplanningchart Toplevelmilestones Process Diseaseorientated Updateddiseaseorientated Finaldiseaseorientated Initialprojectspecific staircase Refinedbasedonmarketresearchandtrialresults staircase Finalpre launch Onlyifissues LCM MS1 MS2 TG1 MS4 TG2 TG3 TG4 MS8 Globalmarketing Targetlabel Positioning Branding Updatedannually Broadinitial UpdatedasCDiselected Updatedbasedondevelop mentstudiesandfocusgroupswithKOLs Finalpre launchbasedonmarketresearchandclinicaltrials Repositionifnecessary Initialverypreliminary Updatedbasedonmarketresearchandfocusgroups Finalpre launchbasedoninputfrommarketsandtrials Rebrandedonlyinunusualsituations CoverskeydimensionsProductdevelopmentGlobalmarketingProductsupplyPatentsEtc Toplevelmilestonesandmoredetailedactivities Bestpracticetargetsfor extend phase Examplesofproductextensions Patientbasedinnovation Safety tolerabilityprofile Lineextensions Pharmaco economic Further expandedindications Newindication Examplesofproductextensions Waystocreateproductextension Description Examples Capturingbenefitsofcontinuedresearch Source UKofficeofHealthEconomics MarketletterJune13 2001 25 40 ofsalesoftopsellingdrugsinUK USAareforindicationsdiscoveredonlyafterthedrugswerelaunched Impactofnewindications ExperienceshowsSubstantialspillovereffectsfrombeingfirstcompanytolaunchindicationFirstmovercangetupto10 moremarketshareevenwhereoff labelexistsThefollower runningthesameindications usuallyisnotabletoimprovehismarketposition ExampleofpossibleindicationsforSSRIsMajordepressionPreventionofrelapseofdepressionPremenstrualdysphoricdisorderAnxiety generalandpanicattacksObsessivecompulsivedisordersEatingdisorders anorexiaandbulimiaSubstanceabuseSocialphobia Wherecancompanygainsharebypioneeringindications Wherecancompanyleverageclasseffect SustainedresultswithproactiveLifeCycleManagement exampleVoltaren Source IMS Patentlife extended10yearsafterexpirythroughproactiveproductre launchesUSD1billionglobalsalesin1997 SalesinGermanyDEMMillions Patentexpiry Gel Sustainedrelease Suppository Plain GlobalmarketsharePercent 1993 94 95 96 97 1982 83 84 85 86 87 88 89 90 91 92 93 0 40 80 120 160 IncreasingchallengetomaintainKOLnetworkdemandsfocus SponsoredSupported Characterization Thoughtleaders Providecriticaldata Prescribers MarketingmeasuresScientificeventsinitiatedbycompanyInvolvementinsalesforcetraining Influencers Heavilyinvolvedinteaching Followers CommandvastmajorityofprescriptionsVeryheterogeneousandvolatilelimitedunderstanding Laggards Lagbehindnewtherapydevelopments SpecialcompanyeventstoleverageOPLs e g Semi Annualupdate forheavyprescribersSalesforcevisits Informationusingmarketingmeasuresotherthansalesforcecontact OPL Highprescribers Lowprescribers Retainingandmotivatingtoptalentoveryearsrequiresmorethanmoney Greattasks DifferentiatedcompensationHightotalcompensation FreedomandautonomyJobhasexcitingchallengesCareeradvancementandgrowth Greatproduct Compensation ValuesandcultureWellmanagedproductCompanyhasexcitingchallengesStrongperformance Bestpracticetargetsfor sustain phase 5keycompetitiveleverstomaximizelatelifecycleNPV Keylevers Possibleactions Internalbarrierstoaddresslifecycleextensions Possibleresponse DeterminewhichgenericcompetitorsarelikelytoenterStudycaseexamplesUsescenariomodelingtoquantifyimpactandassesspotentialopportunity Establishmoresophisticatedrisk rewardmeasuresFocusontotalproductopportunityratherthanannualbudgetingforin lineproductsLCMrevenuesimportanttosustainingperformancethrough droughts OutsourcetheLCMworktoconservein houseresources e g transferringownership Non traditionalskillsneededinlateLifeCycleManagement TraditionalFocus Thisyear sprofitplan RequiredFocus NPVofasset Saleseffectiveness Licensingandacquisitioning partnering Productteam Productteam Today sdiscussion KeyelementsofLifeCycleManagement ThoughtsonhowtoorganizeforLCM Keyissues Designprinciples Drivelifecyclemanagementaroundthemajorplanningevents earlyonmilestonesandlaterinannualplanningcycle Createclearrolesandresponsibilitiesbetweenglobalandmarkets Documentlifecyclemanagementthinkinginasimpledocumentthatpotentiallyisbroaderthanthebusinessplandocument Focusareasandearlyrecommendations Clarifydecision makingaroundLCM MakeLCM plananintegralpartoftollgatedecisionsMakeLCMplanningpartofannualportfoliomanagementprocess Definerolesandresponsibilities Definewhohaswhatresponsibilities Definethecompanylifecycleplan UpgradetheLCM plantoarealannualstrategydocumentforpostlaunchDefinethecompanyLCM plan alignedwithmarkets OrganizeforcreationandmanagementoftheLCM plan Clarifyleadership commercialversustechnicalCreateastanding recurringLCMsub teamincludingkeymarkets MakeLCMapriorityinannualplanning DefinetheroleinannualplanningDefinethecompanyminimumstandardLinkbudgetstoLCMplanning Lifecyclethinkingshouldbepartoftheearlydevelopmenttollgatedecisions ChoiceoffirstindicationTargetlabelassessmentPreliminarytargetTargetlabelevolutionovertimePatent IPstrategy ChoiceofCDandbackupRoughlifecyclevisionFuturedevelopmentactivitiesEvolutionofpositioningUpdatedtargetlabelassessmentStaircaseDevelopmentprojectplanforproposedscenarioScopeScaleInvestmentforspeed UpdatedLCMplanAgreedvisionwithmarketsFuturedevelopmentinitiativesEvolutionofpositioningFuturemarketinginitiativesUpdateddevelopmentprojectplanforproposedscenarioEnsuresupplyUpdatedtargetlabelassessment Final launch targetlabelUpdatedLCMplan Pre CD CDnomination Proofofconcept Approvaltolaunch AgoodLCMplanconsidersabroadrangeofstrategicinitiatives Whatisrequiredtoreachvision objectives Marketingandsales Clinicaldevelopment Other Marketpenetrationprograms Globalpositioningandcoordinationprograms Newmarketing salesapproaches Newclaims indications Lineextensions Repositioningofotherclasses Productionandlogisticsimprovementprogram Renegotiateallianceagreement CreatequalitystandardoverallandwithintheLCMplan ExamplesDecisionsshouldbebasedonadeeperlevelofinsightintooverallmarketsituationthanwhatresidesinanysinglemarketAvoiddoing alittleofeverything Avoidmismatchbetweenglobalandlocalambition BeclearonoverallstrategicdirectionEachplanshouldincreasethefuturevalueofproductbasedondefiningessentialactivitiesforproductgrowthEnsurethatinitiativesfocusonbothdevelopmentandmarketingleversacrosstimeUseinnovativetoolsandframeworktopushthinking e g wargames strategicstaircasesetc Lifecycleplan annualportfolioreviewpostlaunch Chapter Content Qualityguideline 2 Decisionrequired Explainwhatmanagementi

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