The-Role-of-Medical-Affairs-in-Shaping-Brand-Devel

TheRoleofMedicalAffairsinShapingBrandDevelopmentPRINCETONPHARMACOMPLIANCECONFERENCEJune7,2004MichaelEdwinKafrissen,MD,MSPHKeyThemes•ChangingEnvironment–ChangingRolesforMedicalAffairs•MedicalAffairsandItsPartners–HowtheElementsoftheCompanyDiffer•ClinicalCommercialOptimization–Planningvs.Reaction•EnablersandObstaclesMedicalAffairsandHCC•Clinicalcommercialoptimizationrequiresspecializedskills,involvementbeginningindevelopmentandextendingthroughlifecycle.•AmasteryofHCCfacilitatesnotonlylegalandethicalbehaviorbutalsocommercialsuccess.ChangingEnvironment–ChangingRoles1.Whatwedemonstrateiswhatwecansay–label,publication,evidence-base.2.HCCcodifiesbusinessethicsandgoodscience–neithermeetsuniversalagreement.3.Pipeline,developmentcosts,margins–theproduct/moleculelifecyclevalue.4.Customertypes,customerexpectations.MedicalAffairsandPartners–Time&Space*DivisionTimeFocusResearchDevelopment3-10Years+DrugtoDevelopmentApprovalMedicalAffairsCrisis-7YearsLifeCycleNewProduct2-3YearsLaunchBrand¼-1YearMarket&ShareSalesWeek–1YearComp.Plan*Roughexamplesfordiscussion.ClinicalCommercialOptimizationPlanningSteps•Understandmolecule,clinicalissues,customerdrivers.•Earlyadvicefromexperts,KOL’s,promotionalpartners.•Developclinical,epidemiologic,outcomes,andpublicationplan.•Influencerequiresexpertise–teammayevolve.•Executionrequiresexpertise–teammayevolve.•Informationmustbeinplacetopermitappropriateadoption,includingCME.•Flexibility–newdata,newtechnology,competitiveactivity.•Ascustomersconsolidate,evidenceisdemanded,andregulationclarifies,MedicalAffairsrolewillgrowinlifecycleplanning,execution,communication,andepisodicissuemanagement.•Eachproduct/moleculemustbecharacterizedappropriatelyanddevelopedtoitsoptimalextent.AskilledandenabledMedicalAffairsfunctionisthebestinvestmentfortheforeseeablefuture.