Session 8 - BIO17-Dr. Thani Jambulingam · 2017. 6. 14. · #BIO2017 R&D Marketing Interface Dr....
Transcript of Session 8 - BIO17-Dr. Thani Jambulingam · 2017. 6. 14. · #BIO2017 R&D Marketing Interface Dr....
#BIO2017
R&DMarketingInterface
Dr.ThaniJambulingamPh.D.,Professor,PfizerFellow,ArrupeResearchFellow
DepartmentofPharmaceuticalandHealthcareMarketingErivanK.HaubSchoolofBusiness
SaintJoseph’sUniversityPhiladelphia,PA19131
13thAnnualBiotechnologyEntrepreneurshipBootCampBIOInternationalConvention
June18,2017
#BIO2017
LearningObjectives• Highlighttheimportanceofcommercialteaminputintoproduct
developmentstrategyinaearlystagebiotech/medicaldevicecompany
• Understandtheroleofmarketinginearlystagecompaniestoshapetheproductlifecycletoachievethebestcommercialsuccess.
• Describetheprocessofcreatingacommerciallyappealingtargetproductprofile(TPP).
• LearnhowtodevelopaTPPframeworktodeliverbetteroutcomes.
#BIO2017Trends• Healthcarepriority:costcontrol,accessandpricetransparency
• Decreasingaccesstophysicians
• Shiftingpowerbalancetowardpayers
• Reimbursementmodelsfocusonvalue/outcome
• Growthofalternativedeliverymodelsandpartnerships
• Digitaltransformationenhancingpatientcentricityandengagement
#BIO2017
PharmaLossofExclusivity
Source:MedicinesuseandspendingintheU.S.– IMSReport, May2017
#BIO2017
SegmentsofPharmaceuticalMarket
Source:UnderstandingtheNewCommercialModelsinthePharmaceuticalIndustry– AnIMSReport,2009
#BIO2017
GrowthofSpecialtyProducts
Source:MedicinesuseandspendingintheU.S.– IMSReport, May2017
#BIO2017
Brandsvs.GenericsShares
Source:MedicinesuseandspendingintheU.S.– IMSReport, May2017
#BIO2017
Brandsvs.GenericsShares
Source:MedicinesuseandspendingintheU.S.– IMSReport, May2017
#BIO2017CMSFrameworkCategorizingPaymentstoProviders
Description
MedicareFee-for-Serviceexamples
§ Paymentsarebasedonvolumeofservicesandnotlinkedtoqualityorefficiency
Category1:FeeforService–NoLinktoValue
Category2:FeeforService–LinktoQuality
Category3:AlternativePaymentModelsBuiltonFee-for-ServiceArchitecture
Category4:Population-BasedPayment
§ Atleastaportionofpaymentsvarybasedonthequalityorefficiencyofhealthcaredelivery
§ Somepaymentislinkedtotheeffectivemanagementofthepopulationoranepisodeofcare
§ Paymentsstilltriggeredbydeliveryofservices,butopportunitiesforsharedsavingsor2-sidedrisk
§ Paymentisnotdirectlytriggeredbyservicedeliverysovolumeisnotlinkedtopayment
§ Cliniciansandorganizationsarepaidandresponsibleforthecareofabeneficiaryforalongperiod(e.g.,≥1year)
§ LimitedinMedicarefee-for-service
§ MajorityofMedicarepaymentsnowarelinkedtoquality
§ Hospitalvalue-basedpurchasing
§ PhysicianValueModifier
§ Readmissions/HospitalAcquiredConditionReductionProgram
§ AccountableCareOrganizations§ Medicalhomes§ Bundledpayments§ ComprehensivePrimaryCareinitiative
§ ComprehensiveESRD§ Medicare-MedicaidFinancialAlignmentInitiativeFee-For-ServiceModel
§ EligiblePioneerAccountableCareOrganizationsinyears3-5
§ Marylandhospitals
Source:RajkumarR,ConwayPH,TavennerM.CMS─engagingmultiplepayersinpaymentreform.JAMA2014;311:1967-8.
#BIO2017
2016
30%
85%
2018
50%
90%
CMSTargetPercentageof‘AlternativePaymentModels’by2016- 2018
2014
~20%
>80%
20110%
~70%
GoalsHistoricalPerformance
AllMedicareFFS(Categories1-4)FFSlinkedtoquality(Categories2-4)Alternativepaymentmodels(Categories3-4)
Source:RajkumarR,ConwayPH,TavennerM.CMS─engagingmultiplepayersinpaymentreform.JAMA2014;311:1967-8.,CMSwebsite
#BIO2017WhatProportionoftheLaunchesareInnovative?
InthevaluedrivenpostAccountableCareAct(ACA)eraonly24percentofthelaunches
wouldbetrulyinnovative
Source:BeyondtheStorm:TheLaunchExcellenceintheNewNormal,McKinseyReport2013,pp.6
#BIO2017
InnovativeProduct
Adifferentiatedproduct(solution)thatoffersameaningful advantage(value)overexisting
treatmentsforagivencondition
Howcanmarketingshapetheproduct?
#BIO2017
4 Ps, As, & Objectives of Marketing
4Ps 4As Objectives
Product Acceptability AddressUnmet Needs
Price Affordability ValuetoPayers
Place Accessibility CreateConvenience
Promotion Awareness CommunicationofValue
#BIO2017HowtoImprovetheProbabilityofSuccess?
$Development Launch Patent Loss
TimeLaunch
++
- -
Research
•SignificantsunkcostsduringR&Dandpoormarketperformanceoftheproductwillbecostly•Canearlystageandcontinuousmarketinginputchangethis?
#BIO2017
IdealProductLifeCycle
Simultaneous and smooth global launch
R&D Efficiencies /Effectiveness
$Development Launch Patent Loss
TimeLaunch
++
- -
Research
#BIO2017
Meeting StakeholdersNeeds
Simultaneous and smooth global launch
R&D Efficiencies /Effectiveness
$Development Launch Patent Loss
TimeLaunch
++
- -
Research
#BIO2017EarlyMarketingInputCanImproveProductSuccess
Simultaneous and smooth global launch
R&D Efficiencies /Effectiveness
$ Development Launch Patent Loss Time
Launch
++
- -
Research
MarketingInput
#BIO2017WhatwillcollaborationachieveFrom…..
Org
aniz
atio
nal
Rol
esSt
ages
of
Dev
elop
men
t
Discovery
Pre-Clinical
Manufacturing
Marketing
Sales
RegulatoryClinical
Discovery ExploratoryDevelopment
FullDevelopment Registration Launch Post-Launch
Growth
IP HEOR/Pricing/Reimbursement
#BIO2017WhatwillcollaborationachieveTo…..anIntegratedCommercialModel
Org
aniz
atio
nal
Rol
esSt
ages
of
Dev
elop
men
t
Discovery Marketing
Discovery ExploratoryDevelopment
FullDevelopment Registration Launch Post-Launch
Growth
Development(preclinical, clinical, regulatory)
IntellectualProperty
UpstreamRoleofMarketingisCriticalfordevelopinganIdealLabelandProductSuccess!
HEOR/ PricingReimbursement Manufacturing
Sales
#BIO2017
What is TPP?
21
• In2007FDAcreatedaguidancedocumentonTPPasastrategicprocessdevelopmenttooltofacilitateeffectivecommunicationbetweentheindustryandreviewstaff
• TPPisthedirectionaltoolthathasasignificantimpactonthedrugdevelopmentprocessandinparticular,itsmarketingorganization
• TPPconvertdiscoveriesintocompanies!
• MarketingaspartofcommercialteamcanshapetheTPP
#BIO2017Startwithendinmind:Howshouldthelabellooktomeetcustomerneeds?
SustainableTPPsatisfyingmarketneeds
Patient
HCP
Pharmacist
Payer
Conductmarketresearchtogaininsightsoncustomerneeds
#BIO2017HowcanTPPbeshapedbyMarketing?
• Indication
• Dosageform
• Dose,frequency
• Differentiation
– Efficacy
– Safety
– Economic
AttributesShapedbyMarketing
n Proposedindication
n Developformulation
n Developtrade-dress
n Establishefficacy/superiority
n Establishsafetyadvantage
n Developforpediatricuse
n Pharmacoeconomicdata
TPP
#BIO2017
Whoshouldworktogether?
SustainableTPPsatisfyingmarketneeds
Regulatory
Marketing
Clinical
Research
Goal:Todeliverstrongdevelopmentplanwith
superiorclinicalperformance,patientbenefitandhealtheconomicvalue
#BIO2017
TargetMarketProfile(TMP)
StrategicTargetProfile(STP)TargetProductProfile(TPP) DynamicSummaryof
thedrugthatismostlikelytolaunch
Avisionofhowtheproductshouldmeet
theneedsofthemarket
Delineatestheunmetneedsofthemarketforwhichtheproductis
viable
STRATEGIC FRAMEWORK
Source:Tebbey,PaulW.andCharlesRink,“TPP:ARenaissanceforitsDefinitionandUse,JournalofMedicalMarketing,Vol.9(4),301-307.
#BIO2017StrategicFrameworkTarget MarketProfile(TMP)
Purpose Captures allthekeyinformationaboutthemarket
Content Therapeuticareas/diseases• UnmetNeed• PatientPopulations• Driversofuse• Competitiveassessment• Economiccostofdisease
Rigidity CreatebeforetheSTPorTPPDetailsareupdatedasfindingsemerge,butcorefactschangeonlyinresponsetomajormarketevents
#BIO2017StrategicFrameworkTarget MarketProfile(TMP) StrategicTargetProfile(STP) TargetProductProfile(TPP)
Purpose Captures allthekeyinformationaboutthemarket
Avisionforaproductthatwillmeettheneedsofthemarket
Content Therapeuticareas/diseases• UnmetNeed• PatientPopulations• Driversofuse• Competitiveassessment• Economiccostofdisease
Target attributes(desiredprofile)• Valuedrivers/Positioning• GlobalReach• Pricing/Reimbursement• PatientShare• Revenue– Profitability• Pharmacoeconomics• Investments(R&D,COGS,SGA)• Costofgoods• Licenses,Royalties
Rigidity CreatebeforetheSTPorTPPDetailsareupdatedasfindingsemerge,butcorefactschangeonlyinresponsetomajormarketevents
Set atthebeginningofclinicaldevelopmentandupdatedonlywhennecessitatedbychangesintheTMP
üPositioningüGlobalSalesForecastüDevelopmentalLogic
üRegulatoryandReimbursement
StrategyüProductValue
#BIO2017StrategicFrameworkTarget MarketProfile(TMP) StrategicTargetProfile(STP) TargetProductProfile(TPP)
Purpose Captures allthekeyinformationaboutthemarket
Avisionforaproductthatwillmeettheneedsofthemarket
Arecordofthedrugthatismostlikelytolaunch
Content Therapeuticareas/diseases• UnmetNeed• PatientPopulations• Driversofuse• Competitiveassessment• Economiccostofdisease
Target attributes(desiredprofile)• Valuedrivers• Global• Pricing/Reimbursement• PatientShare• Revenue– Profitability• Pharmacoeconomics• Investments(R&D,COGS,SGA)• Costofgoods• Licenses,Royalties
Indications andusage(label)• Dosingandadministration• Contraindications• Warningsandprecautions• Adversereactions• Description• ClinicalPharmacology• ClinicalStudies• Storageandhandling
Rigidity CreatebeforetheSTPorTPPDetailsareupdatedasfindingsemerge,butcorefactschangeonlyinresponsetomajormarketevents
Set atthebeginningofclinicaldevelopmentandupdatedonlywhennecessitatedbychangesintheTMP
Updatedasclinicalandpharmacologic findingsemergeandinresponsetoguidancefromregulatoryauthorities
#BIO2017QuestionsthatneedstobeaskedandansweredduringtheTPPprocess
Source:BeginwithEndinMind– WhitePaperPremierResearch,2015
#BIO2017
PortfolioOptimization– Go/NoGo
• Specification– TPP– Current,Minimal,Ideal&Expected
• Resources– ManpowerandCost
• Timeline– MilestoneSchedule
• Risk– ProbabilityofSuccess(Technical,Commercial)
#BIO2017TPPinGo/NoGoDecisions
#BIO2017TPPCriteria
#BIO2017
SampleTPP
Source:https://neuroscienceblueprint.nih.gov/resources/target-product-profile.htm,accessedJune14,2017
#BIO2017BestDevelopmentStrategies…• Usethestrategicframework(TMP,STP)toshapeTPPanddefineclinicaland
commercialvalue
• TPPprovidesdevelopmentallogicandsavescosttodrugdiscoveryanddevelopmentprogramandmeettheneedsofthemarketplace
• EncouragesrightdialogwithinthecompanyandwiththeFDAtooptimizelabelandpromotabilityforcommercialsuccess
• Theidealdevelopmentstrategyidentifykeymilestones-criticaltimes,whentheabilityofaprojecttoattainitsTPPcanbeassessed- andestablish“go/nogo”successcriteria
#BIO2017
MarketingCreate“BeyondthePill”Solution
CoreProduct
IndicationsDosageForm
DoseFrequencyEfficacySafety
#BIO2017MarketingCreate“BeyondthePill”Solution
CoreProduct
IndicationsDosageForm
DoseFrequencyEfficacySafety
MarketingInsights
Marketingshouldshapethe“Label”fortheproduct
#BIO2017MarketingCreate“BeyondthePill”Solution
CoreProduct
Data
EndPointsPatientPopulation
StudyDesignPharmacoeconomics
CompetitiveComparatorsManufacturing
MarketingInsights
#BIO2017MarketingCreate“BeyondthePill”Solution
CoreProduct
Data
REMSDiagnostics
DeliverySystemMonitoringSystemProductTracking
DistributionSupportSalesSupport
LoyaltyProgramsBehaviorModification
Programs
MarketingInsights
Services
#BIO2017MarketingCreate“BeyondthePill”Solution
CoreProduct
Data
CodingReimbursementFormularyStatusRiskSharing
PayforPerformanceCoupons
PatientAssistance
MarketingInsights
Services
Financial
#BIO2017MarketingCreate“BeyondthePill”Solution
CoreProduct
Data
Services
Financial
PerceivedValue
MarketingInsightstoManageTrustandPerceivedValue
#BIO2017
Source:Tyndallet.al.TheTPPasatoolforregulatorycommunication:advantageousbutunderused,Nature,March2017,pp.156
ResearchshowsTPPisvaluablebutunderused
#BIO2017
Source:Tyndallet.al.TheTPPasatoolforregulatorycommunication:advantageousbutunderused,Nature,March2017,pp.156
ResearchshowsTPPValuablebutUnderused
#BIO2017FinalRemarks• Startwithendinmind• StrengthentheR&DMarketing(Commercial)interface• Assemblecrossfunctionalcommercialdevelopmentteam• Assignamarketingmanagertothedevelopmentteam• Incorporatemarketresearchandcompetitiveintelligencein
clinicaltrialplanningandlabeldevelopment• Engagepayersearlyontogetvaluableinputindevelopment• SuccessiswhenthefinalversionofTPPissimilartotheannotated
draftlabeling!
#BIO2017
Questions?