Session 8 - BIO17-Dr. Thani Jambulingam · 2017. 6. 14. · #BIO2017 R&D Marketing Interface Dr. Thani Jambulingam Ph.D., Professor, Pfizer Fellow, Arrupe Research Fellow Department

#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


#BIO2017

Brandsvs.GenericsShares


#BIO2017

Brandsvs.GenericsShares


#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


TimeLaunch

++

- -

Research

#BIO2017

Meeting StakeholdersNeeds




TimeLaunch

++

- -

Research

#BIO2017EarlyMarketingInputCanImproveProductSuccess



$ 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)


Avisionforaproductthatwillmeettheneedsofthemarket


Target attributes(desiredprofile)• Valuedrivers/Positioning• GlobalReach• Pricing/Reimbursement• PatientShare• Revenue– Profitability• Pharmacoeconomics• Investments(R&D,COGS,SGA)• Costofgoods• Licenses,Royalties


Set atthebeginningofclinicaldevelopmentandupdatedonlywhennecessitatedbychangesintheTMP

üPositioningüGlobalSalesForecastüDevelopmentalLogic

üRegulatoryandReimbursement

StrategyüProductValue

#BIO2017StrategicFrameworkTarget MarketProfile(TMP) StrategicTargetProfile(STP) TargetProductProfile(TPP)


Avisionforaproductthatwillmeettheneedsofthemarket

Arecordofthedrugthatismostlikelytolaunch


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


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


CoreProduct

Data

EndPointsPatientPopulation

StudyDesignPharmacoeconomics

CompetitiveComparatorsManufacturing

MarketingInsights


CoreProduct

Data

REMSDiagnostics

DeliverySystemMonitoringSystemProductTracking

DistributionSupportSalesSupport

LoyaltyProgramsBehaviorModification

Programs

MarketingInsights

Services


CoreProduct

Data

CodingReimbursementFormularyStatusRiskSharing

PayforPerformanceCoupons

PatientAssistance

MarketingInsights

Services

Financial


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?

Documents

Session 8 - BIO17-Dr. Thani Jambulingam · 2017. 6. 14. · #BIO2017 R&D Marketing Interface Dr. Thani Jambulingam Ph.D., Professor, Pfizer Fellow, Arrupe Research Fellow Department