the future health ecosystembeappweb.be/wp-content/uploads/2017/05/december13th.pdf · tomorrow’s...

ThefuturehealthecosystemThenewrulestowin

December16th,2016IngridMaes

Ourmissionistobringlifesciencesinnovationstothemarket

Weareadeepsectormanagementconsultingexpertsinstrategymanagement,businessandmarketaccessstrategy,finance&fundingandstrategyimplementation&changemanagementwithalongtrackrecordinhealthcare&lifescience.

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Ourapproachisbasedonconnectingdifferentcapabilitiesprovidingaseamlesslyintegratedservicefromstrategyformulationtoimplementation

• Valuationandfundingservices

• Industryinsightanalysis

• Businessmodelre-alignment

• Strategyformulation&businessplanning,strategyimplementation

• Businessprocesstransformation

• Programmanagement&changemanagement

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• Identifying the key drivers that will shape the future healthcare environment • Understand the resulting implications on the current business

• Future role of Medical• Explore the new way of interacting with stakeholders

The new rules to win and … become successful!

Keyobjectivestoday

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©IngridMaes

Asanindustryweareexperiencingaperfectstorm

Shiftfromcurativetopreventive

InformationmanagementPrecisionmedicine Technological

advancesAging&risingawareness

Unsustainablehealthcarecosts&increasedpayer

scrutiny

Newentrantsmovingintothe

healthecosystem

Thequestforevidence&increased

riskaverseness

Consumerism&digitization,innovativetechnologies

Socio-economic&behavioralinfluences

©IngridMaes

Weareatthe“transistormoment”oflifescience

• Artificial Intelligence• Improvements ofour understanding ofthebrain• Antibiotics• Cancer• Geneediting• Microbiome• Organ regeneration• Stemcells

"Every timeyou talkto Siri, oruse GoogleMaps, you areusing aformofartificialintelligence.Thesame technology couldbe used inmany healthcare applications,

such asanalyzing cancer patient dataand recommending moreeffective

treatments,”GoogleVenturesPresident,Bill Maris

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8technologies areto revolutionize lifesciences:

Thetechnologies arepartoflifescience’s “transistormoment”,atrigger that will enable it to advanceatarate comparable to therapide rise ofcomputing inrecentdecades.

…thesetrendswill havemajorimplications for howwecreate value,our businessmodelsandour ways ofworking

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©IngridMaes

Tomorrow’shealthcaresystemwillbeconnectedandfocusedonoutcomesandactionablehealthcaredata,incentivizingpreventionandcure

1940 1980 2000 2014 2020

Rethinkingtodaytobereadyforthefuture

Theimplication:companieswillhavetoswitchfromsellingproductsorservicestosellingpreventionandmanagingoutcomes.

©IngridMaes

Thefutureecosystemwillbefocusedontheindividual,strengtheningthepoweroftheconsumer…

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Evidencebased&outcomesdriven/value-basedHC

Individualconsumer/patientatthecentre

Ecosystemstakeholdercollaboration&co–

creation

Consumerengagement&prevention,shareddecision-making

Integrating disperseddatasources&bigdata

…thesemegatrendswill havemajorimplications for how wecreate value,our businessmodelsand our wayofworking.

©IngridMaes

…demandingabusinessmodelbasedon4keyelementstoberelevantinthefuturehealthecosystem

Offervaluableinnovation

1.Leveragetechnologyanddata

2.Set-uppartnerships&collaborations

3.Enablestakeholdershareddecision-making

4.

Improvedpatientcare&outcomes/patientcentric-view

©IngridMaes

…demandinganewbusinessmodelbasedon4keyelementstoberelevantinthefutureecosystem

Improvedoutcomes/patient–consumercentric-view

Innovationisnotjustnewproducts,butimprovedoutcomeforstakeholders(unmetmedicalneeds)

Utilising differenttechnologiestogettomorecompetitivesolutions

Partneringbeyondthetraditionaleco-system

Allstakeholdersneedtobeinvolvedindeterminingthevalueofproductsandservices





4.

©IngridMaes

Thenewbusinessmodel:Innovationisnotjustnewproducts,butimprovedoutcomeforthestakeholders





4.


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Butwhatexactlyisinnovation?…andwhosaysaproductorserviceisinnovative?

To succeed choose your business model carefully… What is health innovation? More than just products…

And how will value be created and captured and how will a company secure competitive advantage.

Time

QualityInnovation==Value

X

Cost

Service

X

Source:PwC

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Thereisanincreasingnumberofconsumerhealthcareplayers,alsoenteringthemedicalmarket…

…thatareredefiningindustryboundaries

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Insurersarestartingtomarketdirectlytoconsumers

FMCGandICT/high-techplayersareenteringthehealthspaceandmaster

customerpreferences

Source: Winning the Battle for Consumer Healthcare, AT Kearney; internet search, own analysis

©IngridMaes

InthesamewayalsonewplayersareenteringtheDx market,withsmartconnectedproductscompetitionistransforming

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POCT,wearables,self-testsandmHealth playersmarketdirectly

toconsumers

RocheDx

SiemensDx

AbbottDx

BioMérieux

MajorDx companies

Samsung

Apple

Google

Microsoft

Nike

Qualcomm

IBM

©IngridMaes

Healthconsumerismexamples

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GoogleXwearablewithclinicalgradesensor

Bayer– Nintendo

QualcommLife- 2net™Platform

Novartis/Google– Smartcontactlens

Sources:www.familyware.be/nl/content/be-well-point www.qualcommlife.com/wireless-health;www.bayercontour.com/Blood-Glucose-Monitoring/Didget.aspx

©IngridMaes

“Theempowermentoftheconsumerthroughdigitaltechnologyisfacingbrandswithrealclients…Suddenlytheytalkbackandtheyknowwhattheywantandtheywantitnow!”

Patient centricity isnolonger just viewed asanice-to-have,butacommercialimperative.

Source:EyeforPharma

Consumerismwillurgecompaniestobecomeapartnerinthepatientjourneywithdigitalmediaasenabler

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CollectingreliableQoL evidenceunderreal-worldconditions.

Roche‘sSmartphone-basedRemotePatientMonitoringappforParkinson:

Thedigitalextensionforphysicians,deployedtoaninterventionalPDclinicaltrial

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Source: https://www.youtube.com/watch?v=d2Ofu-Bf_p8

• complementstraditionalphysician-ledassessmentswithautomatedteststhatcontinuouslymeasuresymptomfluctuations.

• FirsttimethatanappisusedtomeasurediseaseandsymptomseverityinamedicinedevelopmentprograminParkinson’sdisease

• Activetestandpassivemonitoring

©IngridMaes

Thenewbusinessmodel:Utilising differenttechnologiestogettomorecompetitivesolutions



2.Set-upartnerships &collaborations


4.


©IngridMaes

Healthoutcomeswillbeanessentialelementandwillacceleratetheshiftfromtreatmenttoprevention

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Pre-natal&birth HealthyLife Asympto-

maticEarly

treatmentOngoingtreatment

Late-stagetreatment

Diagnosticsandmonitoringdevices

Shift

Information,SoftwareandServices

HealthOutcomesDiagnostics Therapeutics

Data&informationfeed-backloop

©IngridMaes

2020“Innovation”meansmuchmorethannewtools;itincludesthedevelopmentandthedeliveryofpatientcenteredsolutions

Thepathto2020

Patient-centered CareBroad,highvolume applications

Affordabletestingthatcanbedone anytime,anywhere,withubiquitous technology

Technology&data: Medical&ConsumerDemand:

Consumer&patientEngagementApplications evolving tosupportmorecomplicatedscreeninganddiagnostics

Screeningformorecomplicateddiseases (e.g.cancer)thatcanbedoneatthepointofneed

onaregularbasis

TheScienceofPreventionGeneticprofiling/PCR testing

Screeningandtestingdone anywherethatenablescustomizedtreatmentplansbasedon

geneticsub-type

Source:ReworkedfromDealactivityandother trends intheIVDsector, PwC,2011;OliverWyman:TheVolume-to-ValueRevolution, 2012

Wirelesspatientmonitoring/mHealth

Smartchipsensornetworks:theinternetof

everything

Bigdata&datascience/expertsystems/thenew

technologystack

Openinnovation&crowdsourcing

©IngridMaes

• NanotherapeuticsDeliveryoftherapeuticagentsorrepair tospecific cellsororgansinthehumanbody

Newtechnologieswillshiftagendasfromtreatmenttopreventionandcureofdiseases…tobecomeanintegralpartofhealthcaredelivery

• RegenerativeMedicineReplacementorregenerationofhumancells torestorenormalfunctionandpotentiallyreverse thecourseofadisease

• GeneTherapyIntroductionofmodifiedDNAintoahumancellwiththeintenttoproduceafunctionalprotein.Assuch,itisaimedfortoimprovetheeffectivenessoftreatmentofsomediseasesandpotentially toprovidecuresforothers

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UsePervasiveMonitoring- miniaturedevicesandwirelessnetworks– InternetofThings,tomonitorpatientsonareal-timebasisintheirhomeenvironment

• ProvidesfeedbackonAdverseEventsordeliversmedicationasrequired

• Improvespatientcompliancebyprovidingimmediate feedbackduringclinical trialsorpost-launch

• 3Dprinting

ofdevices /ondemand production everywhere

©IngridMaes

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Thereisa...agrowingunderstandingofhowthehumanbodyworksatmolecularlevel

Thisledtothedevelopmentofanin-silico modelofthemolecularandcellularcomponentsofthehumanbody,theVirtualMan/Woman

In-silico modelswillallowforpreliminary testingandsimulation inordertogetlaterin-humanat once

In-silico andon-chiptestingtocutclinicaltestingandpredicthowproductdesignswillbehaveinreal-worldenvironments

Physiome ProjectIntegrativefunctionofcells

organsandorganisms

LivingHumanProjectIn-silico modelofthehuman

musculoskeletal system

TheStepConsortiumThehumanbodyasasingle

complexsystem

©IngridMaes

Target ID Design of molecule

Synthesis of molecule

Hit ID/ screening

of molecule

Testing of molecule in

vitro

Testing of molecule in

vivo

Human Pharma-cology

(phase 1)

Therapeutic Exploratory

(phase II)

Therapeutic Confirmatory

(phase III)Submission

Therapeutic Use

(Phase IV)

Current R&D Process

Mixed computer/lab

Lab work

In silico

Testing in Man

Nirvana R&D Process

Target ID Design of Treatment

Testing of treatment

Synthesis of

TreatmentTesting in Man Submission Clinical Use

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TheeffectofnewtechnologiesontheR&Dprocess willresultinreplacementoflargescaleconfirmatorytrialswith“conditional”approvalsand“real-life”trials

Target IDDesign &

initial testing of treatment

Synthesis of treatment

Further testing of treatment in

vitro

Testing of treatment

in vivoTesting in Man Submission Clinical Use

Likely 2020 R&D Process

©IngridMaes

Resultinginexpeditedclinicaldevelopmentwithfewerpatientstoparticipatepriortoachievinglicensingauthorisation

• Confidence inmechanismfromresearchwork

• Epidemiologicaldata

• Diseaseknowledge• Knowledge/data

fromclinicalusageorsimilarproducts

• Proofofvaluerequirements

CIECIS

Launch

FirstintoMan(AdaptiveDesign)20-

100pts

1year 0.5year

1.5years

CIE– Confidence inEfficacyCIS– Confidence inSafety

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LivelicenseClinicalUse

Automatedsubmission/app

rovals

Replacementoflargescaleconfirmatorytrialswith“conditional”approvalsand“real-life”trials,

ByconductingmoreIn-silicomodelingpriortorunningclinicaltrialsthenumberofpatientsandnumberofstudiesneededtogainconfidenceinefficacyandsafetyofamoleculewillbesignificantlyreduced.

©IngridMaes

Thetrue value ofdatadepends ontheinsights youcan extractfrom it by applying powerful dataanalytics

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Increasedprocessingpower

ElectronicHealth

Records(EHR)

Automateddecisionsupport

systems/AI/vector

machines

Expandedstorage

Complexdataanalysis

Computermodelling

Platformstoextractpatterns&deviationsandtovisualizedatainandacrossmultipleclinicaltrialsandinreal-lifewillrenderdatatrulyvaluabletotheallstakeholders

©IngridMaes

Manyrecentlystartedinitiativessupportdata&datascience

Initiative: Description

TheCooperativeModelofHealth(CH)

Cooperativeofindividuals/patients providing healthinformation toanintegratedplatform

i4Health(UK) Providing insightsintopooledNHSmedicaldataforpharmaceuticalresearch

PACeR Collaborativeofleadinghealthcareandbiopharmaceutical organizations toAdvanceClinical electronic Researchand secondary use ofdata

EMIF(IMI)EuropeanMedicalInformationFramework aimstodevelop apatient-levelcommondataandaccessplatformformedicalandresearchdataonobesityandAlzheimer’sdisease.

Fusion Insights GivingfreeaccesstoElectronic Medical Recordsfor generalpractitionersandbusiness modelfocusedonmarketandoutcomes research

Crohnology Patient-poweredresearchnetworktocollectandprovide real-worldevidence dataforCrohn patients

Trends:

• Dataaggregationfromdifferentdatasources

• Empoweredpatientsprovidingdata

• Real-world datacollectionanduse

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©IngridMaes

Thenewbusinessmodel:Partneringbeyondthetraditionaleco-system





4.


©IngridMaes

Thebusinessmodeloftodaymustchangetoonethatfullyembracescollaboration

PRESENT

• CentredonsecuringandprotectionofIP

• Leveragingscale todeliveranextensivesalesandmarketingpresence.

• Singlecompanies,deploying avarietyofcontractualrelationships,but seekingtosecureprofitsontheirown– a‘profitalone’modeland “stay-in-control”model

• Volumedriven

2020

• Patentsalonewillnolongersuffice• Profitalone’modelwillhavegonethesamewayastheblockbustermodel.

• Acompany’sabilitytodevelopcollaborativebusinessmodelswilldictatesuccessinthe2020world.

• The“partnerability index”willbecomekey

• ‘Profitalone’willhavebeenreplacedby‘profitingtogether’bydevelopingnetworksofcollaboration

• Value driven

The“Partner-abilityindex”willdictatesuccess

©IngridMaes

Dueto(Patient,Physician,Payer)shiftingtooutcomes,thepatientismovingtothecenterofthehealthcarestage

Pharma

Provider(hospitals,doctors)

PatientPayors Regulatory

Pharma

Provider

Patient

Payors Regulatory

FutureHistorical

Thisfocusonpatientoutcomesmakesadherenceimprovementandremotepatientmonitoringcriticaltoallstakeholders

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Anexpected alliance thatwill function ina

sophisticatedmanner

©IngridMaes

• Driving patient centricity• Ambassador• Patient-reported outcome measures aiding

patient-centricity within healthcare.• Benefits of treatment from patient

perspective -patient-reported outcomes measures(PROMs) reflecting the “voice of the patient

Therole oftheCPOand thePatient AffairsOffice

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“The new health ecosystem needs tobe more about health than disease, and more about how people live theirlives than about the specificdiseases themselves".

“PROMs are no longer ‘nice to have,’ but critical for successful regulatoryapproval, reimbursement andcredibility to patients".

Pfizer CPO

Katarina Halling, PRO Group Director, AstraZeneca

Dr Anne Beal, Sanofi

©IngridMaes

InnovationisateamsportAllstakeholdersmustbeconvincedtheproductsandservicesareinnovativeandbringrealvalue

Aninnovativeproductorserviceneedsalldecisionmakerstoagreethatitimproves

patientoutcomes

Regulator

Manufac-turer

Research/Academia

Patients Payers

Investors

Healthcareproviders

Prescribers

4.

©IngridMaes

Workingtogethertopulltheoutcomesdatalever

Outcomesproof=price

Understandingthevaluedriversperstakeholdergrouparemostimportantatallpointsinthebusinesscycle

©IngridMaes

Therearemultipledimensionsofproductvalue,beyondefficacyandsafety,supportedbyreal-worldevidence(RWE)

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PatientvalueandHTA(HealthTechnologyAssessments)/Payervalueexpandsvaluedimensionsinhealthpolicyandpractice

(Burdenofillness,effectivenessandsafety

inreal-world,costeffectiveness,budgetimpact)

IntegratedEvidenceGeneration

ProviderValue

SocietalValue

HTA/PayerValue

PatientValue

Clinical Value EconomicValue

• Effectiveness• Cost-effectiveness• Cost-utility• Budgetimpact• Long-termoutcomes

• Morbidity• Mortality• Symptoms

(e.g.pain)• Functionality• Preferences• QualityofLife

• Directandindirectcosts• Cost-outcomesratio• Costconsequences• Healthutilities&QALYs

• Efficacy• Safety• Morbidity• Mortality

• Effectiveness• Tolerabilityandsafety• Compliance• Adherence• Convenience

• Equalaccesstohealthcare• Returntowork,participation• Caregiverburden

©IngridMaes

RWEincreasinglysupportsvaluegenerationacrossallphasesofclinicalresearch

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Phase 1 2 3 3b Launch 4

Valuefoundation Clinical Studies onefficacyandsafety

Real-World Evidenceforvaluegeneration

Literature review&meta-analyses

Review therapyarea/diseases

Epidemiology ofdiseases/indications

Databaseanalysesoftreatmentpractice,clinicalpathways,outcomes

Patientprofilingforimproved riskbenefit/cost-effectiveness

Ethnographicpatientstudiestorefinepatientneeds

ResourceconsumptionwithStandardofCare

Evidenceforcost-effectiveness inHTAcountries

Patient preferences

Compliance&adherence

Comparativeeffectiveness/safety

OutcomesStudies/PragmaticStudies

PointofCarestudiesindatabases

Riskmanagementplan

Pharmacovigilance/Surveillance©IngridMaes

©IngridMaes

• Clinicalstudiesmustbecollaborativelydesignedtoanswerspecificquestionsfromthestart

• Clinicaltrialsofthefuturewillmarrytheneeds ofthepatients,payers,providersandregulatorswiththeagendaofthepharma company

• Datafromacrossthevaluechainwillbetransparentandsharedenablingittobelinkedthroughsemantictechnologytoenhancetrialdesign,patientmonitoringandtreatmentduringstudies

Anewmodelfor designand operation ofclinical trialswill be needed

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� Common agreed agenda� Common, shared infrastructure

Regulator

©IngridMaes

Digital transformation & the new science:

• Big data

• In-silico / virtual R&D

• New analytics

• Translational research

• “Omics”

• Precision medicine / CDx

• Collaborative R&D models

• Externalisation of research: external R&D ecosystem

• Focus on value

• Live-licensing

• Transparent data sharing, RWE

1. 2. 3. 4.New designs for clinical trials:

• Sophisticated, flexible and adaptive clinical trial designs

• Patient-centric trials

• Real-life, in-life trials

• Live-licensing

• Single patient trials

Resultinginfutureclinicaldevelopmenttobevirtual,collaborativeandin-life

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©IngridMaes

Pharmaceuticalcompanieswillneedto:

• CollaborateextensivelyandtransparentlyacrossanintegratedHealthcareValueChaintodelivermedicinespeoplewanttopayfor

• Stoptryingtodoeverythingitselfandworkwithanetworkofgroupstobuildknowledgeandunderstandingaboutthehumanbodyandthepathophysiologyofdiseases

• Decidewhattypeofcompanytheywanttobeandchangetheirbusinessmodel,skillsandculturetoreflectthis

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Aseismicchangeinthepharmaceuticalindustryisrequiredtoremainsuccessful

©IngridMaes

Winnerswillhavetoadoptnewskillsetsandrulestowin

• Ultimatelydrugdevelopmentwillhavetoleadtobetterdrugsatlowercosts/unmetmedicalneeds

• Defineclinical treatmentpathwaysandmakehealthoutcomestheprimaryorientationofscientificengagement

• Conductreal-worldevidenceanalysis

• Embarkondigitalmediaopportunities

• Buildcentralknowledgeanddatarepositories forHEOR

• Dataintegrationwilloffernewinsightsandprovidenewtherapeutic tailoredopportunities

• Runeffectivealliance models• Build “owningthediseasemarket”solutions

• co–creationwithdifferentstakeholderswillbecomekeyforsuccess(partnerabilityindex,stakeholderpowershift)

• Enhancepatientaccess toandbestuseofoptimalmedical treatmentbydemonstratingvalue toHCPandpayersthroughouttheentire lifecycleofaproduct

• Engagewithpatients/consumers

Winnershaveto:


1.Technologyanddata

2.Partnerships&collaborations

3.cross-stakeholder"decisionmaking

4.

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©IngridMaes

• Embracethehealthcarechangeagenda• Masterthecost/benefitalongside

safety/efficacy• Recognisewhereprofitgoesandwhy/

plugleaksinthehealthcaresystem• Creatingvalueforcustomersandcollect

proofofthatvalue,usingRWE• Demonstratetheworthofyour

productswithRWE• Stakeholderengagement(teamsport!)• Runeffectiveallianceandcollaboration

models.

Newskillswillbeimportantinthisnewworld,called“medicalentrepreneurship”

Winnerswilllookforcontributionsto:

©IngridMaes

Tobesuccessfulyourvaluepropositionandbusinessmodelhastofocuson4keyelementstoberelevant


1.Data&technologyinnovationgohandinhand

2.LonerswillbelosersStoptryingtodoeverythingbyyourself

3.Outcomeswilldrivethedialogueandwillbethe“newcurrency”

4.


[email protected]

©IngridMaes

[email protected]

HenryHofmannManagingDirector+41796684097henry.hofmann@inovigate.com

Inovigate BelgiumSneeuwbeslaan 142610AntwerpenBelgium

Inovigate SchweizChristophMerian-Ring114153ReinachSwitzerland

This publication has been prepar ed for general guidance on matters of interes t only, and does not constitute professi onal advice.You should not ac t upon the information contained i n this publication without obtai ning specific professional advice. Norepresentation or warranty (express or implied) is given as to the accuracy or completeness of the information contai ned in thispublication, and, to the extent permitted by law, Inovigate, its mem bers, employees and agents accept no liability, and disclaim allresponsibility, for the consequences of you or anyone else ac ting, or refraining to act, in reliance on the information contai ned inthis publication or for any decision based on it.© 2013 Inovigate. All rights reserved.

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