The future health ecosystembeappweb.be/wp-content/uploads/2017/05/december13th.pdf · Tomorrow’s...
Transcript of 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
Offervaluableinnovation
1.Leveragetechnologyanddata
2.Set-uppartnerships&collaborations
3.Enablestakeholdershareddecision-making
4.
©IngridMaes
Thenewbusinessmodel:Innovationisnotjustnewproducts,butimprovedoutcomeforthestakeholders
Offervaluableinnovation
1.Leveragetechnologyanddata
2.Set-uppartnerships&collaborations
3.Enablestakeholdershareddecision-making
4.
Improvedpatientcare&outcomes/patientcentric-view
©IngridMaes
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
©IngridMaes
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
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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©IngridMaes
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
Offervaluableinnovation
1.Leveragetechnologyanddata
2.Set-upartnerships &collaborations
3.Enablestakeholdershareddecision-making
4.
Improvedpatientcare&outcomes/patientcentric-view
©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
Offervaluableinnovation
1.Leveragetechnologyanddata
2.Set-uppartnerships&collaborations
3.Enablestakeholdershareddecision-making
4.
Improvedpatientcare&outcomes/patientcentric-view
©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
Thenewbusinessmodel:Allstakeholdersneedtobeinvolvedindeterminingthevalueofproductsandservices
Offervaluableinnovation
1.Leveragetechnologyanddata
2.Set-uppartnerships&collaborations
3.Enablestakeholdershareddecision-making
4.
Improvedpatientcare&outcomes/patientcentric-view
©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:
Offervaluableinnovation
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
Offervaluableinnovation
1.Data&technologyinnovationgohandinhand
2.LonerswillbelosersStoptryingtodoeverythingbyyourself
3.Outcomeswilldrivethedialogueandwillbethe“newcurrency”
4.
Improvedpatientcare&outcomes/patientcentric-view
©IngridMaes
HenryHofmannManagingDirector+41796684097henry.hofmann@inovigate.com
Inovigate BelgiumSneeuwbeslaan 142610AntwerpenBelgium
Inovigate SchweizChristophMerian-Ring114153ReinachSwitzerland
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