Aderenza terapeutica

I Cittadini, i Pazienti e la Rivoluzione Digitale in FarmacologiaLuca Pani, M.D.

Director General, Italian Medicines Agency (AIFA), Rome CHMP and SAWP Member; EUMBT and ERMS ChairEuropean Medicines Agency (EMA), London

@Luca__Pani - [email protected]

Spoleto, 6 Giugno 2015

Modified after D. Singh, DIA Paris 2015

Public Declaration of transparency/interests* Note: For this talk, I am not receiving any compensation *Luca Pani, in accordance with the updated policy on Conflict of Interest Regulations approved by AIFA Board of Directors (25.03.2015) and published on the Official Journal of 15.05.2015 according to 0044 EMA/513078/2010 on the handling of the conflicts of interest for scientific committee members and experts

Interests in pharmaceutical industryNOCurrentlyLast 2 years More than 2 years but less than 5 years agoDirect interests:Employment with a companyxConsultancy for a companyxStrategic advisory role for a companyxFinancial interestsxOwnership of a patentxIndirect interests:Principal investigatorxInvestigatorxIndividuals Institution/Organisation receives a grant or other fundingx


DisclaimerThe views expressed in this presentation are personal and may not be understood or quoted as being made on behalf of or reflecting the position of EMA, AIFA or any of their committees or working parties.

They are not intended to be an official and/or binding regulatory position.

These slides cannot be used without written permission.


We are really talking about Big Data !!And all this is already old data...


Align business strategy to analyticsPharmaceutical organizations need to decide to focus on areas which are core to themWhich area will deliver greatest value in shortest time(Like: Patient safety, Study Design, Patient outcomes)Pressing organizational operational challengeIndustry benchmarking

Develop actionable plan to successfully implement analyticsModified after D. Singh, DIA Paris 2015


How business should manage information and learn from it...Business Optimization Analytical MaturityUnsystematicBasicCompetitiveDifferentiatingBreakawaySpread sheet and excel fileMaster data ManagementBasic data warehouseData warehouse appliances and dashboardsStructured and Unstructured dataAdvanced information managementContent analyticsPredictive, Real time analysisBasic operational needsData orientedLack of analytical skill setManual data manipulationConsistent and trusted reportingStandard data definition and governanceBusiness scenario modellingDeep analytical skill setsInformation is governedActionable insights, pre-emptive and predictive business managementInformation deemed as strategic assetLeverage Big Data


Big Data and Real World Evidence


Data sources in pharma from multiple functions... PlansClaimsMember PopulationsRisk ModelsOpen DataInfluencersPublicationsLongitudinal DataPhysician SurveyLMIEMR, HERQuality of CareOutcomesBiomedical SensorsBlogsHealth WebsitesTwitter/ FacebookHelp websitesPharma WebsitesHigh Throughput Assay DataClinical TrialsDisease ManagementHEORSentimentConsumer SensorsClinicalProviderPatientPayerSocial MediaReal WorldPharma Co.


Personal Sensors are here!


Data Architecture for Big Data AnalysisRegistries, Cohort DBs, SurveysUnstructured / Semi StructuredExternal data source Internal data source UnstructuredApplication dataData Acquisition ETLData VirtualizationData AnalysisData Integration CleaningSemantic AnalysisSemantic & Document RepositoryInternal data source Presentation LayerSemantic SearchSelf Service BIAd-hoc AnalyticsInsights for decision makingClinical/Healthcare Metadata RepositoryDashboardsStatisticalComputingEnvironmentModified after D. Singh, DIA Paris 2015


Critical Success FactorsDevelop a scalable infrastructure that leverages existing and new information assetsAlign people, processes and information to sustain strategic information over timeEstablish end-to-end information-driven strategies and objectives that promote business prioritiesPlan and achieve short-term and long-term ROI


Challenges are not few but many

Right data selection and aggregating widely dispersed dataCost of data aggregationDelivering data in a timely way to the systems and people that need it Providing decision makers with complete and accurate insights Generate information that can have immediate impact on patient treatment or patient safety issuesEnsure data quality, security and privacy standardsEnsuring that a proper architecture platform is established to enable desired resultsModified after D. Singh, DIA Paris 2015


The real challenge...


#thankyou


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Aderenza terapeutica

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