Laboratory Informatics In The Digital Era

Transcription

Laboratory Informatics in theDigital EraMichael ShanlerResearch Vice President, Life Science R&D

Dynamic Recombination

What We’ll DiscussScientificIndustries1. Forces and technology trends impactingall businesses in the “Digital Era”2. CIO priorities3. IT environment for Scientific Industries4. How technology will enable laboratoryinnovation transformationStrategicTechnologyTrends & ITLab ITCIO Priorities

Forces Impacting All Businesses#3CONFIDENTIAL AND PROPRIETARY 2015 Gartner, Inc. and/or its affiliates. All rights reserved. Gartner and ITxpo are registered trademarks of Gartner, Inc. or it's affiliates.

We Are in the Beginning of a DigitalRenaissance

Technologies Supporting “The Nexus of Forces” EnableBusiness TransformationMassive Collaboration -Any X Connectivity –Cross-organizationdevice, platformsComplexity IncreasesBig Data & AnalyticsCloud TechnologyDistributed Infrastructure

The Collision of the Nexus of Forces andthe Internet of Things

The Collision of the Nexus of Forces andthe Internet of Things 2009:1.6B personal devices 1B “things” 2020:7B personal devices 30B “things”

Has Spawned “Digital Business” Digital Business Is the Creation ofNew Business Designs by Blurringthe Digital and Physical Worlds. Digital Business Is SpecificallyFocused on Peer Exchange andCommunication Between:Business (Including Process andInformation), People and PhysicalThings as Equal Entities.

CONVERGENCE 9Of the PHYSICAL with the DIGITALWhere nearly every asset, consumable, biologic, process, chemical, etc.will have a data associated

What Can we Learn from Yelpabout “Convergence”?Monocle

Gartner Strategic Technology Trends#11 CONFIDENTIAL AND PROPRIETARY 2015 Gartner, Inc. and/or its affiliates. All rights reserved. Gartner and ITxpo are registered trademarks of Gartner, Inc. or it's affiliates.

CollectionExtract greaterof Devices,meaning from aInformation,rapidly expandingApps, Servicesset of sourcesaround individualsTop 10StrategicTechnologyTrendstechnology architectures and platforms must changeto support the world of digital and autonomous business enabledby the digital mesh and smart machines

What Are the CIO Priorities?#13 CONFIDENTIAL AND PROPRIETARY 2015 Gartner, Inc. and/or its affiliates. All rights reserved. Gartner and ITxpo are registered trademarks of Gartner, Inc. or it's affiliates.

Life Science IT Spending – Where’s the money going?RunGrowTransformInnovation

cross industry avg 3.4%IT FTEs as % ofRevenueIT FTEs as % ofTotal Employeescross industry avg 4.8%! Reduced InternalCapabilities!

CIO Top Priorities Contextualizedfor Laboratory ITHow do I better understand what is happening in my test?How do I improve the ROI of my Lab IT Systems?How do I scale globally (or reduce costs of on-premises IT)?How do I offer better remote capabilities for labs?“How can I leverage scientific data and insights more broadly?How do I better protect my data in shared environments?How do we improve collaboration for experiments?

Meanwhile, What is the Lab IT Environmentfor Scientific industries?#17 CONFIDENTIAL AND PROPRIETARY 2015 Gartner, Inc. and/or its affiliates. All rights reserved. Gartner and ITxpo are registered trademarks of Gartner, Inc. or it's affiliates.

The New Normal with Distributed R&D & Supply ChainExternal PartnersPASTInternal External Contract /Transactional InnovationDistributed SharedInnovation Technology-based strategic partners to execute clinical development activities Increased collaboration, increased access Globalized infrastructures for sharing very complex R&D / Manuf. data Extreme agility required for clinical insights delivered via analytics

Externalization What does the Enterprise Really Know?R&D “darkart”VendorMythsInnovationon gyVision“Shadow IT” Dominates R&D Informatics

VELOCITYVOLUMEBIGDATAVARIETY[Image Source: Shutterstock]COMPLEXITY

Application Complexity: How Many Apps Do You Really Use?Need? Want?

Laboratory IT Application TrendLower QualityToo many vendors(Rationalize Harmonize) Higher CostsLower EfficiencyValueDifficult InnovationsVendorAVendorBSDMSELN 2PipelineELN 1LIMS 1CDSLIMS trategy

Laboratory IT Application TrendValueToo many vendors(Rationalize Harmonize)VendorAVendorBSDMSELN 2PipelineELN 1LIMS 1CDSLIMS trategy

Laboratory IT Application TrendHigher QualityE-Lab Informatics PlatformStrategy Lower CostsHigher EfficiencyValueEasier InnovationsSDMSELN 2PipelineELN 1LIMS 1CDSLIMS 2EDSRequestInventoryCustomizationLab Informatics PlatformWhen addsvaluePlatform-strategy

Hyped Informatics TechnologyELN-providedby LIMSResearch LIMSSaaS LIMSSaaS ELNEnterpriseLIMS “4.0”Lab InformaticsSuitesCloud ELNQM LIMSELN“3.0”Generic ELNBio ELNSource: Gartner (FEB 2014)Chem ELNQA/QC ELN

Lots of “Bit Players.” Few Enterprise PartnersPr oducteCLINICALCDMIVRSIW RSeCOAePROCTMSNamesClinicalDat aW ar ehouseEDCPVMonit or ingSafet y/Adver seEventRepor t ingSyst emeSubmissionClinicalSit eMonit or ingAnalyt icsLab Informatics components categories as claimed by vendors 80“LabInformatics”VERY FEW “ENTERPRISE” VENDORSMost lack broad functionality.componentMost lack executionvendorsMost don’t have global coveragetrackedMost are built on old architectures

Solution Suitability for R&D ITSolution SuitabilityLKJYes, the capabilities Increase .but .IHthe long term IT complexity, validation challenges & costs increase, too.GFEDCCORECONFIGURECUSTOMIZEBAVery LowLowCoreGartner, Inc (2015) ’sMediumHighVery HighConfigurationCustomization ’s ’s

LabInformaticsexperiencehas been agiant, stickymess.So What to Do?

How to understand the relationships?Today’s ChallengesWill Be Overcome CreatingSignificant OpportunitiesWhat does this mean for Laboratory IT?#29 CONFIDENTIAL AND PROPRIETARY 2015 Gartner, Inc. and/or its affiliates. All rights reserved. Gartner and ITxpo are registered trademarks of Gartner, Inc. or it's affiliates.

The Inevitable.But the type of cloud will need tobe matched to workflow, needs,risk aversion, etc.

Gartner Prediction – ELN challengesBy 2017, 80% of ELN* will underperform due tochanging R&D needs and unsustainable servicemodels, requiring replacement or overhauls.*process and data workflowsPredicts 2014: Manufacturer R&D Gets Smarter About Innovation in the Digitalized Era02 December 2013 G00259030

Gartner Prediction – Big Data Project ChallengesBy 2019, 30% of the top 100 life science R&D ITorganizations will have successfully moved bigdata projects from proof of concept (POC) andpilots into production.*process and data workflowsPredicts 2016: Digital Generates Business Value Opportunities in Life Science02 December 2015 G00292201

Gartner Prediction – Multiples R&D IssuesBy 2018, (only) 15% of manufacturers will use turnkey solutions to translatescientific information into engineering-based new product development(NPD) actions.By 2019, the blurring of industry boundaries will drive 25% of major R&Dactivities, enabling brand-new digital products and services.By 2018, 90% of scientific R&D organizations will struggle entering the"digital era," due to hurdles with legacy laboratory systems and unfamiliarIoT environments.Predicts 2016: The Rise of Digital R&D Without Borders01 December 2015 G00291729

The Digital Lab Journey Is Going to Be Wild Focus: Leveragenew data sourcesand drive informeddecisionsEraDigitalElectronic Outcome: Newbusiness modelsleveraging newentitiesPeopleBusinessThingsPaper

Now imagine a Yelp Monocle (AR) Laboratory Performance

No Longer Is this Science Fiction

QR code recognition built into Process.Leverage Laboratory ExecutionImproved System of RecordWith built in Compliance

Protocol & Consumables Information on Demand.Record into ELN or LIMS

Location Services With Security AuthenticationWarm up the HPLCbefore you arrive

Define Your Future

To make this work SystemsPeopleLaboratory and R&D Workflows; Informatics, S/W.(Scientist, Managers, Collaborators)Creative, InsightfulContext, Analytics, ITDynamic processesInternet-Connected ThingsLab Equipment, Labels, Sensors, Beacons, RFID,Smart Phones, Wearables (Glasses, watches) Keycards, Tablets.“smart” products

Increasing Laboratory IoT Maturity Requires EvolutionaryInvestment and New SkillsWhat is required of IT, skills,processes, technology?Different Ascendancy Phases of IoT(1) Incremental andlayered technologyinvestments, (2)process changes and(3) new skills requiredPrescriptiveWhat is the Enteprisevalue of IoTAnalytics?PredictiveTransformInnovate systemsDiagnosticDescriptiveIoT Autonomics, ML, rules enginesModel & Simulate characterize productsIoT, HPC, graph computingIoT Analytics and visualization, semantic enrichmentCollect observe and experiment (point to point)Connect Devices, Systems (point to point)IoTMaturity“smart”, AI, VPAs, “Cognitive” IoTBeacons, sensors, IoT InfrastructureLevel 1Level 2Level 3Level 4Level 5Initial /UnawareOpportunistic /VisibleOrganized /ProactiveEnterprise /BusinessPartnershipsTransformative/ BusinessDifferentiation

Now .Imagine Your Lab of theFuture TransformInnovate systemsModel & Simulate characterize productsCollect observe and experiment (point to point)Connect Devices, Systems (point to point)

Start with Imagining the Journey.“ Tomorrow, Our scientists will be able to .”In 5 YrsIn 2 YrsToday

Going Digital Requires New Working PartsMaturityWho CanDo it?Technology "Hype" How to select the right onesto work together? How to put these into motion? How to manage hype and portfolios?WhichTechnologyBets?Pace Layer ApproachSystems of InnovationSystems of DifferentiationSystems of RecordCan youexecuteBiModal ITandManage it?From, "Hype Cycle for Life Sciences, 2014," 30 July 2014 (G00264354)Image Source: Shutterstock

The future is unknown, but the technology precursors forbig changes are here, today.The ability to live with that uncertainty and then embrace itquickly will be a key success factor in the future.Help the stakeholders visualize new businessopportunities that are enabled by IT and technology.

Thank You

Supplemental

ing AWS in GxP art-11-annex-11/

mHealth Apps to capture analog data, remotely.Even pull data from Analog,Unconnected equipment

Hyped Informatics Technology Source: Gartner (FEB 2014) ELN "3.0" Enterprise LIMS "4.0" Lab Informatics Suites Bio ELNChem QA/QC ELN Generic ELN SaaS ELN Cloud ELN QM LIMS Research LIMS ELN-provided by LIMS SaaS LIMS