Laboratory Informatics in the Digital Era. Michael Shanler Research Vice President, Life Science R&D

Transcription

1 Laboratory Informatics in the Digital Era Michael Shanler Research Vice President, Life Science R&D

2 Dynamic Recombination

3 What We ll Discuss 1. Forces and technology trends impacting all businesses in the Digital Era Scientific Industries 2. CIO priorities 3. IT environment for Scientific Industries Strategic Technology Trends & IT 4. How technology will enable laboratory innovation transformation CIO Priorities Lab IT

4 Forces Impacting All Businesses #3 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.

5 We Are in the Beginning of a Digital Renaissance

6 Technologies Supporting The Nexus of Forces Enable Business Transformation Massive Collaboration - Cross-organization Any X Connectivity device, platforms Complexity Increases Big Data & Analytics Cloud Technology Distributed Infrastructure

7 The Collision of the Nexus of Forces and the Internet of Things

8 The Collision of the Nexus of Forces and the Internet of Things 2009: 1.6B personal devices + 1B things 2020: 7B personal devices + 30B things

9 Has Spawned Digital Business Digital Business Is the Creation of New Business Designs by Blurring the Digital and Physical Worlds. Digital Business Is Specifically Focused on Peer Exchange and Communication Between: Business (Including Process and Information), People and Physical Things as Equal Entities.

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

11 What Can we Learn from Yelp about Convergence? Monocle

12 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.

13 Collection of Devices, Information, Apps, Services around individuals Extract greater meaning from a rapidly expanding set of sources Top 10 Strategic Technology Trends technology architectures and platforms must change to support the world of digital and autonomous business enabled by the digital mesh and smart machines

14 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.

15 Life Science IT Spending Where s the money going? Run Grow Transform Innovation

16 cross industry avg = 3.4% IT FTEs as % of Revenue IT FTEs as % of Total Employees cross industry avg = 4.8%! = Reduced Internal Capabilities!

17 CIO Top Priorities Contextualized for Laboratory IT How 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?

18 Meanwhile, What is the Lab IT Environment for 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.

19 The New Normal with Distributed R&D & Supply Chain External Partners Internal Capabilities PAST Company PRESENT FUTURE Internal Innovation External Contract / Transactional Innovation Distributed Shared Innovation 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

20 Externalization What does the Enterprise Really Know? R&D dark art Vendor Myths Vaporware promises R&D Activities Innovation on the Fringe New Technology Vision Shadow IT Dominates R&D Informatics

21 VELOCITY VOLUME BIG DATA VARIETY [Image Source: Shutterstock] COMPLEXITY

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

23 Value Laboratory IT Application Trend Too many vendors (Rationalize Harmonize) Vendor A Pipeline ELN 1 ELN 2 Vendor B EDS SDMS CDS Request LIMS 1 LIMS 2 Inventory Customization Vendor Z = Platform-strategy Lower Quality Higher Costs Lower Efficiency Difficult Innovations

24 Value Laboratory IT Application Trend Too many vendors (Rationalize Harmonize) Vendor A Pipeline ELN 1 ELN 2 Vendor B EDS SDMS CDS Request LIMS 1 LIMS 2 Inventory Customization Vendor Z Platform-strategy

25 Value Laboratory IT Application Trend E-Lab Informatics Platform Strategy = Higher Quality Lower Costs Higher Efficiency Easier Innovations SDMS LIMS 1 ELN 2 CDS Pipeline EDS LIMS 2 ELN 1 Request Inventory Customization Lab Informatics Platform Platform-strategy When adds value

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

27 Product Names eclinical CDM IVRS IWRS ecoa epro CTMS Clinical Data Warehou se EDC PV Monitorin g Safety / Adverse Event Reporting System esubmissi on Clinical Site Monitorin g Analytics Lots of Bit Players. Few Enterprise Partners Lab Informatics components categories as claimed by vendors ~ 80 Lab Informatics component vendors tracked VERY FEW ENTERPRISE VENDORS Most lack broad functionality. Most lack execution Most don t have global coverage Most are built on old architectures

28 Solution Suitability for R&D IT Solution Suitability L K J I Yes, the capabilities Increase..but. H the long term IT complexity, validation challenges & costs increase, too. G F E D C CORE CONFIGURE CUSTOMIZE B A Very Low Low Medium High Very High Core Configuration Customization Gartner, Inc (2015) $ s $$ s $$$ s

29 Lab Informatics experience has been a giant, sticky mess. So What to Do?

30 How to understand the relationships? Today s Challenges Will Be Overcome Creating Significant Opportunities What 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.

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

32 Gartner Prediction ELN challenges By 2017, 80% of ELN* will underperform due to changing R&D needs and unsustainable service models, requiring replacement or overhauls. *process and data workflows Predicts 2014: Manufacturer R&D Gets Smarter About Innovation in the Digitalized Era 02 December 2013 G

33 Gartner Prediction Big Data Project Challenges By 2019, 30% of the top 100 life science R&D IT organizations will have successfully moved big data projects from proof of concept (POC) and pilots into production. *process and data workflows Predicts 2016: Digital Generates Business Value Opportunities in Life Science 02 December 2015 G

34 Gartner Prediction Multiples R&D Issues By 2018, (only) 15% of manufacturers will use turnkey solutions to translate scientific information into engineering-based new product development (NPD) actions. By 2019, the blurring of industry boundaries will drive 25% of major R&D activities, 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 unfamiliar IoT environments. Predicts 2016: The Rise of Digital R&D Without Borders 01 December 2015 G

35 The Digital Lab Journey Is Going to Be Wild Era Focus: Leverage new data sources and drive informed decisions Digital Outcome: New business models leveraging new entities Electronic Paper People Business Things

36 Now imagine a Yelp Monocle (AR) + Laboratory Performance

37 No Longer Is this Science Fiction

38 QR code recognition built into Process..Leverage Laboratory Execution Improved System of Record With built in Compliance

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

40 Location Services With Security + Authentication Warm up the HPLC before you arrive

41 Define Your Future

42 To make this work People (Scientist, Managers, Collaborators) Systems Laboratory and R&D Workflows; Informatics, S/W. Creative, Insightful Context, Analytics, IT Dynamic processes Internet-Connected Things Lab Equipment, Labels, Sensors, Beacons, RFID, Smart Phones, Wearables (Glasses, watches) Keycards, Tablets. smart products

43 Increasing Laboratory IoT Maturity Requires Evolutionary Investment and New Skills What is the Enteprise value of IoT Analytics? Different Ascendancy Phases of IoT Predictive Prescriptive Transform What is required of IT, skills, processes, technology? (1) Incremental and layered technology investments, (2) process changes and (3) new skills required smart, AI, VPAs, Cognitive IoT Innovate systems IoT Autonomics, ML, rules engines Diagnostic Model & Simulate characterize products IoT, HPC, graph computing Descriptive Collect observe and experiment (point to point) IoT Analytics and visualization, semantic enrichment Connect Devices, Systems (point to point) Beacons, sensors, IoT Infrastructure IoT Maturity Level 1 Level 2 Level 3 Level 4 Level 5 Initial / Unaware Opportunistic / Visible Organized / Proactive Enterprise / Business Partnerships Transformative / Business Differentiation

44 Now.Imagine Your Lab of the Future Transform Innovate systems Model & Simulate characterize products Collect observe and experiment (point to point) Connect Devices, Systems (point to point)

45 Start with Imagining the Journey. Tomorrow, Our scientists will be able to. In 5 Yrs In 2 Yrs Today

46 Going Digital Requires New Working Parts Maturity Technology "Hype" Who Can Do it? Which Technology Bets? How to select the right ones to work together? How to put these into motion? How to manage hype and portfolios? Pace Layer Approach Systems of Innovation Systems of Differentiation Systems of Record Can you execute BiModal IT and Manage it? From, "Hype Cycle for Life Sciences, 2014," 30 July 2014 (G ) Image Source: Shutterstock

47 The future is unknown, but the technology precursors for big changes are here, today. The ability to live with that uncertainty and then embrace it quickly will be a key success factor in the future. Help the stakeholders visualize new business opportunities that are enabled by IT and technology.

48 Thank You

49 Supplemental

50 e/using_aws_in_gxp_systems.pdf

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