Laboratory Informatics in the Digital Era - Michael Shanler Research Vice President, Life Science R&D - Paperless Lab Academy
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Laboratory Informatics in the
Digital Era
Michael Shanler
Research Vice President, Life Science R&D
Dynamic Recombination
What We’ll Discuss
Scientific
1. Forces and technology trends impacting Industries
all businesses in the “Digital Era”
2. CIO priorities
Strategic
Technology
3. IT environment for Scientific Industries Trends & IT
Lab IT
4. How technology will enable laboratory
CIO Priorities
innovation transformation
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.
We Are in the Beginning…
…of a Digital
Renaissance
Technologies Supporting “The Nexus of Forces” Enable
Business Transformation
Massive Collaboration - Any X Connectivity –
Cross-organization device, platforms
Complexity Increases Cloud Technology
Big Data & Analytics Distributed Infrastructure
The Collision of the Nexus of Forces and the Internet of Things …
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”
… 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.
CONVERGENCE
9
Of the PHYSICAL…
…with the DIGITAL
Where nearly every asset, consumable, biologic, process, chemical, etc.
will have a data associatedWhat Can we Learn from Yelp
about “Convergence”?
MonocleGartner 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.
Collection
Extract greater
of Devices,
meaning from a
Information,
rapidly expanding
Apps, Services
set of sources
around individuals
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 machinesWhat 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?
Run Grow Transform
InnovationIT FTEs as % of
Revenue
cross industry avg = 3.4%
IT FTEs as % of
Total Employees
= Reduced Internal
cross industry avg = 4.8%! Capabilities!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?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.The New Normal with Distributed R&D & Supply Chain
External Partners Internal Capabilities
PAST Company PRESENT FUTURE
Internal
External Contract / Distributed Shared
Innovation
Transactional Innovation 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 analyticsExternalization…What does the Enterprise Really Know?
R&D “dark Innovation
art” on the
Fringe
Vendor
R&D
Myths New
Activities
Technology
Vaporware
promises Vision
“Shadow IT” Dominates R&D InformaticsVELOCITY VOLUME
BIG
DATA
VARIETY COMPLEXITY
[Image Source: Shutterstock]Application Complexity: How Many Apps Do You Really Use? Need? Want?
Laboratory IT Application Trend
Lower Quality
Too many vendors Higher Costs
(Rationalize Harmonize) = Lower Efficiency
Difficult Innovations
Vendor
Vendor B
Value
A
SDMS LIMS 1
ELN 2 CDS Vendor
Pipeline Z
EDS LIMS 2
ELN 1 Request Inventory
Customization Platform-strategyLaboratory IT Application Trend
Too many vendors
(Rationalize Harmonize)
Vendor
Vendor B
Value
A
SDMS LIMS 1
ELN 2 CDS Vendor
Pipeline Z
EDS LIMS 2
ELN 1 Request Inventory
Customization Platform-strategyLaboratory IT Application Trend
Higher Quality
E-Lab Informatics Platform = Lower Costs
Strategy Higher Efficiency
Easier Innovations
Value
SDMS LIMS 1
ELN 2 CDS
Pipeline
EDS LIMS 2
ELN 1
Lab Informatics Platform When adds
Request Inventory
value
Customization Platform-strategyHyped Informatics Technology
ELN-provided
Research LIMS
by LIMS
SaaS LIMS
SaaS ELN Enterprise QM LIMS
LIMS “4.0”
Lab Informatics ELN
Suites Cloud ELN “3.0”
Generic ELN
Bio ELN Chem ELN QA/QC ELN
Source: Gartner (FEB 2014)Lots of “Bit Players.” Few Enterprise Partners
eCLINICAL CDM IVRS IW RS eCOA ePRO CTMS
Pr oduct
Dat a
Nam
Clinical
es
EDC PV
M onit or in
Safet y
Event
/ Adver se
Repor t ing
eSubm
on
issi Clinical
Sit e
Analyt ics
W ar ehou g Syst em M onit or in
se g
Lab Informatics components categories as claimed by vendors
~ 80
VERY FEW “ENTERPRISE” VENDORS
“Lab
Informatics” Most lack broad functionality.
component Most lack execution
vendors Most don’t have global coverage
tracked Most are built on old architecturesSolution 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 $$’s $$$’sLab
Informatics
experience
has been a
giant, sticky
mess.
So…What to Do?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.The Inevitable.
But the type of cloud will need to
be matched to workflow, needs,
risk aversion, etc.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 G00259030Gartner 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 G00292201Gartner 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 G00291729
The Digital Lab Journey Is Going to Be Wild
• Focus: Leverage
new data sources
and drive informed
decisions
Era
• Outcome: New
Digital business models
leveraging new
entities
People
Electronic
Business
Things
PaperNow imagine a Yelp Monocle (AR) + Laboratory Performance
No Longer Is this Science Fiction
QR code recognition built into Process
..Leverage Laboratory Execution
Improved System of Record
With built in ComplianceProtocol & Consumables Information on Demand
..Record into ELN or LIMSLocation Services With Security + Authentication
Warm up the HPLC
before you arriveDefine Your Future
To make this work…
Systems
People
Laboratory and R&D Workflows; Informatics, S/W.
(Scientist, Managers, Collaborators)
Creative, Insightful Context, Analytics, IT Dynamic processes
Internet-Connected Things
Lab Equipment, Labels, Sensors, Beacons, RFID,
Smart Phones, Wearables (Glasses, watches) Keycards, Tablets.
“smart” productsIncreasing Laboratory IoT Maturity Requires Evolutionary
Investment and New Skills What is required of IT, skills,
processes, technology?
Different Ascendancy Phases of IoT
(1) Incremental and
layered technology
investments, (2)
Prescriptive process changes and
What is the Enteprise (3) new skills required
value of IoT
Predictive Transform “smart”, AI, VPAs, “Cognitive” IoT
Analytics?
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
Level 1 Level 2 Level 3 Level 4 Level 5
IoT
Maturity Initial / Opportunistic / Organized / Enterprise / Transformative
Unaware Visible Proactive Business / Business
Partnerships DifferentiationNow…
….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)Start with Imagining the Journey.
“ Tomorrow, Our scientists will be able to __________.”
In 5 Yrs
In 2 Yrs
TodayGoing Digital Requires New Working Parts
Maturity
How to select the right ones
Who Can
Do it? to work together?
How to put these into motion?
Technology "Hype" How to manage hype and portfolios?
Which
Technology
Bets?
Can you
Pace Layer Approach
Systems of Innovation
execute
Systems of Differentiation
BiModal IT
and
Systems of Record
Manage it?
From, "Hype Cycle for Life Sciences, 2014," 30 July 2014 (G00264354)
Image Source: ShutterstockThe 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.Thank You
Supplemental
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https://aws.amazon.com/compliance/gxp-part-11-annex-11/mHealth Apps to capture analog data, remotely.
Even pull data from Analog,
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