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Bio-IT World Conference & Expo 2017 - Laboratory Informatics in the Fast Lane

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Shooki Grasiani

In order to survive in a rapidly-evolving and competitive environment, organizations must accelerate innovation, adopt agile solutions and remove the barriers to innovation.

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INFORMATICS Laboratory Informatics in the Fast Lane February 10, 2016 Laboratory Informatics in the Fast Lane ABBOTT INFORMATICS CHOOSE TRANSFORMATION Shooki Grasiani Product Management and Global Marketing Specialty Products Shooki.Grasiani@abbott.com Bio-IT | May 2017 | Boston
TODAY’S AGENDA: 30 MINUTES 1 2 3 4 A reality check of the laboratory informatics’ promise The macro-environment shifts The big technology trends and why they matter Adapting your delivery approach to leverage the power of these trends
WHAT IS LABORATORY INFORMATICS? “Laboratory informatics is the specialized application of information technology aimed at optimizing laboratory operations. It is a collection of informatics tools utilized within laboratory environments to collect, store, process, analyze, report, and archive data and information from the laboratory and supporting processes. Laboratory informatics includes the integration of systems, the electronic delivery of results to customers, and the supporting systems including training and policies. Examples of laboratory informatics include: LIMS, ELNs, CDS, and SDMS” ASTM.org (2016)
WHAT IS LABORATORY INFORMATICS?
Enter presentation title February 12, 2018 OF THE LABORATORY INFORMATICS’ REALITY CHECK PROMISE CHOOSE TRANSFORMATION
THE PROMISE… “Improved transparency to lab work status” “Powering ground-breaking research” “Reduced costs and improved efficiency” “Reduced out of specs results” “Simplifies regulatory compliance” “Minimizes errors or ’lost’ data” “Get consistent quality across sites” “Reduced Cycle time by over 200%” “make new drug development easier”
REALITY CHECK Let’s look at Some data!  Has Laboratory Informatics improved productivity?  Has Laboratory Informatics helped to ensure compliance?
HAS LABORATORY INFORMATICS IMPROVED PRODUCTIVITY?  Drug companies are producing half as many drugs at triple the cost as two decades ago.  These companies are forced to cut cost and reinvent themselves, concentrating on the core strength and outsourcing function like R&D.
HAS LABORATORY INFORMATICS IMPROVED PRODUCTIVITY?  Figuring out why better science hasn’t meant more drugs is one of the great puzzles facing the global pharmaceuticals industry.  Informatics hasn’t help to move the needle so far. NMEs per $B R&D spent (inflation adjusted)
HAS LABORATORY INFORMATICS HELPED TO ENSURE COMPLIANCE?  FDA 483 citations are on the rise almost in every industry.  Strong spikes in the Food and drug categories. FDA 483 Inspection Citations * Source: Chemical Engineering magazine, March 2014,
#1 challenge to fulfil the laboratory informatics promise?
Enter presentation title February 12, 2018 THE MACRO-ENVIRONMENT SHIFTS CHOOSE TRANSFORMATION
CHANGE IN MANUFACTURING DISTRIBUTION  In 2010 China finally overtook the USA to becoming the leading manufacturer  Japan and Germany are also declining % of value added in global manufacturing
CHANGE IN R&D SPENDING  The outsourcing trend moved from manufacturing to R&D.  Europe is declining while Asia is on the rise. R&D Spending Relative to the US between 2007-15
PHD DEGREES IN NATURAL SCIENCE & ENGINEERING  Workers with S&E expertise are an integral part of a nation’s innovative capacity  China took the lead in 2007  More than half of the S&E graduates in the US are foreign- born. Many go back to their native countries post graduation PhD degrees in natural sciences and engineering, by selected country/economy
DISTRIBUTION OF PATENTS IS CHANGING  In 2010, for the first time in history, China surpassed the United States in total patent filings.  Transition from “Made in China” to “Thought of, designed, developed and made in China”  The switch to “First to file” from “First to invent” will accelerate IP filings Patent applications for the top 5 offices
THE SHIFT IN INNOVATION IN PHARMA AND BIOTECH Companies in the top 20 pharma decreased their share of origination of new molecular entities (NMEs) from 73% to 50% over the last decade  Shift: growing number of smaller companies  This means smaller labs, fewer people and pressure for more automation  Employees wearing more than one hat  Diverse organizations - comes and go  Takeaway: Not exactly inline with enterprise informatics Source: IMS Health World Reviews and MIDAS, December 2014. World Review 2005 & 2010.
Enter presentation title February 12, 2018 THE BIG TECHNOLOGY TRENDS AND WHY THEY MATTER CHOOSE TRANSFORMATION
CONSUMERIZATION ”Consumerization is the specific impact that consumer- originated technologies can have on enterprises. It reflects how enterprises will be affected by, and can take advantage of, new technologies and models that originate and develop in the consumer space, rather than in the enterprise IT sector.” Gartner (2016)
CONSUMERIZATION MOBILITY, REAL TIME APPLICATION AND FREEWARE Users Users spend less time in the office and expect to be able work anytime anywhere and have access to all their work resources Devices The explosion of devices is a challenge for the standard-based approach of corporate IT. Researches use glasses with augmented reality technology. Apps There are apps for everything. Users are used to free apps that are convenient and enabling real time access. Growing usage in business for Google Apps and collaboration tools.
CONSUMERIZATION UX AND RESPONSIVE DESIGN MODERN LOOK AND FEEL Captivating colors, layout and controls that reflect modern & flat application designs GREATER FOCUS ON USER EXPERIENCE The user experience is being redesigned to be intuitive and elegant HTML5/ W3C & RESPONSIVE DESIGN Leveraging HTML5/W3C and using responsive design technology to adapt to your screen size and orientation. Why?  Expectations: functional is no longer enough  Future proof: Different range of screens and resolutions demand responsive design  Better buy-in: visual objects create positive emotional reactions among users  Efficiency: Simpler UX reduces support and training cost
CLOUD DEPLOYMENT VALUE PROPOSITION CAPEX TO OPEX Month by month subscription rather than large capital investment upfront FASTER TIME TO LAUNCH Get up and running quickly SCALE AS YOU NEED Start with what you need now, add licenses over time as your grow DATA CENTER FACILITIES Top tier hardware and software ACCESS TO IT SUBJECT MATTER EXPERTS Resources with Server, Database and Network Admin Experience REDUNDANCY & DISASTER RECOVERY Backup and Disaster Recovery Plans in Place REDUCED COST Reduce your overall costs LET US MANAGE YOUR INFORMATICS SOFTWARE, SO YOU CAN FOCUS ON RUNNING YOUR BUSINESS
CLOUD DEPLOYMENT GROWTH OF BUSINESS APPLICATION SAAS Source: Apps Run The World, April 2016  As of 2013, SalesForce.com made it onto the list of top 10 enterprise software for the first time for a SaaS company  Now Amazon (70% growth 2014-2015) and Adobe also made it to the list.  The arrival of SaaS providers among the elite says a lot about the growing importance of the cloud for business applications
CLOUD DEPLOYMENT THE EVOLUTION
ANALYTICS & BIG DATA THE CHALLENGE OF BIG DATA VOLUME (SCALE) A lot of data. Cannot be handled by a single database, computer or spreadsheet. UNDERSTANDING DATA Rows and columns must be translated into meaningful insights VARIETY (SOURCE) Data may be in disparate sources, unstructured, unpredictable size & rate of arrival. VELOCITY (SPEED) Process incoming data and get answers quickly enough. DATA QUALITY The data is jeopardized if the data is not accurate or timely. Is data governance in place to ensure the data is clean? What about outliers?
ANALYTICS IT’S A DATA LAND GRAB DATA LAKES A shift that uses Hadoop technology to deliver insight across large, broad, diverse set of data. It helps correlating data to other data. DATA AS A SERVICE Product and Data that can be provided on demand BENEFITS  Agility – no need for extensive knowledge of the underlying data  Cost-effectiveness – SMEs build the base and outsource the presentation layer  Data quality – using sophisticated algorithms PRICING MODELS  Quantity-based pricing – related to the amount of used data  Pay per call - charge for each call from the customer to the API WHY? BECAUSE DATA IS POWER.
SELF-SERVICE & AUTOMATION WHY DOES SELF SERVICE MATTER? “Control leads to compliance, autonomy leads to engagement” Daniel Pink Author, Drive: The surprising truth about what motivates us Empowering employee and enabling self-service approach is the next big movement in business education. Those who embrace it will thrive.
Enter presentation title February 12, 2018 Cloud Deployment  Flexibility  Speed  Intelligence  Ease of Use Wearable Mobile User Experience Elastic App Platform using PaaS Big Data Analytics Self Service & Automation LEAN/ Business Process Management (BPM) Social Collaboration THE FUTURE OF INFORMATICS APPLICATIONS
Cloud Deployment Wearable Mobile User Experience Elastic App Platform using PaaS Analytics Self Service & Automation Business Process Management (BPM) Social Collaboration  Flexibility  Speed  Intelligence  Ease of Use THE FUTURE OF INFORMATICS APPLICATIONS Would this technology enough to solve your lab challenges?
Enter presentation title February 12, 2018 ADAPTING YOUR DELIVERY APPROACH TO LEVERAGE THE POWER OF THESE TRENDS CHOOSE TRANSFORMATION
#1 challenge to fulfil the laboratory informatics promise?
Proprietary and confidential — do not distribute 32 ADAPTING YOUR PROCESSES TECHNOLOGY IS NOT ENOUGH… Best in Breed “Good Enough” Complex Simple & Agile Data Management Insight Management Efficiency, Compliance Focus (training & instrumentation) Value Focus Operations Innovation Site Level Support Self-Support, Empower Users
INFORMATICS Laboratory Informatics in the Fast Lane February 10, 2016 THANK YOU CHOOSE TRANSFORMATION Shooki Grasiani Product Management and Global Marketing Specialty Products, Abbott Informatics Shooki.Grasiani@abbott.com Asset #: M2017-05-005-US-AP Bio-IT | May 2017 | Boston

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Bio-IT World Conference & Expo 2017 - Laboratory Informatics in the Fast Lane

  • 1. INFORMATICS Laboratory Informatics in the Fast Lane February 10, 2016 Laboratory Informatics in the Fast Lane ABBOTT INFORMATICS CHOOSE TRANSFORMATION Shooki Grasiani Product Management and Global Marketing Specialty Products Shooki.Grasiani@abbott.com Bio-IT | May 2017 | Boston
  • 2. TODAY’S AGENDA: 30 MINUTES 1 2 3 4 A reality check of the laboratory informatics’ promise The macro-environment shifts The big technology trends and why they matter Adapting your delivery approach to leverage the power of these trends
  • 3. WHAT IS LABORATORY INFORMATICS? “Laboratory informatics is the specialized application of information technology aimed at optimizing laboratory operations. It is a collection of informatics tools utilized within laboratory environments to collect, store, process, analyze, report, and archive data and information from the laboratory and supporting processes. Laboratory informatics includes the integration of systems, the electronic delivery of results to customers, and the supporting systems including training and policies. Examples of laboratory informatics include: LIMS, ELNs, CDS, and SDMS” ASTM.org (2016)
  • 4. WHAT IS LABORATORY INFORMATICS?
  • 5. Enter presentation title February 12, 2018 OF THE LABORATORY INFORMATICS’ REALITY CHECK PROMISE CHOOSE TRANSFORMATION
  • 6. THE PROMISE… “Improved transparency to lab work status” “Powering ground-breaking research” “Reduced costs and improved efficiency” “Reduced out of specs results” “Simplifies regulatory compliance” “Minimizes errors or ’lost’ data” “Get consistent quality across sites” “Reduced Cycle time by over 200%” “make new drug development easier”
  • 7. REALITY CHECK Let’s look at Some data!  Has Laboratory Informatics improved productivity?  Has Laboratory Informatics helped to ensure compliance?
  • 8. HAS LABORATORY INFORMATICS IMPROVED PRODUCTIVITY?  Drug companies are producing half as many drugs at triple the cost as two decades ago.  These companies are forced to cut cost and reinvent themselves, concentrating on the core strength and outsourcing function like R&D.
  • 9. HAS LABORATORY INFORMATICS IMPROVED PRODUCTIVITY?  Figuring out why better science hasn’t meant more drugs is one of the great puzzles facing the global pharmaceuticals industry.  Informatics hasn’t help to move the needle so far. NMEs per $B R&D spent (inflation adjusted)
  • 10. HAS LABORATORY INFORMATICS HELPED TO ENSURE COMPLIANCE?  FDA 483 citations are on the rise almost in every industry.  Strong spikes in the Food and drug categories. FDA 483 Inspection Citations * Source: Chemical Engineering magazine, March 2014,
  • 11. #1 challenge to fulfil the laboratory informatics promise?
  • 12. Enter presentation title February 12, 2018 THE MACRO-ENVIRONMENT SHIFTS CHOOSE TRANSFORMATION
  • 13. CHANGE IN MANUFACTURING DISTRIBUTION  In 2010 China finally overtook the USA to becoming the leading manufacturer  Japan and Germany are also declining % of value added in global manufacturing
  • 14. CHANGE IN R&D SPENDING  The outsourcing trend moved from manufacturing to R&D.  Europe is declining while Asia is on the rise. R&D Spending Relative to the US between 2007-15
  • 15. PHD DEGREES IN NATURAL SCIENCE & ENGINEERING  Workers with S&E expertise are an integral part of a nation’s innovative capacity  China took the lead in 2007  More than half of the S&E graduates in the US are foreign- born. Many go back to their native countries post graduation PhD degrees in natural sciences and engineering, by selected country/economy
  • 16. DISTRIBUTION OF PATENTS IS CHANGING  In 2010, for the first time in history, China surpassed the United States in total patent filings.  Transition from “Made in China” to “Thought of, designed, developed and made in China”  The switch to “First to file” from “First to invent” will accelerate IP filings Patent applications for the top 5 offices
  • 17. THE SHIFT IN INNOVATION IN PHARMA AND BIOTECH Companies in the top 20 pharma decreased their share of origination of new molecular entities (NMEs) from 73% to 50% over the last decade  Shift: growing number of smaller companies  This means smaller labs, fewer people and pressure for more automation  Employees wearing more than one hat  Diverse organizations - comes and go  Takeaway: Not exactly inline with enterprise informatics Source: IMS Health World Reviews and MIDAS, December 2014. World Review 2005 & 2010.
  • 18. Enter presentation title February 12, 2018 THE BIG TECHNOLOGY TRENDS AND WHY THEY MATTER CHOOSE TRANSFORMATION
  • 19. CONSUMERIZATION ”Consumerization is the specific impact that consumer- originated technologies can have on enterprises. It reflects how enterprises will be affected by, and can take advantage of, new technologies and models that originate and develop in the consumer space, rather than in the enterprise IT sector.” Gartner (2016)
  • 20. CONSUMERIZATION MOBILITY, REAL TIME APPLICATION AND FREEWARE Users Users spend less time in the office and expect to be able work anytime anywhere and have access to all their work resources Devices The explosion of devices is a challenge for the standard-based approach of corporate IT. Researches use glasses with augmented reality technology. Apps There are apps for everything. Users are used to free apps that are convenient and enabling real time access. Growing usage in business for Google Apps and collaboration tools.
  • 21. CONSUMERIZATION UX AND RESPONSIVE DESIGN MODERN LOOK AND FEEL Captivating colors, layout and controls that reflect modern & flat application designs GREATER FOCUS ON USER EXPERIENCE The user experience is being redesigned to be intuitive and elegant HTML5/ W3C & RESPONSIVE DESIGN Leveraging HTML5/W3C and using responsive design technology to adapt to your screen size and orientation. Why?  Expectations: functional is no longer enough  Future proof: Different range of screens and resolutions demand responsive design  Better buy-in: visual objects create positive emotional reactions among users  Efficiency: Simpler UX reduces support and training cost
  • 22. CLOUD DEPLOYMENT VALUE PROPOSITION CAPEX TO OPEX Month by month subscription rather than large capital investment upfront FASTER TIME TO LAUNCH Get up and running quickly SCALE AS YOU NEED Start with what you need now, add licenses over time as your grow DATA CENTER FACILITIES Top tier hardware and software ACCESS TO IT SUBJECT MATTER EXPERTS Resources with Server, Database and Network Admin Experience REDUNDANCY & DISASTER RECOVERY Backup and Disaster Recovery Plans in Place REDUCED COST Reduce your overall costs LET US MANAGE YOUR INFORMATICS SOFTWARE, SO YOU CAN FOCUS ON RUNNING YOUR BUSINESS
  • 23. CLOUD DEPLOYMENT GROWTH OF BUSINESS APPLICATION SAAS Source: Apps Run The World, April 2016  As of 2013, SalesForce.com made it onto the list of top 10 enterprise software for the first time for a SaaS company  Now Amazon (70% growth 2014-2015) and Adobe also made it to the list.  The arrival of SaaS providers among the elite says a lot about the growing importance of the cloud for business applications
  • 25. ANALYTICS & BIG DATA THE CHALLENGE OF BIG DATA VOLUME (SCALE) A lot of data. Cannot be handled by a single database, computer or spreadsheet. UNDERSTANDING DATA Rows and columns must be translated into meaningful insights VARIETY (SOURCE) Data may be in disparate sources, unstructured, unpredictable size & rate of arrival. VELOCITY (SPEED) Process incoming data and get answers quickly enough. DATA QUALITY The data is jeopardized if the data is not accurate or timely. Is data governance in place to ensure the data is clean? What about outliers?
  • 26. ANALYTICS IT’S A DATA LAND GRAB DATA LAKES A shift that uses Hadoop technology to deliver insight across large, broad, diverse set of data. It helps correlating data to other data. DATA AS A SERVICE Product and Data that can be provided on demand BENEFITS  Agility – no need for extensive knowledge of the underlying data  Cost-effectiveness – SMEs build the base and outsource the presentation layer  Data quality – using sophisticated algorithms PRICING MODELS  Quantity-based pricing – related to the amount of used data  Pay per call - charge for each call from the customer to the API WHY? BECAUSE DATA IS POWER.
  • 27. SELF-SERVICE & AUTOMATION WHY DOES SELF SERVICE MATTER? “Control leads to compliance, autonomy leads to engagement” Daniel Pink Author, Drive: The surprising truth about what motivates us Empowering employee and enabling self-service approach is the next big movement in business education. Those who embrace it will thrive.
  • 28. Enter presentation title February 12, 2018 Cloud Deployment  Flexibility  Speed  Intelligence  Ease of Use Wearable Mobile User Experience Elastic App Platform using PaaS Big Data Analytics Self Service & Automation LEAN/ Business Process Management (BPM) Social Collaboration THE FUTURE OF INFORMATICS APPLICATIONS
  • 29. Cloud Deployment Wearable Mobile User Experience Elastic App Platform using PaaS Analytics Self Service & Automation Business Process Management (BPM) Social Collaboration  Flexibility  Speed  Intelligence  Ease of Use THE FUTURE OF INFORMATICS APPLICATIONS Would this technology enough to solve your lab challenges?
  • 30. Enter presentation title February 12, 2018 ADAPTING YOUR DELIVERY APPROACH TO LEVERAGE THE POWER OF THESE TRENDS CHOOSE TRANSFORMATION
  • 31. #1 challenge to fulfil the laboratory informatics promise?
  • 32. Proprietary and confidential — do not distribute 32 ADAPTING YOUR PROCESSES TECHNOLOGY IS NOT ENOUGH… Best in Breed “Good Enough” Complex Simple & Agile Data Management Insight Management Efficiency, Compliance Focus (training & instrumentation) Value Focus Operations Innovation Site Level Support Self-Support, Empower Users
  • 33. INFORMATICS Laboratory Informatics in the Fast Lane February 10, 2016 THANK YOU CHOOSE TRANSFORMATION Shooki Grasiani Product Management and Global Marketing Specialty Products, Abbott Informatics Shooki.Grasiani@abbott.com Asset #: M2017-05-005-US-AP Bio-IT | May 2017 | Boston