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Data Integration for the Life Sciences Industry
Regulatory, Compliance and Operational Challenges and
Best Practice Solutions
Christopher C. Biddle


November 2010




           2933 West Germantown Pike    Toll Free : 800 618-0836
           Building 2, Suite 204        Fax : 610 666-1006
           Fairview Village, Pa 19409   Email : info@idealnetinc.com
           USA
Taking Your Business to the Next Level™




   Agenda
   • IdealNet Corporate Overview

   • Compliance Challenges: Past, Present, & Future

   • Regulation – Ramifications for Non Compliance

   • Data required to Maintain Compliance

   • Existing and Historical Data Integration Approaches
   • Common Pain Points with Existing Approaches
   • Introduction to Data Virtualization
   • Data Virtualization – Enable Business Intelligence (BI)
   • Easy Data Integration and Ongoing Data Management (Harmonization)
     thru MDM


                                           Page 2                        © 2010 IdealNet, Inc.
IdealNet Corporate Overview
Taking Your Business to the Next Level™



  • Ideal Systems, Inc. was formed in 1994 : provided Enterprise Software and
    consulting

  • IdealNet, Inc. was formed in 2002 and absorbed the Ideal Systems, Inc.
    consulting practice

  • Provides expert Business and Technical consulting services to Life Sciences
    customers

  • Clients include all of the top 10 Tier 1 Pharmaceutical Manufacturers as well
    as numerous Tier 2 Manufacturers and Biotech, Medical Device, Hospital
    Group Purchasing Organizations (GPOs), and Distributors

  • Areas of expertise include Commercial and Regulatory Contracting, Finance,
    Business Intelligence & Analytics, and Sales Force Automation

  • Many years of experience in implementing, integrating, and upgrading
    Enterprise Software solutions for Life Sciences customers

  • Based on the East Cost in a Philadelphia, PA suburb with clients throughout
    the world                                            Page 3                     © 2010 IdealNet, Inc.
IdealNet Partial Client List
Taking Your Business to the Next Level™




                                                           Page 4        © 2010 IdealNet, Inc.
Compliance Challenges: Past, Present, and Future
Taking Your Business to the Next Level™



  The Past (and ongoing)

  •Food and Drug Administration (FDA) regulations

  •Centers for Medicare & Medicaid Services (CMS)
    – Medicaid

  •Commercial Contracts
    – Chargebacks

  The Present (and ongoing)

  •Centers for Medicare & Medicaid Services (CMS)
    – Government Pricing
    – Deficit Reduction Act (DRA)
    – Medicare Part D

  The Future (and ongoing)

  •The Healthcare Reform Act (HCA)

  •Aggregate Spend                                       Page 5                       © 2010 IdealNet, Inc.
Regulation – Ramifications for Non Compliance
Taking Your Business to the Next Level™



  • Products temporarily or permanently pulled from the market by the FDA

  • Large Fines and Settlements for violations
     – For example, Best Price violation settlements in excess of $100 million
       each

  • Office of Inspector General (OIG) Audits

  • Expanded powers to pursue charges directly against corporate
    executives
     – Direct fines
     – Incarceration

  • Market effects of bad publicity




                                                         Page 6                      © 2010 IdealNet, Inc.
Data required to Maintain Compliance
Taking Your Business to the Next Level™



  • Enterprise Resource Planning (ERP)
     – SAP, JDEdwards, Oracle

  • Clinical Trial Systems

  • New Drug Application (NDA)

  • Internal Data Warehouse

  • Custom, “Home Grown” Systems

  • Supply Chain Systems
     – Contract Management
     – Sales Tracing

  • Warehouse & Distribution Management Systems

  • Document Repository Systems




                                                         Page 7                  © 2010 IdealNet, Inc.
Existing and Historical Data Integration Approaches
Taking Your Business to the Next Level™


  Extract, Transform, Load (ETL)

  •Informatica®

  •Talend®

  •SAP Business Objects Data Integrator™

  •Etc…

  Enterprise Application Integration (EAI)

  •Microsoft BizTalk®

  •Apache Camel®

  •Guaraná DSL

  •Etc…

  Home grown

  •SQL (Oracle PLSQL, Microsoft SQLServer, etc…)

  •3G Programming Languages (C++, J2EE, etc…)             Page 8                       © 2010 IdealNet, Inc.
Common Pain Points with Existing Approaches
Taking Your Business to the Next Level™


  • Numerous segments of custom vendor or internal code
     – Easily breaks when any underlying data structure or associated
       technology changes
     – Requires constant, expensive maintenance
     – Often, proprietary development technologies are involved which raises
       cost

  • Setup and Deployment of Tools is Cumbersome
     – Non intuitive or only partially intuitive User Interfaces
     – Requirements for intermediary data warehouse structures
        • Significant synchronization issues
        • Low performance due to movement of massive data sets
     – High price consultants with expertise in the specific tools are required to
       implement and often for subsequent changes

  • Closed or Obsolete Architectures
     – The technology is not scalable for future needs
     – Connectivity to new database technologies or data source objects is
       severely limited or non-existent                 Page 9                       © 2010 IdealNet, Inc.
Introduction to Data Virtualization
Taking Your Business to the Next Level™


  Queplix

  •Provides immediate and comprehensive visibility to all
  data (tables, fields, etc…) across all data sources

  •Automatically integrates with underlying security
  models for each data source

  •Empowers business users as well as IT like No Other
  tool or option
    – Easy to use and uniform User Interface allows users to
       setup and control all aspects of data integration
    – Automatically uses vendor approved APIs within
       Software Blades for all data sources
    – Non invasive approach via Metadata layer does not
       disrupt underlying data sources
    – Very flexible while simultaneously providing class
       leading performance

                                                          Page 10               © 2010 IdealNet, Inc.
Data Virtualization – Enable Business Intelligence (BI)
Taking Your Business to the Next Level™


• Users can rapidly design and build meaningful BI reports and
  dashboards

• No requirement for IT or outside consultants to modify a “data
  catalog” to add, change, or delete fields

• No intermediary Data Warehouse means : no performance
  drain via large movements of data, elimination of dangerous
  data synchronization issues, any BI tool can access the
  Queplix model as opposed to some which require proprietary,
  intermediary data stores

• Underlying data source changes are automatically reflected
  within Queplix in a manner which does not “break” any usage
  at any level




                                                          Page 11                        © 2010 IdealNet, Inc.
Easy Data Integration and Ongoing Data Management
                                                       (Harmonization) thru MDM
Taking Your Business to the Next Level™




 • Unlike existing ETL or EAI tools, Queplix both connects data easily And Harmonizes it
    – Rules are controlled by the User
    – Straightforward User Interface with no coding required
    – Underlying rules within each data source are also automatically accommodated

 • Legacy, custom data integration and harmonization code can be completely replaced

 • Internal, home grown relational database sources can also be accessed and harmonized via Queplix.
   Again, No coding required

 • As data sources are virtual, Queplix then allows for ease of movement for underlying local data
   sources to migrate to the Cloud or SaaS model
                                                         Page 12                               © 2010 IdealNet, Inc.
Thank You
Talk to a Queplix or IdealNet representative now to
schedule a demo or Proof of Concept initiative
Contact Christopher C. Biddle at cbiddle@idealnetinc.com




                          Visit us online at www.idealnetinc.com



         2933 West Germantown Pike              Toll Free : 800 618-0836
         Building 2, Suite 204                  Fax : 610 666-1006
         Fairview Village, Pa 19409             Email : info@idealnetinc.com
         USA

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IdealNet and Queplix Webinar

  • 1. Data Integration for the Life Sciences Industry Regulatory, Compliance and Operational Challenges and Best Practice Solutions Christopher C. Biddle November 2010 2933 West Germantown Pike Toll Free : 800 618-0836 Building 2, Suite 204 Fax : 610 666-1006 Fairview Village, Pa 19409 Email : info@idealnetinc.com USA
  • 2. Taking Your Business to the Next Level™ Agenda • IdealNet Corporate Overview • Compliance Challenges: Past, Present, & Future • Regulation – Ramifications for Non Compliance • Data required to Maintain Compliance • Existing and Historical Data Integration Approaches • Common Pain Points with Existing Approaches • Introduction to Data Virtualization • Data Virtualization – Enable Business Intelligence (BI) • Easy Data Integration and Ongoing Data Management (Harmonization) thru MDM Page 2 © 2010 IdealNet, Inc.
  • 3. IdealNet Corporate Overview Taking Your Business to the Next Level™ • Ideal Systems, Inc. was formed in 1994 : provided Enterprise Software and consulting • IdealNet, Inc. was formed in 2002 and absorbed the Ideal Systems, Inc. consulting practice • Provides expert Business and Technical consulting services to Life Sciences customers • Clients include all of the top 10 Tier 1 Pharmaceutical Manufacturers as well as numerous Tier 2 Manufacturers and Biotech, Medical Device, Hospital Group Purchasing Organizations (GPOs), and Distributors • Areas of expertise include Commercial and Regulatory Contracting, Finance, Business Intelligence & Analytics, and Sales Force Automation • Many years of experience in implementing, integrating, and upgrading Enterprise Software solutions for Life Sciences customers • Based on the East Cost in a Philadelphia, PA suburb with clients throughout the world Page 3 © 2010 IdealNet, Inc.
  • 4. IdealNet Partial Client List Taking Your Business to the Next Level™ Page 4 © 2010 IdealNet, Inc.
  • 5. Compliance Challenges: Past, Present, and Future Taking Your Business to the Next Level™ The Past (and ongoing) •Food and Drug Administration (FDA) regulations •Centers for Medicare & Medicaid Services (CMS) – Medicaid •Commercial Contracts – Chargebacks The Present (and ongoing) •Centers for Medicare & Medicaid Services (CMS) – Government Pricing – Deficit Reduction Act (DRA) – Medicare Part D The Future (and ongoing) •The Healthcare Reform Act (HCA) •Aggregate Spend Page 5 © 2010 IdealNet, Inc.
  • 6. Regulation – Ramifications for Non Compliance Taking Your Business to the Next Level™ • Products temporarily or permanently pulled from the market by the FDA • Large Fines and Settlements for violations – For example, Best Price violation settlements in excess of $100 million each • Office of Inspector General (OIG) Audits • Expanded powers to pursue charges directly against corporate executives – Direct fines – Incarceration • Market effects of bad publicity Page 6 © 2010 IdealNet, Inc.
  • 7. Data required to Maintain Compliance Taking Your Business to the Next Level™ • Enterprise Resource Planning (ERP) – SAP, JDEdwards, Oracle • Clinical Trial Systems • New Drug Application (NDA) • Internal Data Warehouse • Custom, “Home Grown” Systems • Supply Chain Systems – Contract Management – Sales Tracing • Warehouse & Distribution Management Systems • Document Repository Systems Page 7 © 2010 IdealNet, Inc.
  • 8. Existing and Historical Data Integration Approaches Taking Your Business to the Next Level™ Extract, Transform, Load (ETL) •Informatica® •Talend® •SAP Business Objects Data Integrator™ •Etc… Enterprise Application Integration (EAI) •Microsoft BizTalk® •Apache Camel® •Guaraná DSL •Etc… Home grown •SQL (Oracle PLSQL, Microsoft SQLServer, etc…) •3G Programming Languages (C++, J2EE, etc…) Page 8 © 2010 IdealNet, Inc.
  • 9. Common Pain Points with Existing Approaches Taking Your Business to the Next Level™ • Numerous segments of custom vendor or internal code – Easily breaks when any underlying data structure or associated technology changes – Requires constant, expensive maintenance – Often, proprietary development technologies are involved which raises cost • Setup and Deployment of Tools is Cumbersome – Non intuitive or only partially intuitive User Interfaces – Requirements for intermediary data warehouse structures • Significant synchronization issues • Low performance due to movement of massive data sets – High price consultants with expertise in the specific tools are required to implement and often for subsequent changes • Closed or Obsolete Architectures – The technology is not scalable for future needs – Connectivity to new database technologies or data source objects is severely limited or non-existent Page 9 © 2010 IdealNet, Inc.
  • 10. Introduction to Data Virtualization Taking Your Business to the Next Level™ Queplix •Provides immediate and comprehensive visibility to all data (tables, fields, etc…) across all data sources •Automatically integrates with underlying security models for each data source •Empowers business users as well as IT like No Other tool or option – Easy to use and uniform User Interface allows users to setup and control all aspects of data integration – Automatically uses vendor approved APIs within Software Blades for all data sources – Non invasive approach via Metadata layer does not disrupt underlying data sources – Very flexible while simultaneously providing class leading performance Page 10 © 2010 IdealNet, Inc.
  • 11. Data Virtualization – Enable Business Intelligence (BI) Taking Your Business to the Next Level™ • Users can rapidly design and build meaningful BI reports and dashboards • No requirement for IT or outside consultants to modify a “data catalog” to add, change, or delete fields • No intermediary Data Warehouse means : no performance drain via large movements of data, elimination of dangerous data synchronization issues, any BI tool can access the Queplix model as opposed to some which require proprietary, intermediary data stores • Underlying data source changes are automatically reflected within Queplix in a manner which does not “break” any usage at any level Page 11 © 2010 IdealNet, Inc.
  • 12. Easy Data Integration and Ongoing Data Management (Harmonization) thru MDM Taking Your Business to the Next Level™ • Unlike existing ETL or EAI tools, Queplix both connects data easily And Harmonizes it – Rules are controlled by the User – Straightforward User Interface with no coding required – Underlying rules within each data source are also automatically accommodated • Legacy, custom data integration and harmonization code can be completely replaced • Internal, home grown relational database sources can also be accessed and harmonized via Queplix. Again, No coding required • As data sources are virtual, Queplix then allows for ease of movement for underlying local data sources to migrate to the Cloud or SaaS model Page 12 © 2010 IdealNet, Inc.
  • 13. Thank You Talk to a Queplix or IdealNet representative now to schedule a demo or Proof of Concept initiative Contact Christopher C. Biddle at cbiddle@idealnetinc.com Visit us online at www.idealnetinc.com 2933 West Germantown Pike Toll Free : 800 618-0836 Building 2, Suite 204 Fax : 610 666-1006 Fairview Village, Pa 19409 Email : info@idealnetinc.com USA