Oracle Pedigree and Serialization Manager (OPSM): A Solution for
Drug Supply Chain Integrity

Robert Nientker
Business Dev...
The following is intended to outline our general
product direction. It is intended for information
purposes only, and may ...
Presentation Topics

• Current Situation Analysis                                                    <Insert Picture Here>...
OPSM Themes and Business Drivers

• Safe and Secure Supply Chain
  • Counterfeit Medication hurts Patients: and YOU
  • Pr...
News… Recent FDA Warnings




           © 2008 Oracle Corporation – Proprietary and Confidential   6
Counterfeit Goods - Big Business

• Counterfeit drug commerce will grow 13% annually through 2010

• In 2010, this illegal...
Importance of Supply Chain Integrity
       Combination of regulatory, global and business pressures
• Global Counterfeiti...
Serialization Business Benefits




Source: AMR Research, “The Track and Trace Paradox: Will the Healthcare Value Chain be...
Anti-Counterfeit Measures


  Safe and Secure Supply Chain

   Authentication                                           (e...
Anti-Counterfeit Measures


         Safe and Secure Supply Chain

         Authentication                                ...
•The California ePedigree Approach
       Tracks Movement Through Each Node in the Supply Chain




 Pedigree ID
  Pedigre...
The Evolving European Approach
Focus on Serialization and Authentication




                             •13
Global Regulatory View
• US States
  • FL and other states are enforcing pedigree-only regulations today
  • CA ePedigree ...
© 2008 Oracle Corporation – Proprietary and Confidential   15
Key ideas for changes to EC legislation submitted for public
 consultation




• Require the outer packaging of medicinal ...
Key ideas for changes to EC legislation submitted for public
 consultation




• Require the possibility to trace each pac...
Key ideas for changes to EC legislation submitted for public
 consultation




• Require the possibility of tracing owners...
Key ideas for changes to EC legislation submitted for public
 consultation




• Submit the manufacturing / import of acti...
Presentation Topics

• Current Situation Analysis                                                     <Insert Picture Here...
<Insert Picture Here>




So How Oracle Can Help?




         © 2008 Oracle Corporation – Proprietary and Confidential   ...
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                                                        'DWD VHUYLFHV

  3RVVLEOH HYHQWV IURP
  :D...
So How Oracle Can Help?

• Experience in dealing with large data volumes




               © 2008 Oracle Corporation – Pr...
Oracle Database 11g
High Performance, Always Available, Easy To Manage




                 © 2008 Oracle Corporation – Pr...
So How Oracle Can Help?

• Experience in dealing with large data volumes
• Security built in to database product




     ...
Security Features of Oracle Database


•Encryption - Advanced Security
•Segregation of Duties - Label Security
•Secure tes...
Policy Driven Access Control
   Oracle Label Security
                                                                    ...
So How Oracle Can Help?

• Experience in dealing with large data volumes
• Security built in to database product
• High pe...
Oracle Fusion Middleware


•Integration – SOA Suite
•High performance – JRockit
•No bottlenecks on line – Coherence
•Large...
Oracle Pedigree  Serialization Management•
           Communicates with Other Systems, Partners and Reg. Agencies
        ...
OPSM is a Solution That…

• Delivers serialization and pedigree management in a
  single application

• Can be implemented...
Unrivaled Leadership in Open Standards



                •BPEL

                         •RBAC
Presentation Topics

•   Current Situation Analysis         •Insert Picture Here

•   Oracle Solution Strategy
•   Develop...
OPSM Operational Dashboard
Entry Point into OPSM




                        •34
•Oracle Pedigree and Serial Manager
                                       Intuitive Screen Layouts


 •Task              ...
•Transaction View
Multiple Levels of Drilldown




                   •Drilldown to
                      Details




    ...
Drilldown to Transaction Details and Pedigree Data




 •Outbound
Pedigree Data




•Drilldown to
   Details




         ...
Drilldown to Transaction Details and Pedigree Data

                                         •View other
                 ...
Packaging Hierarchy Maintenance
Rich Interactivity Designed into User Interface




               •*


                 •...
Oracle Pedigree  Serialization Manager
         Complete, Open and Integrated


 • Purpose-built for and with the pharma i...
Oracle ePedigree Roadmap
     Customer preparedness is our goal
    •   11/07          •   12/0      •   2/08        •   3...
Questions?




         robert.nientker@oracle.com
                     +31 650 808 972


         © 2008 Oracle Corporati...
•43
Saglik Opsm Overview Nov 2009 Nientker
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Saglik Opsm Overview Nov 2009 Nientker

  1. 1. Oracle Pedigree and Serialization Manager (OPSM): A Solution for Drug Supply Chain Integrity Robert Nientker Business Development Director Life Sciences Europe, Middle-East & Africa
  2. 2. The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle. © 2008 Oracle Corporation – Proprietary and Confidential 2
  3. 3. Presentation Topics • Current Situation Analysis <Insert Picture Here> • Oracle Solution Overview • Next Steps © 2008 Oracle Corporation – Proprietary and Confidential 3
  4. 4. OPSM Themes and Business Drivers • Safe and Secure Supply Chain • Counterfeit Medication hurts Patients: and YOU • Product Recalls damage Pharma Brand Image ($) • Targeted recall management • Compliance • US States - Provide ePedigree from Point of Manufacturing • US Federal – Focusing on securing SC for imported drugs and APIs. • EMEA – Serialization and Authentication • Business Efficiencies • Total of 3.4B prescriptions annually in US with about $300B in revenue • Better returns management (costs industry about $2B / year and ) • Improve accuracy and minimize erroneous chargebacks •4
  5. 5. News… Recent FDA Warnings © 2008 Oracle Corporation – Proprietary and Confidential 6
  6. 6. Counterfeit Goods - Big Business • Counterfeit drug commerce will grow 13% annually through 2010 • In 2010, this illegal business will generate $75B in revenues – a 92% increase from 2005, (Combined revenue of Pfizer and AstraZeneca) • FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006 • Counterfeit medicines may account for 10-30% of the market in developing countries © 2008 Oracle Corporation – Proprietary and Confidential 7 The Lancet , Volume 371 , Issue 9624 , Pages 1551 - 1551
  7. 7. Importance of Supply Chain Integrity Combination of regulatory, global and business pressures • Global Counterfeiting exceeds $50B • Impacts 3.4B prescriptions annually in • About $2B annually and increasing US • Controlling/Validating returns • As much as 1%, or 34M doses could be • Systems to detect counterfeits counterfeit • Assess and authorize valid returns • Systems to authenticate product Product Returns Integrity • Protect brand integrity Channel Regulatory Integrity Compliance • Diverted product impacting profitability • California ePedigree • Inventory shrinkage and damage control • US State by State regulations • Identification/reporting of suspect • Will FDA act? EU Commission? shipments • Turkey, Italy, Belgium serialization • Parallel trade initiatives © 2008 Oracle Corporation – Proprietary and Confidential 8
  8. 8. Serialization Business Benefits Source: AMR Research, “The Track and Trace Paradox: Will the Healthcare Value Chain be Ready to Comply Globally?”, Wayne McDonnell, William McNeill, and Hussain Mooraj, April 2009 •9
  9. 9. Anti-Counterfeit Measures Safe and Secure Supply Chain Authentication (e)-Pedigree ID Physical Track Trace Verify Verify ProActive Retrospective Product Transaction Security Security © 2008 Oracle Corporation – Proprietary and Confidential 10
  10. 10. Anti-Counterfeit Measures Safe and Secure Supply Chain Authentication (e)-Pedigree ID Physical Track Trace Verify Verify ProActive Retrospective Product Transaction Security Security Europe US © 2008 Oracle Corporation – Proprietary and Confidential 11
  11. 11. •The California ePedigree Approach Tracks Movement Through Each Node in the Supply Chain Pedigree ID Pedigree Pedigree ID Pedigree Pedigree ID Pedigree Pedigree ID Pedigree PharmaDrug PharmaDrug g PharmaDrug g g PharmaDrug EPC serial # EPC serial # EPC serial # EPC serial # Manufacturer M r anufacturer Manufacturer Manufacturer Wholesaler 1 Wholesaler 1 Wholesaler 1 Wholesaler 2 Wholesaler 2 Pharmacy • An ePedigree is an Electronic record, containing information regarding each transaction resulting in a change of ownership of a prescription drug, from sale by manufacturer, through acquisition and sale by a wholesaler, until final sale to a pharmacy or person furnishing, administering or dispensing the prescription drug •12
  12. 12. The Evolving European Approach Focus on Serialization and Authentication •13
  13. 13. Global Regulatory View • US States • FL and other states are enforcing pedigree-only regulations today • CA ePedigree law now 1/1/15 and has federal preemption language • US Federal • FDA Amendments Act • Develop standards for UID and authentication tools by April 2010 • FDA Globalization Act • Pilot for foreign finished drugs and ingredients announced • EMEA • Italy, Belgium, Turkey, Greece others requiring serialization today • Spain and Serbia working on legislation requiring serialization • EFPIA program to implement serialized 2D data matrix and authentication of products at point of dispensation. 2009 pilot in Sweden • Other Countries • China, Brazil •14
  14. 14. © 2008 Oracle Corporation – Proprietary and Confidential 15
  15. 15. Key ideas for changes to EC legislation submitted for public consultation • Require the outer packaging of medicinal products to be sealed • The right to opening the outer packaging would be restricted to the market authorisation holder and end- user © 2008 Oracle Corporation – Proprietary and Confidential 16
  16. 16. Key ideas for changes to EC legislation submitted for public consultation • Require the possibility to trace each pack and perform authenticity checks • This could be attained by a mass serialisation feature on the outer packaging © 2008 Oracle Corporation – Proprietary and Confidential 17
  17. 17. Key ideas for changes to EC legislation submitted for public consultation • Require the possibility of tracing ownership and transactions of a specific batch • achieved by making a specific record (pedigree) obligatory © 2008 Oracle Corporation – Proprietary and Confidential 18
  18. 18. Key ideas for changes to EC legislation submitted for public consultation • Submit the manufacturing / import of active ingredients ( API ) to a mandatory notification procedure • Render information on notified parties available in a Community database © 2008 Oracle Corporation – Proprietary and Confidential 19
  19. 19. Presentation Topics • Current Situation Analysis <Insert Picture Here> • Oracle Solution Overview • Next Steps © 2008 Oracle Corporation – Proprietary and Confidential 20
  20. 20. <Insert Picture Here> So How Oracle Can Help? © 2008 Oracle Corporation – Proprietary and Confidential 21
  21. 21. H3HGLJUHH 9HULILFDWLRQ 'DWD VHUYLFHV 3RVVLEOH HYHQWV IURP :DUHKRXVH 0DQDJHPHQW 'LVWULEXWLRQ VLWHV LI IXOO 7UDFN 7UDFH UHTXLUHG (53 6HULDOLVDWLRQ GDWD IURP RWKHU 0DVWHU FRPSDQ 6HULDOLVDWLRQ PDQXIDFWXULQJ VLWHV DSS GDWDVWRUH 6FKHGXOH %DWFK 'DWD EDWFKHV XSORDG 'DWD EDFN WR FHQWUDO VVWHP WR (53 0DQXIDFWXULQJ FRQWURO VVWHP VFDQV ' PDWUL[ WR UHWXUQ DFWXDO VHULDO QXPEHUV $OORFDWHG QR VSRLOHG SUREOHP LWHPV DQG SDOOHWFDVHLWHP UHODWLRQVKLSV ¦§ § ¡ ¢ 6HULDOLVDWLRQ ¦ ¢ DSS GDWDVWRUH *HQHUDWH VHULDOV ORFDO UHSRVLWRU DW DQG VHQG WR PDQXIDFWXULQJ   ¡ ¥ ¢ £ 0DQXIDFWXULQJ VLWH ¤ ¦§ ¨§ ¢ ¦ ¢ RQWURO VVWHP © ¡ © 2008 Oracle Corporation – Proprietary and Confidential 22
  22. 22. So How Oracle Can Help? • Experience in dealing with large data volumes © 2008 Oracle Corporation – Proprietary and Confidential 23
  23. 23. Oracle Database 11g High Performance, Always Available, Easy To Manage © 2008 Oracle Corporation – Proprietary and Confidential 24
  24. 24. So How Oracle Can Help? • Experience in dealing with large data volumes • Security built in to database product © 2008 Oracle Corporation – Proprietary and Confidential 25
  25. 25. Security Features of Oracle Database •Encryption - Advanced Security •Segregation of Duties - Label Security •Secure test data - Data Masking •Compliance - Audit Vault, Total Recall •No “all powerful” DBA - Database Vault © 2008 Oracle Corporation – Proprietary and Confidential 26
  26. 26. Policy Driven Access Control Oracle Label Security Group HQ Level Americas EU ASIA USA Canada UK France Top Secret Confidential EU Sensitive ASIA Americas Compartment © 2008 Oracle Corporation – Proprietary and Confidential 27
  27. 27. So How Oracle Can Help? • Experience in dealing with large data volumes • Security built in to database product • High performance middleware © 2008 Oracle Corporation – Proprietary and Confidential 28
  28. 28. Oracle Fusion Middleware •Integration – SOA Suite •High performance – JRockit •No bottlenecks on line – Coherence •Large data volumes – Data Integrator © 2008 Oracle Corporation – Proprietary and Confidential 29
  29. 29. Oracle Pedigree Serialization Management• Communicates with Other Systems, Partners and Reg. Agencies • Validate the authenticity of a serial • Check for holds, expiration or recalls • Manufacturers get additional views into where their product is consumed •External •Public / Private •Serial Database • Pedigree •4 •4 •1 •Oracle Pedigree and Serialization Manager •Downstream •Upstream •Trading Partner •Trading Partner •2 •3 • Returns / •Pedigrees received from Recalls •1 upstream trading partners •2 •Pkg system requests serials • Pkg / Labeling •3 •OPSM sends serials • System •Pkg system sends actual •2 package data to OPSM •Pedigree and/or serial data •4 sent to outside partners or regulatory databases •30
  30. 30. OPSM is a Solution That… • Delivers serialization and pedigree management in a single application • Can be implemented as an Edge application with minimal changes to your existing ERP system • Will remove the burden of massive product serial data volumes from your existing ERP system • Is built on the Oracle Fusion SOA and designed to be integrated to Oracle, legacy and 3rd party ERP systems
  31. 31. Unrivaled Leadership in Open Standards •BPEL •RBAC
  32. 32. Presentation Topics • Current Situation Analysis •Insert Picture Here • Oracle Solution Strategy • Development History and Partners • Solution Details •33
  33. 33. OPSM Operational Dashboard Entry Point into OPSM •34
  34. 34. •Oracle Pedigree and Serial Manager Intuitive Screen Layouts •Task •Simple Tab Lists Navigation •Easy Access Search •Collapsible panes and panels •35
  35. 35. •Transaction View Multiple Levels of Drilldown •Drilldown to Details •36
  36. 36. Drilldown to Transaction Details and Pedigree Data •Outbound Pedigree Data •Drilldown to Details •37
  37. 37. Drilldown to Transaction Details and Pedigree Data •View other transactions for this unit •Serial Details •38
  38. 38. Packaging Hierarchy Maintenance Rich Interactivity Designed into User Interface •* •* •* •* •39
  39. 39. Oracle Pedigree Serialization Manager Complete, Open and Integrated • Purpose-built for and with the pharma industry • Integrated serialization and pedigree management • Delivering regulatory compliance and business value •40
  40. 40. Oracle ePedigree Roadmap Customer preparedness is our goal • 11/07 • 12/0 • 2/08 • 3/0 • 9/08 • 12/0 • 4/09• Futur 7 8 8 e • CA deadline is Jan. • Dedicated • CA delays to 2015, • UI prototype • Release AIA 2009 Development team Gov. signs law feedback PIP for OPSM • Business formed sessions with -EBS 11.5.10 Requirements CFG 12.1 documented integration • Announced intent to build solution • Additional integrations and enhancements • OPSM 1.0 Release • Formed Customer • Communicate • OPSM V1 • Pedigree mgmt for Focus Group strategy to CA BoP refocused on distributors and (CFG) • CA delays to 2011 serialization pharmacies • Reviewed • Switch to Fusion • Portal, PDA unit Requirements 11gR1 tech stack verification w/customers • Complete • Planned (Subject to Change) •41
  41. 41. Questions? robert.nientker@oracle.com +31 650 808 972 © 2008 Oracle Corporation – Proprietary and Confidential 42
  42. 42. •43

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