The document discusses Oracle's Pedigree and Serialization Manager (OPSM) solution for maintaining integrity in pharmaceutical supply chains. It outlines challenges like counterfeiting and the need for serialization, ePedigree, and track-and-trace capabilities. OPSM provides a single application to manage serialization and pedigree data across global supply chains in compliance with evolving regulations. It leverages Oracle Fusion Middleware and databases to handle large data volumes securely and with high performance.

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. 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. Presentation Topics
• Current Situation Analysis <Insert Picture Here>
• Oracle Solution Overview
• Next Steps
© 2008 Oracle Corporation – Proprietary and Confidential 3

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

6. News… Recent FDA Warnings
© 2008 Oracle Corporation – Proprietary and Confidential 6

7. 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

8. 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

9. 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

10. 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

11. 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

12. •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

13. The Evolving European Approach
Focus on Serialization and Authentication
•13

14. 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

15. © 2008 Oracle Corporation – Proprietary and Confidential 15

16. 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

17. 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

18. 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

19. 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

20. Presentation Topics
• Current Situation Analysis <Insert Picture Here>
• Oracle Solution Overview
• Next Steps
© 2008 Oracle Corporation – Proprietary and Confidential 20

21. <Insert Picture Here>
So How Oracle Can Help?
© 2008 Oracle Corporation – Proprietary and Confidential 21

22. 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

23. So How Oracle Can Help?
• Experience in dealing with large data volumes
© 2008 Oracle Corporation – Proprietary and Confidential 23

24. Oracle Database 11g
High Performance, Always Available, Easy To Manage
© 2008 Oracle Corporation – Proprietary and Confidential 24

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. Unrivaled Leadership in Open Standards
•BPEL
•RBAC

33. Presentation Topics
• Current Situation Analysis •Insert Picture Here
• Oracle Solution Strategy
• Development History and Partners
• Solution Details
•33

34. OPSM Operational Dashboard
Entry Point into OPSM
•34

35. •Oracle Pedigree and Serial Manager
Intuitive Screen Layouts
•Task •Simple Tab
Lists Navigation
•Easy Access
Search
•Collapsible panes
and panels
•35

36. •Transaction View
Multiple Levels of Drilldown
•Drilldown to
Details
•36

37. Drilldown to Transaction Details and Pedigree Data
•Outbound
Pedigree Data
•Drilldown to
Details
•37

38. Drilldown to Transaction Details and Pedigree Data
•View other
transactions
for this unit
•Serial Details
•38

39. Packaging Hierarchy Maintenance
Rich Interactivity Designed into User Interface
•*
•* •* •*
•39

40. 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

41. 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

42. Questions?
robert.nientker@oracle.com
+31 650 808 972
© 2008 Oracle Corporation – Proprietary and Confidential 42

43. •43