Safe and Secure
Building a Global Traceability Foundation to Drive Visibility, Efficiency and Compliance
Common Misconceptions and Key Considerations
Robin Koh,Chief Strategy Officer,
SupplyScape Corporation
© 2009 SupplyScape Corporation. All Rights Reserved.
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Agenda
• Main Drivers for Global Track and Trace
• Key Considerations for Building Global Traceability Foundation– 4 Common Misconceptions– Implementation Approach to Global Serialization
• Key Takeaways
© 2009 SupplyScape Corporation. All Rights Reserved.
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Safe and Secure Supply Chain
Safe & Secure Supply Chain Model
Pharmaceutical Co Wholesaler Pharmacy
Chain of Custody Security
TransactionSecurity
TraceTrack
Pedigree
Individual Product Security
ProductSecurity
ProductAuthentication
IDAuthentication
Authentication
© 2009 SupplyScape Corporation. All Rights Reserved.
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Drivers For Global Traceability
Regulatory Compliance
ProductSecurity
Global Traceability
Regulatory Compliance
Global Pharma Safety Incidents
Sources: Organisation for Economic Co-operation and Development
964
04
196
02
484
03
1,123
05
1,412
06
1,759
07
Product Security
States considering pedigree laws / rules
PDMA in effect. No state activity
States with pedigree laws / rules today
US Pedigree Regulations
In place In development
Global Serialization & Codification Regulations
70%Medical
Professional
18% Subscriber
Source: BCBSA Survey of Blue Plans’ Anti-Fraud Programs
ReimburseIn-accuracy
5% Med Unnec.36%
Services Not Rendered
9%Excess Charges
35%Other(1)
2%Pharm Fraud
4% Service Over Utilization
9%Upcoded Service
© 2009 SupplyScape Corporation. All Rights Reserved.
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Complexity of Global Serialization Proliferation of Regulatory Requirements
1. Time to implement serialization is usually underestimated
2. Flexibility to handle future requirements is often overlooked
3. Business benefits are difficult to quantify
© 2009 SupplyScape Corporation. All Rights Reserved.
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Agenda
• Main Drivers for Global Track and Trace
• Key Considerations for Building Global Traceability Foundation– 4 Common Misconceptions– Implementation Approach to Global Serialization
• Key Takeaways
© 2009 SupplyScape Corporation. All Rights Reserved.
7
Misconception #1:‘I Can Wait’Case Study
–A global manufacturer planning for France’s (CIP13) 2D Data Matrix requirement in 2011
Lesson’s Learned–Many variables lengthen the time for implementation–Number of qualified vendors available–Working with CMO networks is more involved than expected–Piloting 1 or 2 packaging lines does not adequately prepare
for the scalability issues associated with a corporate roll-out
The Plan is Nothing, but Planning is Everything Dwight D Eisenhower
© 2009 SupplyScape Corporation. All Rights Reserved.
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Misconception #2:‘Serialization has Limited ROI’
Least Realistic More Realistic
CAPEX PackagingCAPEX ACF
Program
ACF
Impact on Line Efficiency
Additional Labor
Data Monitoring
CAPEX-Internal
Additional Label Cost
CAPEX CMO
CAPEX DC
Software Maintenance
Recurring BenefitCAPEX - One TimeRunning Cost
CAPEX IT
Anti-Counterfeit Program #2
Patient Safety Program #1
Label Standardize Program
Sales Enhancement Program #2Anti-Counterfeit
Program #1
Recall EnhancementProgram
Supply Chain Efficiency Program
SC Visibility Program #1
Sales Enhancement Program #1
Data Reform Program
Benefit Programs by Level of Effort Required and the Magnitude of Benefit
UpsidePotential
DownsideImpact
© 2009 SupplyScape Corporation. All Rights Reserved.
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Misconception #3‘Countries are Driving Towards One Standard’
Case Study- In the original design of the MIT solution, there is a
fundamental assumption that there will be a homogenous number management system
Lesson’s Learned- Harmonizing on data carriers & numerical structure are
different things- Number assignment from multiple sources- Random numbers and non-sequential numbers are
different things- There is no guarantee on future requirements
Your Requirements vs. Available Solutions
© 2009 SupplyScape Corporation. All Rights Reserved.
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Misconception #4‘Serial Number Lookup is an Authentication System’
ProductSecurity
ProductAuthentication
IDAuthentication
Authentication
Building a more complete system: Alert Patients on Adverse Events in Real
Time (e.g. Recall)
Provide Accurate Data for Detection and Prevention in addition to Investigation
Pattern, Pace & Place
Detect False Positives
Authenticate Physical Anti-Counterfeiting Features
Individual Product Security
© 2009 SupplyScape Corporation. All Rights Reserved.
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Agenda• Main Drivers for Global Track and Trace
• Key Considerations for Building Global Traceability Foundation– 4 Common Misconceptions– Implementation Approach to Global Serialization
• Key Takeaways
© 2009 SupplyScape Corporation. All Rights Reserved.
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Suggested Approach to Global Serialization Global Framework, Local Alignment
Develop a clear understanding of costs, timing, resources and operational changes needed to meet requirements
Develop local guidance based on corporate standards
Construct and execute a plan to address immediate requirements using localized approach
Build a migration plan to integrate into corporate strategy
Execute the integration plan to migrate local solution into global strategy
Define Global Strategy & Guidelines
Address Local Requirements
Migrate To Global Plan
© 2009 SupplyScape Corporation. All Rights Reserved.
13
Agenda
• Main Drivers for Global Track and Trace
• Key Considerations for Building Global Traceability Foundation– 4 Common Misconceptions– Implementation Approach to Global Serialization
• Key Takeaways
© 2009 SupplyScape Corporation. All Rights Reserved.
14
• Serialization is Global and Uncoordinated EU, China and USA moving in parallel
• Manufacturers must Assume a Global Perspective
There are a set of concrete steps you can take
• Serialization can Provide ROI if you know where to look
• Few Vendors Understand the Global Issues and Misconceptions
Key Takeaways
© 2009 SupplyScape Corporation. All Rights Reserved.
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Looking ForwardBusiness Opportunities in Supply Chain Traceability
What if you could?Leverage investments in product
serialization initiatives to drive a higher return on product and brand protection?
Increase new product launch success by ensuring proper supply into key markets?
Establish a global network of trading partners to provide greater visibility into distribution channels?
Overcome barriers to entry into new markets by more efficiently addressing local distribution requirements?
Facilitate financial reconciliation across chargeback, rebate, and re-imbursements across your supply network?
© 2009 SupplyScape Corporation. All Rights Reserved.
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Next StepsGet Started on Developing a Global Traceability Foundation
Contact Mary Hall Contact Mary Hall todaytoday to schedule a to schedule a
consultation!consultation!781.503.7462, [email protected]
Visit Visit SupplyScape.com to SupplyScape.com to
learn morelearn morewww.supplyscape.com