1.
1
Track and Trace
How far can it go?

2.
2
BUILD GROW PROTECT

3.
Track and Trace around us
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FedEx, UPS & Strava are registered trademarks of their respective companies and are used here for non-commercial use for illustrative purposes only

4.
Pharmaceutical Track and Trace History
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Source: FDA.org

5.
Pedigree Requirements in
Pharmaceuticals
1988 – Federal Pedigree Requirements (amended
1992)
2003 Florida
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5
2012 Inconsistent Patchwork2011 / 2012 California

6.
California e-Pedigree Legislation
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Unproven
Technology
Packaging
AccuracyCosts
Implementation
Privacy

7.
U.S. Pharmaceutical Distribution
Top 3
Distributors
85%
Next 5
5%
Next 10
5% All Other
5%
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Source: http://www.mdm.com/2013_pharmaceuticals_mdm-market-leaders

8.
Issue focused approach
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9.
Federal Legislation
Drug Supply Chain Security Act (DSCSA)
• Introduced in 2011 as part of Drug Quality and Security
Act
• Signed into Law November 27, 2013
• Requires to build a Tracing regime over 10 years to:
• Enable verification of drug legitimacy
• Enhance detection and notification of illegitimate products
• Facilitate more efficient recalls
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10.
DSCSA – Key Provisions
• National Standard with Preemption
• Product identifier
• Product tracing
• Distribution Chain Licensing
• Increased requirements for all parties
• Increased Penalties
• Product verification procedures
• Quarantine, Notification, Records
• Increased Penalties
• 10 Year Implementation
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11.
• Public Process with all stakeholders
• Integrated approach of technology & policy
• Fits existing systems, business models and distribution
• Endorses interoperable market driven standards
• Cost effective customer driven solutions
DSCSA – Key Lessons
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12.
Outcomes
http://youtu.be/IQXFss4difw
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Source: http://www.in-pharmatechnologist.com/Regulatory-Safety/Lilly-
backs-track-and-trace-and-commits-102m-to-fight-counterfeits

13.
Around the World
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14.
Interoperability is key
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15.
Exploratory stages
Fishing Industry Pilot Liquor
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16.
Cautionary Tales
Conflict Minerals Timber
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17.
Track & Trace Best Practices
• Public Process with all stakeholders
• Facilitated by dedicated neutral forum / party
• Comprehensive approach of technology & policy
• Interoperable market-driven open standards
• Customization for existing systems and business
models
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18.
Paradigm Shift
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Technology
&
Application
Issue
Government
Stakeholder
s
Industry,
NGO’s etc.
Policy
Options
Interoperability

19.
Open Standard Benefits
• Foundational layer
for interoperability
• Competition drives
down costs
• Implementation and
compliance
• Broad adoption,
and utilization
• Flexibility for future
changes
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Source: http://en.wikipedia.org/wiki/History_of_the_Internet

20.
Track and Trace Framework
1. Involve all stakeholders
2. What are the issue(s): Magnitude & Priority
3. Gap / Need analysis of existing systems and policy
4. Develop integrated customized approach
• Policy
• Data
• Interoperable technology
5. Customize and optimize application solutions
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21.
Defining the issue
Counterfeit /
Unauthorized
Production
Genuine
Production
Authorized
Retailer
Unauthorized
Distribution
Legal
Distribution
Unauthorized
Reseller
End
User
Legend:
Genuine
Product / Legal
Distribution
Genuine Product
/ Grey /
Smuggled
Illegal Product
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22.
Potential Opportunities
Military Technology Luxury
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Source: cnn.com Source: watchstudios.cn

23.
Potential Opportunities
Food Safety Tobacco
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24.
Going Forward
• Cooperation amongst all stakeholders
• Dual customer focus: Government and industry
• Development of open standards
• Involvement / Establishment of neutral entities
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