simulating a secure solution for the us drug supply chain
TRANSCRIPT
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Simulating a Secure Solution
for the US Drug Supply
Chain
Robert Celeste
Partner at RC Partners,
Former Senior Director at GS1 US
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SIMUL8 Corporation | SIMUL8.com | [email protected]
1 800 547 6024 | +44 141 552 6888
Presenters
Robert Celeste
Partner at RC Partners,
former Senior Director at GS1 US
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PARTNERS © RC Partners 2015 4
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PARTNERS © RC Partners 2015 5
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PARTNERS © RC Partners 2015 6
… ARE PRODUCTS THAT NOBODY WANTS.
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PARTNERS © RC Partners 2015 7
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PARTNERS © RC Partners 2015 8
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Vial height is
approximately
34 mm
Vial height is
approximately
35 mm
Amgen Counterfeit
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PARTNERS © RC Partners 2015 9
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PARTNERS © RC Partners 2015 10
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PARTNERS © RC Partners 2015 11
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PARTNERS © RC Partners 2015 12
A growing number
of countries require
a standard means
of identifying Rx
Products,
Authenticating
their entry into
commerce and
tracing them back
to their source
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PARTNERS © RC Partners 2015 13
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HOW COULD WE PROVE THAT IT WAS POSSIBLE TO CREATE WHAT THE LAW REQUIRED?
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Pro
du
ct
Ce
rtific
atio
nPe
dig
ree
Da
ta
Ownership Ownership
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THE US PHARMACEUTICAL SUPPLY CHAIN – SIMPLE VIEW
Manufacturer Wholesaler PharmacyContract
ManufacturerRaw Material
SupplierWholesaler
Limited number of Distributors creates
a Pilot and Implementation
bottleneck
Multiple Scenarios, Inference Models and
Exceptions are difficult and
expensive to test in the actual supply
chain
PARTNERS © RC Partners 2015 15
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WHAT COULD ATTEMPT TO UNDERSTAND FROM THE SIMULATION?
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Scenario Item level T&T Lot Level T&T 2nd Sn, 1 up, 1 dn
Counterfeit introduced in return
Counterfeit introduced via repackaging
Counterfeit introduced via wholesale
Cargo theft – sold to hospital
1. Can a counterfeit be detected by a legitimate trading partner?
2. Can a counterfeit be hidden by an illegitimate trading partner?
3. What is the mechanism for detection (trading partner, inspection, etc.)?
For given regulatory requirements, business rules, data set and architecture:
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WHAT IF THERE WERE MULTIPLE INTERPRETATIONS OF THE LAW?
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Scenario Item level T&T Lot Level T&T 2nd Sn, 1 up, 1 dn
Counterfeit introduced in return
Counterfeit introduced via repackaging
Counterfeit introduced via wholesale
Cargo theft – sold to hospital
1. Can a counterfeit be detected by a legitimate trading partner?
2. Can a counterfeit be hidden by an illegitimate trading partner?
3. What is the mechanism for detection (trading partner, inspection, etc.)?
For given regulatory requirements, business rules, data set and architecture:
Change a
Rule or
process step
Re-Run the
Model
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PARTNERS © RC Partners 2015 18
Scenario Setup(Policy Decisions)
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PARTNERS © RC Partners 2015 19
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PARTNERS © RC Partners 2015 20
Reports and Analysis(Scenario Impact)
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THE BIG PICTURE
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”A WHOLESALER CAN NOT RECEIVE AN ITEM UNLESS THE PEDIGREE MATCHED”
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WAS THAT A MISTAKE OR CRIMINAL ACTIVITY?
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© RC Partners 2015
PARTNERS
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PARTNERS © RC Partners 2015 25
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© RC Partners 2015
PARTNERS
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© RC Partners 2015
PARTNERS
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PARTNERS © RC Partners 2015 30
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WWW.RCPARTNERS.BIZ
PARTNERS © RC Partners 2015 31
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