simulating a secure solution for the us drug supply chain
Post on 16-Jul-2015
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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
SIMUL8 Corporation | SIMUL8.com | info@SIMUL8.com
1 800 547 6024 | +44 141 552 6888
Presenters
Robert Celeste
Partner at RC Partners,
former Senior Director at GS1 US
SIMUL8 Corporation | SIMUL8.com | info@SIMUL8.com
1 800 547 6024 | +44 141 552 6888
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… ARE PRODUCTS THAT NOBODY WANTS.
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Vial height is
approximately
34 mm
Vial height is
approximately
35 mm
Amgen Counterfeit
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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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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
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
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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:
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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Scenario Setup(Policy Decisions)
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Reports and Analysis(Scenario Impact)
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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© RC Partners 2015
PARTNERS
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© RC Partners 2015
PARTNERS
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RCELESTE@RCPARTNERS.BIZ
WWW.RCPARTNERS.BIZ
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SIMUL8 Corporation | SIMUL8.com | info@SIMUL8.com
1 800 547 6024 | +44 141 552 6888
QUESTIONS
• Please forward any topics you would like
to see covered to claire.c@simul8.com
• Continue the discussion on SIMUL8 in
Health – LinkedIn Group
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