This webinar discusses how serialization alone does not equal comprehensive brand protection and explores additional authentication strategies. It presents a case study where a serialization model, pedigree model, and solution using a unique digital signature correctly identified 36%, 20%, and 100% of counterfeits respectively. Maximizing existing serialization investments with covert authentication that establishes the uniqueness of each package and enables trusted mobile engagement was presented as the most effective approach.
2. 4
What serialization is…… and isn’t
How serialization does not necessarily
equate to comprehensive brand protection
How the package itself is such an integral
component to brand protection
1
2
3
How mobile authentication can be enabled for
better brand protection
3. This webinar is
intended to be
interactive
Information contained in
this webinar is current as
of January 2017
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BEFORE WE DIVE IN…
WEBINAR SERIES
4. JIM SINISGALLI
DIRECTOR, PRODUCT MANAGEMENT
FOR SYSTECH INTERNATIONAL
Jim Sinisgalli is Director of Product Management – Brand Protection. He presently
leads and guides Systech’s anti-counterfeit and authentication business to develop
strategies which protect brands from counterfeiting, diversion and other illicit trade. He
is responsible for developing and executing Systech’s authentication strategy working
with leaders across products and services, and sales. Jim has over an over twenty
year career as visionary leader with half of his career spent protecting customer’s most
precious assets from data to physical product.
PRESENTER
8. EU BOOKEND MODEL
Pharmaceutical
Manufacturer and
Parallel Distributor
Wholesaler Distributors Pharmacist Patient
Risk-based
verification
by Wholesale
distributors
National System 1 - n
Product #
Batch
Expiry
S/N
European
Hub
Verification
upon
dispense to
Patient
Upload Data
9. THE PEDIGREE MODEL
Track & Trace captures data at
each step in the supply chain
across partner boundaries
Data captured and saved at each step
Manufacturer Packaging Wholesale distributors Dispenser
ESSENTIALLY AN AUDIT TRAIL IS COLLECTED AND STORED
WHERE IS THE VALIDATION?
10. DOES THE EU FMD OR THE DSCSA STOP FALSIFIED MEDICINE?
EU FMD
• Only applies to prescription medications
• Does include Anti-Tampering requirement
• Which counterfeiters can mimic
• The first product that is scanned and verified “wins”
DSCSA
• Doesn't even require verification or authentication
• Applies similarly to other global serialization laws
NO, NEITHER THE EU FMD OR THE DSCSA STOP FALSIFIED MEDICINE
SERIALIZATION = COMPLIANCE
12. THE PACKAGE AS AN INTEGRAL
COMPONENT OF BRAND
PROTECTION
13. CORE ELEMENTS OF ANTI-COUNTERFEITING STRATEGY
• Tamper-evident packaging or tamper-resistant closures for
all medicines
• A unique serial number for each medicine pack
• Use of overt, covert or forensic authentication features,
but consider:
• Impact to current production
• Cost
• Training requirements
• Degree of accuracy
• Requires material, equipment or processes
• Authentication turn-around time
• Degree of vulnerability of being defeated by counterfeiters
14. ANTI-COUNTERFEITING PACKAGING STRATEGIES AVAILABLE
Overt Technologies
Authenticated with Visual Inspection
Covert Technologies
Authenticated with Technology
Holograms Security Seals
Colour Shifting Inks Watermarks
RFID Optical
Chemical Microtaggants
15. SYSTECH UNISECURE™
Non-Additive
Leverage existing
packaging
Covert
Counterfeiters cannot
see to replicate
Secure
Cannot be reverse
engineered
Mobile
Smartphone enabled,
trusted engagement
Barcodes
Serialized and/or non-
serialized
Global
Enables authenticated
traceability
Systech derives a
unique identification
signature from an
existing bar code
16. THE HEART OF UNISECURE
Vibrations Manufacturing
tolerances
Humidity Consumable
variance
UNIQUE FACTORS
Printing is dynamic – there are small-
scale variations in every print mark
Line speed
The result is a unique signature or UniSignature™ “individualizing” each and every item.
UniSecure takes advantage of these
microscopic variations to generate an
inherent, covert security feature
DATA CARRIERS
17. MOBILIZE AUTHENTICATION
▪ Authentication capabilities for
inspectors, consumers and third parties
▪ BYOA (Bring Your Own Application) –
UniScan will easily integrate into any
mobile application
▪ UniSecure’s Software Development Kit
enables BYOA for iOS and Android
18. MAXIMIZE YOUR INVESTMENT IN SERIALIZAION
Create trusted uniqueness for each and every
package
• Expand usage of regulatory compliance data
mark
• Enables serialization to become a covert
authentication layer
• Transforms serialized data mark into an authentic
and unique data mark
This is the authentic one!
21. 21
A UNISECURE FIELD PILOT
POINT OF PACKAGING FOR
PHARMACEUTICAL PRODUCTS
POINT OF DISPENSATION FOR
PHARMACEUTICAL PRODUCTS
SOFTWARE SOLUTION PROVIDER
/ SIMULATED DISTRIBUTOR
22. PILOT PROCESS
Batch 1: ESM model
scanning serialized
numbers at the supply chain
end-points (production and
dispensation)
Batch 2: Pedigree model
(DSCSA) scanning
serialized numbers at each
point in the supply chain
(production, storage,
wholesaler, dispensation)
Batch 3: UniSecure solution
capturing original print mark
for instant authentication at
any point of the supply
chain
3 Batches - Each batch contained:
500 cartons - 450 “genuine”
products and 50 “counterfeit”
23. PILOT PROCESS
Batch 1: ESM model
scanning serialized numbers
at the supply chain end-
points (production and
dispensation)
Batch 3: UniSecure solution
capturingoriginal print mark
for instant authenticationat
any point of the supply chain
Batches 1 & 3 were then shipped
directly to St James’s Hospital in
Ireland
24. PILOT PROCESS
Batch 2 was further split into 2
separate parts, simulating
distribution to multiple locations
Batch 2: Pedigree model (DSCSA)
scanning serialized numbers at
each point in the supply chain
(production, storage, wholesaler,
dispensation)
Batch 2a: Pedigree model 250 items Batch 2b: Pedigree model 250 items
25. PILOT RESULTS
Batch 1: ESM model
scanning serialized numbers
at the supply chain end-
points (production and
dispensation)
Batch 3: UniSecure solution
capturingoriginal print mark
for instant authenticationat
any point of the supply chain
Batches 1 & 3 were then shipped
directly to St James’s Hospital in
Ireland
26. PILOT RESULTS
Batch 1: ESM model scanning
serialized numbers at the supply
chain end-points (production and
dispensation)
Batches 1 & 3 were then shipped
directly to St James’s Hospital in
Ireland
36% (18 of the 50) counterfeit products that were randomly added to the
batch were incorrectly verified.
27. PILOT RESULTS
Batch 2: Pedigree model (DSCSA)
scanning serialized numbers at
each point in the supply chain
(production, storage, wholesaler,
dispensation
Batches 1 & 3 were then shipped
directly to St James’s Hospital in
Ireland
20% (10 of the 50) counterfeit products that were randomly added to the batch
were verified..
28. PILOT RESULT
Batch 3: UniSecure solution
capturing original print mark for
instant authentication at any point
of the supply chain
Batches 1 & 3 were then shipped
directly to St James’s Hospital in
Ireland
100% of the counterfeit products were identified at authentication ensuring
no counterfeit product went to patients
29. Serialization Compliance Serialization Compliance
Covert Protection
Uniqueness Established
Unique Authentication
Trusted Engagement
MAXIMIZE YOUR INVESTMENT IN SERIALIZATION
CREATE TRUSTED UNIQUENESS FOR EVERY PACKAGE
This is the authentic one!
30. SYSTECH UNISECURE
SECURE
Cannot be reverse engineered or duplicated
SMARTPHONE ENABLED
Puts authentication into many hands
UNIVERSAL BARCODES
Works for serialized or non-serialized
GLOBAL REACH
Enables authenticated traceability
NON ADDITIVE
Leverage existing package
COVERT
Counterfeiters cannot see, as it uses
existing data marks
31. Please submit your questions
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