Transcript Slide 1

Let’s build a smarter pharmaceutical supply chain.
Smarter, Safer Drugs
InfoSphere Traceability Server
IBM Software Group
Smarter planet opportunities are everywhere....
smarter safe smarter solutions
pharmaceuticals
for retail
smarter
data center
smarter
healthcare
smarter supply
chains
smarter
transportation
smarter
food
smarter
smarter industrial
manufacturing
operations
smarter
traffic
smarter water
management
smarter
cities
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Serialization and the New Era of Visibility
The ability to obtain and verify the location, status and history of an item.
Pharmaceuticals: Can I be sure my prescription
drugs are not counterfeit?
Parts: Which parts were assembled in my car
and are they authentic?
Food: Where does my food come from?
Returnable Containers: Do my suppliers
have enough containers to meet my
production needs?
The IBM Supply Chain solution enables customers in multiple industries to
answer these questions today.
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The world is changing and becoming more…
Instrumented
Interconnected
Intelligent
The explosion of new information,
when integrated, analyzed, and acted
upon using new types of intelligence,
enables solutions that
… help build Smarter Safer Drugs
Trace Events in a ‘Physical Meets Digital’ World
Serialized information links physical world assets, resources and infrastructure with the
digital world of event processing, business analytics and optimization.
Supply Chain
Optimization
Asset
Optimization
Extend supply chain
visibility, analytics and
collaboration to transform
supply chain operations.
Full lifecycle asset
management through
real-time visibility,
optimization and
traceability
Production
Process
Optimization
Leverage industry
information for asset
design and process
optimization.
Physical
Infrastructure
Focus on smarter
buildings, smarter water
management, smarter
grids, etc.
Supply Chain Visibility Can Produce Better Outcomes
Stock-Outs – Excess safety
4.5% of revenue is lost due to
supply chain inefficiencies.
stock is 10% of inventory at
Manufacturers and $700-800K
of excess inventory at each
hospital and retail pharmacy
- IDC
8-10% of Worldwide Drug
Supply is Counterfeit – up to
$75 billion a year in lost sales
- WHO
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Global Serialization Trends
Concern for counterfeit drugs, diversion and patient safety is driving
a global trend with legislative and serialization requirements
IBM provides a common platform to allow flexibility to accommodate
new standards
EU Panel Votes to Crack Down on Illegal Medicines
ASSOCIATED PRESS April 27, 2010
BRUSSELS - The battle against counterfeit medicines took a big step forward Tuesday when the European Parliament public health panel
approved a bill to crack down on a fast growing industry worth (EURO)10.5 billion ($14 billion) a year in Europe alone. If it becomes law,
drug makers must produce medicines that can be tracked from the factory to the patient to make sure no one tampers with the content.
Trusted Physical Data is Converted into Usable Information
Reporting & Analytics
Xylinke
Xylinke
Blood Thinner
 End-to-end Traceability
 Inventory Visibility
 Temperature Tracking
Business Benefits




Increased supply chain visibility
Reduced counterfeiting and diversion
Increased Consumer Safety
Increased efficiency for conducting
recalls and returns
TRUSTED
Pharma
Manufacturer
INFORMATION
Distribution/ Export
Retailer / Hospital
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Smarter Supply Chain Architecture – Supply Chain Visibility
Events are captured at various points in the supply chain, stored in a in a
secure traceability network and can be shared with trading partners
InfoSphere
Traceability
Server
Manufacturing
Plant
Distribution
Center
InfoSphere
Traceability
Server
Distribution
Center
InfoSphere
Traceability
Server
Retail
Location
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Types of Data
WHAT
WHERE
Manufacturing Data
Location
 Lot/Batch
 Expiration
Environment Data
 Temperature
Transactional Data
 PO
 Invoice
WHY
Business Process
 Receipt
 Ship
InfoSphere
Traceability
Server
 City/State
 Country/Region
 Store #
 Dock #
 Port #
WHEN
Timestamp
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Standards Based Solution Components
√ GS1/EPCglobal Certification
http://www.epcglobalinc.org/certification/sw_cert
Alternate
Solution Architecture
Standard Network Architecture
Internal
Applications
External
Applications
EPCIS Query Interface
ePedigree
√
EPCIS Event
Repository
EPCIS Capture Interface
√
Readers/Scanners
Vendor C
EPCIS Query Interface
EPCIS Query Interface
InfoSphere
Traceability Server
Vendor B
EPCIS Capture Interface
EPCIS Capture Interface
Vendor A
Siemens, …)
√
Filtering &
Collection
Reader Protocol
Business
Analytics
(Systech,
WebSphere
Sensor Event Server Optel Vision,
EPCIS Capture
Application
ALE Interface
Shipment
Verification
Solution Architecture
√
ALE Interface
ALE Interface
WebSphere
Sensor Event Server
Vendor A
Reader Protocol
Reader Protocol
Readers/Scanners
Readers/Scanners
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How is Data Captured?
From large to small enterprises
Distributor A
Pharma Manufacturer
IBM
Traceability
Server
EPCIS
Event Capture
Device Management
 Needs to support
multiple customers
 Want to drive value
through internal
visibility
 Wants to purchase and
support own data
management platform
Distributor B
Event Capture
Distributed Event
Capture
Distributed Device
Management
Device Management
Pharmacy C
Device Management
 Needs to support
multiple customers
 Has limited interest in
driving value through
internal visibility
 Government agency
hosts the data servers
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Expected Business Benefits from Track and Trace
Source: AMR Research, 2009
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New Insights – The Power of Analytics to Gain Efficiencies
Xylinke
Xylinke
Blood Thinner
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Compliance (US): Pedigree Types (only IBM supports both)
Pedigree Document
pedigree
receivedPedigree
Pedigree Data Requirements
Topic
Data
Source
Unique
Identifier
Lowest saleable unit unique identifier
Manufacturer
Source of Drug
shippedPedigree
Federal manufacturer registration
number
Manufacturer
Receiving Event
Principal address of the source
Trade or generic name
pedigree
Shipping Event
Quantity
receivedPedigree
pedigree
Commissioning Event
Shipping Event
Name
pedigree
EPCIS Pedigree
Dosage form and strength
Drug
characteristics
Container size
Manufacturer
Receiving Event
Number of containers
Expiration dates
shippedPedigree
Lot number (s)
InitialPedigree
Business name
Address
Each owner
of the drug
Owners
Date of Transaction
Sales Invoice Number
Business name
Each owner
of the drug
Shipping Info
Address
Certification
Contact information of each person
certifying delivery or receipt
Each owner
of the drug
The supply chain path of a drug is
known at any point
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IBM’s Unique Value Proposition
1.
IBM offers the most complete solution components: Device Management,
Capture Middleware, EPCIS, and Pedigree App (both Document and EPCIS
Pedigree) – the only “one stop shop”
2.
IBM employs 400,000 professionals, operates in 170 countries, and has local
expertise and support in any part of the world
3.
IBM has been working with many global regulatory agencies: FDA US (drug
and devices regulation), EFPIA, Brazil,Turkey
4.
IBM solution has been deployed for different use cases in many industries for
cross-learning opportunity
5.
IBM solution provides low operational risk: redundancy, HA, and fail-over
contingency
6.
IBM solution enables extension to business applications such as:
consignment inventory, supply chain visibility, cold-chain management,
chargeback resolution, targeted recall
7.
IBM solution can easily be integrated with many other complementary suite
of products: ILOG, Maximo, MDM, Cognos
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Workshop Invitation
 Ready to learn more about how IBM can help your business?
 IBM experts will arrange to meet with your team to evaluate your current
readiness and make suggestions for next phase deployment needs.
 Our teams have worked with several manufacturers and distributors
globally, and can help you define a process roadmap to obtain
serialization, compliance and help offset on-going costs by evaluating
overall business process efficiencies.
Thank you for your Attention
Smarter, Safer Drugs
InfoSphere Traceability Server
IBM Software Group
BACKUP SLIDES
IBM’s Supply Chain Visibility solution – Platform for Many
Applications
Applications
Inv Mgmt
Data
Center
Cold Chain
Recalls
Prod Auth
ePedigree
RCM
Enterprise Traceability Server (EPCIS)
Serial
Commissioning
Number
Events for units,
Allocation cases and pallets
Aggregation
Events for cases
and pallets
Decommissioning
and De-aggregation
Events for
rework
Shipping Events for
transfers and
customer
shipments
Data Capture Application/Local Traceability Server (EPCIS)
Packaging
Plant
Serial
Numbers
Commissioning Aggregation
Events
Events
Line Management
Decommissioning De-aggregation Shipping
Events
Events
Events
Device Management
Premises Server
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Governments & Industry are concerned for patient safety
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Regulations are Increasing World-wide
Pedigree and
serialization
regulations are a
growing trend
among domestic
and international
regulatory bodies
Risk Management: Product Authentication & Diversion Detection
Challenges
• High risk of product counterfeit and
diversion
• High theft
• Protecting brand identity
• Increased inventory stock
•
•
•
WHO estimates counterfeit drug sales between $35 and 40
billion per year
Between 8 and 10% of the worldwide drug supply is
estimated to be counterfeit
By 2010, more than $75 billion of sales will be lost per year
“Leveraging Track and Trace in the Pharmaceutical Industry”, IBM Whitepaper © 2009
Benefits
• Minimize lost revenue due to
counterfeits
• Minimize lost revenue due to diversions
• Increase patient and consumer safety
• Brand protection and risk mitigation
Companies can identify counterfeit
or stolen product entering their
supply chain
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Risk Management: Targeted Recall
Benefits
Challenges
• Execute a targeted recall quickly
and efficiently
• Inability to execute a targeted
recall
• Enable a targeted recall over a full
recall
• Time, cost and effort to recall
product
• Track progress of recall
• Lost revenue
• Risk to brand identity
Companies can quickly identify where
product has been shipped and
efficiently execute a targeted recall
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Operational / Performance Inefficiencies: Supply Chain Visibility
Challenges
Benefits
• Lack IDC notes the
pharmaceutical industry loses
4.5% of revenue6
• Increased shipment accuracies
• of supply chain collaboration
• Lack of interoperable systems
• Ensure inventory levels are maintained to
meet market demands
• Insufficient traceability
• Reduce spoilage
IDC notes the pharmaceutical industry loses
4.5% of revenue* due to supply chain
inefficiencies
* “IDC Home: The Premier Global Market Intelligence Firm. 11 February 2009.
• Reduce handling cost for discrepancies
• Reduce working capital requirements
• Better forecasting
• Increased operational efficiency
Companies can optimize their business
processes driving operational efficiency
and reducing costs
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Operational / Performance Inefficiencies: Cold Chain Management
Challenges
• High spoilage
• Lack of compliance validation
Benefits
• Improved product efficacy and safety
• Reduced spoilage
• Proof of SOP – regulatory
• Track temperature and shelf-life data
• IMS Health reports worldwide sales of biologic
medications, which require temperaturecontrolled storage and shipping conditions,
increased by 12.5% in 2007  $75 billion
• Nearly double the 6.4% increase in sales of
traditional pharmaceuticals
Companies can increase product
safety and prevent spoilage due to
inefficient processes
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Operational / Performance Inefficiencies: Returnable
Container Management
Container Flow for Manufacturers
Challenges
•
•
•
•
High investment
Cost to replacement
Lack of monitoring
High safety stock requirements
Scrap
New containers
OEM
Benefits
• Reduce Costs
• Reduce returnable asset inventory by up to 40%
• Eliminate between 10-15% of safety stock
• Sharply reduce substitution costs
Plant 2
Plant 1
• Increase Operational Efficiency
3PL
• Eliminate potential shutdowns
• Increase asset utilization
• Optimize operation processes through trading
partner collaboration
• Reduce Risk
• Reduce asset counterfeiting
• Reduce product counterfeiting
• Protect investment
Supplier A
Supplier B
Supplier C
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A Working Deployment Model – Pedigree
1.
2.
3.
4.
Traceability
Server
Traceability
Server
Event repository
and processing
Event repository
and processing
Serial Number Allocation
Data Storage/Management
Performance Measurements
Reporting/Alerting
Data Capture
Line 5
Data Capture
5.
6.
7.
8.
ePedigree
Shipment Verification
Line 6
Print serialized label
Data capture
Units to Case
QA rework
Line 1
WebSphere
Sensor
Event Server
Processing
Line 7
Line 2
Line 3
Processing
Line 4
Phase 1 – One line
Phase 2 – Add’l Lines
Phase 3 – DCs
Phase 4 – Trading
Partner
Data Sharing
A Working Deployment Model – Realizing ROI
Traceability
Server
Traceability
Server
Event repository
and processing
Event repository
and processing
WebSphere
Sensor
Event Server
Data Capture
1. Serial Number Allocation
2. Data Storage/Management
3. Performance Measurements
4. Reporting/Alerting
Line 6
Line 2
Line 3
Line 4
Processing
Phase 1 – One line
Processing
Line 7
5. Print serialized label
6. Data capture
7. Units to Case
8. QA rework
Line 1
Shipment Verification
Line 5
Data Capture
Phase 2 – Add’l Lines
ePedigree
• Returnable container
management
• Logistics Management
• Dwell time
• Cold chain
• Controlled product
• Returns visibility
• Targeted recall
Phase 3 – DCs
• ePedigree
• Shipment verification
• Product authentication
• Diversion detection
• Returns visibility
• Downstream expiration
management
• Downstream inventory
visibility
• Targeted recall
Phase 4 – Trading
Partner
Data Sharing
Reliable Performance
US Pharma Manufacturer
InfoSphere Traceability
Server
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