smarter, safer drugs infosphere traceability server ibm software group let’s build a smarter...
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Smarter, Safer DrugsInfoSphere Traceability Server
IBM Software Group
Let’s build a smarter pharmaceutical supply chain.
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smarter traffic
smarter water management
smarter healthcare
smarter food
smarter supply chains
smarter cities
smarter safe pharmaceuticals
smarter data center
smarter transportation
smarter manufacturing
smarter industrial operations
Smarter planet opportunities are everywhere....
smarter solutions for retail
The IBM Supply Chain solution enables customers in multiple industries to answer these questions today.
Pharmaceuticals: Can I be sure my prescription drugs are not counterfeit?
Returnable Containers: Do my suppliers have enough containers to meet my production needs?
Food: Where does my food come from?
Parts: Which parts were assembled in my car and are they authentic?
Serialization and the New Era of VisibilityThe ability to obtain and verify the location, status and history of an item.
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The world is changing and becoming more…
The explosion of new information,
when integrated, analyzed, and acted
upon using new types of intelligence,
enables solutions that
… help build Smarter Safer Drugs
Instrumented
Interconnected
Intelligent
Trace Events in a ‘Physical Meets Digital’ World
Physical InfrastructureFocus on smarter buildings, smarter water management, smarter grids, etc.
Physical InfrastructureFocus on smarter buildings, smarter water management, smarter grids, etc.
Supply Chain Optimization
Extend supply chain visibility, analytics and collaboration to transform supply chain operations.
Supply Chain Optimization
Extend supply chain visibility, analytics and collaboration to transform supply chain operations.
Asset Optimization
Full lifecycle asset management through real-time visibility, optimization and traceability
Asset Optimization
Full lifecycle asset management through real-time visibility, optimization and traceability
Production Process Optimization
Leverage industry information for asset design and process optimization.
Production Process Optimization
Leverage industry information for asset design and process optimization.
Serialized information links physical world assets, resources and infrastructure with the digital world of event processing, business analytics and optimization.
Supply Chain Visibility Can Produce Better Outcomes
4.5% of revenue is lost due to supply chain inefficiencies.
- IDC
8-10% of Worldwide Drug Supply is Counterfeit – up to $75 billion a year in lost sales
- WHO
Stock-Outs – Excess safety stock is 10% of inventory at Manufacturers and $700-800K of excess inventory at each hospital and retail pharmacy
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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 MedicinesASSOCIATED 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.
XylinkeXylinkeBlood Thinner
Retailer / HospitalDistribution/ ExportPharma
Manufacturer
T R U S T E D I N F O R M A T I O N
Trusted Physical Data is Converted into Usable Information
Reporting & Analytics 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
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Distribution Center
Distribution Center
Retail Location
InfoSphere Traceability
Server
InfoSphere Traceability
Server
InfoSphere Traceability
Server
Manufacturing Plant
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
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WHEREWHAT
WHY WHEN
Timestamp
Manufacturing Data Lot/Batch
Expiration
Environment Data Temperature
Transactional Data PO
Invoice
InfoSphere Traceability
Server
Types of Data
Location City/State
Country/Region
Store #
Dock #
Port #
Business Process Receipt
Ship
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Readers/Scanners
Reader Protocol
Filtering & Collection
ALE Interface
EPCIS CaptureApplication
EPCIS Capture Interface
EPCIS Event Repository
EPCIS Query Interface
Internal Applications
External Applications
Standard Network Architecture
Readers/Scanners
Reader Protocol
WebSphereSensor Event Server
ALE Interface
WebSphereSensor Event Server
EPCIS Capture Interface
InfoSphereTraceability Server
EPCIS Query Interface
ePedigreeShipment
Verification
Solution Architecture
√ GS1/EPCglobal Certificationhttp://www.epcglobalinc.org/certification/sw_cert
√
√
√
√
BusinessAnalytics
Standards Based Solution Components
(Systech, Optel Vision, Siemens, …)
Readers/Scanners
Reader Protocol
Vendor A
ALE Interface
Vendor A
EPCIS Capture Interface
Vendor B
EPCIS Query Interface
Vendor C
AlternateSolution Architecture
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Distributor B
Pharmacy C
Distributor A
Pharma Manufacturer
How is Data Captured?From large to small enterprises
Distributed Event Capture
Distributed Event Capture
IBMTraceability
Server
IBMTraceability
Server
Distributed Device Management
Distributed Device Management
Event CaptureEvent Capture
EPCISEPCIS
Device ManagementDevice Management
Event CaptureEvent Capture
Device ManagementDevice Management
Device ManagementDevice Management
Needs to support multiple customers
Want to drive value through internal visibility
Wants to purchase and support own data management platform
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 XylinkeXylinkeBlood Thinner
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TopicTopic DataData SourceSource
Unique Unique IdentifierIdentifier
Lowest saleable unit unique identifier Manufacturer
Source of DrugSource of Drug
Name
ManufacturerFederal manufacturer registration number
Principal address of the source
Drug Drug characteristicscharacteristics
Trade or generic name
Manufacturer
Quantity
Dosage form and strength
Container size
Number of containers
Expiration dates
Lot number (s)
OwnersOwners
Business name
Each owner of the drug
Address
Date of Transaction
Sales Invoice Number
Shipping InfoShipping InfoBusiness name Each owner
of the drugAddress
CertificationCertificationContact information of each person certifying delivery or receipt
Each owner of the drug
Commissioning Event
EPCIS Pedigree EPCIS Pedigree
Shipping Event
Shipping Event
Receiving Event
Receiving Event
pedigree
receivedPedigree
pedigree
shippedPedigree
pedigree
receivedPedigree
pedigree
shippedPedigree
InitialPedigree
Pedigree DocumentPedigree Document Pedigree Data RequirementsPedigree Data Requirements
Compliance (US): Pedigree Types (only IBM supports both)
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.
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.
Smarter, Safer DrugsInfoSphere Traceability Server
IBM Software Group
Thank you for your Attention
BACKUP SLIDES
Data Capture Application/Local Traceability Server (EPCIS)
Line Management Device Management Premises Server
Enterprise Traceability Server (EPCIS)
Serial Numbers
Commissioning Events
Aggregation Events
Decommissioning Events
De-aggregation Events
ShippingEvents
Data Data CenterCenter
Packaging Plant
ePedigreeePedigreeInv MgmtInv Mgmt Cold ChainCold Chain RecallsRecalls RCMRCMProd AuthProd AuthApplicationsApplications
Serial Number
Allocation
Commissioning Events for units, cases and pallets
Aggregation Events for cases
and pallets
Decommissioning and De-aggregation
Events for rework
Shipping Events for transfers and
customer shipments
IBM’s Supply Chain Visibility solution – Platform for Many Applications
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Governments & Industry are concerned for patient safety
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Pedigree and serialization
regulations are a growing trend
among domestic and international regulatory bodies
Regulations are Increasing World-wide
Challenges• High risk of product counterfeit and
diversion• High theft• Protecting brand identity• Increased inventory stock
Benefits• Minimize lost revenue due to
counterfeits• Minimize lost revenue due to diversions• Increase patient and consumer safety• Brand protection and risk mitigation
Risk Management: Product Authentication & Diversion Detection
Companies can identify counterfeit or stolen product entering their supply chain
• 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
• 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
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Risk Management: Targeted Recall
Challenges• Inability to execute a targeted
recall
• Time, cost and effort to recall product
• Lost revenue
• Risk to brand identity
Benefits
• Execute a targeted recall quickly and efficiently
• Enable a targeted recall over a full recall
• Track progress of recall
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
Companies can optimize their business processes driving operational efficiency and reducing costs
Challenges
• Lack IDC notes the pharmaceutical industry loses 4.5% of revenue6
• of supply chain collaboration
• Lack of interoperable systems
• Insufficient traceability
Benefits• Increased shipment accuracies
• Reduce handling cost for discrepancies
• Reduce working capital requirements
• Ensure inventory levels are maintained to meet market demands
• Reduce spoilage
• Better forecasting
• Increased operational efficiencyIDC notes the pharmaceutical industry loses
4.5% of revenue* due to supply chain inefficiencies
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.
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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
Companies can increase product safety and prevent spoilage due to inefficient processes
• IMS Health reports worldwide sales of biologic medications, which require temperature-controlled storage and shipping conditions, increased by 12.5% in 2007 $75 billion
• Nearly double the 6.4% increase in sales of traditional pharmaceuticals
• IMS Health reports worldwide sales of biologic medications, which require temperature-controlled storage and shipping conditions, increased by 12.5% in 2007 $75 billion
• Nearly double the 6.4% increase in sales of traditional pharmaceuticals
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New containers
Container Flow for Manufacturers
Operational / Performance Inefficiencies: Returnable Container Management
OEM
Challenges• High investment• Cost to replacement• Lack of monitoring• High safety stock requirements
Scrap
Supplier A Supplier B Supplier C
Plant 1 Plant 2
3PL
Benefits• Reduce Costs
• Reduce returnable asset inventory by up to 40%• Eliminate between 10-15% of safety stock• Sharply reduce substitution costs
• Increase Operational Efficiency• Eliminate potential shutdowns• Increase asset utilization• Optimize operation processes through trading
partner collaboration• Reduce Risk
• Reduce asset counterfeiting• Reduce product counterfeiting• Protect investment
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A Working Deployment Model – Pedigree
Line 1Line 1
Data CaptureData Capture
1. Serial Number Allocation2. Data Storage/Management3. Performance Measurements4. Reporting/Alerting
1. Serial Number Allocation2. Data Storage/Management3. Performance Measurements4. Reporting/Alerting
ProcessingProcessing
5. Print serialized label6. Data capture7. Units to Case8. QA rework
5. Print serialized label6. Data capture7. Units to Case8. QA rework
Line 2Line 2
Line 3Line 3
Line 4Line 4
Line 5Line 5
Line 6Line 6
Line 7Line 7
TraceabilityServer
Event repository and processing
TraceabilityServer
Event repository and processing
WebSphereSensor
Event Server
WebSphereSensor
Event Server
Phase 1 – One linePhase 1 – One line Phase 2 – Add’l LinesPhase 2 – Add’l Lines Phase 3 – DCsPhase 3 – DCs
Phase 4 – TradingPartner
Data Sharing
Phase 4 – TradingPartner
Data Sharing
ProcessingProcessing
Data CaptureData Capture
ePedigree
Shipment Verification
ePedigree
Shipment Verification
TraceabilityServer
Event repository and processing
TraceabilityServer
Event repository and processing
• ePedigree• Shipment verification• Product authentication• Diversion detection• Returns visibility• Downstream expiration
management• Downstream inventory
visibility• Targeted recall
• Returnable container management
• Logistics Management• Dwell time• Cold chain• Controlled product
• Returns visibility• Targeted recall
A Working Deployment Model – Realizing ROI
Line 1Line 1
Data CaptureData Capture
1. Serial Number Allocation2. Data Storage/Management3. Performance Measurements4. Reporting/Alerting
1. Serial Number Allocation2. Data Storage/Management3. Performance Measurements4. Reporting/Alerting
ProcessingProcessing
5. Print serialized label6. Data capture7. Units to Case8. QA rework
5. Print serialized label6. Data capture7. Units to Case8. QA rework
Line 2Line 2
Line 3Line 3
Line 4Line 4
Line 5Line 5
Line 6Line 6
Line 7Line 7
TraceabilityServer
Event repository and processing
TraceabilityServer
Event repository and processing
Phase 1 – One linePhase 1 – One line Phase 2 – Add’l LinesPhase 2 – Add’l Lines Phase 3 – DCsPhase 3 – DCs
Phase 4 – TradingPartner
Data Sharing
Phase 4 – TradingPartner
Data Sharing
ProcessingProcessing
Data CaptureData CaptureePedigree
Shipment Verification
ePedigree
Shipment Verification
TraceabilityServer
Event repository and processing
TraceabilityServer
Event repository and processing
WebSphereSensor
Event Server
WebSphereSensor
Event Server
InfoSphere Traceability Server
Reliable PerformanceUS Pharma Manufacturer
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