smarter, safer drugs infosphere traceability server ibm software group let’s build a smarter...

Smarter, Safer DrugsInfoSphere Traceability Server

IBM Software Group

Let’s build a smarter pharmaceutical supply chain.

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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


Server


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


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


InfoSphereTraceability Server


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


Vendor B


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



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


ProcessingProcessing

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


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


Data Sharing



ePedigree

Shipment Verification

ePedigree


TraceabilityServer


TraceabilityServer


• 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







Line 2Line 2

Line 3Line 3

Line 4Line 4

Line 5Line 5

Line 6Line 6

Line 7Line 7

TraceabilityServer


TraceabilityServer


Phase 1 – One linePhase 1 – One line Phase 2 – Add’l LinesPhase 2 – Add’l Lines Phase 3 – DCsPhase 3 – DCs


Data Sharing


Data Sharing


Data CaptureData CaptureePedigree


ePedigree


TraceabilityServer


TraceabilityServer


WebSphereSensor

Event Server

WebSphereSensor

Event Server

InfoSphere Traceability Server

Reliable PerformanceUS Pharma Manufacturer

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smarter, safer drugs infosphere traceability server ibm software group let’s build a smarter...

Documents

smarter buildings

smarter grids

smarter solutions

supply chain optimization

smarter safer drugs

supply chain visibility

supply chain operations

supply chain inefficiencies