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Smarter, Safer Drugs InfoSphere Traceability Server IBM Software Group Let’s build a smarter pharmaceutical supply chain.

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Presentation on theme: "Smarter, Safer Drugs InfoSphere Traceability Server IBM Software Group Let’s build a smarter pharmaceutical supply chain."— Presentation transcript:

1 Smarter, Safer Drugs InfoSphere Traceability Server IBM Software Group Let’s build a smarter pharmaceutical supply chain.

2 2 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

3 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 Visibility The ability to obtain and verify the location, status and history of an item. 3

4 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

5 Trace Events in a ‘Physical Meets Digital’ World Physical Infrastructure Focus on smarter buildings, smarter water management, smarter grids, etc. Physical Infrastructure Focus 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.

6 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 $ K of excess inventory at each hospital and retail pharmacy 6

7 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.

8 Xylinke Blood Thinner Retailer / Hospital Distribution/ Export Pharma 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 8

9 Distribution Center Retail Location 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 9

10 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 10

11 Readers/Scanners Reader Protocol Filtering & Collection ALE Interface EPCIS Capture Application EPCIS Capture Interface EPCIS Event Repository EPCIS Query Interface Internal Applications External Applications Standard Network Architecture Readers/Scanners Reader Protocol WebSphere Sensor Event Server ALE Interface WebSphere Sensor Event Server EPCIS Capture Interface InfoSphere Traceability Server EPCIS Query Interface ePedigree Shipment Verification Solution Architecture √ GS1/EPCglobal Certification √ √ √ √ Business Analytics 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 Alternate Solution Architecture 11

12 Distributor B Pharmacy C Distributor A Pharma Manufacturer How is Data Captured? From large to small enterprises Distributed Event Capture IBM Traceability Server IBM Traceability Server Distributed Device Management Event Capture EPCIS Device Management 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  Needs to support multiple customers  Has limited interest in driving value through internal visibility  Government agency hosts the data servers 12

13 Expected Business Benefits from Track and Trace Source: AMR Research,

14 New Insights – The Power of Analytics to Gain Efficiencies Xylinke Blood Thinner 14

15 TopicDataSource Unique Identifier Lowest saleable unit unique identifierManufacturer Source of Drug Name Manufacturer Federal manufacturer registration number Principal address of the source Drug characteristics Trade or generic name Manufacturer Quantity Dosage form and strength Container size Number of containers Expiration dates Lot number (s) Owners Business name Each owner of the drug Address Date of Transaction Sales Invoice Number Shipping Info Business name Each owner of the drug Address Certification Contact information of each person certifying delivery or receipt Each owner of the drug Commissioning Event EPCIS Pedigree Shipping Event Receiving Event pedigree receivedPedigree pedigree shippedPedigree pedigree receivedPedigree pedigree shippedPedigree InitialPedigree Pedigree Document Pedigree Data Requirements Compliance (US): Pedigree Types (only IBM supports both) The supply chain path of a drug is known at any point 15

16 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 16

17 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.

18 Smarter, Safer Drugs InfoSphere Traceability Server IBM Software Group Thank you for your Attention

19 BACKUP SLIDES

20 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 Shipping Events Data Center Packaging Plant ePedigreeInv MgmtCold ChainRecallsRCMProd Auth Applications 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 20

21 Governments & Industry are concerned for patient safety 21

22 Pedigree and serialization regulations are a growing trend among domestic and international regulatory bodies Regulations are Increasing World-wide

23 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 ©

24 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 24

25 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 revenue 6 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 efficiency 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

26 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 26

27 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 ASupplier 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 27

28 A Working Deployment Model – Pedigree Line 1 Data Capture 1.Serial Number Allocation 2.Data Storage/Management 3.Performance Measurements 4.Reporting/Alerting Processing 5.Print serialized label 6.Data capture 7.Units to Case 8.QA rework Line 2 Line 3 Line 4 Line 5 Line 6 Line 7 Traceability Server Event repository and processing WebSphere Sensor Event Server Phase 1 – One linePhase 2 – Add’l LinesPhase 3 – DCs Phase 4 – Trading Partner Data Sharing Processing Data Capture ePedigree Shipment Verification Traceability Server Event repository and processing

29 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 1 Data Capture 1.Serial Number Allocation 2.Data Storage/Management 3.Performance Measurements 4.Reporting/Alerting Processing 5.Print serialized label 6.Data capture 7.Units to Case 8.QA rework Line 2 Line 3 Line 4 Line 5 Line 6 Line 7 Traceability Server Event repository and processing Phase 1 – One linePhase 2 – Add’l LinesPhase 3 – DCs Phase 4 – Trading Partner Data Sharing Processing Data Capture ePedigree Shipment Verification Traceability Server Event repository and processing WebSphere Sensor Event Server

30 InfoSphere Traceability Server Reliable Performance US Pharma Manufacturer 30


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