Smarter, Safer Drugs InfoSphere Traceability Server IBM Software Group Let’s build a smarter pharmaceutical supply chain. Smarter, Safer Drugs InfoSphere Traceability Server IBM Software Group Welcome. On behalf of IBM’s Software Group, thank you for joining us today. We are going to explore an exciting software solution for Pharmaceutical Track & Trace, which is comprised of two IBM software products: InfoSphere Traceability Server …and Websphere Sensor Events CLICK

Smarter planet opportunities are everywhere.... smarter safe pharmaceuticals smarter solutions for retail smarter supply chains smarter food smarter manufacturing smarter industrial operations The solution is a perfect example of IBM’s initiative around building a Smarter Planet. IBM is helping companies save money and create safer supply chains. CLICK smarter data center smarter healthcare smarter transportation smarter traffic smarter water management smarter cities 2

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 ability to track and trace serialized items offers companies new visibility…. You can now obtain and verify the location, status and history of an item, product or any physical asset. Traceability can also help address questions around counterfeit drugs, authentic car parts, and food supply. CLICK The IBM Supply Chain solution enables customers in multiple industries to answer these questions today. 3 3

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 Serialization is part of today’s modern supply chain….a supply chain that is more instrumented, interconnected and intelligent than ever before. As demand for more serialized information increases, there is an explosion of new information. When integrated, analyzed, and acted upon using new types of intelligence, IBM helps companies build and leverage their serialized supply chain to enable solutions that help build a Smarter, Safer Drug Supply CLICK

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 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 Let’s take a look into how traceability enables a smarter, Safer and more efficient manufacturing and supply chain. There are four major aspects of this ‘Physical Meets Digital World’ that can have a dramatic impact and drive efficiency in your business. CLICK Asset Optimization…..Products are captured in real-time and tracked through new event visibility, at more granular levels than ever before; Supply chain Optimization: There is new visibility available and also business process correlation to events, not just internally but also selectively and securely shared with trading partners; Efficiciency and additional process optimization can be gained from event visibility for simple and complex business processes & infrastructure. Production Process Optimization Leverage industry information for asset design and process optimization. Physical Infrastructure Focus on smarter buildings, smarter water management, smarter grids, etc. 5

Supply Chain Visibility Can Produce Better Outcomes 4.5% of revenue is lost due to supply chain inefficiencies. Stock-Outs – Excess safety stock is 10% of inventory at Manufacturers and $700-800K of excess inventory at each hospital and retail pharmacy - IDC The opportunity for Smarter Business results are all around us. In the Pharma Industry ….recent regulatory requirements to improve drug safety demand that companies modernize their supply chains and increase visibility and efficiency. In addition to regulatory drivers, there is also a need to act due to lost revenue from inefficient supply chain visibility, stock outs and the need to take additional steps to combat counterfeit products from entering the overall drug supply. CLICK 8-10% of Worldwide Drug Supply is Counterfeit – up to $75 billion a year in lost sales - WHO 6

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 The trend towards more regulation and serialization of pharmaceutical products is increasing globally. The number of countries acting on general concern for drug safety and moving toward some form of enhanced serialization to conform with tightening standards is a trend that will continue. Working with IBM, your company can leverage a standards-based technology platform that is purpose-built to allow for consistent deployment and accommodate on-going changes with country-to-country requirements. CLICK 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 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 Xylinke Blood Thinner T R U S T E D I N F O R M A T I O N Before we talk about how to proceed in creating traceability projects within your operation, it is important for everyone to keep in mind the Whole Supply Chain perspective. A Traceability system needs to be a trusted source of information. The completed traceability system will be only as good as its weakest link. So it is essential to identify all the stakeholders and establish buy-in and cooperation. There is a compelling business value proposition for each stakeholder in the chain (including governments, not shown here). All parties will benefit from risk mitigation and reduced liability, but other benefits will vary by stakeholder. Key benefits beyond compliance with regulations may include increased access to global markets; Increased quality control; Improved demand visibility; and forecasting or enhancing brand image and sales. CLICK Pharma Manufacturer Distribution/ Export Retailer / Hospital 8

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 InfoSphere Traceability Server InfoSphere Traceability Server Manufacturing Plant Distribution Center Distribution Center Retail Location This diagram depicts what a typical supply chain might look like. In terms of traceability, the red dots you see here represent ‘read points’. These read points are where information is captured about the particular product, item or asset being tracked. Events, such as receiving and shipping, are captured and stored to form a complete history. In addition, this information around What, Where, When, Why and Who can trigger alerts, as well as simple and complex business processes IBM Traceability Server allows event data to be securely shared with trading partners. CLICK 9

InfoSphere Traceability Server Types of Data WHAT WHERE Location City/State Country/Region Store # Dock # Port # Manufacturing Data Lot/Batch Expiration Environment Data Temperature Transactional Data PO Invoice InfoSphere Traceability Server Now let’s look at the type of information you capture and how a centralized repository can help. InfoSphere Traceability Server is based on a global technology standard called EPCIS – electronic product code information services. EPCIS event data tells you a lot of information about the movement of a product. An event contains information such as what the product is, where the product was seen, when the product was seen and why the product was there. As a central, intelligent hub of information, you have the ability to track all of this information, and make important decisions to help with operational issues such as inventory management and counterfeit detection. CLICK WHY WHEN Timestamp Business Process Receipt Ship 10

Standards Based Solution Components √ GS1/EPCglobal Certification http://www.epcglobalinc.org/certification/sw_cert Alternate Standard Network Architecture Solution Architecture Solution Architecture Readers/Scanners Reader Protocol Filtering & Collection ALE Interface EPCIS Capture Application EPCIS Capture Interface EPCIS Event Repository EPCIS Query Interface Internal Applications External ePedigree Shipment Verification Business Analytics Vendor C √ EPCIS Query Interface EPCIS Query Interface InfoSphere Traceability Server Vendor B √ EPCIS Capture Interface EPCIS Capture Interface WebSphere Sensor Event Server Vendor A (Systech, Optel Vision, Siemens, …) IBMs Traceability Solution is an implementation of the EPCIS standard, a cross-industry standard that is part of the EPCglobal/GS1 standard network architecture. Traceability Server is comprised of a data capture interface, data repository and data exchange interface and is completely aligned with EPCglobal standards. IBM has another software product within the stack, the WebSphere Sensor Event Server. Together, Traceability Server and Websphere Sensor Event Server make up the IBM Track & Trace Solution and work together to enable capture, store and share of EPCIS data. CLICK √ ALE Interface ALE Interface WebSphere Sensor Event Server Vendor A √ Reader Protocol Reader Protocol Readers/Scanners Readers/Scanners 11

How is Data Captured? From large to small enterprises Distributor A Needs to support multiple customers Want to drive value through internal visibility Wants to purchase and support own data management platform EPCIS Pharma Manufacturer IBM Traceability Server Event Capture Device Management Distributor B Needs to support multiple customers Has limited interest in driving value through internal visibility Distributed Event Capture Event Capture The model used with Traceability Server and Websphere Sensor Events is flexible to allow for multiple trading partners to share information effectively and securely, and only provide visbiliity to what is important to share. CLICK Device Management Distributed Device Management Pharmacy C Government agency hosts the data servers Device Management 12

Expected Business Benefits from Track and Trace And the benefit of greater inventory visibility within the supply chain consistently shows up as the number one need and business benefit of track and trace solutions according to industry research. CLICK Source: AMR Research, 2009 13 13

New Insights – The Power of Analytics to Gain Efficiencies Xylinke Blood Thinner With inventory visibility, your company will be given new insights into new data. As part of its core functionality, IBM’s Traceability Server includes powerful analytics and reports specific to the needs of your business. CLICK 14 14

Compliance (US): Pedigree Types (only IBM supports both) Pedigree Document Pedigree Data Requirements EPCIS Pedigree pedigree receivedPedigree shippedPedigree InitialPedigree Topic Data Source Unique Identifier Lowest saleable unit unique identifier Manufacturer Source of Drug Name Federal manufacturer registration number Principal address of the source Drug characteristics Trade or generic name 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 Certification Contact information of each person certifying delivery or receipt Commissioning Event Shipping Event Receiving Event Shipping Event Receiving Event IBM supports both document and EPCIS data requirements, and is the only solution to offer this. CLICK The supply chain path of a drug is known at any point 15

IBM’s Unique Value Proposition 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” IBM employs 400,000 professionals, operates in 170 countries, and has local expertise and support in any part of the world IBM has been working with many global regulatory agencies: FDA US (drug and devices regulation), EFPIA, Brazil,Turkey IBM solution has been deployed for different use cases in many industries for cross-learning opportunity IBM solution provides low operational risk: redundancy, HA, and fail-over contingency IBM solution enables extension to business applications such as: consignment inventory, supply chain visibility, cold-chain management, chargeback resolution, targeted recall IBM solution can easily be integrated with many other complementary suite of products: ILOG, Maximo, MDM, Cognos We believe your company can leverage IBM experience to make ready your supply chain……and get ready for a more complex serialized supply chain. We are current on status for all global standards for serialization, and you can depend on a team to help you deploy your solution with over 400,000 professionals in 170 countries worldwide. With the largest compatible suite of complementary solutions, look for IBM to streamline your deployment process and lower overall costs. 16 16

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. We hope you have found today’s overview both informative and engaging. From our experience, it is most important that you make the decision to act and get started with the process toward Smarter, Safer Supply Chain today. Take advantage of our experience and our free workshop to learn more about how IBM can help your specific business needs. CLICK

Smarter, Safer Drugs InfoSphere Traceability Server IBM Software Group Thank you for your Attention Smarter, Safer Drugs InfoSphere Traceability Server IBM Software Group On behalf of IBM’s Software Group, thank you for joining us today.

BACKUP SLIDES

IBM’s Supply Chain Visibility solution – Platform for Many Applications Inv Mgmt Cold Chain Recalls Prod Auth ePedigree RCM Data Center Enterprise Traceability Server (EPCIS) 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 Data Capture Application/Local Traceability Server (EPCIS) Serial Numbers Commissioning Events Aggregation Events Decommissioning Events De-aggregation Events Shipping Events Packaging Plant Line Management Device Management Premises Server 20

Governments & Industry are concerned for patient safety Regulatory Compliance remains the main driver in Pharmaceutical Track & Trace. Governments and Industry are concerned for patient safety. Both in the United States and in Europe, serialization laws are pending. On the left, are 2 maps of serialization laws in the US and in Europe. On the right, you see an example of a pedigree generated by the IBM system that depicts each movement of a drug and helps guarantee its authenticity. IBM’s Solution for Pharmaceutical Track & Trace helps companies adhere to global compliance regulations, enables trading partner connectivity and ensures a safer more secure drug supply chain. 21

Regulations are Increasing World-wide Pedigree and serialization regulations are a growing trend among domestic and international regulatory bodies California FDA China Korea Brazil EU Turkey

Risk Management: Product Authentication & Diversion Detection 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 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 Companies can identify counterfeit or stolen product entering their supply chain “Leveraging Track and Trace in the Pharmaceutical Industry”, IBM Whitepaper © 2009 23 23

Risk Management: Targeted Recall Benefits Execute a targeted recall quickly and efficiently Enable a targeted recall over a full recall Track progress of recall Challenges Inability to execute a targeted recall Time, cost and effort to recall product Lost revenue Risk to brand identity Companies can quickly identify where product has been shipped and efficiently execute a targeted recall 24

Operational / Performance Inefficiencies: Supply Chain Visibility 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 efficiency IBM’s WebSphere RFID Information can lead to better inventory within your own enterprise and within visibility up and down your supply chain. By enabling secure data sharing with trading partners, suppliers can react more efficiently to demand and retail outlets can reduce out of stock scenarios. IDC notes the pharmaceutical industry loses 4.5% of revenue* due to supply chain inefficiencies Companies can optimize their business processes driving operational efficiency and reducing costs * “IDC Home: The Premier Global Market Intelligence Firm. 11 February 2009. 25

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 Control temperature, monitors Complimenting existing cold environment 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 Companies can increase product safety and prevent spoilage due to inefficient processes 26

Operational / Performance Inefficiencies: Returnable Container Management New containers Container Flow for Manufacturers Challenges High investment Cost to replacement Lack of monitoring High safety stock requirements Scrap Plant 1 Plant 2 OEM 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 3PL Supplier A Supplier B Supplier C 27 27

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

A Working Deployment Model – Realizing ROI Traceability Server Event repository and processing Traceability Server Event repository and processing WebSphere Sensor Event Server Data Capture Serial Number Allocation Data Storage/Management Performance Measurements Reporting/Alerting ePedigree Shipment Verification Line 5 Line 6 Data Capture Processing ePedigree Shipment verification Product authentication Diversion detection Returns visibility Downstream expiration management Downstream inventory visibility Targeted recall Line 7 Print serialized label Data capture Units to Case QA rework Returnable container management Logistics Management Dwell time Cold chain Controlled product Returns visibility Targeted recall Line 2 Line 1 Line 3 Line 4 Processing Phase 4 – Trading Partner Data Sharing Phase 1 – One line Phase 2 – Add’l Lines Phase 3 – DCs

Reliable Performance US Pharma Manufacturer InfoSphere Traceability Server Shown results were achieved in the unit, case, pallet performance test of InfoSphere Traceability Server 30