ISPE New Jersey Chapter Professional Development Day

1. ISPE New Jersey Chapter Professional Development Day March 20th,2014

2. Today’s Discussion Points Serialization Definitions and Drivers 1 Compliance Strategy 2 Operational Governance 3 Deployment Strategy 4 Early Lessons Learned 5

3. SERIALIZATION DEFINITIONS & DRIVERS

4. Business Drivers • Patient Safety: Insure the integrity of pharmaceutical products throughout the supply chain • Counterfeiting deterrent • Deter re-introduction of stolen goods into supply chain (with T&T) • Allows “Authentication” through the supply chain • ePedigree – confirmed movement through legitimate supply chain • Compliance: Increasing regulations (US and Global) • US legislation: requires ePedigree with pathway to Track and Trace. Unit level serialization by Nov 2017. • EU Falsified Medicines Directive: requires serialization and tamper evidency in ~2017/2018 through EU country delegated acts (with pharmacy authentication) • Emerging Markets: (Argentina, China, Turkey, India, etc.) have enacted Serialization regulations typically requiring Trace & Trace

5. Definitions: Regulatory Impact on Operations GS1Standards Serialization • Applying a unique identification code to the retail unit of sale • Authentication • Confirming the authenticity of the unique identification code, typically at the point of dispense • Track and Trace • Determining the location of product as it moves through the supply chain • ePedigree • Documenting the chain of ownership of the product as it moves through the supply chain • Aggregation and Inference (required for T&T) • Every item, case and pallet is assigned a serial number • Items are aggregated to cases (parent / child relationship) • Cases are aggregated to pallets • Unit level serial numbers can be “inferred” by reading the case or pallet serial number

6. COMPLIANCE STRATEGY

7. Compliance Strategy • Included as one component of a comprehensive supply chain security program • Work with industry groups to understand and help develop standards and influence the approach (e.g., PhRMA, EFPIA, GS1, Rx 360) • Market alignment process to clearly understand the requirements for successful deployment • Understand the global landscape to minimize impact to your design strategy • Tracking SKU compliance

8. Market Compliance Enablement Serialization PMO Market Logistics / SC Enabling WS Market Enabling Core Team Market Mfg Market Enabling WS Market GL&S External Supply Enabling WS Supply Network Enabling WS BT Enabling WS Market Reg. Affairs Market Artwork BU Mgt • Activity: • Actively monitor mandates • Monitor in program local solution • Monitor in program enterprise solution for requirement changes • Activity: • Determine initial scope and sourcing strategy for mandate • Document mandate compliance milestones • Request and approve program funding • Initiate market engagement • Activity: • Form local market team and meeting cadence • Finalize approach and design for scope • Update Enterprise master schedule to include identified enablement activities • Activity: • Coordination of schedule and resources • Enable impacted Pfizer supply chain • Enable data management across Pfizer supply chain • Enhance Enterprise solution • Activity: • Onboard SKUs within the network • Monitor and track SKU onboarding / compliance • Activity: • Transition supply chain and enabling functions to standard operational activity • Ongoing monitoring

9. Global Landscape Authentication 2017 / 2018 Internal External Internal EU Member Markets Serialization Data to/from Site Lines Serialized Product Data Serialized Product Data Data Updates from Plant WH (including tracked shipments) Serialized Product Data Data Updates Serialized Product Data Phasing Lot – 2015 SN – 2017 WH – 2019 T&T – 2023 Serialized Products from Mfg Enterprise Solution LSP (O2C WH) Distribution Serialized Product Data (Manual / Local BT Solution) Local Solution In-house (WMS WH) Non-Serialized Products from Mfg Non-Core Examples Mandate Evaluation

10. OPERATIONAL GOVERNANCE

11. Program Governance • Corporate spokesperson • Communicate business impact • Elevate issues to Executive Leadership Team (ELT) Executive Sponsor • Endorse Program Deployment /Compliance Plan • Endorse cost avoidance strategies (sourcing changes) • Endorse investment deferrals and associated risks • Participate in quarterly updates and elevate issues Program Governance Supply Chain Security Program Governance Committee • Oversight and guidance of PMO workstream activities • Establish core solution strategies and scope • Obtain funding for workstream resources • Establish and monitor Program Deployment/Compliance Plan • Stakeholder communication and awareness PMO Steering Team • Day to day management of PMO • Coordination of workstream activities • Development of program metrics PMO Program Leads Program Operations Program Operations Program Financial Management Market Enablement & BU Engagement End User Chg Mgt & Training Logistics & Supply Chain Enablement Supply Network Enablement BT Solution Enablement Capital Controls & Optimization External Supply Enablement Industry Alignment / Customer Engagement

12. Program Operations GTS – GE PGS BT Trade GTS – Packaging GL&S Steering Committee External Supply Market Enablement Program Co-Leads Program Co-Leads Program Leads Program Financial Management Industry Alignment / Cust Engagement Market Enablement & BU Engagement Logistics & Supply Chain Enablement End User ChgMgmt & Training • CPA Allocation • Oper Cost Impacts • Operational Budgeting, Forecasting & Accounting • E2E Pilots • Industry Engagement • Policy & Regulatory Influence • Country Engagement • Market Regulatory Requirements • Market Enablement • “Operationalize” Serialization • End User / Process Change Mgt • CI • Global Process Mgt • Logistics Deployments • Supply Chain SKU Onboarding PMO Supply Network Enablement BT Solution Enablement Capital Controls & Optimization Program Operations External Supply Enablement • Capital Planning & Optimization • Capital Funding & Controls • Capital Reporting • Solution Platform Architecture • Site Line Deployments • SKU Compliance • Data Management Architecture • Solution Deployments • MDM • CMO Project / Relationship Mgt • CMO Line Deployments • CMO Funding Model • Network Compliance • Scope & Change Mgt • Schedule Mgt • Enterprise wide representation, participation and collaboration • Matrix organization with defined and integrated roles and responsibilities • Sourcing strategy for External & Internal site packaging lines

13. DEPLOYMENT STRATEGY

14. Deployment Strategy • Engage with Suppliers and Logistic Service Providers to create awareness, provide solution assistance and build capabilities • Adapt work processes in line with Serialization and Traceability requirements on network supply and distribution strategies/practices • Build Serialization and Traceability competencies throughout the network • Establish flexible technical solution based on standards are deployable in modules • Develop a master plan to track and achieve compliance

15. Operating Model Program Operations • Activity: • Coordinate alignment of all workstreams to ensure successful mandate compliance • Management of Enterprise schedule • Report Program and mandate status • Manage Issue and risks • Monitor and track progress across all in scope mandates • Manage program communications • Manage program scope and financials • Activity: • Actively monitor mandates / regulations not in scope of program • Monitor in program local solution requirement changes • Monitor in program enterprise solution for requirement changes • Monitor and bring back learnings from pilots • Activity: • Determine initial scope and sourcing strategy for mandate • Document mandate compliance milestones • Request and approve program funding • Initiate market engagement • Activity: • Form local market team and meeting cadence • Finalize approach and design for scope • Update Enterprise master schedule to include enablement schedules from all workstreams impacted • Secure site / source funding • Activity: • Coordination of schedule and resources • Enable impacted internal supply chain • Enable data management across internal supply chain • Enhance Enterprise solution • Lead change management and training across internal Supply Chain • Transition to Enterprise support • Activity: • Onboard SKUs within the network • Monitor and track SKU onboarding / compliance • Activity: • Transition supply chain and enabling functions to standard operational activity • Ongoing monitoring *Phases may occur in parallel or cyclical nature

16. Deployment Strategy • Understand Regulatory Landscape • Markets Served – US, EU and Emerging Market (i.e. Argentina, China, India, Korea, Columbia, Brazil, etc) • Product Portfolio vs. Line Allocation • Line Consolidation • Deferment Consideration • Line Assessments • Process Flow/Mapping - > Alignment and application of appropriate Global Solution • Asset - Upgrade, Redeploy vs. New • Collection and management of Master Data • Artwork Change Management/Guidance Documents • Impact on Supply Network

17. Packaging Line Serialization SCT Packaging Line enabling prerequisites: Delivery of required equipment (e.g., new labeler or case packer) Developing SKU artwork Compiling SKU master data (+50 elements / SKU) Availability of Serialization Solution Partner SME Availability of Serialization SME Availability of BT Serialization SME Availability of production window (3 to 6 weeks of downtime)

18. Online Serialization & Aggregation A/P/V A/P/V P/V P/V P/V P/V P/V P/V Online Serialization & Aggregation (blisters) Case Packer Case Conveyor Cartoner Packer Online Serialization & Aggregation (bottles / vials) Case Packer Case Packer Case Case Labeler Labeller Packer Packer P/V P/V Case Packer Online Serialization Authentication blisters Case Conveyor Cartoner Packer Online Serialization Authentication bottles / vials Case Level Aggregation Unit Level Serialization

19. Unit Serialization & Aggregation Alternatives A/P/V A/P/V A/P/V A/P/V P/V P/V P/V P/V P/V P/V P/V P/V Cartoner (blister) Case Packer Case Conveyor Online Aggregation for high volume SKUs Packer Brite Stock Postpone Serialization & Aggregation at second site Vial Filling Case Packing Online Serialization & Aggregation Case Conveyor Packer Brite Stock Serialization & Aggregation Postponed Aggregation for low volume SKUs (same site) Cartoner (blister) Conveyor Unit Level Serialization Postponed Aggregation Postponed Aggregation performed at second site Case Case manual or semi-automatic case packing manual or semi-automatic case packing Cartoner (blister) Packer Packer Conveyor Unit Level Serialization Postponed Aggregation Case Level Aggregation Unit Level Serialization

20. Supply Network Impact Serialization Supply Network Landscape Line 1 • Impact on Sites • Capacity impact from deployments (3-6 weeks downtime) • OEE impact • Reduced agility for SKU movements between pkg lines • Exception handling • Site Warehouses • Schedule based on serialized lines • Manage serialized and non-serialized product • Aggregation rework • Sampling • Track shipments • Update serialization information in the SCT Line 2 Line 3 Line 4 Line 5 Sites Line 6 • 3rd Party Contract Operations • Extensive collaboration needed - understanding requirements and delivery • Dynamic schedule: changing mandates and vendor readiness • Agreement on commercial impact (COGS impact vs. funded capital) • Opportunity to consolidate to fewer suppliers

21. EARLY LESSONS LEARNED

22. Early Lessons Learned • Start Early – pilot early and often • Do not underestimate complexity… especially information technology aspects • Partner with your serialization provider and align on the deployment schedule • Build technical and operational knowledge • Keep your antennae up – don’t ignore changing signals • Consider all impacts to your organization • Develop tools and toolkits to enhance competencies through your organization • Communicate, communicate, communicate – never too much

23. Mark Wessel • Global Serialization Program Leader Global Technology Services • Pfizer Global Supply