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Building A Global Pharmaceutical Traceability Foundation
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Building A Global Pharmaceutical Traceability Foundation

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Traceability of pharmaceutical products as they move through the global supply chain. Regulations, technology standards, trading partner interoperability can all be barriers for companies seeking to …

Traceability of pharmaceutical products as they move through the global supply chain. Regulations, technology standards, trading partner interoperability can all be barriers for companies seeking to gain the benefits of supply chain visibility and collaboration. Join SupplyScape in reviewing the key considerations and common misconceptions about pharmaceutical traceability.

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  • 1. Building a Global Traceability Foundation to Drive Visibility, Efficiency and Compliance Common Misconceptions and Key Considerations Robin Koh, Chief Strategy Officer, SupplyScape Corporation
  • 2. Agenda
    • Main Drivers for Global Track and Trace
    • Key Considerations for Building Global Traceability Foundation
      • 4 Common Misconceptions
      • Implementation Approach to Global Serialization
    • Key Takeaways
  • 3. Safe & Secure Supply Chain Model Safe and Secure Supply Chain Pharmaceutical Co Wholesaler Pharmacy Chain of Custody Security Transaction Security Trace Track Pedigree Individual Product Security Product Security Product Authentication ID Authentication Authentication
  • 4. Drivers For Global Traceability Regulatory Compliance Product Security Global Traceability Regulatory Compliance States considering pedigree laws / rules PDMA in effect. No state activity States with pedigree laws / rules today US Pedigree Regulations In place In development Global Serialization & Codification Regulations 70% Medical Professional 18% Subscriber Global Pharma Safety Incidents Sources: Organisation for Economic Co-operation and Development 964 04 196 02 484 03 1,123 05 1,412 06 1,759 07 Product Security Source: BCBSA Survey of Blue Plans’ Anti-Fraud Programs Reimburse In-accuracy 5% Med Unnec. 36% Services Not Rendered 9% Excess Charges 35% Other (1) 2% Pharm Fraud 4% Service Over Utilization 9% Upcoded Service
  • 5. Complexity of Global Serialization Proliferation of Regulatory Requirements
    • Time to implement serialization is usually underestimated
    • Flexibility to handle future requirements is often overlooked
    • Business benefits are difficult to quantify
  • 6. Agenda
    • Main Drivers for Global Track and Trace
    • Key Considerations for Building Global Traceability Foundation
      • 4 Common Misconceptions
      • Implementation Approach to Global Serialization
    • Key Takeaways
  • 7. Misconception #1: ‘ I Can Wait’
    • Case Study
      • A global manufacturer planning for France’s (CIP13) 2D Data Matrix requirement in 2011
    • Lesson’s Learned
      • Many variables lengthen the time for implementation
      • Number of qualified vendors available
      • Working with CMO networks is more involved than expected
      • Piloting 1 or 2 packaging lines does not adequately prepare for the scalability issues associated with a corporate roll-out
    The Plan is Nothing, but Planning is Everything Dwight D Eisenhower
  • 8. Misconception #2: ‘Serialization has Limited ROI’ Least Realistic More Realistic CAPEX Packaging CAPEX ACF Program ACF Impact on Line Efficiency Additional Labor Data Monitoring CAPEX-Internal Additional Label Cost CAPEX CMO CAPEX DC Software Maintenance Recurring Benefit CAPEX - One Time Running Cost CAPEX IT Anti-Counterfeit Program #2 Patient Safety Program #1 Label Standardize Program Sales Enhancement Program #2 Anti-Counterfeit Program #1 Recall Enhancement Program Supply Chain Efficiency Program SC Visibility Program #1 Sales Enhancement Program #1 Data Reform Program Benefit Programs by Level of Effort Required and the Magnitude of Benefit Upside Potential Downside Impact
  • 9. Misconception #3 ‘ Countries are Driving Towards One Standard’
    • Case Study
      • In the original design of the MIT solution, there is a fundamental assumption that there will be a homogenous number management system
    • Lesson’s Learned
      • Harmonizing on data carriers & numerical structure are different things
      • Number assignment from multiple sources
      • Random numbers and non-sequential numbers are different things
      • There is no guarantee on future requirements
    Your Requirements vs. Available Solutions
  • 10. Misconception # 4 ‘ Serial Number Lookup is an Authentication System’
    • Building a more complete system :
      • Alert Patients on Adverse Events in Real Time (e.g. Recall)
      • Provide Accurate Data for Detection and Prevention in addition to Investigation
      • Pattern, Pace & Place
      • Detect False Positives
      • Authenticate Physical Anti-Counterfeiting Features
    Product Security Product Authentication ID Authentication Authentication Individual Product Security
  • 11. Agenda
    • Main Drivers for Global Track and Trace
    • Key Considerations for Building Global Traceability Foundation
      • 4 Common Misconceptions
      • Implementation Approach to Global Serialization
    • Key Takeaways
  • 12. Suggested Approach to Global Serialization Global Framework, Local Alignment
    • Develop a clear understanding of costs, timing, resources and operational changes needed to meet requirements
    • Develop local guidance based on corporate standards
    • Construct and execute a plan to address immediate requirements using localized approach
    • Build a migration plan to integrate into corporate strategy
    • Execute the integration plan to migrate local solution into global strategy
    Define Global Strategy & Guidelines Address Local Requirements Migrate To Global Plan
  • 13. Agenda
    • Main Drivers for Global Track and Trace
    • Key Considerations for Building Global Traceability Foundation
      • 4 Common Misconceptions
      • Implementation Approach to Global Serialization
    • Key Takeaways
  • 14.
    • Serialization is Global and Uncoordinated
      • EU, China and USA moving in parallel
    • Manufacturers must Assume a Global Perspective
      • There are a set of concrete steps you can take
    • Serialization can Provide ROI if you know where to look
    • Few Vendors Understand the Global Issues and Misconceptions
    Key Takeaways
  • 15. Looking Forward Business Opportunities in Supply Chain Traceability
    • What if you could?
    • Leverage investments in product serialization initiatives to drive a higher return on product and brand protection?
    • Increase new product launch success by ensuring proper supply into key markets?
    • Establish a global network of trading partners to provide greater visibility into distribution channels ?
    • Overcome barriers to entry into new markets by more efficiently addressing local distribution requirements?
    • Facilitate financial reconciliation across chargeback, rebate, and re-imbursements across your supply network?
  • 16. Next Steps Get Started on Developing a Global Traceability Foundation Contact Mary Hall today to schedule a consultation! 781.503.7462, mhall@supplyscape.com Visit SupplyScape.com to learn more www.supplyscape.com