S P O N S O R E D B Y

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Joel McDonald
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1 S P O N S O R E D B Y

2 The Value of Visibility Data Seeing and Benefiting from Data after its Capture Example: Preparing for Serialization and Pedigree within the U.S. Pharmaceutical Supply Chain

3 Agenda GS1 Healthcare US Traceability Adoption WorkGroup 2015 Readiness Program 2015 Readiness Workshops

4 GS1 Healthcare US Visibility in Healthcare Initiatives GS1 US 2010

5 GS1 Healthcare US - Visibility in Healthcare GS1 Healthcare US Traceability Adoption WG Visibility in Healthcare Industry Think Tank Setting Industry Strategy 130 Key business processes (Industry Roadmap) Significant company and regulator participation You are Here Visibility in Healthcare Programs 1 st : 2015 Readiness Program Building the Industry Reference Model Implementation Tactics Unique, U.S. Pharmaceutical Reference Model Additional company participation Learning Workshops Catching Up Direct application of Leaders findings Group Implementation Programs Getting it done with a community Security in numbers Unique, Testing tool Prerequisite to Certification Products, Tools and Online Services U.S. Pharmaceutical Test Engine Pre-Pilot tool

6 GS1 Healthcare US Secure Supply Chain Task Force What we ve been doing since 2003 Raw Material Supplier Contract Manufacturer Manufacturer Wholesaler Wholesaler Pharmacy

7 U.S. Pharmaceutical Industry Business Drivers Solving Real Business Issues In 2009 we identified 130 business processes that could benefit from visibility data. In 2010 we will continue to define the details behind each process.

Customs clearance Diversion Examples: Vendor Managed Inventory Investigations Perfect Order Infection

8 Business Drivers Solving Real Business Issues Examples: Forward Logistics Reverse Logistics Recalls Returns Withdrawals Shrink/Loss Prevention Pharmacy Theft Cargo Theft Cold Chain Chargebacks Rebates Customs clearance Diversion Examples: Vendor Managed Inventory Investigations Perfect Order Infection Control Patient Flow Dispensing Errors Operating room turns Pharma co-vigilance Waste stream management

9 U.S. Pharmaceutical Industry 2009 Initiatives Detailed information flows for: Phase 1: Basic Forward Logistics Phase 2: Drop Ship, Repackaging, Kitting Phase 3: Reverse Logistics Phase 4: Exception Processing 9

10 GS1 Healthcare US 2015 Readiness Program Preparing for Serialization and Visibility within the U.S. Pharmaceutical Supply Chain GS1 US 2010

GS1 Healthcare US - Visibility in Healthcare GS1 Healthcare US Traceability Adoption WG Visibility in Healthcare Industry Think Tank Setting Industry Strategy 130 Key business processes

11 GS1 Healthcare US - Visibility in Healthcare GS1 Healthcare US Traceability Adoption WG Visibility in Healthcare Industry Think Tank Setting Industry Strategy 130 Key business processes (Industry Roadmap) Significant company and regulator participation Visibility in Healthcare Programs 1 st : 2015 Readiness Program Building the Industry Reference Model Implementation Tactics Unique, U.S. Pharmaceutical Reference Model Additional company participation Learning Workshops Catching Up Direct application of Leaders findings You are Here Group Implementation Programs Getting it done with a community Security in numbers Unique, Testing tool Prerequisite to Certification Products, Tools and Online Services U.S. Pharmaceutical Test Engine Pre-Pilot tool

U.S. Pharmaceutical Industry Business Drivers State

be identified by the GTIN and a unique Serial Number

tracked through the Supply Chain In the near future*,

the Lot Number or a Serial Number have states, or

12 U.S. Pharmaceutical Industry Business Drivers State and Federal Regulation By 2016, Pharmaceuticals will: be identified by the GTIN and a unique Serial Number have dispositions associated with each item Be tracked through the Supply Chain In the near future*, Medical Devices may: be identified by the GTIN and the Lot Number or a Serial Number have states, or Dispositions associated with each item * Pending FDA Regulatory action

13 Implementation Issues

14 Raw Material Supplier U.S. Pharmaceutical Industry Limited number of pilot partners Contract Manufacturer Manufacturer Wholesaler Wholesaler Pharmacy Limited number of Distributors creates a Pilot and Implementation bottleneck Multiple Scenarios, Inference Models and Exceptions are difficult and expensive to test in the actual supply chain

15 U.S. Pharmaceutical Industry What needs to be tested? Business Scenarios Aggregation Model Exceptions Pure overage Pure shortage Pedigree serial discrepancy - Different serial, right lot Pedigree serial discrepancy - Different lot Pedigree serial & lot incorrect Product inference problem Quantity inference problem Physical inventory overage Physical inventory shortage Chain of Custody Full Case Case Tote Item 10+ variations on each Business Scenario Pharmacy Theft Recall Investigation Full Case 30 + Exception Processes have been identified Case Tote Item Full Case Case Tote Item 130+ Business Scenarios have been identified Full Case Case Tote Item 130 Scenarios x 10 variations x 30 Exception Processes ,000 + variations to test!

16 U.S. Pharmaceutical Industry FAQs How to fit all the pieces together? What can companies do prior to costly pilots?

GS1 Healthcare US Secure Supply Chain product and information flow diagrams via simulation techniques.

17 U.S. Pharmaceutical Industry 2015 Readiness Program Experience a post 2015 U.S. Pharmaceutical supply chain world (start of serialization and Pedigree) Creation of a working 2015 reference model Animate GS1 Healthcare US Secure Supply Chain product and information flow diagrams via simulation techniques. Make available a facility whereby companies can test their future implementations against the reference model

18 2015 Readiness Program Benefits Test the impact of policy decisions on: Operations Information infrastructure Cash flow and funds management Visualize your processes logically or in a virtual environment Identify problem areas before implementation Explore the potential effects of modifications Confirm that all variables are known Optimize your operations Understand why observed events occur Communicate the integrity and feasibility of your plans Compare the value of alternate scenarios

19 2015 Readiness Program Additional Trading Partners to be added to the Simulations Contract Manufacturers (packaged finished goods) Chain drug stores (w/warehouses) 3PL s Wholesalers that purchase from other wholesalers Hospital Pharmacy Manufacturer to Pharmacy (not drop ship) Manufacturer to clinic / practice office Small Wholesaler Specialty Wholesaler (limited # of products purchased) Exclusive Wholesaler Specialized Wholesaler (trades only with Dr. offices and Clinics) Specialty pharmacy (limited # of products purchased) Manufacturer to manufacturer s pharmacy Manufacturer to repackager (repackaging detail held until 2 nd Qtr)

20 U.S. Pharmaceutical Industry 2015 Readiness Program Reference Model Supply Chain Simulation Future Application Capabilities

21 GS1 Healthcare US - Visibility in Healthcare GS1 Healthcare US Traceability Adoption WG Visibility in Healthcare Industry Think Tank Setting Industry Strategy 130 Key business processes (Industry Roadmap) Significant company and regulator participation Visibility in Healthcare Programs 1 st : 2015 Readiness Program Building the Industry Reference Model Implementation Tactics Unique, U.S. Pharmaceutical Reference Model Additional company participation Learning Workshops Catching Up Direct application of Leaders findings Group Implementation Programs Getting it done with a community Security in numbers You are Here Unique, Testing tool Prerequisite to Certification Products, Tools and Online Services U.S. Pharmaceutical Test Engine Pre-Pilot tool

22 2015 Readiness Workshop Exercise 1 Given your organization s position in the supply chain, walk through the information sharing decisions your organization will make to prepare for 2015: Apply those decisions to the GS1 Healthcare US U.S. Pharmaceutical Supply Chain Reference Model Learn how your decisions: impacted your information position impacted other trading partners in the reference model Exercise 2 Participants will use the output of the existing GS1 Healthcare US U.S. Pharmaceutical Supply Chain Reference Model to determine: the location of a number of Pharmaceutical products the disposition of a number of Pharmaceutical products how many bottles of a particular Lot # remain in the supply chain what simulated trading partners would have been contacted to answer each question GS1 US

23 GS1 Healthcare US 2015 Readiness Program Preparing for Serialization and Visibility within the U.S. Pharmaceutical Supply Chain GS1 US 2010

24 2015 Readiness Program Benefits Test the impact of policy decisions on: Operations Information infrastructure Cash flow and funds management Visualize your processes logically or in a virtual environment Identify problem areas before implementation Explore the potential effects of modifications Confirm that all variables are known Optimize your operations Understand why observed events occur Communicate the integrity and feasibility of your plans Compare the value of alternate scenarios

25 Questions? CORPORATE HEADQUARTERS Princeton Pike Corporate Center 1009 Lenox Drive, Suite 202 Lawrenceville, NJ USA T E info@gs1us.org Connect with the GS1 US community on

The Value of Visibility. Bob Celeste GS1 Healthcare US

The Value of Visibility. Bob Celeste GS1 Healthcare US The Value of Visibility Bob Celeste GS1 Healthcare US The role of GS1 GS1 is a not-for-profit organisation dedicated to the design and implementation of global standards to improve the efficiency and visibility