J&J Seminar Feb 21 08

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J&J Seminar Feb 21 08

  1. 1. Introductions – Opening Remarks
  2. 2. Agenda <ul><li>Morning Session </li></ul><ul><li>8:30 – 9:45 Introductions/Opening Remarks </li></ul><ul><li>Who is Expeditors? </li></ul><ul><li>Temperature Control Language </li></ul><ul><li>Recent Trends in Temp Control </li></ul><ul><li>Strategy: Validation & Qualification </li></ul><ul><li>Expeditors Temperature Control Air Product </li></ul><ul><li>Break </li></ul><ul><li>10:00 – 12:00 Temp Control Case Studies </li></ul><ul><li>US Exports </li></ul><ul><li>– Reagents 2-8C, Vaccines 2-8C, Transdermal Patches 15-30 C </li></ul><ul><li>US Imports </li></ul><ul><li>– Biological Finished Products 2-8C, Finished Dosage 15-30C, Frozen Biological API -20 C, </li></ul><ul><li>12:00 – 1:00 Lunch </li></ul><ul><li>Afternoon Session </li></ul><ul><li>EWR Facility Tour </li></ul><ul><li>CBP Security Programs </li></ul><ul><li>Compliance Systems – CBP, FDA, USDA, DEA </li></ul><ul><li>Break </li></ul><ul><li>300 Risk Management </li></ul><ul><li>Future Temp Control Developments at Expeditors </li></ul><ul><li>Closing Remarks </li></ul>
  3. 3. Expeditors <ul><li>Who we are, What we do </li></ul>
  4. 4. Temperature Control Terminology <ul><li>Speaking a common language </li></ul><ul><li>“ Cold Chain” no longer… </li></ul><ul><li>Today the phrase is “Temperature Control” </li></ul><ul><li>Other important terms we have learned from our customers: </li></ul><ul><li>Product Stability Profiles </li></ul><ul><li>Label Requirements </li></ul><ul><li>Validation </li></ul><ul><li>Qualification </li></ul><ul><li>Excursion </li></ul><ul><li>Temp Tale / Data Logger </li></ul>
  5. 5. Common Temperature Ranges Active Ingredients Biological agents Raw Materials Reagent Active Ingredient Bulk Dosage Finished Dosage Vaccines Insulin Reagent Solid Dosage Gel Caps Trans-dermal Patches Ointments/Lotions Ampules
  6. 6. <ul><li>What we’ve seen: </li></ul><ul><ul><li>Internal: </li></ul></ul><ul><ul><li>The emergence of Quality Assurance in the logistics process </li></ul></ul><ul><ul><li>External: </li></ul></ul><ul><ul><li>FDA – 483 Citations </li></ul></ul><ul><ul><li>USP 1079 - Procedures </li></ul></ul><ul><ul><li>PDA Technical Report 39 – Recommendations & Guidelines </li></ul></ul>Recent Trends in Temp Control:
  7. 7. Temperature Control at Expeditors <ul><li>Our History in Temp Control: </li></ul><ul><ul><li>1981 – 2004: Branch driven </li></ul></ul><ul><ul><li>108 global Rx and MD customers all developed and serviced based on local branch operations/sales </li></ul></ul><ul><ul><li>Strong Air Freight Product – executing transit time </li></ul></ul><ul><li>Expeditors Temp Controlled qualified process: </li></ul><ul><ul><ul><li>72 hours/96 hours/120 hours validated transit requirements </li></ul></ul></ul><ul><ul><ul><li>Cold storage when needed </li></ul></ul></ul><ul><ul><li>Very successful but we saw the TC landscape changing </li></ul></ul><ul><ul><li>2005 – Present: Branch and Corporate Driven </li></ul></ul><ul><ul><li>Global TC initiative based on documenting known best practice of our branches </li></ul></ul><ul><ul><li>Training, Systems, Vendors, </li></ul></ul><ul><ul><li>In 2007 alone our TC business grew 51% globally </li></ul></ul><ul><ul><li>Customer based today is 142 global TC customers </li></ul></ul>
  8. 8. Strategy: Validation and Qualification <ul><li>Types of Temperature Controlled Shipments </li></ul><ul><li>Active Packaging </li></ul><ul><li>Systems: </li></ul><ul><li>Contains temp monitor that triggers cooling and heating </li></ul><ul><li>Airline units </li></ul><ul><ul><li>Envirotainer </li></ul></ul><ul><ul><li>E2 </li></ul></ul><ul><ul><li>Unicooler </li></ul></ul><ul><ul><li>FDX RKN </li></ul></ul><ul><li>Route planning based on aircraft size and availability </li></ul><ul><li>Re-icing and fresh batteries </li></ul><ul><li>Passive Packaging </li></ul><ul><li>Systems: </li></ul><ul><li>Traditional “Cold Chain” </li></ul><ul><li>Validated insulated container </li></ul><ul><li>Validated for transit time </li></ul><ul><li>Route planning based on destination </li></ul><ul><li>Contingency planning in the event that transit is not met </li></ul><ul><li>Understanding when and when not to put in cold storage </li></ul><ul><li>Standard Packaging: </li></ul><ul><li>New breed of TC shipment </li></ul><ul><li>Label Requirement often dictates temp range </li></ul><ul><li>Easy with FCL ocean or FTL truck </li></ul><ul><li>More difficult with Air Freight </li></ul><ul><ul><li>Exposure </li></ul></ul><ul><ul><li>Routing </li></ul></ul><ul><ul><li>Ground Handling </li></ul></ul><ul><ul><li>Airline programs </li></ul></ul><ul><li>Airline Equipment </li></ul><ul><ul><li>Wraps/Stabilizer bars </li></ul></ul><ul><li>Packaging supplements </li></ul>
  9. 9. Expeditors Temperature Control Air Product <ul><li>Repeatable, Globally consistent and Measured </li></ul><ul><li>Training - General Awareness, Operations & Supply Chain Systems – shipment processing Approved Suppliers – Airlines, etc T&I – Acct Mgmt - DLSOP Expeditors Intranet </li></ul>
  10. 10. <ul><li>Break </li></ul>
  11. 11. Process Mapping at Expeditors <ul><li>Used widely in by our Account Managers and Product Managers to document process solutions for our customers </li></ul>
  12. 12. Case Studies: Customer Process Maps <ul><li>Temperature Controlled US Air Exports: </li></ul><ul><ul><li>Chilled Diagnostic Reagents - STL > LON </li></ul></ul><ul><ul><li>Chilled Vaccines - origin PHL & IAD </li></ul></ul><ul><ul><li>Controlled Room Temp Trans-dermal Patches –JFK > BFS </li></ul></ul>
  13. 13. Case Studies: Customer Process Maps <ul><li>Temperature Controlled US Air Imports: </li></ul><ul><li>Chilled Commercial Biological Products (ORK > BOS) </li></ul><ul><li>Controlled Room Temp Finish Dosage Tablets (MAD > ATL) </li></ul><ul><li>Frozen Biological API (MIL > SDF) </li></ul><ul><li>Transportation Cost Reductions for Temp Control </li></ul>
  14. 14. Lunch

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