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MANAGING CONTRACT PARTNERSHIPS

MANAGING CONTRACT PARTNERSHIPS. Webinar Hosted by Pharmaceutical Manufacturing Wednesday, November 7 2012 Presented by Hedley Rees, Biotech PharmaFlow. Agenda. What is behind the ‘supply chain heat’ Where do contractors fit in? Management strategies based on segmentation

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MANAGING CONTRACT PARTNERSHIPS

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  1. MANAGING CONTRACT PARTNERSHIPS Webinar Hosted by Pharmaceutical Manufacturing Wednesday, November 7 2012 Presented by Hedley Rees, Biotech PharmaFlow

  2. Agenda • What is behind the ‘supply chain heat’ • Where do contractors fit in? • Management strategies based on segmentation • The procurement cycle • Building a foundation for the future

  3. Supply chain ‘heat’

  4. Where is the heat coming from? • Shortages…… • Economically motivated adulteration…… • Recalls….. • Cost of Goods issues… • Counterfeiting….. • Theft….. • Diversion…..

  5. The fall-out…. • Crippling impacts in the areas of patient safety, brand image and reputation, costs of remediation, customer service and investor confidence. A UNIVERSAL CRY FOR CHANGE! • From regulators, governments, other competent authorities and patient advocacy groups.

  6. Stakeholders pile in…. • …EU implements Falsified Medicines Directive. • …EMA consults on dramatic tightening of GDP/GMP • …FDA pens “Pathway to Global Safety and Quality”. • …President Obama wades in on drug shortages. • …US HELP Congressional Committee consults. • …US Pharmacopeia consults on new Chapter < 1083 >. • …PEW Charitable Trust writes report “After Heparin”. • …GS1 Global Traceability Standard for Healthcare (GTSH). • …FDA Safety and Innovation Act (FDASIA), Title VII

  7. Where do contractors fit in?

  8. Roles in the Pharma Supply Chain Responsible for supply chain

  9. The Scope of Contractual Relationships • QP and other professional services such as GMP audits of suppliers Washing/depyrogenation/sterilisation of packaging materials used in manufacture. • Hosting of IT functions • Document archiving and storage • Qualification/validation work for premises • Maintenance /calibration of equipment • Storage and distribution • Artwork generation and print ready material • Assessment and sourcing of starting and packaging materials Ref: GMP/GDP INSPECTORS WORKING GROUPGMP/GDP IWG Document Ref: EMEA/INS/GMP/648678/2009

  10. Dis-integration of the supply chain Outsourcing begins in earnest…..

  11. Contractor Management in Context • Immensely complex interactions. • Relationships are 3rd party. • Contractually driven. • Power and dependence. • Management by Segment.

  12. Strategies based on segmentation

  13. Procurement Portfolio High Financial Relevance Low Complexity of Supply Market Many Suppliers Single Supplier Based on Kraljic Matrix, HBR 1983

  14. Procurement Portfolio Management High Financial Relevance Low Complexity of Supply Market Many Suppliers Single Supplier Figure 1 A segmentation approach based on Kraljic Matrix

  15. The procurement cycle

  16. The Procurement Cycle – Strategic Segment

  17. Building a foundation for the future

  18. It starts in early stage development… Supply chain thinking?

  19. Building successful contractor partnerships

  20. Thank You

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