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The Safety of our Drugs and Devices

The Safety of our Drugs and Devices. The Complex Reality Marla A. Phillips, Ph.D. Xavier University June 10, 2013. 85 majors 334 fulltime faculty Chem , Bio, Physics, Math. Xavier University. Founded in 1831 7,019 total students 4,368 undergraduates. Xavier University - Mission.

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The Safety of our Drugs and Devices

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  1. The Safety of our Drugs and Devices The Complex Reality Marla A. Phillips, Ph.D. Xavier University June 10, 2013

  2. 85 majors 334 fulltime faculty Chem, Bio, Physics, Math Xavier University Founded in 1831 7,019 total students 4,368 undergraduates

  3. Xavier University - Mission Our mission is to educate each student intellectually, morally, and spiritually …for a world that is increasingly diverse, complex and interdependent …as they cultivate lives of reflection, compassion and informed action

  4. Xavier Health Inspiring Collaboration… Leading Innovation… Making a difference

  5. Making a Difference QARA Institute FDA National Forum FDA/Xavier PharmaLink Not bound by structure Not defined by a building Solution tailored to the need Not bound by our own research goals

  6. Tell me…..and I'll forget; show me…..and I may remember; involve me…..and I'll understand - Chinese Proverb

  7. Not if……but When and Where FDASIA 155,000 deaths from foodborne Salmonella China recalls infant formula FDA Global Engag. Rpt. Bio-terrorism Act 1.4 million fake anti-malaria drug packets seized in Angola Africa from China Tainted cough syrup kills 21 in Panama Falsified Medicines Directive Pew Rpt After Heparin FSMA Spinach recall in 39 states due to potential of E. coli Melamine in pet food may not be accidental

  8. Integrity of Supply Initiative IMDRF FSMA Industry FDASIA Creating Best Practice After Heparin Xavier Rx-360 Regulators Congress FDA Strategic Priorities IPEA GFSI

  9. Integrity of Supply Initiative Mission Statement: To determine true root causes related to the challenges of improving Integrity of Supply, and to identify sustainable solutions that can be tied to Return on Investment – returns related to increased safety, decreased cost, improved reliability, or all three.

  10. What causes you the greatest concern related to your supply chain and suppliers? (initial focus on in-coming materials)

  11. Kick-off Meeting August 2012

  12. Top Themes by Vote

  13. Top Themes by Vote Agility Reliability Visibility Desire Leverage R&D Integration Small Suppliers Harmonization Change Control Certification Database Communication Culture Risk Management Legal Implications Keep it Simple Benchmarking ROI Stakeholder Involvement Supplier Expectations Co-Location Enablers

  14. Pre-Initiative Assessment January 2012 – August 2012

  15. Pre-Initiative Data • Interviewed approx. 50 people • FDA: each of the industry regulator groups • Companies (6): cross-functional representation • Industry Associations (4): PhRMA, MDMA, GPhA, IPEC • Outside experts: (5) Pharma/Device, (2) Food, (2) General – authors of 12 books • Research • Meetings with Congress – Senate HELP and House Energy & Commerce Committees • New Legislation • Newly released and relevant books and articles • Data Analysis • Comparison of the three industry supply chain characteristics from interviews • Interview data in SWOT format

  16. SWOT Analysis

  17. SWOT Analysis

  18. SWOT Analysis

  19. SWOT Analysis

  20. SWOT Analysis

  21. SWOT Analysis

  22. Themes Supported by Data

  23. Root Cause Identification Agility, Reliability, Visibility

  24. Agility Team Objective Improve supply chain agility in the Medical Device, Pharma and Food/Beverage industries by leaning the supplier/materials change process and reducing inherent industry barriers. • First confirm the Key Change Process Areas that require the largest amount of time in Supply Change Management • Second validate root cause of the pain/barrier Can we include you on the survey?

  25. Agility – Regulatory Barriers The regulatory barriers currently in place hinder the agility we need to manage our supply chain in a way that would improve the Integrity of Supply. • So even if we streamline our own processes, we often cannot act as quickly as needed to resolve or prevent issues. • Companies often choose to stay with substandard practices or suppliers due to the hurdles involved in change – internally and with regulatory authorities. • Do you feel barriers • are due more to: • Complexity • Requirements • Bottlenecks

  26. Reliability Team: Inputs by Process Step Manage Supplier / Supply Chain Define Business/ Quality Rqmts. Select/Approve Supplier/Supply Chain Select Potential Supplier/ Supply Chain RFQ What do you feel are the main root causes related to the concern of reliability? Your response can be associated with any part of the process

  27. Reliability Team: Top 6 Votes Manage Supplier / Supply Chain Define Business/ Quality Rqmts. Select/Approve Supplier/Supply Chain Select Potential Supplier/ Supply Chain RFQ

  28. Is there Hope? It starts with YOU We have already identified “Opportunities” through SWOT Next steps include benchmarking other industries Global regulators are working together Industry is working together It ends with EVERYONE

  29. Questions? Marla A. Phillips, Ph.D. phillipsm4@xavier.edu 513-745-3073

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