Pharm tech core traceability presentation


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Pharm tech core traceability presentation

  1. 1. Track & Trace<br />
  2. 2. Core Services<br />Workflow Management Program Services Strategic Solutions CAPAValidation Business Value<br />Technology<br />Integration<br />Traceability<br />Systems<br />ROI<br />Quality <br />Management <br />Systems<br />
  3. 3. What We Do<br />“PharmTech turns costs into investments.”<br />
  4. 4. About Us<br /><ul><li>Established in 1995
  5. 5. Emphasis on FDA compliance and regulated industries </li></ul>Pharmaceutical, Medical Device and Biotech<br /><ul><li> Headquartered in Libertyville, Illinois
  6. 6. Employee Owned ESOP
  7. 7. In 2007 we focused our activities to address concerns of pharmaceutical clients on U.S. & Ex-US regulatory guidelines surrounding Track & Trace.</li></li></ul><li>Our People<br /><ul><li>Management/PMs average 10 years experience
  8. 8. Associates average 6 years experience
  9. 9. Permanent staff iscomprised of
  10. 10. ASQ Certified Quality Auditors
  11. 11. Certified Supply Chain Professionals (CSCP)
  12. 12. Quality Engineers and Managers
  13. 13. IT personnel
  14. 14. 4-year technical degreed professionals</li></li></ul><li>Our Clients<br /><ul><li>Primarily Fortune 100 clients
  15. 15. 100,000 + hrs compliance services in 2008-2010
  16. 16. >75% repeat business
  17. 17. Approximately 50% projects > 5,000 hrs
  18. 18. Current projects in California, Georgia, Illinoisand Texas</li></li></ul><li>Global Mandates<br />Turkey Item Level Serialization June 2009<br />Serbia August 2009<br />Turkey Aggregation June 2010<br />France CIP13 , 2D Bar Code January 2011<br />Columbia January 2012<br />Brazil GS1, 2D Bar Code, Labels January 2012<br />Spain 2D Bar Code 2012<br />Italy 2D Bar Code 2012<br />EU Package Serialization January 2014<br />US- CA Serialization & E-Pedigree January 2015<br />
  19. 19. Traceability: What’s behind it?<br />Patient Safety<br />Traceability assists in;<br /><ul><li> Recall Management
  20. 20. Diversion
  21. 21. Counterfeit
  22. 22. Reimbursement
  23. 23. Theft</li></li></ul><li>Identifying Business Value<br />“Life Science leaders are looking at these regulatory requirements as an opportunity to improve business process and operations, enhance patient safety and protect the brand.”<br />-HussainMooraj, AMR Research<br />“Pharmaceutical Focus 2011: Supply Chain” Eyefortransport<br />
  24. 24. ROI is Everywhere<br />Reducing Days on Hand Inventory<br />Recall Management<br />Demand Planning<br />End to End<br />Real Time Tracking<br />Anti Counterfeiting<br />ROI<br />Cycle Time Balancing<br />Vendor Managed Inventory (VMI)<br />Improved Asset Utilization<br />Process Standardization<br />Cash Flow Management<br />Chargeback Management<br />Import Process Monitoring<br />Lot Restriction Application<br />Perfect Order<br />Trade Promotion Optimization<br />Process Modeling & Simulations<br />Good Distribution Practices<br />Diversion<br />Planning, Production & Logistics<br />Shelf Life<br />Cold Chain Monitoring<br />
  25. 25. Immediate ROI Opportunities<br />Asset Visibility, Tracking & Utilization<br />Issue Resolution and Opportunities<br />Real Time Response<br />Pedigree & Authentication Capture<br />Leverage Captured Data for Improvements in;<br /> Sales & Marketing<br /> Inventory Control<br /> Logistics<br /> Workflow Processes<br /> Cash-to-Cash<br /> Perfect Order<br />Recall Management<br />Identification of Diversion & Counterfeiting<br />
  26. 26. Planning for Business Value<br />
  27. 27. Phase 1: Strategy<br /><ul><li>Process Mapping
  28. 28. Business Process Analysis
  29. 29. Gap Analysis
  30. 30. Current State/Future State Evaluation
  31. 31. Time and Motion Studies
  32. 32. Commercial Relationships
  33. 33. Manufacturing Standards</li></ul>Strategy<br />
  34. 34. Phase 2: Planning<br /><ul><li>Impact Analysis
  35. 35. Business Value Propositions
  36. 36. Traceability Architecture Development
  37. 37. Strategic Solutions
  38. 38. Systems Recommendations
  39. 39. User Requirements
  40. 40. Long Term Planning & Forecasting
  41. 41. Solutions Provider Analysis</li></ul>Planning<br />
  42. 42. Phase 3: Implementation<br />Implementation<br /><ul><li>Project Management
  43. 43. GS1 Conversion
  44. 44. Internal Test & Validation
  45. 45. Trading Partner Connection
  46. 46. Piloting</li></li></ul><li>End to End Visibility<br />Challenge:<br /><ul><li>Pharmaceutical manufacturer had near zero visibility into their supply chain.
  47. 47. Concerned with forthcoming regulatory requirements.</li></ul>Scope of Work:<br /><ul><li>Pilot serialization program to understand;
  48. 48. Data usage
  49. 49. implementation timeline & costs
  50. 50. line impact and required inventory build</li></li></ul><li>End to End Visibility<br />Results:<br /><ul><li>Dashboards, Metrics
  51. 51. Trading Partner data share
  52. 52. Visibility of Actual Demand
  53. 53. Budget clarity
  54. 54. Compliance architecture in place
  55. 55. Reduction in inventory and ingredient costs
  56. 56. End to End integration</li></li></ul><li>Real World : Real Value<br />With increasing costs of drug development, finding ways to boost market share of existing branded drugs which have gone off patent was of prime concern, as branded drugs have higher premium than competing generics.<br />Challenge:<br /><ul><li>Flat sales and generic equivalents
  57. 57. Current system too costly.
  58. 58. Need serialization compatibility</li></li></ul><li>Real World: Real Value<br />Results:<br /><ul><li>Serialization mitigated future regulatory concerns
  59. 59. Authentication achieved
  60. 60. Automated software for dispenser,
  61. 61. Direct billing
  62. 62. Inventory fulfillment
  63. 63. Scheduling
  64. 64. 3% increase in overall market share
  65. 65. Extensible to other products and divisions</li></li></ul><li>Going Beyond a Traditional Serialization Pilot<br />Pharmaceutical manufacturer wanted to know what manufacturing technology solution, standards and process changes would be needed to deal with serialization of a product.<br />Challenge:<br />New technology assessment<br />Standards Conversion<br />Uncertain regulations<br />Limited budget<br />Scope of Work:<br />Proof of concept <br />Advised client to incorporate additional<br />
  66. 66. Going Beyond a Traditional Serialization Pilot<br />Business Value Highlights:<br />Original purpose successful <br />In addition, without additional piloting costs:<br /><ul><li>Proved viability of authentication
  67. 67. Answered process questions
  68. 68. Provided operational improvement
  69. 69. Forward compatible
  70. 70. Influence industry direction </li></li></ul><li>Reduce Days on Hand Inventory<br />Challenge: <br />Need to reduce Days on Hand (DOH) costs associated with excessive inventory in the wrong locations.<br />Business Value:<br />Near real time supply chain view of product in progress and historical data.<br />Monitoring of key process changes as they occur, expediting the confirmation of the enacted improvements <br />Reduction in site specific inventory to match production level demand<br />Decrease in manufacturing times<br />
  71. 71.
  72. 72. Traceability Planning<br />PharmTech<br />Traceability Readiness<br />Analysis<br />Customized Traceability Solution<br />
  73. 73. TraceabilityPlanningMaking Sure ThatThe Solution Is Interoperable With Existing Systems<br />Customized Traceability Solution<br />Client<br />ERP<br />Business Processes<br />Customized Traceability Solution<br />Cultural Features<br />Ex-US Ops<br />Third Party Relations<br />
  74. 74. The Traceability Solution<br />BUSINESS VISION<br />Provide “Real Time” internal and external visibility, meeting Global Supply Chain objectives through integration of global traceability standards and technology. <br />BUSINESS PROCESSESEnable new and accurate sources of information from the extended supply chain for improvement of productivity and performance.<br />TRACEABILITY APPLICATION Integrates event information derived from desired data sources in the distributed supply chain, displaying business activity and intelligence in a dashboard format.<br />INFRASTRUCTUREBuilt on a standardized and secure foundation enabling delivery of event data for tracking forward and tracing backward the flow of product.<br />
  75. 75. Why PharmTech?<br />Project Leadership & Innovation<br />Credentialed: 16 year track record in Pharmaceuticals<br /> Founded Traceability Solutions Group<br />Cost Effective: Lump Sum Proposal<br /> Budget and project clarity from day 1<br />We Live in Your Space with an emphasis on;<br />Facilities, compliance, equipment and process<br />History of delivering ROI <br /> We don’t talk about value, we find it!<br />
  76. 76. Next Steps…<br />Michael Stewart<br />Traceability & Supply Chain Visibility<br />Direct (847) 281-8924<br />Cell (815) 403-8425<br /><br />