PharmTech is a company that provides track and trace and serialization solutions for pharmaceutical and medical device clients. They have experience implementing traceability solutions globally since 2007. Their services include assessing business needs, developing traceability strategies, planning implementations, and ensuring solutions deliver ROI through improved supply chain visibility and business process optimization. They take a holistic approach to help clients meet regulatory requirements while gaining additional business benefits.

1. Track & Trace

2. Core ServicesWorkflow Management Program Services Strategic Solutions CAPAValidation Business ValueTechnologyIntegrationTraceabilitySystemsROIQuality Management Systems

3. What We Do“PharmTech turns costs into investments.”

4. About UsEstablished in 1995

5. Emphasis on FDA compliance and regulated industries Pharmaceutical, Medical Device and Biotech Headquartered in Libertyville, Illinois

6. Employee Owned ESOP

7. In 2007 we focused our activities to address concerns of pharmaceutical clients on U.S. & Ex-US regulatory guidelines surrounding Track & Trace.Our PeopleManagement/PMs average 10 years experience

8. Associates average 6 years experience

9. Permanent staff iscomprised of

10. ASQ Certified Quality Auditors

11. Certified Supply Chain Professionals (CSCP)

12. Quality Engineers and Managers

13. IT personnel

14. 4-year technical degreed professionalsOur ClientsPrimarily Fortune 100 clients

15. 100,000 + hrs compliance services in 2008-2010

16. >75% repeat business

17. Approximately 50% projects > 5,000 hrs

18. Current projects in California, Georgia, Illinoisand TexasGlobal MandatesTurkey Item Level Serialization June 2009Serbia August 2009Turkey Aggregation June 2010France CIP13 , 2D Bar Code January 2011Columbia January 2012Brazil GS1, 2D Bar Code, Labels January 2012Spain 2D Bar Code 2012Italy 2D Bar Code 2012EU Package Serialization January 2014US- CA Serialization & E-Pedigree January 2015

19. Traceability: What’s behind it?Patient SafetyTraceability assists in; Recall Management

20. Diversion

21. Counterfeit

22. Reimbursement

23. TheftIdentifying Business Value“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.”-HussainMooraj, AMR Research“Pharmaceutical Focus 2011: Supply Chain” Eyefortransport

24. ROI is EverywhereReducing Days on Hand InventoryRecall ManagementDemand PlanningEnd to EndReal Time TrackingAnti CounterfeitingROICycle Time BalancingVendor Managed Inventory (VMI)Improved Asset UtilizationProcess StandardizationCash Flow ManagementChargeback ManagementImport Process MonitoringLot Restriction ApplicationPerfect OrderTrade Promotion OptimizationProcess Modeling & SimulationsGood Distribution PracticesDiversionPlanning, Production & LogisticsShelf LifeCold Chain Monitoring

25. Immediate ROI OpportunitiesAsset Visibility, Tracking & UtilizationIssue Resolution and OpportunitiesReal Time ResponsePedigree & Authentication CaptureLeverage Captured Data for Improvements in; Sales & Marketing Inventory Control Logistics Workflow Processes Cash-to-Cash Perfect OrderRecall ManagementIdentification of Diversion & Counterfeiting

26. Planning for Business Value

27. Phase 1: StrategyProcess Mapping

28. Business Process Analysis

29. Gap Analysis

30. Current State/Future State Evaluation

31. Time and Motion Studies

32. Commercial Relationships

33. Manufacturing StandardsStrategy

34. Phase 2: PlanningImpact Analysis

35. Business Value Propositions

36. Traceability Architecture Development

37. Strategic Solutions

38. Systems Recommendations

39. User Requirements

40. Long Term Planning & Forecasting

41. Solutions Provider AnalysisPlanning

42. Phase 3: ImplementationImplementationProject Management

43. GS1 Conversion

44. Internal Test & Validation

45. Trading Partner Connection

46. PilotingEnd to End VisibilityChallenge:Pharmaceutical manufacturer had near zero visibility into their supply chain.

47. Concerned with forthcoming regulatory requirements.Scope of Work:Pilot serialization program to understand;

48. Data usage

49. implementation timeline & costs

50. line impact and required inventory buildEnd to End VisibilityResults:Dashboards, Metrics

51. Trading Partner data share

52. Visibility of Actual Demand

53. Budget clarity

54. Compliance architecture in place

55. Reduction in inventory and ingredient costs

56. End to End integrationReal World : Real ValueWith 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.Challenge:Flat sales and generic equivalents

57. Current system too costly.

58. Need serialization compatibilityReal World: Real ValueResults:Serialization mitigated future regulatory concerns

59. Authentication achieved

60. Automated software for dispenser,

61. Direct billing

62. Inventory fulfillment

63. Scheduling

64. 3% increase in overall market share

65. Extensible to other products and divisionsGoing Beyond a Traditional Serialization PilotPharmaceutical manufacturer wanted to know what manufacturing technology solution, standards and process changes would be needed to deal with serialization of a product.Challenge:New technology assessmentStandards ConversionUncertain regulationsLimited budgetScope of Work:Proof of concept Advised client to incorporate additional

66. Going Beyond a Traditional Serialization PilotBusiness Value Highlights:Original purpose successful In addition, without additional piloting costs:Proved viability of authentication

67. Answered process questions

68. Provided operational improvement

69. Forward compatible

70. Influence industry direction Reduce Days on Hand InventoryChallenge: Need to reduce Days on Hand (DOH) costs associated with excessive inventory in the wrong locations.Business Value:Near real time supply chain view of product in progress and historical data.Monitoring of key process changes as they occur, expediting the confirmation of the enacted improvements Reduction in site specific inventory to match production level demandDecrease in manufacturing times

72. Traceability PlanningPharmTechTraceability ReadinessAnalysisCustomized Traceability Solution

73. TraceabilityPlanningMaking Sure ThatThe Solution Is Interoperable With Existing SystemsCustomized Traceability SolutionClientERPBusiness ProcessesCustomized Traceability SolutionCultural FeaturesEx-US OpsThird Party Relations

74. The Traceability SolutionBUSINESS VISIONProvide “Real Time” internal and external visibility, meeting Global Supply Chain objectives through integration of global traceability standards and technology. BUSINESS PROCESSESEnable new and accurate sources of information from the extended supply chain for improvement of productivity and performance.TRACEABILITY APPLICATION Integrates event information derived from desired data sources in the distributed supply chain, displaying business activity and intelligence in a dashboard format.INFRASTRUCTUREBuilt on a standardized and secure foundation enabling delivery of event data for tracking forward and tracing backward the flow of product.

75. Why PharmTech?Project Leadership & InnovationCredentialed: 16 year track record in Pharmaceuticals Founded Traceability Solutions GroupCost Effective: Lump Sum Proposal Budget and project clarity from day 1We Live in Your Space with an emphasis on;Facilities, compliance, equipment and processHistory of delivering ROI We don’t talk about value, we find it!

76. Next Steps…Michael StewartTraceability & Supply Chain VisibilityDirect (847) 281-8924Cell (815) 403-8425mstewart@PharmTechInc.com