2013 : The Year ofPharmaceutical Serialization
3 Critical Areas to EmbraceTopicsTo Super Charge Your ProjectIntroductionsMandates12 Lessons LearnedEnd to End Program Man...
Your SpeakerMichael StewartVice President,Track &Trace ProjectsIndustry speaker & author of articles and white papers;Seri...
Established in 1995FDA regulated industry focusPharmaceutical, Medical Device & BiotechPartnered with traditional, virtual...
Track & Trace ProjectsPharmTech has been working with leading pharmaceutical manufacturers sincethe introduction of the Ca...
GS1 standardizationProcess mappingRationalizationProcess automation & optimizationUser requirements, Functionalrequirement...
PharmTech s Role as theTranslator
US & INTERNATIONALMANDATES
Traceability DefinedTraceability is the ability to TRACK FORWARD, (item levelserialized product), the movement through spe...
CaliforniaSerialization & e-PedigreeItem level serialization, smallest saleable unitElectronic pedigree, passed in interop...
3 takeawaysDESERT BEFORE THE MEAL
Scalabilitytomorrows needsLeverageTime & ExpertiseIdentifyBusiness Value3 Essential Program ElementsBuild these into your ...
If only you knew now you do.12 LESSONS LEARNED
Lessons Learned 1-41) A serializationTEAM does not have an I in it.2) It is not the technology that will fail, people will...
Lesson Learned 5-85) Vendors think they have the Silver Bullet.6) Your Be ready date is not January 1, 2015.7) You can not...
Lesson learned 9-129) Fatter data pipes are needed.10) Piloting is far more than serialized distribution.11) Scale for tom...
TRACK & TRACEROAD MAP
Is this the High Level Strategy?
Successful Program Management
Successful Project ManagementGap AnalysisProcess Mapping As Is vs. To BeBusiness Process AnalysisCurrent State/Future Stat...
Project Timeline
Strategy DevelopmentDevelop a comprehensive strategic plan to:Identify gaps in systems and processes to receive, store, di...
Traceability is new-You don t know what you don t know. Use our learning curveTechnology interoperability and Data shareMa...
OPPORTUNITIES FORBUSINESS VALUE"In a world where outcomes count foreverything, it s not molecules that createvalue but, ra...
Immediate ROI OpportunitiesAsset Visibility, Tracking & UtilizationIssue Resolution and OpportunitiesReal Time ResponsePed...
Real World : Real ValueWith increasing costs of drug development, finding ways to boost market shareof existing branded dr...
Real World: Real ValueResults:Serialization mitigated future regulatory concerns700 Clinic Pilot (Currently 1500)Authentic...
Improved AdherenceChallenge:Manufacturer losing opportunities in a high-value self-injectable betweenPhysician Recommendat...
Improved AdherenceBusiness Value Highlights;-Provided web based education and financial assistance to patient toaccelerate...
Going Beyond a TraditionalSerialization PilotPharmaceutical manufacturer wanted to know what manufacturingtechnology solut...
Going Beyond a TraditionalSerialization PilotBusiness Value Highlights:Original purpose successfulSolutions providers vett...
Identify new value internallyReceiveIngredientsBulkDrugProcessingPackagingDistributionCenter
Reduce Days on Hand InventoryChallenge:Need to reduce Days on Hand (DOH) costs associated withexcessive inventory in the w...
Wrap Up
Scalabilitytomorrows needsLeverageTime & ExpertiseIdentifyBusiness Value3 Essential Program ElementsBuild these into your ...
Traceability is new-You don t know what you don t know. Use our learning curveTechnology interoperability and Data shareMa...
Michael StewartCell (815) 403-8425Office (847) 281-8924mstewart@pharmtechinc.com
2013 Year of Pharmaceutical Serialization - Get it Right
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2013 Year of Pharmaceutical Serialization - Get it Right

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Pharmaceutical serialization en mass will occur in 2013 due to US and es-US regulations to track products at the item level. Michael Stewart of PharmTech Inc. shares his insight into the project Management pitfalls and allows you to use his learning curve working with top 10 pharmaceutical manufacturers, contract manufacturers and virtual manufactures to get ROI and business value in addition to compliance. Turn a perceived cost into an investment.

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2013 Year of Pharmaceutical Serialization - Get it Right

  1. 1. 2013 : The Year ofPharmaceutical Serialization
  2. 2. 3 Critical Areas to EmbraceTopicsTo Super Charge Your ProjectIntroductionsMandates12 Lessons LearnedEnd to End Program Management for SuccessIdentifying Business Value (Recent Projects)
  3. 3. Your SpeakerMichael StewartVice President,Track &Trace ProjectsIndustry speaker & author of articles and white papers;SerializationProject Managemente-PedigreeAuthenticationSupply ChainVisibilityLeveraging systems for efficiency and business valueContributor:
  4. 4. Established in 1995FDA regulated industry focusPharmaceutical, Medical Device & BiotechPartnered with traditional, virtual and contract manufacturers/packagersHQ in Chicago, IL with projects coast to coastLed projects in Serialization & e-Pedigree since CA releasedAccess to 100+ project resources nationwideManufacturing Packaging IT Supply Chain QualityProject Management and Project Staffing are our strengthsAverage experience:Project Managers 10 yearsAssociates 6 yearsPeopleBackground
  5. 5. Track & Trace ProjectsPharmTech has been working with leading pharmaceutical manufacturers sincethe introduction of the California legislation and has been involved in projectssuch as:Gap Analysis and Mapping current & future state processesEvaluating solutions providersSerialized data share and systems integration & interoperabilityImplementing GS1standards for location and product identificationPiloting for serialized product and tradesProgram and Project Management and staffing for serialization and traceabilityRevising strategy in response to legislation and industry shifts
  6. 6. GS1 standardizationProcess mappingRationalizationProcess automation & optimizationUser requirements, FunctionalrequirementsCommercial RelationshipsSystems integrationDocument workflow managementProject Specific ServicesAdherence (Patient & Clinic)Specialty pharmacy servicesSystems validationCAPA systemsGap analysisEHR/EMR integrationProduct life cycle business valueSupplier assessment, management &improvementBrand revenue enhancement
  7. 7. PharmTech s Role as theTranslator
  8. 8. US & INTERNATIONALMANDATES
  9. 9. Traceability DefinedTraceability is the ability to TRACK FORWARD, (item levelserialized product), the movement through specified stage(s) ofthe extended supply chain and TRACE BACKWARDS the history,application or location of that which is under considerationGS1 GTSH 1.0.0 Feb-2009
  10. 10. CaliforniaSerialization & e-PedigreeItem level serialization, smallest saleable unitElectronic pedigree, passed in interoperable format for eachtransaction of ownership change50% of a manufacturers products by Jan. 1, 2015100% of a manufacturers products by Jan. 1, 2016Wholesalers and re-packagers must accept and forwardproducts with e-Pedigree by July 1, 2016Pharmacy and pharmacy warehouses must accept and passe-Pedigree by July 1, 2017Non Compliance?Civil fines, injunctions and/or criminal prosecutionFines up to $5,000 PER OCCURRENCE**Each saleable unit is considered an occurrence.
  11. 11. 3 takeawaysDESERT BEFORE THE MEAL
  12. 12. Scalabilitytomorrows needsLeverageTime & ExpertiseIdentifyBusiness Value3 Essential Program ElementsBuild these into your activities
  13. 13. If only you knew now you do.12 LESSONS LEARNED
  14. 14. Lessons Learned 1-41) A serializationTEAM does not have an I in it.2) It is not the technology that will fail, people will.3) Do not start at the line/equipment level.4) Identify BusinessValue
  15. 15. Lesson Learned 5-85) Vendors think they have the Silver Bullet.6) Your Be ready date is not January 1, 2015.7) You can not do this all internally.8) Document. Document. Document.
  16. 16. Lesson learned 9-129) Fatter data pipes are needed.10) Piloting is far more than serialized distribution.11) Scale for tomorrow.12) Experienced project personnel are finite.
  17. 17. TRACK & TRACEROAD MAP
  18. 18. Is this the High Level Strategy?
  19. 19. Successful Program Management
  20. 20. Successful Project ManagementGap AnalysisProcess Mapping As Is vs. To BeBusiness Process AnalysisCurrent State/Future State EvaluationReview Commercial RelationshipsStrategic Impact AnalysisCost-Benefit AnalysisBusiness Value PropositionsTraceability Architecture DevelopmentUser RequirementsFunctional RequirementsStrategic SolutionsVendor EvaluationSystems RecommendationsSolutions Provider AnalysisLong Term Planning & ForecastingSolutions Provider SelectionGS1 Standards ConversionInternal Test & ValidationTrading Partner ConnectionPiloting
  21. 21. Project Timeline
  22. 22. Strategy DevelopmentDevelop a comprehensive strategic plan to:Identify gaps in systems and processes to receive, store, distributeserialized data, in an interoperable environment. Focus on leveragingexisting technology systems, as available.Assess solutions providers on a high level for traceability requirements.Comply with California legislation related to serialization and e-pedigree.Possess the forward capability to comply with future legislation.Integrate and align with trading partners.Realize business value, in addition to compliance.
  23. 23. Traceability is new-You don t know what you don t know. Use our learning curveTechnology interoperability and Data shareMagnitude of work-GS1 Standardization (GTINs, GLNs) -Workflow process changes-Business Rules -Third Party Relationships-Impact: Cost, Process, Facilities -Pilot testing-Trading partner integration -Exception reportingRegulatory deadline-24 monthsAvailability of talent-Limited # of resources with experienceIdentify business value/ROI in advance to capture ItWhy Start Today
  24. 24. OPPORTUNITIES FORBUSINESS VALUE"In a world where outcomes count foreverything, it s not molecules that createvalue but, rather, the ability to integratedata, products and services in a coherentbusiness offering.- PwC, Pharma 2020: Supplying the Future
  25. 25. Immediate ROI OpportunitiesAsset Visibility, Tracking & UtilizationIssue Resolution and OpportunitiesReal Time ResponsePedigree & Authentication CaptureLeverage Captured Data for Improvements in;Sales & MarketingInventory ControlLogisticsWorkflow ProcessesCash-to-CashPerfect OrderRecall ManagementIdentification of Diversion & Counterfeiting
  26. 26. Real World : Real ValueWith increasing costs of drug development, finding ways to boost market shareof existing branded drugs which have gone off patent was of prime concern, asbranded drugs have higher premium than competing generics. There wereseveral challenges related to known costs and pending need for serialization.Challenge:Flat sales and generic equivalentsCurrent system too costly.Need serialization compatibilityScope of Work:System replacementItem level serializationIdentify business value
  27. 27. Real World: Real ValueResults:Serialization mitigated future regulatory concerns700 Clinic Pilot (Currently 1500)Authentication achievedAutomated software for dispenser,Direct billing to MedicareInventory fulfillmentPatient SchedulingReduced customer service staff 40%3% increase in overall market shareExtensible to other products and divisions
  28. 28. Improved AdherenceChallenge:Manufacturer losing opportunities in a high-value self-injectable betweenPhysician Recommendation & Decision Day (by patient) as well as thetime line between Prior Authorization & Benefit Verification.PhysicianRecommendationDecisionDayPatientPriorAuthorizationInsuranceDenialBenefitVerificationApprovalDeliveryAdherence30-60 Day Cycle
  29. 29. Improved AdherenceBusiness Value Highlights;-Provided web based education and financial assistance to patient toaccelerate Decision Day choice-Integrated with EHR s and Third Party Providers to remain HIPAA compliant-Opt-in at clinic level by patients for manufacturer provided education, thirdparty marketing and pre-populated benefits forms for benefits.-Decision Day to Prior Authorization goes from an endless loop to 20 minutes.-Automated Prior Authorization & Benefit Verification process reducing Decline toPA Submission to Approval 30-60 days to 72 hours.-Increased clinic and patient adherence.PhysicianRecommendationDecisionDayPatientPriorAuthorizationInsuranceDenialBenefitVerificationApprovalDeliveryAdherence4-6 Day Cycle
  30. 30. Going Beyond a TraditionalSerialization PilotPharmaceutical manufacturer wanted to know what manufacturingtechnology solution, standards and process changes would beneeded to deal with serialization of a product.Challenge:New technology assessmentStandards ConversionUncertain regulationsLimited budgetScope of Work:Proof of conceptEngage trading partners on e-PedigreeAdvised client to incorporate additional questions
  31. 31. Going Beyond a TraditionalSerialization PilotBusiness Value Highlights:Original purpose successfulSolutions providers vetted & selectedPlanned, Designed & Piloted solutionIn addition, without additional piloting costs:Proved viability of authentication & e-PedigreeAnswered process questionsProvided operational improvementForward compatibleInfluence industry direction
  32. 32. Identify new value internallyReceiveIngredientsBulkDrugProcessingPackagingDistributionCenter
  33. 33. Reduce Days on Hand InventoryChallenge:Need to reduce Days on Hand (DOH) costs associated withexcessive inventory in the wrong locations.Business Value:Near real time supply chain view of product in progress and historicaldata.Monitoring of key process changes as they occur, expediting theconfirmation of the enacted improvementsReduction in site specific inventory to match production leveldemandDecrease in manufacturing times
  34. 34. Wrap Up
  35. 35. Scalabilitytomorrows needsLeverageTime & ExpertiseIdentifyBusiness Value3 Essential Program ElementsBuild these into your strategy activities
  36. 36. Traceability is new-You don t know what you don t know. Use our learning curveTechnology interoperability and Data shareMagnitude of work-GS1 Standardization (GTINs, GLNs) -Workflow process changes-Business Rules -Third Party Relationships-Impact: Cost, Process, Facilities -Pilot testing-Trading partner integration -Exception reportingRegulatory deadline-24 monthsAvailability of talent-Limited # of resources with experienceIdentify business value/ROI in advance to capture ItWhy Start Today37
  37. 37. Michael StewartCell (815) 403-8425Office (847) 281-8924mstewart@pharmtechinc.com
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