Serialziation & e-Pedigree: 8 Project Myths That Can Derail You
8 Myths & Lessons Learned: Serialization & e-Pedigree Presented by: Michael Stewart Track & Trace Projects
AgendaPharmTechSerialization & e-Pedigree8 Myths or Lessons LearnedOpportunitiesNext Steps… Q&A
PharmTech Overview • Established in 1995 • FDA regulated industry focusBackground Pharmaceutical, Medical Device & Biotech • Headquartered in suburban Chicago, IL • Employee owned • Access to 100+ resources nationwide • Average experience: People Project Managers 10 years Associates 6 years ASQ Certified Quality Auditors Certified Supply Chain Professionals (CSCP) Quality Engineers IT Personnel
Track & Trace ProjectsPharmTech has been working with leading pharmaceutical manufacturers since theintroduction of the California legislation and has been inv olved in projects such as:• Ev aluating solutions prov iders• Serialized data share and systems interoperability• Standards implementation (GS1 standards)• Piloting for serialized product and trades• Mapping current & future state processes• Long-range planning & Impact analysis• Supply chain integration• Rev ising strategy in response to legislation and industry shifts
Traceability Defined“Traceability 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 consideration” GS1 GTSH 1.0.0 Feb-2009
California Serialization & e-PedigreeItem level serialization, smallest distributed 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, 2016Non Compliance?Civ il fines, injunctions and/or criminal prosecutionFines up to $5,000 PER OCCURRENCE* *Each saleable unit is considered an occurrence.
Myth #1 It’s a (fill in the blank) Project• Lesson:• Cross functional, holistic view
Myth #2 Pick a card, any card• Lesson:• Don’t pick a solution until you know the problem.• Choose strategy before tactic.
Myth #3 Internalize “strategy” development projects• Could vs. Should• Over-stretched staff• Time, training and temperament• Ramp up time vs Next Step Lesson: Leverage industry experience and knowledge
3 Phase Traceability Readiness Strategy Gap Analysis Process Mapping Business Process Analysis Current State/Future State Evaluation Review Commercial Relationships Strategic Impact Analysis Cost-Benefit Analysis Business Value Propositions Traceability Architecture Development Strategic Solutions Planning Systems Recommendations Solutions Provider Analysis User Requirements Functional Requirements Long Term Planning & Forecasting Solutions Provider Selection Project Management GS1 Standards Conversion Internal Test & Validation Trading Partner Connection Implementation Piloting
Myth #4 We just need to get compliant, then we’ll find value.• Lesson:• Begin with the end in mind.• You will get the system you plan for.
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.Challenge:• Flat sales and generic equivalents• Current system too costly.• Need serialization compatibilityScope of Work:• System replacement• Item level serialization• Identify business value
Real World: Real ValueResults:Serialization mitigated future regulatory concerns700 Clinic PilotAuthentication achievedAutomated software for dispenser, •Direct billing to Medicare •Inventory fulfillment •Patient Scheduling •Reduced customer service staff 40%3% increase in overall market shareExtensible to other products and divisions
Myth #5 Time is on my side• Lesson:• Develop a strategic business plan• Understand cost, impact and workflow changes effected• Strategy to full implementation 6months-3 years
Myth # 6 Virtual Manufacturer My timeline is shorter. Has your company conducted a Track & Trace Readiness Analysis?Less time? Maybe.No ownership of lines to serialize. Yes NoContingencies: Unsure• Are the CMO’s/Packagers on your timeline?• When will they be ready to pilot? Test? Integrate?• What solution will each CMO go with?• Who is responsible contractually for serialization?• How do you want to receive the serialized product data?• How do they want to send the serialized product data? (All of them?)• How important is your business to them? Them to you?• Are they willing to be guided by your companyi, or do you have to accept their solution?• Can your systems seamlessly integrate with 40+ technology systems
Myth #7 We need more clarity on…Waiting on…California delaying a 3rd timeUniversal standardsFDA guidelinesTechnologyBig pharmaTPCM/TPCPA white unicornLesson:The activities from strategic business planning are evergreen.Opportunities are found when you are looking for them.
Identify new value in projects Receiv e Drug Distribution Bulk PackagingI ngredients Processing Center
Reduce Days on Hand InventoryChallenge:Need to reduce Days on Hand (DOH) costsassociated with excessive inventory in the wronglocations.Business Value:Near real time internal view of ingredients and product in progress andhistorical dataMonitoring of key process changes as they occur, expediting theconfirmation of the enacted improvementsReduction in site specific inventory to match production level demandDecrease in manufacturing times and reduction in warehousing space
Myth #8 Leadership won’t fund the project until they have to "In a world where outcomes count for everything, it’s not molecules that create value but, rather, the ability to integrate data, products and services in a coherent business offering.“ - PwC, Pharma 2020: Supplying the FutureLesson:Identify and quantify the non-compliance benefitsInstalling a business system, not a compliance project
Immediate ROI OpportunitiesAsset Visibility, Tracking & UtilizationIssue Resolution and OpportunitiesReal Time Responsee-Pedigree & Authentication CaptureLev erage Captured Data for Improvements in; Rev enue Gains in Sales & Marketing Inventory Control Cycle time reductions Logistics Serialized return & chargebacks Speed import/export approvals Supply Chain QA Human workflow managementRecall ManagementIdentification of Div ersion & Counterfeiting
Improved Adherence Challenge: Manufacturer losing opportunities in a self-injectable between Physician Recommendation & Decision Day (by patient) as well as the time line between Prior Authorization & Benefit Verification. Recommendation Patient Insurance Approv al Adherence Decision Day DeliveryPhysician Prior Authorization Benefit Verification Denial 30-60 Day Cycle
Improved Adherence Recommendation Patient Insurance Approv al Adherence Decision Day Delivery Prior Authorization Physician Benefit Verification Denial 4-6 Day CycleBusiness Value Highlights;-Provided web based education and financial assistance to patient to accelerate 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, third party marketing and pre-populated benefits forms for benefits.-Decision Day to Prior Authorization goes from an “endless loop” to 20 minutes rather than 1-2 months.-Automated Prior Authorization & Benefit Verification process reducing Decline to PA Submission to Approval”30-60 days to 72 hours.-Increased clinic and patient adherence.
Myth #8 Piloting is a formality- Plug & Play • Temporary systems • Volume considerations • Data share with trading partners • Exception handling • Line jams • Label changes • Internal data integrity • Integration of third parties • Receipt and Sending of serialized data• Lesson:• You don’t know what you don’t know• Proper strategic planning and allocating enough time for a full pilot is critical
Why Start Today• Traceability is new in pharma (even to the providers) -You don’t know what you don’t know. Use our learning curve• Technology interoperability and Data share• Magnitude of work• -GS1 Standardization (GTINs, GLNs) -Workflow process changes• -Business Rules -Commercial Relationships• -Impact: Cost, Process, Facilities -Pilot testing• -Trading partner integration -Exception reporting• Regulatory deadline -36 months• Availability of talent• -Limited # of resources with experience• Identify business value/ROI in advance to capture It