8 Myths & Lessons Learned: Serialization & e-Pedigree

Presented by:

Michael Stewart Track & Trace Projects

Agenda
PharmTech Serialization & e-Pedigree 8 Myths or Lessons Learned Opportunities Next Steps Q&A

PharmTech Overview

Established in 1995 FDA regulated industry focus

Pharmaceutical, Medical Device & Biotech

Background

Headquartered in suburban Chicago, IL Employee owned

Access to 100+ resources nationwide Average experience:

Project Managers 10 years Associates 6 years
ASQ Certified Quality Auditors Quality Engineers Certified Supply Chain Professionals (CSCP) IT Personnel

People

PharmTech

ROI
Traceability Systems

Track & Trace Projects

PharmTech has been working with leading pharmaceutical manufacturers since the introduction 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

TERMS & LEGISLATION

Traceability Defined
Traceability is the ability to TRACK FORWARD, (item level serialized product), the movement through specified stage(s) of the 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-Pedigree

Item level serialization, smallest distributed unit Electronic pedigree, passed in interoperable format for each transaction of ownership change 50% of a manufacturers products by Jan. 1, 2015 100% of a manufacturers products by Jan. 1, 2016 Wholesalers and re-packagers must accept and forward products with e-Pedigree by July 1, 2016 Pharmacy and pharmacy warehouses must accept and pass e-Pedigree by July 1, 2016 Non Compliance?
Civ il fines, injunctions and/or criminal prosecution Fines up to $5,000 PER OCCURRENCE*
*Each saleable unit is considered an occurrence.

8 MYTHS & LESSONS LEARNED

Myth #1 Its a (fill in the blank) Project

Lesson: Cross functional, holistic view

Myth #2 Pick a card, any card

Lesson: Dont 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

Planning

Implementation

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 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 Piloting

Myth #4 We just need to get compliant, then well find value.

Lesson: Begin with the end in mind. You will get the system you plan for.

Real World : Real Value

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. Challenge: Flat sales and generic equivalents Current system too costly. Need serialization compatibility Scope of Work: System replacement Item level serialization Identify business value

Real World: Real Value

Results: Serialization mitigated future regulatory concerns 700 Clinic Pilot Authentication achieved Automated software for dispenser, Direct billing to Medicare Inventory fulfillment Patient Scheduling Reduced customer service staff 40% 3% increase in overall market share Extensible 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.

No ownership of lines to serialize.

Less time? Maybe.

Has your company conducted a Track & Trace Readiness Analysis?

Yes No Unsure

Contingencies:

Are the CMOs/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 time Universal standards FDA guidelines Technology Big pharma TPCM/TPCP A white unicorn

Lesson: The activities from strategic business planning are evergreen. Opportunities are found when you are looking for them.

Identify new value in projects

Receiv e I ngredients

Bulk

Drug Processing

Packaging

Distribution Center

Reduce Days on Hand Inventory

Challenge: Need to reduce Days on Hand (DOH) costs associated with excessive inventory in the wrong locations. Business Value: Near real time internal view of ingredients and 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 demand Decrease in manufacturing times and reduction in warehousing space

Myth #8 Leadership wont fund the project until they have to

"In a world where outcomes count for everything, its 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 Future

Lesson: Identify and quantify the non-compliance benefits Installing a business system, not a compliance project

Immediate ROI Opportunities

Asset Visibility, Tracking & Utilization Issue Resolution and Opportunities Real Time Response e-Pedigree & Authentication Capture Lev 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 management Recall Management Identification 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.
Decision Day Physician Prior Authorization Benefit Verification Delivery
Recommendation Patient Insurance Denial Approv al Adherence

30-60 Day Cycle

Improved Adherence
Decision Day Prior Authorization
Denial

4-6 Day Cycle

Business Value Highlights;

-Provided web based education and financial assistance to patient to accelerate Decision Day choice -Integrated with EHRs and Third Party Providers to remain HIPAA compliant -Opt-in at clinic level by patients for manufacturer provided education, third party marketing and prepopulated 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.

Benefit Verification

Physician

Delivery

Recommendation

Patient

Insurance

Approv al

Adherence

Myth #8 Piloting is a formalityPlug & 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 dont know what you dont 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 dont know what you dont know. Use our learning curve

Technology interoperability and Data share Magnitude of work

-GS1 Standardization (GTINs, GLNs) -Business Rules -Impact: Cost, Process, Facilities -Trading partner integration -Workflow process changes -Commercial Relationships -Pilot testing -Exception reporting

Regulatory deadline
-36 months

Availability of talent
-Limited # of resources with experience

Identify business value/ROI in advance to capture It

Next Steps

Questions? Need More Information?

Michael Stewart Cell (815) 403-8425 Office (847) 281-8924 mstewart@pharmtechinc.com