3. PharmTech Overview
• Established in 1995
• FDA regulated industry focus
Background
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
5. 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
7. 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
10. 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.
12. Myth #1 It’s a (fill in the blank) Project
• Lesson:
• Cross functional, holistic view
13. Myth #2 Pick a card, any card
• Lesson:
• Don’t pick a solution until you know the problem.
• Choose strategy before tactic.
14. 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
15. 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
16. 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.
17. 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
18. 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
19. 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
20. 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
No
Contingencies: 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
21. 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.
22. Identify new value in projects
Receiv e Drug Distribution
Bulk Packaging
I ngredients Processing Center
23. 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
24. 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 Future
Lesson:
Identify and quantify the non-compliance benefits
Installing a business system, not a compliance project
25. 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
26. 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
Delivery
Physician
Prior Authorization
Benefit Verification
Denial
30-60 Day Cycle
27. Improved Adherence
Recommendation Patient Insurance Approv al Adherence
Decision Day
Delivery
Prior Authorization
Physician
Benefit Verification
Denial
4-6 Day Cycle
Business 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.
28. 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
29. 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
