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.

1. 2013 : The Year of
Pharmaceutical Serialization

2. 3 Critical Areas to Embrace
Topics
To Super Charge Your Project
Introductions
Mandates
12 Lessons Learned
End to End Program Management for Success
Identifying Business Value (Recent Projects)

3. Your Speaker
Michael Stewart
Vice President,Track &Trace Projects
Industry speaker & author of articles and white papers;
Serialization
Project Management
e-Pedigree
Authentication
Supply ChainVisibility
Leveraging systems for efficiency and business value
Contributor:

4. Established in 1995
FDA regulated industry focus
Pharmaceutical, Medical Device & Biotech
Partnered with traditional, virtual and contract manufacturers/packagers
HQ in Chicago, IL with projects coast to coast
Led projects in Serialization & e-Pedigree since CA released
Access to 100+ project resources nationwide
Manufacturing Packaging IT Supply Chain Quality
Project Management and Project Staffing are our strengths
Average experience:
Project Managers 10 years
Associates 6 years
People
Background

5. Track & Trace Projects
PharmTech has been working with leading pharmaceutical manufacturers since
the introduction of the California legislation and has been involved in projects
such as:
Gap Analysis and Mapping current & future state processes
Evaluating solutions providers
Serialized data share and systems integration & interoperability
Implementing GS1standards for location and product identification
Piloting for serialized product and trades
Program and Project Management and staffing for serialization and traceability
Revising strategy in response to legislation and industry shifts

6. GS1 standardization
Process mapping
Rationalization
Process automation & optimization
User requirements, Functional
requirements
Commercial Relationships
Systems integration
Document workflow management
Project Specific Services
Adherence (Patient & Clinic)
Specialty pharmacy services
Systems validation
CAPA systems
Gap analysis
EHR/EMR integration
Product life cycle business value
Supplier assessment, management &
improvement
Brand revenue enhancement

7. PharmTech s Role as the
Translator

8. US & INTERNATIONAL
MANDATES

9. 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

11. California
Serialization & e-Pedigree
Item level serialization, smallest saleable 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, 2017
Non Compliance?
Civil fines, injunctions and/or criminal prosecution
Fines up to $5,000 PER OCCURRENCE*
*Each saleable unit is considered an occurrence.

12. 3 takeaways
DESERT BEFORE THE MEAL

13. Scalability
tomorrows needs
Leverage
Time & Expertise
Identify
Business Value
3 Essential Program Elements
Build these into your activities

14. If only you knew now you do.
12 LESSONS LEARNED

15. Lessons Learned 1-4
1) 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

16. Lesson Learned 5-8
5) 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.

17. Lesson learned 9-12
9) Fatter data pipes are needed.
10) Piloting is far more than serialized distribution.
11) Scale for tomorrow.
12) Experienced project personnel are finite.

18. TRACK & TRACE
ROAD MAP

19. Is this the High Level Strategy?

20. Successful Program Management

21. Successful Project Management
Gap Analysis
Process Mapping As Is vs. To Be
Business Process Analysis
Current State/Future State Evaluation
Review Commercial Relationships
Strategic Impact Analysis
Cost-Benefit Analysis
Business Value Propositions
Traceability Architecture Development
User Requirements
Functional Requirements
Strategic Solutions
Vendor Evaluation
Systems Recommendations
Solutions Provider Analysis
Long Term Planning & Forecasting
Solutions Provider Selection
GS1 Standards Conversion
Internal Test & Validation
Trading Partner Connection
Piloting

22. Project Timeline

23. Strategy Development
Develop a comprehensive strategic plan to:
Identify gaps in systems and processes to receive, store, distribute
serialized data, in an interoperable environment. Focus on leveraging
existing 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.

24. Traceability is new
-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 -Third Party Relationships
-Impact: Cost, Process, Facilities -Pilot testing
-Trading partner integration -Exception reporting
Regulatory deadline
-24 months
Availability of talent
-Limited # of resources with experience
Identify business value/ROI in advance to capture It
Why Start Today

25. OPPORTUNITIES FOR
BUSINESS VALUE
"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

26. Immediate ROI Opportunities
Asset Visibility, Tracking & Utilization
Issue Resolution and Opportunities
Real Time Response
Pedigree & Authentication Capture
Leverage Captured Data for Improvements in;
Sales & Marketing
Inventory Control
Logistics
Workflow Processes
Cash-to-Cash
Perfect Order
Recall Management
Identification of Diversion & Counterfeiting

27. 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. There were
several challenges related to known costs and pending need for serialization.
Challenge:
Flat sales and generic equivalents
Current system too costly.
Need serialization compatibility
Scope of Work:
System replacement
Item level serialization
Identify business value

28. Real World: Real Value
Results:
Serialization mitigated future regulatory concerns
700 Clinic Pilot (Currently 1500)
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

29. Improved Adherence
Challenge:
Manufacturer losing opportunities in a high-value self-injectable between
Physician Recommendation & Decision Day (by patient) as well as the
time line between Prior Authorization & Benefit Verification.
Physician
Recommendation
DecisionDay
Patient
PriorAuthorization
Insurance
Denial
BenefitVerification
Approval
Delivery
Adherence
30-60 Day Cycle

30. Improved Adherence
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.
-Automated Prior Authorization & Benefit Verification process reducing Decline to
PA Submission to Approval 30-60 days to 72 hours.
-Increased clinic and patient adherence.
Physician
Recommendation
DecisionDay
Patient
PriorAuthorization
Insurance
Denial
BenefitVerification
Approval
Delivery
Adherence
4-6 Day Cycle

31. Going Beyond a Traditional
Serialization Pilot
Pharmaceutical 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 assessment
Standards Conversion
Uncertain regulations
Limited budget
Scope of Work:
Proof of concept
Engage trading partners on e-Pedigree
Advised client to incorporate additional questions

32. Going Beyond a Traditional
Serialization Pilot
Business Value Highlights:
Original purpose successful
Solutions providers vetted & selected
Planned, Designed & Piloted solution
In addition, without additional piloting costs:
Proved viability of authentication & e-Pedigree
Answered process questions
Provided operational improvement
Forward compatible
Influence industry direction

33. Identify new value internally
Receive
Ingredients
Bulk
Drug
Processing
Packaging
Distribution
Center

34. 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 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
demand
Decrease in manufacturing times

35. Wrap Up

36. Scalability
tomorrows needs
Leverage
Time & Expertise
Identify
Business Value
3 Essential Program Elements
Build these into your strategy activities

37. Traceability is new
-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 -Third Party Relationships
-Impact: Cost, Process, Facilities -Pilot testing
-Trading partner integration -Exception reporting
Regulatory deadline
-24 months
Availability of talent
-Limited # of resources with experience
Identify business value/ROI in advance to capture It
Why Start Today
37

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