2013 : The Year of Pharmaceutical Serialization

3 Critical Areas to Embrace

TopicsTo Super Charge Your Project

Introductions

Mandates

12 Lessons Learned

End to End Program Management for Success

Identifying Business Value (Recent Projects)

Your SpeakerMichael StewartVice President, Track & Trace Projects

Industry speaker & author of articles and white papers;• Serialization• Project Management• e-Pedigree• Authentication• Supply Chain Visibility• Leveraging systems for efficiency and business value

Contributor:

• 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

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

• 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

PharmTech’s Role as the Translator

US & INTERNATIONAL MANDATES

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

CaliforniaSerialization & 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, 2015100% 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.

3 takeaways

DESERT BEFORE THE MEAL

Scalability… tomorrows needs

Leverage… Time & Expertise

Identify… Business Value

3 Essential Program ElementsBuild these into your activities

If only you knew…now you do.

12 LESSONS LEARNED

Lessons Learned 1-4

1) A serialization TEAM 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 Business Value

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.

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.

TRACK & TRACEROAD MAP

Is this the High Level Strategy?

Successful Program Management

Successful Project Management

Gap 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

Project Timeline

Strategy DevelopmentDevelop 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.

• 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

OPPORTUNITIES FOR BUSINESS VALUE

"In a world where outcomes count foreverything, it’s not molecules that createvalue but, rather, the ability to integrate

data, products and services in a coherentbusiness offering.“

- PwC, Pharma 2020: Supplying the Future

Immediate ROI OpportunitiesAsset Visibility, Tracking & Utilization

Issue Resolution and Opportunities

Real Time Response

Pedigree & Authentication Capture

Leverage Captured Data for Improvements in;Sales & MarketingInventory ControlLogisticsWorkflow ProcessesCash-to-CashPerfect Order

Recall Management

Identification of Diversion & Counterfeiting

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

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

Improved AdherenceChallenge: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.

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30-60 Day Cycle

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.

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4-6 Day Cycle

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 assessmentStandards ConversionUncertain regulationsLimited budget

Scope of Work:Proof of concept Engage trading partners on e-PedigreeAdvised client to incorporate additional questions

Going Beyond a Traditional Serialization Pilot

Business Value Highlights:Original purpose successfulSolutions providers vetted & selectedPlanned, Designed & Piloted solution

In addition, without additional piloting costs:Proved viability of authentication & e-PedigreeAnswered process questionsProvided operational improvementForward compatibleInfluence industry direction

Identify new value internally

Receive Ingredients 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 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

Wrap Up

Scalability… tomorrows needs

Leverage… Time & Expertise

Identify… Business Value

3 Essential Program ElementsBuild these into your strategy activities

• 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

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Michael StewartCell (815) 403-8425Office (847) 281-8924

mstewart@pharmtechinc.com