8 Myths & Lessons Learned: Serialization & e-Pedigree

Presented by: Michael Stewart Track & Trace Projects

Serialization & e-Pedigree

Agenda

PharmTech

8 Myths or Lessons Learned

Opportunities

Next Steps… Q&A

• Established in 1995

• FDA regulated industry focus

Pharmaceutical, Medical Device & Biotech

• 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 Certified Supply Chain Professionals (CSCP)

Quality Engineers IT Personnel

PharmTech Overview

People

Background

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 involved in projects such as: • Evaluating 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

9

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

• Lesson: • Cross functional, holistic view

Myth #1 It’s a (fill in the blank) Project

• Lesson: • Don’t pick a solution until you know the problem. • Choose strategy before tactic.

Myth #2 Pick a card, any card

• Could vs. Should • Over-stretched staff • Time, training and temperament • Ramp up time vs Next Step

Myth #3 Internalize “strategy” development projects

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

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

Myth #4 We just need to get compliant, then we’ll find value.

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

• Lesson:

• Develop a strategic business plan

• Understand cost, impact and workflow changes effected

• Strategy to full implementation 6months-3 years

Myth #5 Time is on my side

Myth # 6 Virtual Manufacturer My timeline is shorter.

Less time? Maybe. No ownership of lines to serialize. Contingencies: • 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

Has your company conducted a Track & Trace Readiness Analysis?

YesNoUnsure

Waiting on… California delaying a 3rd t ime

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.

Myth #7 We need more clarity on…

Identify new value in projects

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 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

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

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

Immediate ROI Opportunities Asset Visibility, Tracking & Utilization Issue Resolution and Opportunities Real Time Response e-Pedigree & Authentication Capture Leverage Captured Data for Improvements in; Revenue 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 Diversion & 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.

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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 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.

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4-6 Day Cycle

• Lesson: • You don’t know what you don’t know • Proper strategic planning and allocating enough time for

a full pilot is critical

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

• 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 Relat ionships

• -Impact: Cost, Process, Facilit ies -Pilot test ing

• -Trading partner integrat ion -Exception report ing

• Regulatory deadline -36 months

• Availability of talent • -Limited # of resources with experience

• Identify business value/ROI in advance to capture It

Why Start Today

Next Steps…

Questions? Need More Information?

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