building a global pharmaceutical traceability foundation

Safe and Secure

Building a Global Traceability Foundation to Drive Visibility, Efficiency and Compliance

Common Misconceptions and Key Considerations

Robin Koh,Chief Strategy Officer,

SupplyScape Corporation

© 2009 SupplyScape Corporation. All Rights Reserved.

2

Agenda

• Main Drivers for Global Track and Trace

• Key Considerations for Building Global Traceability Foundation– 4 Common Misconceptions– Implementation Approach to Global Serialization

• Key Takeaways


3

Safe and Secure Supply Chain

Safe & Secure Supply Chain Model

Pharmaceutical Co Wholesaler Pharmacy

Chain of Custody Security

TransactionSecurity

TraceTrack

Pedigree

Individual Product Security

ProductSecurity

ProductAuthentication

IDAuthentication

Authentication


4

Drivers For Global Traceability

Regulatory Compliance

ProductSecurity

Global Traceability

Regulatory Compliance

Global Pharma Safety Incidents

Sources: Organisation for Economic Co-operation and Development

964

04

196

02

484

03

1,123

05

1,412

06

1,759

07

Product Security

States considering pedigree laws / rules

PDMA in effect. No state activity

States with pedigree laws / rules today

US Pedigree Regulations

In place In development

Global Serialization & Codification Regulations

70%Medical

Professional

18% Subscriber

Source: BCBSA Survey of Blue Plans’ Anti-Fraud Programs

ReimburseIn-accuracy

5% Med Unnec.36%

Services Not Rendered

9%Excess Charges

35%Other(1)

2%Pharm Fraud

4% Service Over Utilization

9%Upcoded Service


5

Complexity of Global Serialization Proliferation of Regulatory Requirements

1. Time to implement serialization is usually underestimated

2. Flexibility to handle future requirements is often overlooked

3. Business benefits are difficult to quantify


6

Agenda



• Key Takeaways


7

Misconception #1:‘I Can Wait’Case Study

–A global manufacturer planning for France’s (CIP13) 2D Data Matrix requirement in 2011

Lesson’s Learned–Many variables lengthen the time for implementation–Number of qualified vendors available–Working with CMO networks is more involved than expected–Piloting 1 or 2 packaging lines does not adequately prepare

for the scalability issues associated with a corporate roll-out

The Plan is Nothing, but Planning is Everything Dwight D Eisenhower


8

Misconception #2:‘Serialization has Limited ROI’

Least Realistic More Realistic

CAPEX PackagingCAPEX ACF

Program

ACF

Impact on Line Efficiency

Additional Labor

Data Monitoring

CAPEX-Internal

Additional Label Cost

CAPEX CMO

CAPEX DC

Software Maintenance

Recurring BenefitCAPEX - One TimeRunning Cost

CAPEX IT

Anti-Counterfeit Program #2

Patient Safety Program #1

Label Standardize Program

Sales Enhancement Program #2Anti-Counterfeit

Program #1

Recall EnhancementProgram

Supply Chain Efficiency Program

SC Visibility Program #1

Sales Enhancement Program #1

Data Reform Program

Benefit Programs by Level of Effort Required and the Magnitude of Benefit

UpsidePotential

DownsideImpact


9

Misconception #3‘Countries are Driving Towards One Standard’

Case Study- In the original design of the MIT solution, there is a

fundamental assumption that there will be a homogenous number management system

Lesson’s Learned- Harmonizing on data carriers & numerical structure are

different things- Number assignment from multiple sources- Random numbers and non-sequential numbers are

different things- There is no guarantee on future requirements

Your Requirements vs. Available Solutions


10

Misconception #4‘Serial Number Lookup is an Authentication System’

ProductSecurity

ProductAuthentication

IDAuthentication

Authentication

Building a more complete system: Alert Patients on Adverse Events in Real

Time (e.g. Recall)

Provide Accurate Data for Detection and Prevention in addition to Investigation

Pattern, Pace & Place

Detect False Positives

Authenticate Physical Anti-Counterfeiting Features

Individual Product Security


11

Agenda• Main Drivers for Global Track and Trace


• Key Takeaways


12

Suggested Approach to Global Serialization Global Framework, Local Alignment

Develop a clear understanding of costs, timing, resources and operational changes needed to meet requirements

Develop local guidance based on corporate standards

Construct and execute a plan to address immediate requirements using localized approach

Build a migration plan to integrate into corporate strategy

Execute the integration plan to migrate local solution into global strategy

Define Global Strategy & Guidelines

Address Local Requirements

Migrate To Global Plan


13

Agenda



• Key Takeaways


14

• Serialization is Global and Uncoordinated EU, China and USA moving in parallel

• Manufacturers must Assume a Global Perspective

There are a set of concrete steps you can take

• Serialization can Provide ROI if you know where to look

• Few Vendors Understand the Global Issues and Misconceptions

Key Takeaways


15

Looking ForwardBusiness Opportunities in Supply Chain Traceability

What if you could?Leverage investments in product

serialization initiatives to drive a higher return on product and brand protection?

Increase new product launch success by ensuring proper supply into key markets?

Establish a global network of trading partners to provide greater visibility into distribution channels?

Overcome barriers to entry into new markets by more efficiently addressing local distribution requirements?

Facilitate financial reconciliation across chargeback, rebate, and re-imbursements across your supply network?


16

Next StepsGet Started on Developing a Global Traceability Foundation

Contact Mary Hall Contact Mary Hall todaytoday to schedule a to schedule a

consultation!consultation!781.503.7462, [email protected]

Visit Visit SupplyScape.com to SupplyScape.com to

learn morelearn morewww.supplyscape.com

building a global pharmaceutical traceability foundation

Health & Medicine