Delivering a Comprehensive

Serialization Traceability Program

Peggy Staver - Pfizer

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Overview

• Pfizer History
• What it Takes
– Strategies
– Organization
– Solutions
– Business-as-Usual
• Summary

April 21, 2015 2

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Pfizer History
Serialization Myth #1

“There’s Plenty of Time”

April 21, 2015 3

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Pfizer’s History

2014 to present
compliance

2014 – Global
Program
2013 – Global Transformation
Enterprise
Architecture
2010 –
Transitioned E2E
Pilot
2005 – VTag
E2E Pilot • Compliance – China, India II, Korea, US
(Turkey, Argentina, Saudi Arabia Phase 1)
2001 –
Serialization
Initiatives • Active – China, Korea, US, EU, Brazil, Saudi Arabia
Started

• Monitoring – 20+ and counting

• 20+ live sites/CMOs (50+ lines), 6 logistics facilities and 50+ active
ongoing implementations

• Collaboration – GS1, Rx-360, regulators, trade associations, trading partners

April 21, 2015
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 Serialization Compliance Timeline
Saudi Arabia
Nigeria Iran 21 Mar 2015
Jan 1 2013 19 Jan 2015
Argentina Phase I Korea
Anti-Malarial Scratch Label
Dec 2011 - DataMatrix 01 Jan 2016
SMS Solution
Phase I Korea All Products
01 Jan 2015 USA
30% SKU China Brazil 27 Nov 2017
31 Dec 2015 10 Dec 2016 Serialized Product
Argentina All Products Identifiers
Europe Argentina Phase III
Jan 2013
Legislation June 2012 All Products
Phase III
Phase II

Brazil USA
Turkey USA 10 Dec 2015 27 Nov 2023
India China 01 Jan 2015 3 Batches Saudi Arabia Europe
2010 Pkg. (Item - level)
01 Oct 2011 Feb 2013 Product Tracing 12 Mar 2017 Est. Q4 2018
Track China traceability
Phase I Phase I (Lot info) Phase II -Serial
and India Dec 2013 Nigeria
Tertiary Package Number
Trace 01 Jan 2013 Phase II June 2015
Phase II Anti-infectives
Secondary Package SMS Solution

Argentina
Mar/ Apr/
Jun/ Aug 2015
Phase IV

Actively Monitoring
UAE Jordan Taiwan Colombia Mexico Ukraine

4/21/2015 No Confirmed Law Draft Law 5

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 Serialization Enterprise Solution Overview

Supply Network Logistics • Typically 1 integrated government report per mandate

• B2B integration with Trading Partners for traceability
• xx PGS sites • Some markets / other manufacturer’s provision SNs
US • xx SKUs US • x DCs
• xx packs
DATA MANAGEMENT

External Pfizer
US

Internal Pfizer
• xx PGS sites
EU • xx SKUs EU • x DCs*
• xx packs EFPIA
• xx PGS sites (Europe)
EM • xx SKUs EM • x DCs Serialization
• xx packs Control Tower Brazil, China (Import),
(SCT) Local
India Export, Korea,
IC** • x LCs Markets SA Phase II
• xx PGS sites
Total • xx SKUs Total • x sites Local Argentina, China
• xx packs Solution (Domestic), Nigeria, Turkey

Role of Manufacturing, Logistics, CMOs Role of Downstream Supply Chain

• Provision, apply and aggregate SNs (Wholesalers, distributors, pharmacies, etc.)
• Commission and notify SNs “PCS” • Fulfill authentication, track & trace,
• Manage inventory and SN data in parallel pedigree, and other requirements
• Capture events and report as required
• Manage inventory and SN data in parallel
SUPPLY CHAIN

Other Drug
Companies
CMO
Packaging
Line

Pfizer / CMO InterCompany & Wholesale Hospital /

Plant Market Logistics Distributor Pharmacy /
Pfizer Site Warehouse Sites/ LSP Patient

Serial Number Management Transport /Product Flows

Key

Event Capture Serialized Product Data

**InterCompany Logistics Reporting Data Out of Scope
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Strategy
Serialization Myth #2

“Serialization is really just setting

up your packaging lines with some
bar code printers and scanners”

April 21, 2015 7

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What Does It Takes?

Organiza
• Program Breadth?
tion – Global / Regional / Market
– Supply Planning / Manufacturing /
Logistics / Commercial

• Participants?
– Direct / Indirect
– Global / Local

Solution Strategy
• What to Implement?
– Regulation Interpretation
– Line Technologies
– Material Handling
– Data Management

• Ongoing Operations?
– Operationalize
BAU – Enterprise Support
– Maintenance
April 21, 2015 8 8
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Strategies & Methodologies
• Alignment with business and investment plans
– Packaging network optimization (insource/outsource strategies, hubs, etc)
– Postponement and source strategies
– Work center, deferred aggregation or enable line

• Harmonized standards, modular build and consistent timing

• Global solution architecture
– Enterprise data management

Trading Partner Report

Other Mfg Notification

Government Report
Cust Return SNs
Cust Return Info
Shipment SNs
SN Response

Shipment Info
Shipment SNs

Shipment SNs
Shipment Info
SN Request

Notification

SN Mgmt
Notification
– Agile and flexible

SN Mgmt
SN Mgmt
– Leverage existing solutions

• Compliance fulfillment
– Program Operating Model
– Holistic project management

• Learning & continuous improvement

April 21, 2015 9
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 “Commoditize” Mandates
Mandate Classification
Mandate Requirements Common Enablers Event Driven Reporting
• Import • Serial number provisioning • Government
• Authentication • Notification / commissioning • Trading Partners
• Export • Aggregation • Other Manufacturers
• Track & Track • Serial number management

Business Events

Provision & Creation / Product Tracked Tracked Compliance

Apply Aggregation* Availability Receipts Shipment Reporting

Serial Number Management (e.g. provision, commission, ship, rework, destruction, returns)

Mandate Requirements Event Combination

– China Import ProvApply
Notify
Prod Avail
Report
SN Management Modifications
Report
Track Ship
Report
– India Export Prov/Apply
Notify
Prod Avail
Report
– Brazil Import Notify
Prod Avail
Receipt
Report
SN Management Modifications
Report
Track Ship
Report
– US Track Prov/Apply
Notify
Ship
Report
SN Management Modifications
– EU Authentication Prov/Apply
Notify
Prod Avail
Report
April 21, 2015 10
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* Aggregation is often needed for supply chain efficiencies
 Program Operating Model
Program Operating Model
Market Sites & Supply Chain Market

Compliance Business as
Monitoring Evaluation Engagement Enablement
Management Usual

• Monitor mandates • Evaluate scope • Create local • Enable impacted • Onboard, monitor • Transition to
• Influence if needed • Steering Team and market team internal supply chain & track SKUs standard
• Clarify Governance • Deployment and data management within the network operational activity
requirements Committee schedule • Conduct change • Ongoing
approval • Site / source management and monitoring
funding training

Program Operations

• Focus: Market
Site & Supply Chain
Market

• Enablement Projects: driven by market requirements

• Manage Supply: impact of executing enablement projects

• Ongoing Operations: execute on a strategy allowing the company

to operate post program
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Operational Learnings

April 21, 2015 12

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Organization
Serialization Myth #3

“Give it to Engineering …. They will

get it done”

April 21, 2015 13

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Program Governance

April 21, 2015 14

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 Blended Teams

Market:
• In-country
team key to
success

• Partnership &
Influence

Site Solution Provider

OPERATIONAL Liaison
BUILDING CAPABILITY

Source Location:
BT Enablement Team
• Ownership Site Project Implementation
Implementation Lead
Manager Lead Supply Network
Artwork Resource
• Drive operational &
technical capability Supply Network
TECHNICAL
Technical Resource

• Sustainable operations Site Specific Serialization Solution

Resources Provider

KEY Serialization
Hardware OEM(S)
Site Resource Solution Provider
Resource

April 21, 2015 15

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Solution
Serialization Myth #4

“One size fits all”

April 21, 2015 16

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 Modular Building Blocks
India DGFT

China EDMC
US DSCSA

EU FMD
Reusable Parts
• Simple / versatile / agile
• Fulfill different independent
functions
• Put together to address higher level
April 21, 2015 needs 17
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Standard Operational Processes

• Analyze overall network for event capture points in operations

– Lines / CMOs
– Plant warehouses
– Logistics network
– Market distribution network
• Identify operational requirements
to meet / maintain compliance
– Normal “go-forward” process
– “Exception” handling
• Define Operations Requirement Flows
– Operationally “agnostic” to mandates
– Minimize operations impacts
– Automated and / or manual
April 21, 2015 18
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Master Data
Master Data is the “DNA” for the Serialization Program
• It is the “Identity” of the Product and Company Data with
necessary elements
• It is the “Bond” that ties all internal and external supply chain
solutions together
Serialization Program Key Components
• Business processes are the work flows to
be executed
• Master Data is the definition / identity
of what the business processes are to be
acted on and how

Business Process Integration

• Many internal and external business systems need
to be able to work interactively
• The master data serves as the bond that enables
the different solutions to talk in a common
language

April 21, 2015 19 Copyright @ Pfizer Inc. All rights reserved.

Business-As-Usual
Serialization Myth #5

“Serialization only adds to product

cost and does not create business
value”

April 21, 2015 20

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BAU vs. Operationalization

April 21, 2015 21

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 How to Support?
Challenge
• Many potential supply chain
points of failures
• Efficiently find issue source
• Capture/manage issues
traversing the supply chain
• Harmonizing business
partners / tech teams
• Regulatory time constraints
• Explicit knowledge
management
Challenge
• Enterprise support:
• Learning solution, gluing existing support networks
• Support internal or external stakeholders
• Incident and Problem Management
• Routing mechanism:
• “Fastest” routing / resolution of issues traversing groups
• Enterprise Support (COE):
• Mgmt & SMEs for performance and stakeholder mgmt
• Learning machine that provides continuous support &
solution improvement
• Accountability:
• From opening to closing of incidents
• Monitoring problem management effectiveness
April 21, 2015 22
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Summary
Serialization Myth #6

“Once I have funding approved, I

can get this done in a couple of
months”

April 21, 2015 23

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What Does It Takes?

Organiza
• Program Breadth?
tion – Global / Regional / Market
– Supply Planning / Manufacturing /
Logistics / Commercial

• Participants?
– Direct / Indirect
– Global / Local

Solution Strategy
• What to Implement?
– Regulation Interpretation
– Line Technologies
– Material Handling
– Data Management

• Ongoing Operations?
– Operationalize
BAU – Enterprise Support
– Maintenance
April 21, 2015 24 24
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Thank You!!!

April 21, 2015 25

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