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© SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree, RFID, and Business Value: The SAP Comprehensive Roadmap for Serialization in the Life Sciences

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Page 1: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 1

February 20, 2007

Michael LiptonDirector Solution Management RFID / SerializationLife Sciences

Pedigree, RFID, and Business Value: The SAP Comprehensive Roadmap for Serialization in the Life Sciences

Page 2: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

Drug track and trace overview

Key issues and pain points in pharmaceuticals

SAP solution overview and roadmap

Benefit areas, KPIs, and benchmarking

Customer examples

Page 3: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 3

Patient Safety

Increasing Operating Costs

Downward Margin Pressure

Reduced Operating Efficiency

Government Regulations Government Regulations

Pharmaceutical Industry OverviewStandards ActivitiesStandards Activities

• Cost Pressure (esp. Generics)• Supply Chain and Reverse Logistics Opportunity• Complex Multi-step Supply Chain

• Cost Pressure (esp. Generics)• Supply Chain and Reverse Logistics Opportunity• Complex Multi-step Supply Chain

Safe and Secure Supply ChainSafe and Secure Supply Chain

Recalls

Counterfeits

Inventory Turnover

0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

4.00

JOHNSON &

JOHNSON

BRISTO

L MYERS SQUIBB C

OMERCK &

CO IN

C

WYETH

GLAXO

NOVARTIS

SANOFIASTR

AZENECA

ROCHEPFIZER IN

C

20042003

* Calculated from data in each company’s 2003 & 2004 Annual Reports

*Inventory Turnover

0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

4.00

JOHNSON &

JOHNSON

BRISTO

L MYERS SQUIBB C

OMERCK &

CO IN

C

WYETH

GLAXO

NOVARTIS

SANOFIASTR

AZENECA

ROCHEPFIZER IN

C

20042003

* Calculated from data in each company’s 2003 & 2004 Annual Reports

*

Inventory

Diversions

Page 4: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

Drug track and trace overview

Key issues and pain points in pharmaceuticals

SAP solution overview and roadmap

Benefit areas, KPIs, and benchmarking

Customer examples

Page 5: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 5

Best Practices – Safe and Secure Supply Chain

Page 6: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 6

Serialized Track/Trace

MfgMfg

PackingPacking Factory stock

Factory stock

DistributionDistribution

Distr. CenterDistr. Center

InIn StockStock PickPick OutOut

WholesalerWholesaler

Distr. CenterDistr. Center

InIn StockStock PickPick OutOut

Pharmacy/ Hospital

Pharmacy/ Hospital

Shipping

Shipping

RefillStockRefillStock

Shipping

* * * *

* * *

* Places where trace data gets recorded

MfgMfg

PackingPacking Factory stock

Factory stock

DistributionDistribution

Distr. CenterDistr. Center

InIn StockStock PickPick OutOut

Distr. CenterDistr. Center

InIn StockStock PickPick OutOut

WholesalerWholesaler

Distr. CenterDistr. Center

InIn StockStock PickPick OutOut

Distr. CenterDistr. Center

InIn StockStock PickPick OutOut

Pharmacy/ Hospital

Pharmacy/ Hospital

Shipping

Shipping

RefillStockRefillStock

Shipping

* * * *

* * *

* Places where trace data gets recorded

RFID and/ or barcode

Sequential numbers (like license plate) EPC/ EAN coding schemePurpose: authentication & logistics use

Shipping cartonFolding boxBottle

+

RFID and/ or barcode

Sequential numbers (like license plate) EPC/ EAN coding schemePurpose: authentication & logistics use

Shipping cartonFolding boxBottle

+

Page 7: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 7

MAJOR WHOLESALER

SECONDARY

WHOLESALER

DRUG MANUFACTURER

RETAIL PHARMACY

Is Chain of Custody Intact? Pedigree

Page 8: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 8

Product Authentication Techniques

EPC

✔ EPC with Tag ID

01.000DF3E.0043F.000324FG

01.000D34.00FKD.000234DCKPallet

Hierarchy

F43GLVSD335324FL4234GERF33 EPC with SecurityMarking

F43GLVSD335324FL4234GERF33

Page 9: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

Drug track and trace overview

Key issues and pain points in pharmaceuticals

SAP solution overview and roadmap

Benefit areas, KPIs, and benchmarking

Customer examples

“This presentation is a preliminary version and not subject to your license agreement or any other agreement with SAP. This document contains only intended strategies, developments, and functionalities of the SAP® product and is not intended to be binding upon SAP to any particular course of business, product strategy, and/or development. Please note that this document is subject to change and may be changed by SAP at any time without notice.

SAP assumes no responsibility for errors or omissions in this document.”

Page 10: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 10

SAP’s Pharmaceuticals Solution Map 2006

Suppliers, Partners, & Regulatory Agencies

Customers, Channels, & Regulatory Agencies

R&D Operations Distribution Sales & Marketing Service

Time to Market R&D Administration

Pharmaceutical DevelopmentClinical Trial Management

Clinical Trial Supply Management

Product Quality Procure to Pay

Compliant Manufacturing Enterprise LIMS

Equipment Maintenance

Time to Value Supply Chain Planning / Execution

Contract Management Order to Cash

Marketing Sales Operations & Performance Analytics

Field Sales

Product Safety Medical Inquiries

Complaint Management Incidence Reporting & CAPA

Enterprise Management & Support Analytics Financials

Human Capital Management Corporate Service

Compliance Tools and Validation Services

Regulatory Submission

Drug Discovery

Drug Tracking and Tracing

Page 11: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2005, Value Assessment for RFID

RFID Tags RFID Readers

Auto-ID Infrastructure

Exchange Infrastructure

EnterpriseApplications

AII

AII

AII

DeviceManagement

Read and write data/ transmit data to system

• Execute transactions

• Decision support

• Enterprise EPCIS

Routes business data to applications

Stores and translates raw EPC data to business data

Manages multiple readers and standardizes data

Transmit and hold data using radio waves

Function

SAP OfferingPartner Offering

XIXI

Device

Controller

Integration and scalability in compliance with international standards of EPCglobal are the key success factors of the SAP RFID solution landscape

SAP EM

SAP RFID Solution

SAP OER

Page 12: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 12

Enterprise-Wide Deployments

DATA EXCHANGE

TRADINGPARTNERS

SAP Object Event Repository (OER)

AUTO-ID RepositoryEvent Management Analytics

Security Services

AUTO-ID RepositoryEvent Management Analytics

Security Services

QUERY INTERFACEQUERY INTERFACE

CAPTURE INTERFACECAPTURE INTERFACE

Product Tracking

&Authentication

e-ProofOf

Delivery

PromotionManagement

RecallManagement …

Platform

Applications

Page 13: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 13

SAP Auto-ID Solutions Mapped to EPCglobal

EPCIS Capture Interface

EPCISRepository

Filtering & Collection (ALE) Interface

EPCIS Capturing Application

Reader Protocol

Filtering & Collection (“RFID Middleware”)

EPCIS Query Interface

EPCIS Access ing Application

Tag Protocol (UHF Gen 2, Class 0, Class 1)

RFID Reader

RFID Tag

Reader Management

Interface

Reader Management

EPCIS Accessing Application

“Pull”or “Push”mode

“Pull” or “Push”mode

Partner EPCglobal SubscriberEPCglobal Subscriber

Local ONS

ONS Interface

EPCglobal Core Services

ONS Root

EPCIS Discovery

(TBD)

Subscriber Authentication

(TBD)

Manager Number

Assignment

(offline service)ONS I’face(TBD)(TBD)

Optional bypass for real-time

“push”

EPCIS Capture Interface

EPCISRepository

Filtering & Collection (ALE) Interface

EPCIS Capturing Application

Reader Protocol

Filtering & Collection (“RFID Middleware”)

EPCIS Query Interface

EPCIS Access ing Application

Tag Protocol (UHF Gen 2, Class 0, Class 1)

RFID Reader

RFID Tag

Reader Management

Interface

Reader Management

EPCIS Accessing Application

“Pull”or “Push”mode

“Pull” or “Push”mode

Partner EPCglobal SubscriberEPCglobal Subscriber

Local ONS

ONS Interface

EPCglobal Core Services

ONS Root

EPCIS Discovery

(TBD)

Subscriber Authentication

(TBD)

Manager Number

Assignment

(offline service)ONS I’face(TBD)(TBD)

Optional bypass for real-time

“push”

AIIAII

DeviceControllerDevice

Controller

EnterpriseAuto-ID

Repository

XIXI

SAP OIS

PTA …ERP

SAP OER

Object Event

Repository

Page 14: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 14

SAP Auto-ID Infrastructure Product Profile

Maintain EPC number ranges locally in SAP Auto-ID Infrastructure (AII)Configure EPC encoding according to current and emerging standards

EPC Number Ranges

Communication directly with RFID devicesCommunication with major device controllersCertified interface and extensive partner eco-system

Device Interface

Integrate deployment on SAP application systemDeployable with integration to non-SAP back-endDeployable standalone

Deployment

Business Monitoring and Reporting Stock situation at different locationsMovements across/within locationsDwell time/cycle time Current status of tracked objects

Technical Monitoring and ReportingRead/write rate quality reports

BW extractors from SAP AII

Reporting

Import master data for integrated scenario Maintain product, location, and business master data locally forstandalone deployment

Master Data

Has mobile/desktop UIOffers enhanced execution guidance in both mobile and desktop UI

User Interface (UI)

Write an Electronic Product Code (EPC) on each individual tagWrite EPCs in batch mode using an RFID label printerSupport multiple-tag commissioning modes, multiple hierarchies

Tag Commissioning

Page 15: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 15

SAP Event Management (EM)

Notify

Alerts

Monitor

Supply chain object

event 2 event 4

actual events

expected events

event 3

event 1

event 2event 1

Learn

Partner Performance

Measure

Control

Adjust

Collaborate

Simulate

Plan/Schedule

EventEventManagementManagement

Page 16: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 16

Pre-Configured Business Processes

SAP RFIDPlatform to provide business context

Rules, activities, event handlers, data management, integration, and so on

Gateway to SAP applications

Page 17: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 17

Manufacturing and Packaging Process

Electronic Pedigree

PartnerE-Pedigree

PartnerE-Pedigree Rx ASNs

Product / Lot Data

Collect Tag Reads(Commission if writing)

Build Item/Case/Pallet Hierarchy **

CertifiedInterface

Electronic Pedigree

PartnerE-Pedigree

PartnerE-Pedigree Rx ASNs

Product / Lot Data

Collect Tag Reads(Commission if writing)

Build Item/Case/Pallet Hierarchy **

CertifiedInterface

Object EventRepository

Page 18: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 18

Distribution and Logistics Process

Certified Interface

PartnerE-Pedigree

PartnerE-Pedigree

PartnerE-Pedigree

PartnerE-Pedigree

Electronic Pedigree

Rx ASNs

Electronic Pedigree

Rx ASNs

Certified Interface

Goods Receipt Delivery InfoGoods Issue.

Receive against ASN

Build OutboundItem/Case /PalletHierarchy **

Certified Interface

PartnerE-Pedigree

PartnerE-Pedigree

PartnerE-Pedigree

PartnerE-Pedigree

Electronic Pedigree

Rx ASNs

Electronic Pedigree

Rx ASNs

Electronic Pedigree

Rx ASNs

Certified Interface

Goods Receipt Delivery InfoGoods Issue.

Receive against ASN

Build OutboundItem/Case /PalletHierarchy **

Object EventRepository

Page 19: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 19

RFID-Enabled Outbound Processing

Page 20: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 20

Enterprise-Wide Deployments

DATA EXCHANGE

TRADINGPARTNERS

SAP Object Event Repository (OER)

AUTO-ID RepositoryEvent Management Analytics

Security Services

AUTO-ID RepositoryEvent Management Analytics

Security Services

QUERY INTERFACEQUERY INTERFACE

CAPTURE INTERFACECAPTURE INTERFACE

Product Tracking

&Authentication

e-ProofOf

Delivery

PromotionManagement

RecallManagement …

Platform

Applications

Page 21: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 21

Repository

Pkg. Hierarchy(Authentication Level Number)

CustomerShip-to(Tracking)

… n

1

…Delivery # (Tracking)

Lot/ Batch

Product/ Material(Tracking/ Authentication)

EPC

2. Tracking

3. Authentication

Reports

ERP

RFID Devices

External SystemsC

aptu

re S

ervi

ces Q

uery Services

SAP OER

Event Management

1. Capture

PTA Concept

Page 22: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 22

Tracking Services EPC Tracking

Current status/location of EPC List of statuses/locations of EPC within Enterprise

Delivery TrackingList of statuses/locations of EPCs associated with a delivery

Attribute TrackingSelection of deliveries and associated EPCs by:

Order NumberDateCustomerStatusLocationBatch (Lot)Others

Event ManagementTrigger alerts based on exceptions associated with under/over delivery, or supply chain movements that are early/late/not expected/missing

Product

Party Transaction

DRUG MANUFACTURER DISTRIBUTION CENTER

Page 23: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 23

Authentication

[EPC N um bers ]

[ Tag ID – EPC com bination]

[ EPC – Security M arking com bination]

[ Case-Item association]

[ Pallet - Case-Item association]

B asic Au thentication(T iered /Leve l)

[EPC N um bers ]

[ Tag ID – EPC com bination]

[ EPC – Security M arking com bination]

[ Case-Item association]

[ Pallet - Case-Item association]

B asic Au thentication(T iered /Leve l)

EPC AuthenticationAuthentication of one or more EPCs, based on EPC number

Extended AuthenticationAuthentication of one or more EPCs based on EPC, location of itemAuthentication based on EPC, Alternative ID (Tag ID, Holospot®, and so on)

LoggingAll queries logged

AlertingAlert if repeated queries for same item, and so on

Page 24: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 24

Enterprise-Wide Deployments

DATA EXCHANGE

TRADINGPARTNERS

SAP Object Event Repository (OER)

AUTO-ID RepositoryEvent Management Analytics

Security Services

AUTO-ID RepositoryEvent Management Analytics

Security Services

QUERY INTERFACEQUERY INTERFACE

CAPTURE INTERFACECAPTURE INTERFACE

Product Tracking

&Authentication

e-ProofOf

Delivery

PromotionManagement

RecallManagement …

Platform

Applications

Page 25: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 25

RFID-Enabled Electronic Proof of Delivery

Page 26: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 26

Future Serialization Opportunities

Identify and communicate Visibility into magnitude and scope

Problem containment Red-flag and contain affected product at various nodes of the supply network in real-timeAutomatically halt all affected business transactions

ReclaimTargeted reclaiming only affected product – based on EPC serial number traceability, delivery history, and e-Pedigree

Receive/Authenticate

Disposal/Destruction

Assess Cost analysis, credit /debit management

Identify and TraceAssociation of every product instance (EPC) to shipments, invoices, and chargebacks ensures traceability between payments and physical goods

Improved transaction history will significantly improve chargeback/rebate accuracy, reducing errors and manual validations

ValidateCheck against contract dataDouble chargeback and rebate payments due to illegal diversions can be detected automatically by validating sales history

AnalyzeCustomer / contract profitability analysis

Recall Management Chargeback Management

Page 27: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 27

Develop OptimizeDeploy

SAP Product Innovation Lifecycle

03/2005 Q2/200610/200506/2004

Release to customer:SAP AII 2.0

Release to customer:

SAP AII 2.1

SAP AII Feature Pack for

4.0

11/2004

Release to customer:

SAP AII 4.0

Q4/2006

Release to CustomerSAP AII

5.1

Release to customer:

SAP AII Feature

Pack

Q2/2007

Release to CustomerSAP AII

X.X

???

RFID Outbound

Returnables (RTI)BI ReportingEvent MgmtBar Codes

Object Event Repository (OER)EPC Global Data ExchangeProduct Tracking and Authentication (PTA) UID Enablement, Kanban, RFID-enabled EWMESA Enablement of AII

Standalone RFIDPreconfigured toolkit

Reporting

RFID Inbound

SAP RFID Solution Focus

e-Pedigree InterfaceESA Subset

SAP RFID Release Schedule

Page 28: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 28

Zebra

HP

Symbol

Matrix

Acsis

Systech

Globeranger

Infineon

Nokia – under AII certification process

SupplyScape

Cognizant

Strategic Partners

Printronix

LXE

Alien

Peak

Reva

Sun

Intel

Others in process

Mobile

Device Mgmt.

(AII Certified)

Hardware

Printers

e-Pedigree

(Powered by SAP NetWeaver®)

Category

PRODUCTS/SOLUTION

SAP RFIDTechnology

AIIAuto-ID

Infrastructure

Device Mgmt Partners

Device Mgmt Partners

Enterprise EPCIS

Event Manager

XIExchange

Infrastructure

PedigreePartners

PedigreePartners

ERP andBusiness Information

SAP RFIDTechnology

AIIAuto-ID

Infrastructure

Device Mgmt Partners

Device Mgmt Partners

Enterprise EPCIS

Event Manager

XIExchange

Infrastructure

PedigreePartners

PedigreePartners

ERP andBusiness Information

SAP RFID Partner Strategy for Life Sciences

Page 29: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

Drug track and trace overview

Key issues and pain points in pharmaceuticals

SAP solution overview and roadmap

Benefit areas, KPIs, and benchmarking

Customer examples

Wrap-up

Page 30: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 30

200+ RFID Companies; 17+ IndustriesNumber of RFID Customers by Industry [150]

CPG23%

Chemica11%

Lifesciences10%Transportation

7%Hi-Tech

6%

Auto5%

A&D5%

PS5%

Utilities5%

O&G5%

Industrial4%

Services3%

Retail3%

Other3%

Mining1%

Media1%

Mill Products1%

Page 31: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 31

Abbott Labs: Case/Pallet Tagging

AII

ERP system -R/3

Warehouse Management

System

Device Mgmt Partner - ACSIS Device Controller

Update

XI

Pick/Pack

Delivery

Update pallet hierarchy and

delivery

ASN

Delivery

Associate pre-encoded Tags (Case/Pallet) with Delivery

AII

ERP system -R/3

Warehouse Management

System

Device Mgmt Partner - ACSIS Device Controller

UpdateUpdate

XIXI

Pick/PackPick/Pack

DeliveryDelivery

Update pallet hierarchy and

delivery

Update pallet hierarchy and

delivery

ASNASN

DeliveryDelivery

Associate pre-encoded Tags (Case/Pallet) with DeliveryAssociate pre-encoded Tags (Case/Pallet) with Delivery

Page 32: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 32

Purdue Pharma L.P.

Company and project overview:Manufactures class two narcotics; is a key Wal-Mart pharmaceutical supplier

Is world’s first company to tag at item level

Has improved tracking of goods within the facility for controlled substances

Complies with Wal-Mart while achieving internal process improvements

Uses SAP RFID technology to meet these requirements

Business benefitsTactical: Complies with Wal-Mart mandate:

Unit-level tagging by mid-year 2004Case-level tagging by the end of 2006

Strategic: Generates business benefits:Lead the pedigree tracking requirementsDrive cost out of the supply chainIncrease supply chain responsivenessEnsure legislative compliance to the FDA, DEA, and so on

“We selected SAP’s RFID solution not only to achieve this compliance but also to help us generate value for our business in the future. By being able to track our products automatically, we not only fulfill Wal-Mart’s mandate, we also position ourselves to meet future requirements from the FDA & DEA.”

Chuck Nardi, Vice President

Company and project overview:Manufactures class two narcotics; is a key Wal-Mart pharmaceutical supplier

Is world’s first company to tag at item level

Has improved tracking of goods within the facility for controlled substances

Complies with Wal-Mart while achieving internal process improvements

Uses SAP RFID technology to meet these requirements

Business benefitsTactical: Complies with Wal-Mart mandate:

Unit-level tagging by mid-year 2004Case-level tagging by the end of 2006

Strategic: Generates business benefits:Lead the pedigree tracking requirementsDrive cost out of the supply chainIncrease supply chain responsivenessEnsure legislative compliance to the FDA, DEA, and so on

“We selected SAP’s RFID solution not only to achieve this compliance but also to help us generate value for our business in the future. By being able to track our products automatically, we not only fulfill Wal-Mart’s mandate, we also position ourselves to meet future requirements from the FDA & DEA.”

Chuck Nardi, Vice President

Page 33: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 33

Update

Update

Update

Update

Retrieve

HTTPS

HTTPS

RFID Tag Data FlowE- Pedigree Data Flow

ePedigreePartnerXML API

XI

Retrieve

E- Pedigree

Partner System -

Supply Scape

Internet• Delivery #• Batch #• Sales Info.• Esp. Date• NDC Info.• Cust ., P.O. #• Etc.

R/3

• EPC #• Batch #• Del. #• Etc.

SAPEM

• EPC #• Batch #

Pack

• EPC #• Delivery #

OutVault

InVault

ePedigreePartner

XML API

AII

HTTPS

HTTPS

RFID Tag Data FlowE- Pedigree Data Flow

Partner

XIXIe-Pedigree

Partner System -

Supply Scape

InternetInternet• Delivery #• Batch #• Sales Info.• Esp. Date• NDC Info.• ., P.O. #•

R/3

• Delivery #• Batch #• Sales Info.• Esp. Date• NDC Info.• ., P.O. #•

R/3R/3

• EPC #• Batch #• Del. #•

SAPEM

• EPC #• Batch #• Del. #•

SAPRepository

• EPC #•

Pack

• EPC #•

Pack

• EPC #•

OutVault

• EPC #•

OutVault

InVaultInVault

Partner

AIIAII

Purdue Pharmaceuticals: Item-Level Tagging

Page 34: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 34

Warehouse/ Distribution Process(PharmOps Warehouse/ Turn-Table / CPO)Packaging Line

Reader

PLC

Device control/ Data Acquisition System Device control

Camera

PLC Reader … Printer

Serialized informationSerialized information

Managing Managing serialized serialized

informationinformation, local data , local data repositoryrepository

Global Data repository, Global Data repository, Reporting & Alerts (mid Reporting & Alerts (mid ’’07)07)

SAPR/3

E-pedigree

EE--pedigreepedigree

•XI

EnterpriseRepository, PTA

Source : Novartis Pharma AG – SAP Life Sciences Council, 21 April 2006 - Marc Bechet

Warehouse/ Distribution Process(PharmOps Warehouse/ Turn-Table / CPO)Packaging Line

Reader

PLC

Device control/ Data Acquisition System Device control

Camera

PLC Reader … Printer

Serialized informationSerialized information

Managing Managing serialized serialized

informationinformation, local data , local data repositoryrepository

Global Data repository, Global Data repository, Reporting & Alerts (mid Reporting & Alerts (mid ’’07)07)

SAPR/3

E-pedigree

EE--pedigreepedigree

•XI

EnterpriseRepository, PTAEnterpriseRepository, PTA

Source : Novartis Pharma AG – SAP Life Sciences Council, 21 April 2006 - Marc Bechet

Novartis Pharmaceuticals: Item-Level Tagging

Page 35: February 20, 2007 Michael Lipton Director Solution ... · ©SAP AG 2007, 1 February 20, 2007 Michael Lipton Director Solution Management RFID / Serialization Life Sciences Pedigree,

© SAP AG 2007, 35

Jena University Hospital

Company and Project Overview:The Jena University Hospital consists of 26 different facilities. It has 4,000 employees and treats 250,000 patients annually. The hospital selected SAP R/3 and AII as part of an innovative comprehensive solution to prescribing, dispensing, transporting, and administering medications to its patients.

Business Challenge

Every 20th patient in a hospital suffers from an Adverse Drug Event (ADE). More than 55% of these ADEs are avoidable.

The average cost of an ADE is 3000 €.In Germany, with 16.7 million patients treated every year, the potential savings from avoiding ADEs is 1.4 billion €/year.

RFID Business ProcessElectronic order entry of prescriptionsTagging of medications in pharmacy and dispensed in unidose quantitiesTracking of medications transported from pharmacy to intensive care and individual patientsRFID bracelets worn by patientsInstant access to detailed patient informationReal-time matching of medications to patientsRecording of medication in patient files

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Prescription

Commissioning: Pick and verify medication and pack into patient boxes

Load Container: Exit pharmacy to ICU * via automated vehicle

@ ICU: Register container arrival

Empty content of patient box at clinic bed

- Scan tags of health personnel

- Scan patient’s wristband- Scan and record medication- Real-time validation of match

Verify observations

* ICU = Intensive Care Unit

Jena University Hospital: Benefits

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Biomet Medical Devices

Company Overview:Headquartered in Warsaw, Ind., Biomet Inc. designs, manufactures, and markets implants for musculoskeletal medical specialists. With net sales of more than US$1.9B in 2005, Biomet is the world’s fourth-largest company in its industry. Netherlands-based Biomet Europe has 1,800 employees and revenues of 500 million euros.

Business ChallengeBiomet’s inventory consists of a large variety of high-value items

• Items are assembled into loaner sets (kits) • Only a few items are used during

an operation • Partial kits are returned and

visually inspected • Missing items are invoiced and

replenishedBiomet was looking to improve accuracy and reduce the manual effort involved in this process

Business Process for Loaner Kits Goods Issue: Kit scanned by the RFID Tunnel, all items countedGoods Receipt: Kit scanned by RFID Tunnel, remaining items countedDifference: Invoiced to customer and replenishedMismatches: Items from other kits used during surgery are resolved quickly

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RFID-Enabled Business Processes at Biomet

Create Serialized Loaner Sets⇒Tagged Serialized Implant Parts Goods Issue

Records Specific Serial IDs

Consumption of Implants

ReturnedLoaner Sets⇒ Including

Unused ImplantsRegister Consumed

Implant Parts

Invoice Basedon Consumed Implants

Refill Loaner Sets

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Drug track and trace overview

Key issues and pain points in pharmaceuticals

SAP solution overview and roadmap

Benefit areas, KPIs, and benchmarking

Customer examples

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Time

Retail and Regulatory Compliance• Regulatory Case-Level Track/Trace: e-Pedigree; RxASN• Retail CII Item-Level Track/Trace • Retail Shrinkage and Track/Trace

Value-Driven Business ScenariosContracts and Chargebacks

Supply Chain Management• Product Recall management• Product Authentication• End-to-end Track/Trace

• Electronic Proof of Delivery• Supply Chain Analytics

Valu

e Extended Healthcare Applications• Medical Instrument Track/Trace/Invoice• Hospital Medication Administration• Clinical Trial Management

RFID-Enabled Applications are Evolving Quickly from Compliance to Innovative Value Add!

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RFID-Enablement Value Ladder

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Questions?

Mike Lipton

Director, SAP RFID Solution Management

[email protected]

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