Life Sciences The way we do it

Drug Security Network

An Introduction

Locked in Safety
 1

Global Drug Security Network

Safe and secure supply chain solution to prevent

counterfeit drugs.

Global Drug Security Network (DSN)
Counterfeit drugs are one of the biggest
problems for healthcare today. According to
the World Healthcare Organisation over 7%
of pharmaceuticals sold in the world today
are counterfeit, containing the wrong or no
active ingredient and putting patient health
seriously at risk. The US Food and Drug
Administration (FDA) has issued strong
guidelines focusing on measures to combat
counterfeiting and other regulators are set to
follow. Within a few years, pharmaceutical
manufacturers, distributors and retailers will
be required to ensure the security of drugs
passing through their supply chains.
7% of the World Drug Supply Chain is
Counterfeit—World Health Organisation
Wrong packaging
Wrong ingredient
5%
7%
Sub-potent active
ingredient 21%
Pharmaceutical companies can safeguard the
drug supply by using the DSN to authenticate
and transmit electronic pedigrees when they
send and receive pharmaceuticals in the open
supply chain.
The DSN, underpinned by software from
SupplyScape, is the exchange of secure,
compliant and authentic electronic pedigree
documents between pharmaceutical supply
chain partners, using standards-based
technology and transmitted securely over
the Internet.
The SupplyScape software complies with the
requirements of Florida, California, Nevada,
Colorado, New Mexico and the PDMA,
as well as the recommendations of the FDA
and NABP Model Rules.
No active
ingredient
43%
Electronic Pedigree Pilots
Using the DSN, pharmaceutical manufacturers,
distributors and pharmacies can meet the FDA’s
timeline for electronic pedigree pilots and Florida’s
Pedigree Law. To improve patient safety and combat
counterfeits:
„ Participate in the DSN to send, receive and
authenticate electronic pedigrees during your
shipping and receiving operations
„ Use the SupplyScape Electronic PedigreeTM
software to authenticate the pedigrees for inbound
products during receiving, and generate pedigrees
for drug products you ship. SupplyScape
Electronic PedigreeTM transmits authentic,
compliant pedigrees between DSN partners in a
secure XML format over the Internet
„ Run pilots at your location, or take advantage of
the EPC-standard supply chain implementation at
the Pharmaceutical DSN Lab

24%

Poor quality

How it works

Receiving :
Shipping : 2. Authenticate the pedigree before the
1. Transmit outgoing pedigrees for drug arrives, including prior owners
authentication; then ship the drugs 3. Verify in coming product matches the
authenticated pedigree

RETAILER
MANUFACTURER WWHOLESALER
HO LE SALE W WHOLESALER
HO LE SALE
R A R A

Electronic Electronic Electronic

Pedigree Pedigree Pedigree

Each partner authenticates, sends and receives electronic pedigrees using the open DSN over the secure Internet. Participants manage their electronic
pedigree documents in their own data center or as an outsourced service. The electronic pedigree tracks each owner of every drug as it moves through the
supply chain.

Pharmaceutical Drug Security | An Introduction

2

Problem

Counterfeit drugs endanger patients. Over 90%

of counterfeits provide little or no therapeutic
value, and many cause outright harm.

The FDA recommends pilots in 2004 to

accelerate industry adoption of electronic
pedigrees to authenticate and track prescription
drugs in the supply chain.

Benefits

Protect patient safety

Provide safe drugs by eliminating counterfeits.

Increase revenue
Maximize brand security by reducing diversion.
Aids in the recovery of annual revenue loss of
$100 million from counterfeiting.

Comply with FDA and Florida

Ensure distribution in Florida complies with the
state’s stringent pedigree laws. Meet the 2004
FDA pedigree timeline.

Reduce expenses
Reduce recall cost through precise recall scope.
Resolve returns and reconcile reimbursements
quickly and accurately. Improve supply chain
efficiency and accuracy.

Life Sciences
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Capgemini’s DSN Lab

Industry’s first pilot center for electronic pedigrees to

protect patients from counterfeit drugs

DSN Lab Tap the DSN Problem

Pharmaceutical companies can pilot their
solutions to safeguard drugs from counterfeits
at the DSN Lab.
The Lab provides a secure state-of-the-art
environment to comply with today’s Florida
Pedigree Law which expands to all drug
products in July, 2006, while meeting the
FDA timeline.
At the Lab, SupplyScape has implemented
four nodes in a reference supply chain.
It includes a drug manufacturer, two
wholesalers and a pharmacy, all
participating in the DSN.
Companies can use these nodes at the DSN
Lab throughout their pilots for:
Shipping:
1. Transmit outgoing pedigrees to the Lab for
authentication; then ship the drugs
Receiving:
2. Authenticate the pedigree before the drug
arrives, including all prior owners
The DSN is the exchange of secure, compliant
and authentic electronic pedigree documents
between pharmaceutical supply chain
partners using standards-based technology
and transmitted securely over the Internet.
Manufacturers, wholesalers and pharmacies
can use the Lab’s DSN supply chain, which is
implemented with real solutions already
tuned for the pharmaceutical industry:
„ Electronic pedigree
„ Mass serialization using EPC
„ RFID
„ 21 CFR Part 11 compliant repository
Pilots can involve your own company, or
include your supply chain partners.
Focused on patient safety, the FDA recommends
accelerated industry adoption of mass
serialization and electronic pedigrees. Florida
requires pedigrees for all drug products and
supply chain participants in July 2006.
FDA’s 2004 business steps for the
pharmaceutical industry:
„ Establish a team, gain experience and identify
business issues
„ Perform pilots with your supply chain partners
to gain experience, develop opportunities and
identify issues
„ Participate in standard setting groups to
maximize interoperability
„ Work with government agencies to address
regulatory issues associated with pilots

3. Verify incoming product matches the

authenticated pedigree
Benefits

FDA, Florida and California Timeline for Pedigrees and Mass Serialization
„ Hands-on experience with the electronic
2004 2005 2006 2007
pedigree solution
Mass serialize pallets/cases Pilots Some vulnerable Most vulnerable drugs All drugs
drugs „ Work with experts to design your pilot
Mass serialize saleable items Pilots Some highly Most highly vulnerable Most drugs
vulnerable drugs drugs
„ Leverage regulatory, standards and technology
RFID use Pilots Some participants Most participants All participants relationships
except small retailers

FDA electronic pedigree Pilots Most highly vulnerable All drugs „ Accelerate turnkey deployments at your
drugs (Dec. 1, 2006)
own sites
Florida pedigree Top 31 All drugs (July 1, 2006)
drugs

California electronic pedigree All drugs

(Jan. 1, 2007)

Sources: Combating Counterfeit Drugs: A Report from the Food and Drug Administration, 2004;
Florida Prescription Drug Protection Act; California Pharmacy Law

Pharmaceutical Drug Security | An Introduction

4

Solution Partners for the DSN Digital Signatures System Integration

A number of core partners have signed up to „ The Public Key Infrastructure for „ Capgemini provides system integration and

support the DSN: Sun Microsystems, Tyco authentication uses digital signature optional business process outsourcing for
Fire & Security, VeriSign, Documentum. certificates by VeriSign the DSN
Other vendors who provide open solutions Enterprise Architecture „ The DSN is an enterprise solution that can
are also encouraged to participate in the DSN. „ The DSN is a distributed solution interoperate with ERP, WMS, and inventory
architected to scale to the unit volumes in management systems
Electronic Pedigree the pharmaceutical supply chain Business Integration
„ The electronic pedigree software from
„ The EPC Event Manager, middleware and „ Capgemini enables partners through our
SupplyScape meets the requirements of
enterprise architecture components unique Accelerated Solution Environments
PDMA, Florida, California, Nevada,
including hardware are provided by Sun (ASE) and domain expertise to rapidly find
Colorado and New Mexico, and the
Microsystems solutions and resolve business issues.
recommendations of the FDA and NABP
Model Rules RFID Tags and Readers
„ Product-level 13.56 MHz RFID tags, case
21 CFR Part 11 Repositories
915 MHz RFID tags, antennas, and multi-
„ Each node on the DSN stores its pedigrees
protocol readers, as well as reader network
in 21 CFR Part 11 compliant databases
management software are provided by Tyco
provided by Documentum
Fire & Security and ADT Security Services
„ The secure, distributed architecture does
EPCglobal Network
not require a central repository collecting
„ The DSN uses the EPCglobal Network
everyone’s data

The DSN Lab

The DSN Lab

MANUFACTURER WHOLESALER A WHOLESALER B PHARMACY „ Enabling customers to accelerate their pilots,

Shipping Receiving Shipping Receiving Shipping Receiving SupplyScape has implemented four supply
Antenna Antenna Antenna Antenna Antenna Antenna chain nodes on the DSN. This reference
DSN Nodes Reader Reader Reader Reader Reader Reader supply chain includes a manufacturer, two
wholesalers and a pharmacy.

LAN LAN LAN LAN „ Capgemini maintains these DSN nodes at the
Electronic Pedigree DSN Lab in Cambridge, MA for customers to
Field Servers use throughout their pilots. Companies can
ship pedigrees and drug products to the Lab
Intranet Intranet Intranet Intranet and also pilot receiving drugs with pedigrees.
Electronic Pedigree
Secure Secure Secure
Enterprise Servers Internet Internet Internet

21 CFR Part 11 LAN LAN LAN LAN

Compliant Repository

Access to Network
D.C. EPC D.C. EPC D.C. EPC D.C. EPC
Services (Digital
Certificate & EPC)

©2004 Supplyscape Corporation

©2004 SupplyScape Corporation

Life Sciences
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Electronic Pedigree for Pharmaceuticals

RFID EPC pedigree tracks supply chain of custody to

prevent counterfeit drugs

Pedigree for safer drug supply „ Each custodian is added to the drug Mass serialization for efficient tracking
The SupplyScape Electronic Pedigree™ pedigree automatically as the drug moves „ Electronic Product Code (EPC) standard

solution helps prevent counterfeit drugs from
entering the legitimate pharmaceutical
supply chain.
With over 3 billion prescriptions filled in the
US last year alone, paper pedigrees create
significant handling costs and inefficiencies.
Electronic pedigrees are more cost effective.
Customers using the SupplyScape solution
provide safe, secure pharmaceutical
delivery to consumers in a timely and
cost effective manner.
from one company to the next
„ Contains authenticated signature of
each custodian
Counterfeit prevention
„ Authenticates every drug using the EPC
serial number assigned to each unique
drug product
„ Tracks each custodian for every drug
in the chain of custody detailed in the
electronic pedigree
Complies with federal and state laws
makes it possible to mass serialize all drug
products, ensuring each is individually
identified and tracked
„ Radio Frequency Identification (RFID)
tracking based on the EPC standard is the
most efficient method for collecting the
custody information required for drug
pedigrees
„ With RFID, product tracking occurs
automatically, without scanning of bar codes
Advance Pedigree Notice
„ Electronic pedigree documents associated

SupplyScape Electronic Pedigree
„ Most secure and efficient method to track
drugs in the pharmaceutical supply chain
„ Identifies every drug sale and distribution
„ Authenticates drug products
„ Tracks drug products as they move
through the supply chain
„ Manages electronic pedigree documents
„ Meets the stringent requirements of the
PDMA, FDA and state regulations including
Florida and California, and the NABP
Model Rules for safe and secure
pharmaceutical distribution
„ Maintains auditable records for all supply
chain product flow
„ 21 CFR Part 11 compliance for
electronic records
with a shipment are sent in advance
„ Enables automated authentication of
pedigree contents prior to arrival of drugs
on receiving dock
„ Only drugs without verified pedigrees need
to be processed manually
Shipping
„ Shipping or quality personnel authenticate

of record each drug pedigree before drug leaves the site

„ Enables mass serialization of drug products „ Technology streamlines the process
„ Tracks drugs at pallet, case and item level while adhering to strict regulatory and
security procedures
„ Rapid processing of high volumes of drugs
occurs through EPC/RFID and the
Electronic Pedigree tracks drug chain of custody throughout the supply chain
electronic pedigree application

Receiving
Pedigree
„ Electronic Pedigree application
WonderDrug
EPC serial #
authenticates pedigree document
Physical
product Manufacturer „ Quality or receiving personnel authenticate
Electronic
Pedigree flow each drug during receiving
„ Alerts indicate unauthenticated or
unidentified product, which receiving
Pedigree
personnel can stage for quality processing
Pedigree
WonderDrug
WonderDrug EPC serial #
EPC serial #
Manufacturer
Manufacturer Pedigree Wholesaler 1
Wholesaler 1 WonderDrug
EPC serial #
Wholesaler 2

Retail Pharmacist Manufacturer

Wholesaler 1

Wholesaler 2

Pharmaceutical Drug Security | An Introduction ©2004 SupplyScape Corporation

6
Prescription Drug Electronic Pedigree
Recall precision
„ Pedigree enables rapid tracing through all
custodians to source of compromise
„ EPC serialization ensures precise recall
scope, and identifies specific drugs targeted
for recall
Returns
„ Electronic Pedigree application
authenticates pedigree document for
product returns
„ Expedite returns processing
„ Resolve returns unambiguously based on
original purchase terms
Open Industry Standards
„ Based on the EPCglobal Network standards
developed by the MIT Auto-ID Center and
adopted by EPCglobal
„ Secure transmission and access control
protect information integrity
Life Sciences
Pedigree Regulatory Compliance
Expertise
SupplyScape experts, in federal and state
Pedigree Laws, work with each customer to
plan a successful rollout.
Assessment
„ Determine scope of effort for implementing
electronic pedigree
„ Specify business process changes for
regulatory compliance streamlined with
pedigree software
„ Identify optional enterprise system
integration
„ Plan a specific pilot including site, product
and technology selection
Electronic Pedigree
„ Authenticity: Pedigree and product
authentication confirms this drug product is
genuine
„ Drug sales and distributions: show drug
pedigree chain of custody
Pilot
„ Implement electronic pedigree for a
specified drug product
„ Review quality and compliance processes
with new electronic pedigree
„ Measure results
Rollout
„ Define implementation plan for broader
rollout
„ Expand to multiple product lines and sites
to meet state and federal pedigree timelines

Working at the DSN Lab
The DSN Lab
Accelerate your drug security pilots
„ Gain guidance from the MIT Auto-ID Labs
„ Use the Lab’s supply chain on the DSN
„ Fine-tune business and operational processes
internally and with your partners
Work with experts in:
„ Electronic pedigree
„ Life sciences supply chain
„ 21 CFR Part 11 and digital signatures
„ EPC and RFID standards
„ Federal and state pedigree regulations
Results of Accelerated Pilots
„ Meet 2004 FDA timeline for pedigree pilots
„ Gain feedback from the MIT Auto-ID Labs
„ Understand industry directions and research
at quarterly meetings with pharma
colleagues
„ Refine drug security approaches that work
for your products, distribution processes
and partners
„ Gain confidence that the solutions you pilot
at the Lab are scalable for global
deployment
„ Provide specific feedback to the FDA and
state regulators
„ Influence the industry standards
„ Tap the expertise of the many solution
providers contributing technology to the
Lab and the DSN
Pharmaceutical Drug Security | An Introduction
The Process
Your global leaders will work directly with
experts from the DSN in a three-step
accelerated process:
1. Plan >> 2. Test >> 3. Pilot
Level 1: Plan your pilot; explore approaches
In a half-day meeting you and your team will:
1. Participate in a live demonstration of
multiple anti-counterfeit solutions
2. Collaborate on a vision for brand security
3. Explore the technology road maps used at
the Center and the DSN
4. Select which products, manufacturing
lines and distribution centers to pilot;
refine use cases
5. Determine your success criteria
6. Define the business case
Level 2: Run initial tests
In this 3-day collaborative session you and
your extended team will:
1. Execute initial tests and explore options in
the Lab’s quick turnaround environment
2. Gain hands on experience with the Lab’s
live drug security technologies and DSN
pedigree transmissions
3. Specify business process changes required
for a successful pilot and deployment
4. Collaborate with all departments who will
be involved in the anti-counterfeit efforts
5. Achieve in 3 days what normally takes
3 months or more
Level 3: Pilot
In this 4-month pilot you and your extended
team will use your facilities and/or the Lab to:
1. Install hardware and software; resolve
interoperability issues
2. Transmit, receive and authenticate
electronic pedigrees
3. Ship and receive drug products associated
with those pedigrees from your facilities
and/or your supply chain partners
7
4. Refine business and operational processes
for all departments involved in the drug
security effort
5. Comply with federal and state
requirements for mass serialization and
electronic pedigrees
6. Refine the business case
7. Plan to scale your drug security approaches
to other products and locations
Next Steps
Set up a Level 1 meeting with your team to
plan your pilot.
„ Identify a specific pilot plan including site
and product selection
„ Participate in the DSN with your supply
chain partners
Participants gain immediate value by
collaborating with:
„ Capgemini consultants in life sciences,
supply chain and RFID solutions
„ SupplyScape experts on electronic pedigree
„ Life science EPC/RFID experts from Tyco
Fire & Security and Sun Microsystems
Lab Location
The DSN Lab is located in the Capgemini
Accelerated Solution Center in Cambridge,
MA.
Experts at SupplyScape and the MIT Auto-ID
Labs are less than one mile away. Life science
EPC/RFID experts at Tyco Fire & Security and
Sun Microsystems are available to support the
Lab.
8
About Capgemini
and the Collaborative
Business Experience
Capgemini, one of the
world's foremost
providers of Consulting,
Technology and Outsourcing services, has a
unique way of working with its clients,
called the Collaborative Business
Experience.
Backed by over three decades of industry
and service experience, the Collaborative
Business Experience is designed to help our
clients achieve better, faster, more
sustainable results through seamless access
to our network of world-leading technology
partners and collaboration-focused methods
and tools. Through commitment to mutual
success and the achievement of tangible
value, we help businesses implement
growth strategies, leverage technology, and
thrive through the power of collaboration.
Capgemini employs approximately 55,000
people worldwide and reported 2003 global
revenues of 5.7 billion euros.
More information about individual service
lines, offices and research is available at
www.capgemini.com/life
VeriSign operates intelligent infrastructure
services that enable you to find, connect,
secure and transact across today's complex
global networks.
VeriSign was selected by EPCglobal to operate
the root Object Naming Service (ONS) for the
EPCglobal Network, the authoritative
directory of information sources that are
available to describe products in the supply
chain. VeriSign provides a network service
environment to the DSN, as well as security
offerings that authenticate users and encrypt
the information transmitted across the DSN.
These services ensure data integrity and
continuity making the DSN a suitable
environment for sharing critical information.
Life Sciences
SupplyScape provides the Electronic Pedigree
expertise to safeguard and secure the
pharmaceutical supply chain. SupplyScape is
the solution architect for the Drug Security
Network and a leader in defining a standards-
based electronic pedigree solution for the
pharmaceutical industry. For the DSN,
SupplyScape provides:
„ Expertise in Federal and State Pedigree
Regulations
„ Standards-based Solution Architecture for
the DSN
„ Compliant Electronic Pedigree software
„ Implementation design for each DSN
partner to maximize their ROI
„ Implementations at the DSN lab
The SupplyScape Electronic Pedigree software
has been developed with full cooperation
from federal, state and industry participants
in order to meet the federal and state
pedigree laws. It complies with federal and
state pedigree laws and the recommendations
of the FDA and NABP. Using EPC, RFID, bar
codes and industry standards, it streamlines
business operations and enables companies to
safeguard prescription drugs, improve the
speed and quality of shipping and receiving,
expedite returns processing and improve
recall precision.
ADT Security Services, a part of Tyco Fire &
Security, is one of the largest global providers
of fully integrated retail and supply chain
solutions. Offering a full range of physical
layer RFID solutions and services, ADT has
the global strength to deploy worldwide RFID
implementations. No other company offers
the Sensormatic RFID solutions – one of
the first radio frequency technologies to
extend the value proposition of retail supply
chain visibility, agility in decision-making and
RFID compliance to customers worldwide.
SupplyScape and SupplyScape Electronic Pedigree
are trademarks of SupplyScape Corporation
Sun Microsystems is a leading provider of
RFID solutions, software, services, systems,
and Test Centers. Sun has been at the
forefront of EPC and RFID standards
development, starting with our participation
in the MIT Auto-ID Center, where Sun
chaired the Technology Board. Sun is an
active member of EPCglobal, and co-chairs
the Software Action Group in addition to
participating in the Healthcare and Life
Sciences Business Action Group.
Sun systems have been provided to run the
entire DSN environment. The Sun Java™
Systems RFID Event Manager software is
designed to manage and interface with
hundreds of readers and antennae, and
delivers all connectivity and management to
the myriad of devices within the DSN. In
addition, Sun also enables the SupplyScape
software through the Sun™ ONE Application
Server, which provides unsurpassed scale and
performance to the network.
Outside of the DSN, Sun operates RFID Test
Centers worldwide designed to be the first
step in a customer's journey towards a
successful RFID deployment. The Dallas
RFID Test Center, a state-of-the-art 17,000-
square-foot warehouse facility, is the first in
the series of RFID Test Centers being planned
worldwide. For more information on Sun's
RFID offerings, go to www.sun.com/rfid.
Sun, Sun Microsystems, the Sun logo, and Java
are trademarks or registered trademarks of Sun Microsystems, Inc.
in the United States and other countries.
www.capgemini.com/life

For more information:

Capgemini SupplyScape Corporation
DSN Lab 201 Broadway
600 Memorial Drive; Suite 200 Cambridge, MA 02139
Cambridge, MA 02139 www.supplyscape.com
www.capgemini.com/life
Contact:
Contact: Alex Hase
Colin Towner ahase@supplyscape.com
colin.towner@capgemini.com +1 (617) 453 5760 X420
+1 (310) 536-7317

Derek Crates Sun Microsystems, Inc.

derek.crates@capgemini.com One Network Drive
+44 (0)870 908 5008 Burlington, MA 01803
www.sun.com
To book the DSN:
Kerri Friedlaender Contact:
kerri.friedlaender@capgemini.com Liz From
+1 (617) 768 5489 Pharma RFID Practice Lead
Sun Microsystems, Inc.
ADT Security Services +1 (781) 442-2226
One Town Center Road Liz.From@Sun.COM
Boca Raton, FL 33486-1010
+1 (877)258-6424
VeriSign
Contact: Naming and Directory Services
Kevin Lynch 21345 Ridgetop Circle
+1 (401) 846-6123 Dulles, VA 20166
www.adt.com/rfid epc@verisign.com
www.sensormatic.com/rfid www.verisign.com/epc