Counterfeit drugs pose a significant threat as they can harm patients and reduce pharmaceutical company profits. To combat this threat, a multi-level anti-counterfeiting strategy is needed that utilizes various technologies like RFID, ePedigrees, and security labeling. While no single solution is sufficient, a combination of approaches can better secure the drug supply chain, reduce counterfeits in the marketplace, and improve patient safety and brand protection.

1. MULTIPLE STRATEGIES AND TECHNOLOGIES TO COMBAT
COUNTERFEIT DRUGS
Authors: Sanjay Modi and Sanjeev Wadhwa
An anti-counterfeiting The U.S. Food and Drug Administration (FDA) has seen a rise of
strategy helps to counterfeit drug cases since 2000 when there were only six. In 2006,
effectively detect the number of cases rose dramatically to 54 (Bernstein, 2007). The
counterfeit products, market for counterfeit drug is approximately $40 billion (WHO, 2006).
increase audit compliance, According to the Center for Medicines in the Public Interest, counterfeit
and enhance supply chain drug sales globally will reach $75 billion by 2010. This represents an
management capabilities. increase of 90 percent from 2005 (WHO, 2006) and will represent 14
This strategy can identify percent of the total drug market (Pitts, 2005). Furthermore, it is
the multiple best-fit estimated that 10 percent of the global medicines are counterfeit.
solutions for meeting a Approximately 60 percent of counterfeit drug cases occur in less-
company’s requirements developed countries in which 25 percent of their drug supply is
via Radio Frequency counterfeit (Morris, 2006). The largest producers of these drugs are
Identification Devices Southeast Asia, Nigeria, Russia, Mexico, Brazil, and Latin America (U.S.
(RFID), ePedigrees, label Immigration and Customs Enforcement, 2006).
security, dosage unit level
Counterfeit drugs are an increasing threat in the marketplace. These sub-
security, nanotechnology,
standard drugs affect human lives as the quality and/or type of drug is
and other capable
harmful to the patient. These products may not cure the targeted
solutions to combat
diseases and could possibly even kill patients. Also, they affect the
counterfeiting of drug
profits of the companies which manufacture the drugs. Pharmaceutical
products. One item alone
companies invest large amounts of resources to create drugs. They
will not protect the
spend up to 12 years and $1.2 billion on clinical development for drugs
companies from counter-
(Archarya, 2006). However, only 30 percent of drugs which are
feit drugs, but one with a
approved and marketed produce revenues that match or exceed initial
multi-level approach will
costs (DiMasi, 2002). Therefore, any counterfeit drugs sold as legitimate
lead to safeguarding the
drugs reduce the companies’ revenues and lead to lower profits.
supply chain, prevent
erosion of the brand There are five different types of counterfeit mechanisms in which drugs
image, and increase are manufactured or distributed without proper regulatory approval and
revenues. This will result do not meet the determined standards of safety, quality, and efficacy
in decreasing the number (WHO, 2007):
of counterfeit products in
• No active ingredient (43 percent)
the marketplace and
improving patient safety • Low levels of active ingredient (21 percent)
and enhancing product • Poor quality drugs (24 percent)
authenticity and • Wrong ingredients (2 percent)
identification. • Wrong packaging or source (7 percent)
Counterfeiting can apply to both branded and generic products. In
wealthy developed countries, expensive drugs such as hormones,
steroids, and antihistamines are frequently counterfeited due to lifestyle
preferences. While in developing countries, those used to treat life-
threatening conditions such as malaria, TB, and HIV/AIDS are chosen to
be imitated due to their relatively high costs. As this trend continues,
| Multiple Strategies and Technologies to Combat Counterfeit Drugs | 1

2. other drugs such as anti-cancer and anti-virals might Therefore, counterfeit drugs are passed as real drugs
be next on the list due to the high costs of these due to the counterfeiters’ abilities to reproduce items.
drugs and the lucrative returns by the counterfeiters.
Sources of Counterfeit Medicines C o u n terfeit A u th en tic
Counterfeit drugs can be diverted and sold from 1 1. Logo background
various channels within the drug distribution system 2 LO G O LOG O color
due to its complexity. There is no enforced 2. Logo font not bolded
3. Colored protective
government mandate to track the drugs efficiently 3 Logo Logo packaging on rim
on top of bottle
within the system which allows for openings for 4. Border type
counterfeiters throughout the system. Drugs can be 5. Font size
4 6. Border size
diverted from their original purpose and sold outside D ru g D ru g 7. Pill size and shape
the regulated distributed channels. For example, free 5 N am e 8. Name of pill varies
N am e
samples to doctors may be sold illegally within the 50m g
6 50m g Can you tell the difference
if one of the above items
system. Patients may, in turn, sell their prescription were changed?
drugs for a profit. Also, drugs sold for lower prices in
various countries can be sold to other markets where 7
D P5
the price is higher. These drugs are not regulated 8
through safeguards as they are sold outside the
normal distribution channels Figure 1: Difference between Counterfeit and
Authentic Drugs
The 1988 Prescription Drug Marketing Act (PDMA)
introduced a need for paper drug pedigree to track As a result of illegal medical drugs within the system,
the drug from manufacturer to end user. However, it the companies that manufacture and sell the
has yet to be fully implemented throughout the authentic products incur large losses of revenue. This
industry and supply chain due to the high record- decreases sales and profit margins due to other
keeping effort needed to maintain this type of unauthenticated “substitute” products that people
system. Incomplete paper pedigrees lead to are buying in place of the authenticated drug
increasing the risk of counterfeit drugs in the product. Large inventory losses and write-offs are
marketplace as the ingredients or products are not placed on the balance sheets due to routing leakages
tracked within the supply chain. On the other hand, and medicines which were not purchased legally. As
complete paper pedigrees help validate the noted earlier, these drugs threaten patient safety
authenticity of the drug but counterfeiters are finding leading to possible deaths. There are audit and
ways around this paper-based process. For example, regulatory compliance issues with counterfeit drugs
illegitimate secondary wholesalers can prepare fake as they do not follow the regulated channels.
paper pedigree documents which pharmacies detect Furthermore, the supply chain for the drugs is
as valid. An increasing trend is to use tools and complicated due to higher inventory carryover
processes to copy drug labels and packages. This leading to increased costs. The supply chain issues
makes it difficult to identify the real drug from the push for an efficient and reliable tracking mechanism
fake copy due to the striking similarities between the which has yet to be mandated by the industry or
two. Repackaging is another way to bring expired or regulators due to high initial costs and lack of
compromised drugs into the distribution system and industry standards.
mix them with genuine drugs. Finally, the lack of
tamper-evident packaging allows the original Anti-Counterfeit Strategies
packaging to be reused for unregulated drugs An anti-counterfeiting strategy helps to effectively
(HHS, 2004). detect counterfeit products, increase audit
compliance, and enhance supply chain management
The differences between counterfeit and authentic
capabilities. This strategy can identify the multiple
drugs can be difficult to detect unless one looks
best-fit solutions for meeting a company’s
closely at the bottle or packaging. These can be
requirements via Radio Frequency Identification
minor changes in the product container, label, or the
Devices (RFID), ePedigrees, label security, dosage
individual pill that can be hard to visually detect by
unit level security, nanotechnology, and other capable
the human eye. For example, a change in the type of
solutions to combat counterfeiting of drug products.
font, border type, or logo color is difficult to detect
One item alone will not protect the companies from
unless someone knows how they are packaged by the
counterfeit drugs, but one with a multi-level approach
manufacturer (Palmer, 2004; Genentech, 2001).
| Multiple Strategies and Technologies to Combat Counterfeit Drugs | 2

3. will lead to safeguarding the supply chain, prevent training for the end-users. A study by A.T. Kearney
erosion of the brand image, and increase revenues. believes implementation of a RFID system for a
This will result in decreasing the number of manufacturer with $10 billion in prescription sales will
counterfeit products in the marketplace and receive annual benefits of $20 – $55 million with the
improving patient safety and enhancing product system excluding initial and recurring costs. A large
authenticity and identification. It also meets the distributor with $40 billion in prescription product
necessary increased audit compliance by reducing sales will have an annual benefit of $12 – $24 million
the supply chain issues such as time to account and (Paddison, 2005).
inventory tracking. Therefore, this leads to an
In 2005, Pfizer announced it would use RFID tags on
increased bottom-line by effectively locating its
its Viagra® bottles which are sold in the United States.
products within the supply chain from manufacturer
GlaxoSmithKline took the initiative by planning to
to patients. This enables the drug manufacturer to
implement RFID tags on one of its anti-HIV drugs
capture higher revenues for legitimate drugs in the
within the next 18 months. Furthermore, Purdue
marketplace.
Pharma utilized RFID tags on Oxycotin® bottles to
RFID better track and authenticate the medications (FDA,
New trends in the industry are creating unique 2004). RFID tags can be embedded into the label of
opportunities within the anti-counterfeiting market. the medicine bottle or within the blister pack to
The FDA has also recommended that pharmaceutical
companies start using RFID as a means of better
tracking drugs. These are radio transmitters that can RFID
be attached to drug packages, medicine bottles, or XYZ
Pharma
RFID
active ingredient containers and scanned to emit an D ru g
RFID N am e
electronic product code. Individual packages of drugs 50m g
XYZ
or their respective ingredients can be monitored Pharma
throughout the supply chain from manufacturers to
distributors and wholesalers to pharmacies (Wyatt, A. Cartons of B. RFID Tag C. Blister Pack
Drugs Medicine Bottle
2006). As a result of enhanced inventory
management practices, RFID can decrease revenue
losses as a result of stock-outs and drug expirations
and create cost savings of $2 billion worldwide
(Paddison, 2005).
One major obstacle for RFID tags is the costs
associated with the system. As RFID tags become
more of a commodity, the prices for tags and readers
will be significantly lower and lead to more cost
1 2 3
savings. Each passive tag costs $0.25 – $1.00 while Scanner Computer Server
the each reader costs $500 – $3000. Furthermore,
there is the need for other resources such as Figure 3: RFID Tags Embedded Within Cartons of Drugs,
computers, networks, databases, and additional Medicine Bottle Labels or Blister Packs
Benefits and Costs (M = Millions) • Large Manufacturer
Benefits Costs — $10 billion in
Type Total Annual Ongoing Total Costs
One-time Annual Benefits Intangible Benefits One-time prescription
Initially Long-term
product sales
Large Not $20 – $55 $20 – $55 1. Protect Overall $15 – $20 $20 – $40 $8 – $16 $35 – $60 $23 – $36
Manufacturer significant Supply Chain • Large Distributor —
$ 10 bilion in 2. Prevent Stolen
prescription and Lost Products $40 billion in
product sales
prescription
Large $2 – $4 $10 – $20 $12 – $24 3. Decrease Recovery $9 – $20 $3 – $4 $3 – $4 $12 – $24 $12 – $24
Distributor
product sales
Costs of Lost or
$ 40 billion in Recalled Products Source: Paddison, 2005
prescription 4. Protect Brand
product sales Loyalty
Figure 2: Cost and Benefits for RFID Implementations
| Multiple Strategies and Technologies to Combat Counterfeit Drugs | 3

4. prevent easy removal. This is very similar to airline This will provide information on the “chain of
initiatives to utilize RFID tags rather than traditional custody” of the drug and decrease counterfeit drugs
barcodes to track the baggage location in real-time. in the supply chain. As the drug flows through the
The tags have a read rate of 99 percent, whereas bar supply chain from manufacturer to wholesaler(s) to
codes have a read rate of 85-90 percent. This higher pharmacy, each step is tracked via an Internet portal.
read rate leads to less manual sorting due to In the ePedrigree system, the medical product’s
unreadable bar codes. This also decreases the time information is verified and documented during each
and costs in getting the bags to the customers. The step within a secure environment. Therefore, a
current cost for bag retrieval is estimated to be $2.5 product’s path is followed in real-time via the portal
billion a year by The International Air Transport to ensure it is coming into the system from a valid
Association (Demerjian, 2005). source. A new data management infrastructure to
store and share the data has to be implemented
ePedigrees
within the company. A few vendors are already
Another development is the focus on ePedigrees to
providing services for the new system in order to
create a more efficient supply chain in a secure
easily transition into this environment.
environment. The PDMA states that pedigrees are
required for all non-Authorized Distributor of Record The ePedigree shows detailed real-time information
wholesale distributions (SupplyScape, 2006). In regarding the product and its distribution within the
2006, ePedigrees were implemented in only 200 supply chain. It provides general product information
along with a tracking number for easier identification.
As it travels from one location to another, it will
ePedigree System provide the transaction details including names,
addresses, and drug license numbers. It will also have
Tracking Number the receiving person’s name and electronic signature.
Date In addition, it will include details such as the
production number and expiration date so it can
Manufacturer Drug Information easily be traced back in the future for recalls or
Special Handling Information
quality checks (Bernstein, 2007).
Wholesaler/
Manufacturer:
Pharmacy Overt Strategies
Name Name Pharmaceutical companies are experimenting with
Address Address overt strategies such as optically variable devices
Phone Phone
(OVDs) that can help track/authenticate drugs. Some
Email Email
Wholesaler companies are testing holograms, color-shifting inks
License No. License No.
and watermarks that can help them authenticate
Electronic Signature/ID medicine bottles and packages. Similar techniques
Name
Date and Time
Production Number
Expiration Date
Pharmacy
Figure 4: ePedigree System Tracks Real-Time Drug
Information from Manufacturer to Pharmacy
million medicine bottles and blister packs. In
comparison, the number of prescriptions dispensed in
2006 was 3.7 billion (Lamb, 2007). As drug D ru g
Dr
shipments arrive within the various elements of the N am e u
Na g Logo
supply chain, ePedigrees are matched and signed to 50m g 50 m e
m
Lo g
confirm and validate the authenticity of the drugs. Logo go
Software programs show the detailed information of
the validated drugs within the supply chain and their Logo
specific location at various time periods. ePedigree
will be utilized within all steps of the supply chain Figure 5: Color Shifting Logo — Changing the Viewing
from manufacturer to retailer and customer. Angle Shifts the Color
| Multiple Strategies and Technologies to Combat Counterfeit Drugs | 4

5. are currently utilized in safeguarding the U.S. the packaging. For the highest level of security, the
currency. The currency utilizes multiple safeguards markers can be added to the individual pills in order
which makes it difficult, time-intensive, and costly for to identify if the drug is counterfeit. The markers are
counterfeiters. It utilizes a dual color-shifting ink, odorless, tasteless, and approved for human
watermark, security thread within the paper, and new consumption. A quick test kit, similar to a pregnancy
symbols on the bill. In 2004, the pharmaceutical test, can be performed in the field to determine the
companies started using color-shifting ink that authenticity. The pill is put into a special receptor-
changed color depending on the viewing angle so binding liquid, and a test strip is placed into the
counterfeits can be easily recognized by members liquid. If the specified marker is in the pill, the strip
downstream within the supply (Palmer, 2004). Others turns a specific color (Weinberg, 2007). Also, Kodak’s
are experimenting with using inks or dyes and some Traceless® technology incorporates an odorless and
are already using tamper-resistant packaging tape on colorless powder within the medicine packaging label
some of their products. Also, there is a change to or within the drug ingredients. The package is read in
raised printing in which letters are raised above the real-time with a patented handheld reader to
paper for easy inspection and detection for authenticate the drugs. For medicine packaging
counterfeits. labels, this method works with conventional printing
methods and can be utilized during the
Covert Strategies
manufacturing process (Kodak, 2007).
Companies are also shifting to covert strategies
which utilize special devices to authenticate the Benefits
drugs. Authentix utilizes a new method incorporating Pharmaceutical companies are more concerned about
nanotechnology markers (50 nM to 5000 nM in size) brand image and reputation these days than ever
which are mixed into the drug packaging and before. This is one of the key reasons to protect the
individual pills. They can be specifically added to the supply chain by utilizing the latest technologies.
inks, labels, and pill ingredients for easy detection. Counterfeit drugs can lead to drug recall and liability
These markers have spectral properties that “light up” suits which can cost the company millions and billions
when a light with a specific wavelength is placed on of dollars. Fen-Phen was recalled in 1997 and led to
50,000 liability lawsuits. The total costs for the recall
A. Markers Emit Light at Specific Wavelength
and lawsuits were estimated at $14 billion (Gilchrist,
2005). In addition, brand loyalty is compromised as
consumers perceive additional risk when using a
company’s products. It might take several months or
years for a product to regain its market share
D ru g
depending on the severity of the initial damage. This
N am e will result in lost sales and revenue along with the
50m g
high costs of marketing and public relations to bring
the drug back to the market (Paddison, 2005).
An anti-counterfeiting strategy can better analyze
Nanotechnology Specific Wavelength how these methods benefit the client most effectively
Markers Light depending on business needs, requirements, desired
B. Receptor Binding Test level of security, and geographic location. However,
for this strategy to work properly, a multi-step
Pill with approach has to be implemented because an
Marker 3 Authentic individual strategy alone has not worked in the past.
1 2 A multi-level strategy uses complementing
technologies that can provide the most protection for
a company’s brand and the highest level of security.
Counterfeit This will also result in additional costs as the
technologies become more sophisticated and the
Add Pill to Add Test
Receptor Strip quantity of products becomes marked or tagged. A
Binding Liquid basic foundation for protecting the Pharma Value
Chain focuses on tracking methods such as RFID and
Figure 6: Nanotechnology Markers Emit Light at Specific ePedigrees. The next step is to protect the medicine
Wavelengths and Bind to Specific Receptor Binding Liquid
bottles and blister packs with overt technologies by
(Weinberg, 2007)
| Multiple Strategies and Technologies to Combat Counterfeit Drugs | 5

6. Technologies Increased Layers of
Protection
3 Individual Pills
Covert
Pill
• Nano-
Technology
• Ink Markers +
Increasing Costs
Patented Reader
Medicine Bottles
3 Blister Packs
• Color Shift Ink
• Hologram
• Watermarks
3 Boxes RFID
Overt and
• RFID and ePedigree XYZ
Pharma
Pallets
Figure 7: Pharma Value Chain — Shifting Strategies and Technologies from
Overt to Covert Results in Increased level of Security at Higher Costs
increasing safeguards such as raised fonts, color- All of these items will lead to better-guarded supply
shifting inks and logos, holograms, and watermarks chain and costs savings. This will result in decreasing
so they can’t be reproduced by other sources. The the number of counterfeit products in the
final step utilizes covert technologies to protect the marketplace, improving patient safety, and enhancing
individual pills, medicine bottles, and blister packs by product authenticity. It also meets the necessary
incorporating nanotechnology markers and patented increased audit and regulatory compliance by
ink markers and readers for authentication. By using reducing the supply chain issues. Therefore, this
multiple safeguards into a specific product, it makes complementing strategy based on client’s needs
it expensive and time-consuming for the leads to an increased bottom-line by effectively
counterfeiters. Furthermore, higher risk geographic locating its products within the supply chain from
areas for counterfeit drugs require enhanced security manufacturer to patient and reducing leakage during
levels and increased layers of protection in order to the routing process. This enables the drug
protect the Pharma Value Chain. manufacturer to capture higher revenues for
legitimate drugs in the marketplace and protecting
the brand reputation.
Increased Layers of
Technologies
Protection
Nano-
Technology
Pill
Ink Markers+
Reader
Protect Supply Maintain Brand
Increased Layers
Color Shift Ink Chain Reputation
of Protection
Holograms
Watermarks
+
Increase Revenue Enhance Patient
RFID
RFID+ and Profits and Drug Safety
XYZ
Pharma
ePedigrees
Figure 8: Implementation of Multiple Strategies for Protecting the Supply
Chain, Maintaining Brand Reputation, Increasing Revenue and Profits, and
Enhancing Patient and Drug Safety
6

7. References McCarthy, Joe. 2006. “The Practicalities, Perils, and
Acharya, Satish. 2006. “The Productivity Tiger- Time and Promise of RFID.” http://interrelativity.com/rfid/RFID-
Cost Benefits of Clinical Drug Development in India.” Dorkbot-2006-03-01-final.pdf
Pharmalicensing. Morris, Julian and Steven Philips. 2006. “Counterfeit
http://pharmalicensing.com/features/disp/1153412098_4 Medicines in Less Developed Countries.”
4bfac02291f1 www.fightingdiseases.org/pdf/IPN_Counterfeits.pdf
Bernstein, Illasa. 2007. “FDA’s Counterfeit Drug Paddison, Chris. 2005. A.T. Kearney “Executive Agenda -
Initiative.” Busting the Myths of Pharma RFID.”
http://www.unitdose.org/Bernstein.FDA.ppt#499,11,E-
Pedigree http://www.atkearney.com/shared_res/pdf/Busting_the_
Myths_of_Pharma_RFID.pdf
Credit Union National Association. 2007. “New Money’s
Coming.” http://googolplex.cuna.org/12433/privacy.html Palmer, Gary. 2004. “For Pharmacists: Description and
Identification of Counterfeit Drugs.”
Dahold, Shabbir. 2007. “Safeguarding the drug supply http://www.pfizer.com/pfizer/subsites/counterfeit_impor
chain with ePedigrees.” tation/mn_pharmacist_viagra.jsp
http://www.bizjournals.com/masshightech/stories/2007/
05/21/focus2.html Pitts, Peter. 2005. “21st Century Health Care Terrorism:
The Perils of International Drug Counterfeiting.”
DiMasi, J. Et al. 2002. “Returns on Research and www.pacificresearch.org/pub/sab/health/2005/21st_Cen
Development for 1990s New Drug Introduction.” tury_Counterfeiting_Report.pdf
Pharmacoeconomics 20: suppl.3, 11-29.
Roche. 2007. “Getting Prescription Tamiflu: Counterfeit
Demerjian, Dave. 2006. “Never Lose Luggage Again.” Information."
http://www.wired.com/science/discoveries/news/2006/11 http://www.tamiflu.com/getting/counterfeit.aspx
/72181
Shepherd, Marv. 2004. “Counterfeit Drugs and the
FDA. 2005. “Radiofrequency Identification Technology: Pharmacist’s Responsibility.”
Protecting the Drug Supply.” www.thecesolution.com/ce/lessons/AZ_Counterfeit_Dru
http://www.fda.gov/fdac/features/2005/205_rfid.html gs_120104/images/AZ%20Counterfeit.pdf
FDA. 2004. “FDA Announces New Initiative to Protect SupplyScape. 2006. “SupplyScape E-Pedigree.”
the U.S. Drug Supply Through the Use of http://www.supplyscape.com/documents/SupplyScape_
Radiofrequency Identification EPedigreeDatasheet.pdf
Technology”http://www.fda.gov/bbs/topics/news/2004/
NEW01133.html U.S. Immigration and Customs Enforcement. 2006. “ICE
Efforts to Combat Counterfeit Pharmaceuticals.”
Genentech. 2001. “Product Update- Nutorpin AQ.” http://www.ice.gov/pi/news/factsheets/counterfeit_phar
http://www.gene.com/gene/products/information/oppor ms.htm
tunistic/nutropin-aq/update.jsp
Weinberg, Cari. 2007. “Nanotechnology Fingerprints Can
Gilchrist, Sue and Macpherson, Helen. 2005. “Update on Certify Authenticity.”
Recent Development in the Pharmaceutical Industry.” http://www.aip.org/dbis/stories/2007/17021.html
http://www.freehills.com.au/publications/publications_52
20.asp WHO (World Health Organization). 2007. “Frequently
Asked Questions- What are the Different Types of
HHS Task Force On Drug Importation. 2004. “Report on Counterfeit Drug Reported.”
Prescription Drug Importation.”
www.hhs.gov/importtaskforce/Report1220.pdf http://www.who.int/medicines/services/counterfeit/faqs/
15/en/index.html
Kelley, Brenda. 2004. “Securing the Drug Supply from
WHO (World Health Organization). 2006. “Fact Sheet
Counterfeiting Protects Brand Profits.”
No. 275-Counterfeit Medicines.”
www.supplyscape.com/.../Securing_Drug_Supply_from_
www.who.int/mediacentre/factsheets/fs275/en/
Counterfeiting_Protects_Brand_Profits_PMPS_Winter04.
pdf Yankus, Wyatt. 2006. “Counterfeit Drugs: Coming to a
Kodak. 2007. “Kodak Security Solutions Overview- Pharmacy Near You.”
Traceless®.” www.fip.org/files/fip/counterfeit/counterfeits0608-
http://www.graphics1.kodak.com/documents/Traceless%
ACSH.pdf
20Pharmaceutical%20Anticounterfeiting%20Presentatio
n.pdf
Lamb, Ed. 2007. “Top 200 Prescriptions of 2006.”
http://www.pharmacytimes.com/Article.cfm?Menu=1&ID=
4629
7

8. About CSC’s Life Sciences R&D Solutions Enterprise Technology Integration (ETI) — Our ETI
Our solutions span the entire range of drug Practice focuses on business systems strategy — we
development, from basic research at the cellular and align the business system strategy to Business and
molecular levels to human clinical trials of potential organizational strategies to ensure that technology is
medicines that prevent and cure disease. CSC’s Life not implemented for the sake of technology; rather, it
Sciences R&D solutions encompass: serves the business strategy set for R&D. Our
solutions focus on:
Strategy and Process Innovation (SPI) — Our SPI
Practice links business and organizational strategies • Enterprise Content Management — We provide
for R&D to deliver process innovation that solutions that help collaborate, control, and
dramatically increases throughput in clinical comply to 21 CFR Part 11 and global regulatory
development. Our proven solutions in this space bodies. Our expertise includes EDMS strategy,
include: migration, optimization, eBLA, eCTD, SPL, and
PIM. Our thought leadership in this space and our
• Adaptive Clinical Trials — We provide consulting
14 years of expertise in this arena help our clients
and industry expertise to reduce dead time
achieve superior results.
between phases. We effectively leverage
modeling and simulation to reduce number of • Clinical Research Data Management — For
patients in trials and help conduct in-silico trials, structured data, our team provides drug
where appropriate — resulting in cost take-out development data management solutions that
and shortened development cycles. are ICH, HL7, and CDISC compliant. These
systems provide a better way to manage data
• Phase I Outsourcing — Through our division,
from labs, CRO’s, and imaging firms and enable
Dynport Vaccine Corp. (DVC), we provide clients
our clients to achieve significant efficiency and
the ability to outsource entire Phase I studies. We
productivity improvements for the R&D
provide the program management, quantitative
organization.
measures to reduce time and costs, and proven
process that enables clients to conduct more
trials effectively. We currently manage 11 such For more information, visit www.csc.com/lifesciences.
trials.
CSC
• In-Licensing — We implement strategies and Life Sciences Practice
cutting-edge solutions to help pharmaceuticals 1160 West Swedesford Road, Suite 200
and biotechs take full advantage of in-licensing Berwyn, Pennsylvania 19312
to augment their pipelines. Our structured Unites States
solutions ensure that no licensing opportunity is
left unnoticed, and potential blockbuster
opportunities are not given away to competition.
• Bioinformatics Partnership — With the rise of
commercial genomics, companies need to
differentiate themselves from competition by
efficiently managing biostatistics analytics and
bioinformatics. CSC’s Life Sciences Practice
serves as a strategic services partner to the client
and provides standards driven bioinformatics
solutions both through our U.S. and Indian
operations and our strategic alliances with key
partners.
• Anti-counterfeiting Solutions — We leverage our
expertise in defense, consumer products, and
supply chain to deliver novel solutions for solving
the expensive and ever-increasing drug
counterfeiting issues. Our strategy and solutions
go beyond the traditional RFID based solutions
and provide quantifiable ROI.
8

9. About the Authors
Sanjay Modi
CSC Life Sciences
+1.973.243.0023
smodi@csc.com
Sanjay Modi works in CSC Life Sciences R&D
Solutions and is based in New York City. He holds a
MBA from The University of Maryland and a
Bachelor’s of Arts degree in Biology from The
University of Delaware.
Sanjeev Wadhwa
CSC Life Sciences
+1.973.243.0023
swadhwa@csc.com
Sanjeev Wadhwa is a partner and senior strategy
expert within CSC Life Sciences R&D Solutions.
9

10. CSC
266 Second Avenue
Waltham, Massachusetts 02451
United States
+1.800.272.0018
Worldwide CSC Headquarters
The Americas
3170 Fairview Park Drive
Falls Church, Virginia 22042
United States
+1.703.876.1000
Europe, Middle East, Africa
Royal Pavilion
Wellesley Road
Aldershot, Hampshire GU11 1PZ
United Kingdom
+44(0)1252.534000
Australia
26 Talavera Road
Macquarie Park, NSW 2113
Australia
+61(0)29034.3000
Asia
139 Cecil Street
#08-00 Cecil House
Singapore 069539
Republic of Singapore
+65.6221.9095
About CSC
The mission of CSC is to be a global leader in providing
technology enabled business solutions and services.
With the broadest range of capabilities, CSC offers clients
the solutions they need to manage complexity, focus on
core businesses, collaborate with partners and clients,
and improve operations.
CSC makes a special point of understanding its clients and
provides experts with real-world experience to work with
them. CSC is vendor-independent, delivering solutions that
best meet each client’s unique requirements.
For more than 45 years, clients in industries and governments
worldwide have trusted CSC with their business process and
information systems outsourcing, systems integration and
consulting needs.
The company trades on the New York Stock Exchange under
the symbol “CSC.”
Copyright © 2008 Computer Sciences Corporation. All rights reserved.
DS08_0528