Multiple Strategies and Technologies to Combat Counterfeit Drugs
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Multiple Strategies and Technologies to Combat Counterfeit Drugs Multiple Strategies and Technologies to Combat Counterfeit Drugs Document Transcript

  • MULTIPLE STRATEGIES AND TECHNOLOGIES TO COMBAT COUNTERFEIT DRUGS Authors: Sanjay Modi and Sanjeev WadhwaAn anti-counterfeiting The U.S. Food and Drug Administration (FDA) has seen a rise ofstrategy 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). Thecounterfeit products, market for counterfeit drug is approximately $40 billion (WHO, 2006).increase audit compliance, According to the Center for Medicines in the Public Interest, counterfeitand enhance supply chain drug sales globally will reach $75 billion by 2010. This represents anmanagement capabilities. increase of 90 percent from 2005 (WHO, 2006) and will represent 14This strategy can identify percent of the total drug market (Pitts, 2005). Furthermore, it isthe 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 isvia Radio Frequency counterfeit (Morris, 2006). The largest producers of these drugs areIdentification 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 isand other capable harmful to the patient. These products may not cure the targetedsolutions to combat diseases and could possibly even kill patients. Also, they affect thecounterfeiting of drug profits of the companies which manufacture the drugs. Pharmaceuticalproducts. One item alone companies invest large amounts of resources to create drugs. Theywill not protect the spend up to 12 years and $1.2 billion on clinical development for drugscompanies from counter- (Archarya, 2006). However, only 30 percent of drugs which arefeit drugs, but one with a approved and marketed produce revenues that match or exceed initialmulti-level approach will costs (DiMasi, 2002). Therefore, any counterfeit drugs sold as legitimatelead to safeguarding the drugs reduce the companies’ revenues and lead to lower profits.supply chain, preventerosion of the brand There are five different types of counterfeit mechanisms in which drugsimage, and increase are manufactured or distributed without proper regulatory approval andrevenues. This will result do not meet the determined standards of safety, quality, and efficacyin decreasing the number (WHO, 2007):of counterfeit products in • No active ingredient (43 percent)the marketplace andimproving 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
  • other drugs such as anti-cancer and anti-virals might Therefore, counterfeit drugs are passed as real drugsbe 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 ticCounterfeit drugs can be diverted and sold from 1 1. Logo backgroundvarious channels within the drug distribution system 2 LO G O LOG O colordue to its complexity. There is no enforced 2. Logo font not bolded 3. Colored protectivegovernment mandate to track the drugs efficiently 3 Logo Logo packaging on rim on top of bottlewithin the system which allows for openings for 4. Border typecounterfeiters throughout the system. Drugs can be 5. Font size 4 6. Border sizediverted from their original purpose and sold outside D ru g D ru g 7. Pill size and shapethe regulated distributed channels. For example, free 5 N am e 8. Name of pill varies N am esamples to doctors may be sold illegally within the 50m g 6 50m g Can you tell the difference if one of the above itemssystem. Patients may, in turn, sell their prescription were changed?drugs for a profit. Also, drugs sold for lower prices invarious countries can be sold to other markets where 7 D P5the price is higher. These drugs are not regulated 8through safeguards as they are sold outside thenormal distribution channels Figure 1: Difference between Counterfeit and Authentic DrugsThe 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 thehas yet to be fully implemented throughout the authentic products incur large losses of revenue. Thisindustry and supply chain due to the high record- decreases sales and profit margins due to otherkeeping effort needed to maintain this type of unauthenticated “substitute” products that peoplesystem. Incomplete paper pedigrees lead to are buying in place of the authenticated drugincreasing the risk of counterfeit drugs in the product. Large inventory losses and write-offs aremarketplace as the ingredients or products are not placed on the balance sheets due to routing leakagestracked within the supply chain. On the other hand, and medicines which were not purchased legally. Ascomplete paper pedigrees help validate the noted earlier, these drugs threaten patient safetyauthenticity of the drug but counterfeiters are finding leading to possible deaths. There are audit andways around this paper-based process. For example, regulatory compliance issues with counterfeit drugsillegitimate 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 isas valid. An increasing trend is to use tools and complicated due to higher inventory carryoverprocesses to copy drug labels and packages. This leading to increased costs. The supply chain issuesmakes it difficult to identify the real drug from the push for an efficient and reliable tracking mechanismfake copy due to the striking similarities between the which has yet to be mandated by the industry ortwo. Repackaging is another way to bring expired or regulators due to high initial costs and lack ofcompromised drugs into the distribution system and industry standards.mix them with genuine drugs. Finally, the lack oftamper-evident packaging allows the original Anti-Counterfeit Strategiespackaging 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 managementThe differences between counterfeit and authentic capabilities. This strategy can identify the multipledrugs can be difficult to detect unless one looks best-fit solutions for meeting a company’sclosely at the bottle or packaging. These can be requirements via Radio Frequency Identificationminor changes in the product container, label, or the Devices (RFID), ePedigrees, label security, dosageindividual pill that can be hard to visually detect by unit level security, nanotechnology, and other capablethe 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 fromunless someone knows how they are packaged by the counterfeit drugs, but one with a multi-level approachmanufacturer (Palmer, 2004; Genentech, 2001). | Multiple Strategies and Technologies to Combat Counterfeit Drugs | 2
  • will lead to safeguarding the supply chain, prevent training for the end-users. A study by A.T. Kearneyerosion of the brand image, and increase revenues. believes implementation of a RFID system for aThis will result in decreasing the number of manufacturer with $10 billion in prescription sales willcounterfeit products in the marketplace and receive annual benefits of $20 – $55 million with theimproving patient safety and enhancing product system excluding initial and recurring costs. A largeauthenticity and identification. It also meets the distributor with $40 billion in prescription productnecessary increased audit compliance by reducing sales will have an annual benefit of $12 – $24 millionthe 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 onincreased 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 toto patients. This enables the drug manufacturer to implement RFID tags on one of its anti-HIV drugscapture higher revenues for legitimate drugs in the within the next 18 months. Furthermore, Purduemarketplace. Pharma utilized RFID tags on Oxycotin® bottles toRFID better track and authenticate the medications (FDA,New trends in the industry are creating unique 2004). RFID tags can be embedded into the label ofopportunities within the anti-counterfeiting market. the medicine bottle or within the blister pack toThe FDA has also recommended that pharmaceuticalcompanies start using RFID as a means of bettertracking drugs. These are radio transmitters that can RFIDbe attached to drug packages, medicine bottles, or XYZ Pharma RFIDactive ingredient containers and scanned to emit an D ru g RFID N am eelectronic product code. Individual packages of drugs 50m g XYZor their respective ingredients can be monitored Pharmathroughout the supply chain from manufacturers todistributors and wholesalers to pharmacies (Wyatt, A. Cartons of B. RFID Tag C. Blister Pack Drugs Medicine Bottle2006). As a result of enhanced inventorymanagement practices, RFID can decrease revenuelosses as a result of stock-outs and drug expirationsand create cost savings of $2 billion worldwide(Paddison, 2005).One major obstacle for RFID tags is the costsassociated with the system. As RFID tags becomemore of a commodity, the prices for tags and readerswill be significantly lower and lead to more cost 1 2 3savings. Each passive tag costs $0.25 – $1.00 while Scanner Computer Serverthe 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 inType Total Annual Ongoing Total Costs One-time Annual Benefits Intangible Benefits One-time prescription Initially Long-term product salesLarge Not $20 – $55 $20 – $55 1. Protect Overall $15 – $20 $20 – $40 $8 – $16 $35 – $60 $23 – $36Manufacturer significant Supply Chain • Large Distributor —$ 10 bilion in 2. Prevent Stolenprescription and Lost Products $40 billion inproduct sales prescriptionLarge $2 – $4 $10 – $20 $12 – $24 3. Decrease Recovery $9 – $20 $3 – $4 $3 – $4 $12 – $24 $12 – $24Distributor product sales Costs of Lost or$ 40 billion in Recalled Products Source: Paddison, 2005prescription 4. Protect Brandproduct sales LoyaltyFigure 2: Cost and Benefits for RFID Implementations | Multiple Strategies and Technologies to Combat Counterfeit Drugs | 3
  • prevent easy removal. This is very similar to airline This will provide information on the “chain ofinitiatives to utilize RFID tags rather than traditional custody” of the drug and decrease counterfeit drugsbarcodes to track the baggage location in real-time. in the supply chain. As the drug flows through theThe tags have a read rate of 99 percent, whereas bar supply chain from manufacturer to wholesaler(s) tocodes 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’sunreadable bar codes. This also decreases the time information is verified and documented during eachand costs in getting the bags to the customers. The step within a secure environment. Therefore, acurrent cost for bag retrieval is estimated to be $2.5 product’s path is followed in real-time via the portalbillion a year by The International Air Transport to ensure it is coming into the system from a validAssociation (Demerjian, 2005). source. A new data management infrastructure to store and share the data has to be implementedePedigrees within the company. A few vendors are alreadyAnother development is the focus on ePedigrees to providing services for the new system in order tocreate a more efficient supply chain in a secure easily transition into this environment.environment. The PDMA states that pedigrees arerequired for all non-Authorized Distributor of Record The ePedigree shows detailed real-time informationwholesale distributions (SupplyScape, 2006). In regarding the product and its distribution within the2006, 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 PharmacyFigure 4: ePedigree System Tracks Real-Time DrugInformation from Manufacturer to Pharmacymillion medicine bottles and blister packs. Incomparison, the number of prescriptions dispensed in2006 was 3.7 billion (Lamb, 2007). As drug D ru g Drshipments arrive within the various elements of the N am e u Na g Logosupply chain, ePedigrees are matched and signed to 50m g 50 m e m Lo gconfirm and validate the authenticity of the drugs. Logo goSoftware programs show the detailed information ofthe validated drugs within the supply chain and their Logospecific location at various time periods. ePedigreewill be utilized within all steps of the supply chain Figure 5: Color Shifting Logo — Changing the Viewingfrom manufacturer to retailer and customer. Angle Shifts the Color | Multiple Strategies and Technologies to Combat Counterfeit Drugs | 4
  • are currently utilized in safeguarding the U.S. the packaging. For the highest level of security, thecurrency. The currency utilizes multiple safeguards markers can be added to the individual pills in orderwhich makes it difficult, time-intensive, and costly for to identify if the drug is counterfeit. The markers arecounterfeiters. It utilizes a dual color-shifting ink, odorless, tasteless, and approved for humanwatermark, security thread within the paper, and new consumption. A quick test kit, similar to a pregnancysymbols on the bill. In 2004, the pharmaceutical test, can be performed in the field to determine thecompanies 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 thecounterfeits can be easily recognized by members liquid. If the specified marker is in the pill, the stripdownstream within the supply (Palmer, 2004). Others turns a specific color (Weinberg, 2007). Also, Kodak’sare experimenting with using inks or dyes and some Traceless® technology incorporates an odorless andare already using tamper-resistant packaging tape on colorless powder within the medicine packaging labelsome of their products. Also, there is a change to or within the drug ingredients. The package is read inraised printing in which letters are raised above the real-time with a patented handheld reader topaper for easy inspection and detection for authenticate the drugs. For medicine packagingcounterfeits. labels, this method works with conventional printing methods and can be utilized during theCovert Strategies manufacturing process (Kodak, 2007).Companies are also shifting to covert strategieswhich utilize special devices to authenticate the Benefitsdrugs. Authentix utilizes a new method incorporating Pharmaceutical companies are more concerned aboutnanotechnology markers (50 nM to 5000 nM in size) brand image and reputation these days than everwhich are mixed into the drug packaging and before. This is one of the key reasons to protect theindividual 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 liabilityThese markers have spectral properties that “light up” suits which can cost the company millions and billionswhen 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 recallA. 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, desiredB. 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 andFigure 6: Nanotechnology Markers Emit Light at Specific ePedigrees. The next step is to protect the medicineWavelengths 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
  • 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 Costsincreasing safeguards such as raised fonts, color- All of these items will lead to better-guarded supplyshifting inks and logos, holograms, and watermarks chain and costs savings. This will result in decreasingso they can’t be reproduced by other sources. The the number of counterfeit products in thefinal step utilizes covert technologies to protect the marketplace, improving patient safety, and enhancingindividual pills, medicine bottles, and blister packs by product authenticity. It also meets the necessaryincorporating nanotechnology markers and patented increased audit and regulatory compliance byink markers and readers for authentication. By using reducing the supply chain issues. Therefore, thismultiple safeguards into a specific product, it makes complementing strategy based on client’s needsit expensive and time-consuming for the leads to an increased bottom-line by effectivelycounterfeiters. Furthermore, higher risk geographic locating its products within the supply chain fromareas for counterfeit drugs require enhanced security manufacturer to patient and reducing leakage duringlevels and increased layers of protection in order to the routing process. This enables the drugprotect 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
  • References McCarthy, Joe. 2006. “The Practicalities, Perils, andAcharya, 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.pdfPharmalicensing. Morris, Julian and Steven Philips. 2006. “Counterfeithttp://pharmalicensing.com/features/disp/1153412098_4 Medicines in Less Developed Countries.”4bfac02291f1 www.fightingdiseases.org/pdf/IPN_Counterfeits.pdfBernstein, 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.pdfCredit Union National Association. 2007. “New Money’sComing.” 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_imporchain with ePedigrees.” tation/mn_pharmacist_viagra.jsphttp://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_CenDevelopment for 1990s New Drug Introduction.” tury_Counterfeiting_Report.pdfPharmacoeconomics 20: suppl.3, 11-29. Roche. 2007. “Getting Prescription Tamiflu: CounterfeitDemerjian, 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 theFDA. 2005. “Radiofrequency Identification Technology: Pharmacist’s Responsibility.”Protecting the Drug Supply.” www.thecesolution.com/ce/lessons/AZ_Counterfeit_Druhttp://www.fda.gov/fdac/features/2005/205_rfid.html gs_120104/images/AZ%20Counterfeit.pdfFDA. 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.pdfTechnology”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_pharhttp://www.gene.com/gene/products/information/oppor ms.htmtunistic/nutropin-aq/update.jsp Weinberg, Cari. 2007. “Nanotechnology Fingerprints CanGilchrist, Sue and Macpherson, Helen. 2005. “Update on Certify Authenticity.”Recent Development in the Pharmaceutical Industry.” http://www.aip.org/dbis/stories/2007/17021.htmlhttp://www.freehills.com.au/publications/publications_5220.asp WHO (World Health Organization). 2007. “Frequently Asked Questions- What are the Different Types ofHHS 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.htmlKelley, Brenda. 2004. “Securing the Drug Supply from WHO (World Health Organization). 2006. “Fact SheetCounterfeiting 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 aKodak. 2007. “Kodak Security Solutions Overview- Pharmacy Near You.”Traceless®.” www.fip.org/files/fip/counterfeit/counterfeits0608-http://www.graphics1.kodak.com/documents/Traceless% ACSH.pdf20Pharmaceutical%20Anticounterfeiting%20Presentation.pdfLamb, Ed. 2007. “Top 200 Prescriptions of 2006.”http://www.pharmacytimes.com/Article.cfm?Menu=1&ID=4629 7
  • About CSC’s Life Sciences R&D Solutions Enterprise Technology Integration (ETI) — Our ETIOur solutions span the entire range of drug Practice focuses on business systems strategy — wedevelopment, from basic research at the cellular and align the business system strategy to Business andmolecular levels to human clinical trials of potential organizational strategies to ensure that technology ismedicines that prevent and cure disease. CSC’s Life not implemented for the sake of technology; rather, itSciences R&D solutions encompass: serves the business strategy set for R&D. Our solutions focus on:Strategy and Process Innovation (SPI) — Our SPIPractice links business and organizational strategies • Enterprise Content Management — We providefor R&D to deliver process innovation that solutions that help collaborate, control, anddramatically increases throughput in clinical comply to 21 CFR Part 11 and global regulatorydevelopment. 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
  • About the AuthorsSanjay ModiCSC Life Sciences+1.973.243.0023smodi@csc.comSanjay Modi works in CSC Life Sciences R&DSolutions and is based in New York City. He holds aMBA from The University of Maryland and aBachelor’s of Arts degree in Biology from TheUniversity of Delaware.Sanjeev WadhwaCSC Life Sciences+1.973.243.0023swadhwa@csc.comSanjeev Wadhwa is a partner and senior strategyexpert within CSC Life Sciences R&D Solutions. 9
  • CSC266 Second AvenueWaltham, Massachusetts 02451United States+1.800.272.0018Worldwide CSC HeadquartersThe Americas3170 Fairview Park DriveFalls Church, Virginia 22042United States+1.703.876.1000Europe, Middle East, AfricaRoyal PavilionWellesley RoadAldershot, Hampshire GU11 1PZUnited Kingdom+44(0)1252.534000Australia26 Talavera RoadMacquarie Park, NSW 2113Australia+61(0)29034.3000Asia139 Cecil Street#08-00 Cecil HouseSingapore 069539Republic of Singapore+65.6221.9095About CSCThe mission of CSC is to be a global leader in providingtechnology enabled business solutions and services.With the broadest range of capabilities, CSC offers clientsthe solutions they need to manage complexity, focus oncore businesses, collaborate with partners and clients,and improve operations.CSC makes a special point of understanding its clients andprovides experts with real-world experience to work withthem. CSC is vendor-independent, delivering solutions thatbest meet each client’s unique requirements.For more than 45 years, clients in industries and governmentsworldwide have trusted CSC with their business process andinformation systems outsourcing, systems integration andconsulting needs.The company trades on the New York Stock Exchange underthe symbol “CSC.”Copyright © 2008 Computer Sciences Corporation. All rights reserved.DS08_0528