THE ADD (ATTENTION DEFICIT DISORDER) EFFECT
                             IN CLINICAL DEVELOPMENT
                         ...
External Drivers
  $U S (M illions)
                                                                         New Data Type...
File NDA at FDA                              File NDA at FDA           transformation and standardization process are
    ...
Clinical Data Exploration/Review
The patient data review process allows the ability to
look at data across all the trials ...
A commitment by management to develop and                                     closer review of a “data concierge” type ent...
conducted with a lower number of central labs which         Other initiatives such as EDC are supported by
deliver data in...
Finance                                                    Conclusion
The annual budget needs to be driven by a strategic ...
Abbreviations
21CFR 11   Title 21 Code of Federal Regulations
CDISC      Clinical Data Interchange Standards
           Co...
References                                              Smith, Laura. 2006. The Six Sigma Cure. Quality
Acharya, Satish. 2...
About CSC’s Life Sciences R&D Solutions                     Enterprise Technology Integration (ETI) — Our ETI
Our solution...
About the Authors
Sanjay Modi
CSC Life Sciences
+1.973.243.0023
smodi@csc.com
Sanjay Modi works in CSC Life Sciences R&D
S...
CSC

266 Second Avenue
Waltham, Massachusetts 02451
United States
+1.800.272.0018

Worldwide CSC Headquarters

The America...
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The ADD Effect In Clinical Development

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The ADD Effect In Clinical Development

  1. 1. THE ADD (ATTENTION DEFICIT DISORDER) EFFECT IN CLINICAL DEVELOPMENT Authors: Sanjeev Wadhwa and Sanjay Modi • The Tufts Center for Establishing the Strategic Framework for Clinical the Study of Drug Development suggests Information Management: A Holistic Look Through that the R&D pipeline the Lens of a Future Operating Model might be rebounding as the leading U.S. Industry Trends drug companies have Clinical development is a complex process for pharmaceutical companies increased their clinical which bear a high cost to reap the final rewards of potentially billions of trials numbers by dollars after FDA approval. The process can take up to 12 years and greater than 50 requires a great deal of communication and coordination. Clinical data percent has to be properly collected, managed and reviewed in order to obtain full value of the results. The current industry is facing numerous • Frost and Sullivan challenges such as increased number of generics due to patent estimates that the expiration, limited late-stage pipeline drugs, lawsuits, payer influence and global pharmaceutical increased government regulation which lead to decreased profits. It R&D outsourcing needs to find ways to reduce costs in order to be more efficient. market will grow to $24.9 billion by 2007 • Total global spending on clinical development (Phases I-IV) is about 34 percent of total R&D costs • Only three out of every 10 marketed drugs produce revenues that match or exceed initial costs $3,000 $2,722 $2,500 (Millions of 2000 Dollars) After-Tax Present Value $2,000 $1,500 $1,015 $1,000 $629 $433 A fter T ax R & D C o sts $500 $235 $126 $56 $30 $9 $0 $0 1 2 3 4 5 6 7 8 9 10 New Rx Drugs Introduced Between 1990 and 1994 Grouped by Decile According to Sales Figure 1: Source: H. Gabrowski, J. Vernon, and J. DiMilasi, “Returns on Research and Development for 1990s New Drug Introduction,” Pharmacoeconomics 20 (December 2002): suppl. 3, 11 – 29 | The ADD Effect in Clinical Development | 1
  2. 2. External Drivers $U S (M illions) New Data Types $1,200 • ClinPharm, M&S, Genomics and Proteomics Evolution of Industry Standards $900 • Data Standardization – XML, HL7 and RIM $600 – Global Library Standards – CRF templates $300 – Medical versus FDA and ICH Analysis needs $0 Strategy Partnering 1991 1997 1999 2003 2004 • Outsourcing Source: Arcarya, 2006. Pharmalicensing • Data sharing Figure 2: Escalating R&D Costs: Cost of Developing an NME • Data Aggregators Regulatory and Ethical Requirements for Safety and • Rising costs of NME development (2006) Post-Marketing • The Tufts Center for the Study of Drug • Document submission Development suggests that the R&D pipeline – CDISC versus Generic Data Model might be rebounding as the leading U.S. drug • Adverse event signal generation and coding companies have increased their clinical trials numbers by greater than 50 percent Federal Information Technology Impact • Health Information Technology Impact • Frost and Sullivan estimates that the global pharmaceutical R&D outsourcing market will – Pay for Performance grow to $24.9 billion by 2007 – Evidence Based Medicine • The Tufts Center for the Study of Drug – E-Prescribing Development suggests that the R&D pipeline – Electronic Health Records might be rebounding as the leading U.S. drug Long-term benefits of these drivers will lead to an companies have increased their clinical trials acceleration of the drug development process and a numbers by greater than 50 percent development of an integration framework to closely • Frost and Sullivan estimates that the global monitor clinical data. pharmaceutical R&D outsourcing market will grow to $24.9 billion by 2007 Key Accelerators Clinical Data Capture Clinical Study Management Challenges EDC is evolving into a standard in the drug Internal Drivers development process to electronically capture clinical Streamlining Internal Processes data and support large trials. EDC techniques can • Increase clinical development operating cause a 25 percent reduction in the effort compared efficiencies to paper based trials along with reducing labor costs. • Corporate mandate to decrease costs One advantage of EDC allows companies to make • Need for retrospective and prospective metrics drug safety decisions during earlier stages of development with current information. The Massive Data Analytical Burden technology also incorporates lab data processing, • Variant data capture techniques to move data performs multivariate checks across different CRFs capture closer to the patient — EDC, CDMS, for proper data identification, and handles batch e-Sourcing, etc. validation updates and adverse event coding needs. • Data definition for internal and external use These capabilities permit on-line solutions with data • Data transformation entry capability with various entry points and data exchange with remote clinical trial sites. Application Portfolio Diversity/Legacy • Enhance business agility • Increase application re-usability | The ADD Effect in Clinical Development | 2
  3. 3. File NDA at FDA File NDA at FDA transformation and standardization process are important factors, especially within a multi-user Pre-clinical environment and for data sharing with external Phase I Phase II Phase III FDA Phase IV Testing partners. Strategy Clinical Clinical Clinical Submission SAE Another key factor for accelerating clinical Planning Data Data Data Preparation, Handling • Clinical Capture Management Review Review and development is data standardization so translation of R&D Approval information is well defined. If this is not implemented, • HIT this could lead to variability downstream and result in Involves applications and individuals from many groups errors in data analysis. CRF design and templates are and demands a high-level of communication and coordination. essential to minimize different versions of the same form increasing variability. A knowledge management Figure 3: Clinical Study Management Value Chain system could be implemented to leverage previous CRF templates resulting in fewer resources and decreased time commitments to “reinvent the wheel.” Industry experts estimate full implementation of EDC Data standards need to be driven by requestors such in the next 12 to 24 months with lower barriers and as the FDA and the needs of the organization such as more offerings. The larger pharmaceutical companies medical analysis by implementing a CDISC model for have goals for implementation of EDC and to go 75 collecting, storing and processing the data from to 80 percent paperless in the next 12 to 18 months the trials. (Brooks, 2006). CDISC.org recognizes the importance of data Merck Capital Ventures and SAIC reports that standards for the submission and review process for Novartis utilizes EDC in 60 percent of Phase I trials the FDA. It has worked with the FDA and Eli Lilly for and almost 100 percent of Phase II and III trials. This an analysis of mock submissions in order to create a has led to a reduction in contractors for data working prototype for the submission of electronic management from 90 to 20. There is also a decrease data that meets the needs of the FDA reviewers. The in the number of queries to four per 1,000 data end result will be faster review times by the FDA and points versus 51 per 1000 when there were paper- a decrease in costs by companies. In addition it will based trials. The costs associated with the new help regulatory agencies identify drug interactions. system are dramatically lower. The cost per page Proper analysis of the data is a key factor in Clinical goes from $23 to $4.60 when shifting from paper to Data Intelligence. An established data repository with EDC. In addition, the time needed for database lock proper maintenance supports large trials and data went from 10 weeks to 4 days with EDC. The annual processing. Standard information is utilized in savings is in excess of $100 million (Roner, 2006). downstream analysis and transformations in order Another way EDC processes are evolving is with the to input additional data. The data can also be introduction of e-sourcing. Data capture at the leveraged in modeling and simulation for bio- patient’s bedside results in more accurate capturing statistical analysis. CDISC Compliant Repository is not of patient information. Paper writing by the staff and only a submission repository but also a clinical data then transcription is no longer necessary. This results management repository which can be further utilized in less medical and prescription errors along with for additional analysis. better medical care management by increasing With multiple investigator sites, clinical trial patient safety. management consists of having the ability to also Clinical Data Management manage and track these studies at the various Once all the data is collected utilizing the latest locations. The clinical trial information should be methods, it has to be properly managed in order to shared and recorded. Any additional administrative create value in the process. With multiple and even information should be relayed to the users relatively global locations, real-time technology should be quickly so delays will not occur in the development implemented for capturing any changes at any given process. Therefore it should be feasible for global time. The ability to merge data from different scheduling and coordination and protected with databases and adapt to new versions are necessary security features to make it compliant with the as well. Defining and streamlining the data current rules and regulations. | The ADD Effect in Clinical Development | 3
  4. 4. Clinical Data Exploration/Review The patient data review process allows the ability to look at data across all the trials implemented by the ie s e company. This is enhanced by a strong graphical nc ar Care Providers ge lthc report feature to visually see a layered view of all Pu (Public Sector/ y A ea patient data across the trial timeline. If there are bl or t H Commercial) ic safety issues, then proper design implementation will la t e n He gu m al result in safety signal detection when reviewing the Re vern th Ag data. An adverse drug event system can collect, Patients Go en assess and report this event. This system will be able ci es to identify minor and major events to implement the Pharmaceutical/ Payors proper steps. Medical Product Manufacturers With data standardization, there will be ability for batch processing functionality resulting efficiency in reviewing data for specific endpoints. The data Information Technology should also be ready for submission to the FDA via PDF and be 21CFR 11 compliant for proper quality Figure 4 controls. It should be easily searchable, be dynamic, and have the ability to create, track and accept responses from queries sent to the clinical manager Strategic Framework for Clinical for review. Proper EDC/CDM system implementation Information Management can reduce Discrepancy Management as an issue to Due to the high costs of Research and Development, make sure all necessary information has been entered companies must execute new strategies for efficient so more accurate results are obtained from the data. clinical information management to drive operating This also results in less time and costs when efficiency and meet future R&D and regulatory reviewing the data. requirements. These new changes lead to a more strategic framework for planning and decision making The increase use of HIT enables the improvement of along with an emphasis on organizational change quality, safety and cost-effectiveness of healthcare. It management. There needs to be a focus towards the optimizes the clinical study design by allowing development of a vision and strategy which researchers to analyze the clinical records of a emphasizes a strategic roadmap leading to a long- population and evaluate protocol designs before term sustainable advantage. engaging the resources and costs into a clinical program. There will faster recruitment of patients as the sponsor can access eligible patients directly. Culture Controlled product launches will allow companies and regulators to push the drug to market faster as trial Vision and Strategy patients are monitored more effectively. The adaptation of evidence-based medicine guidelines Governance factors real-world outcomes and costs while health Process management models better gauge health risks and diseases within the healthcare network. Also, Relationships performance-based contracts can be tracked to tie reimbursement to outcomes and cost of care. Finally, Organization/People/Skillsets personal health records can allow patients to make knowledgeable healthcare decisions, mange their Applications and Technology health, and enroll in studies. Finance Location Analysis Framework for Future Operating Model Figure 5: Analysis Framework for Future Operating Model | The ADD Effect in Clinical Development | 4
  5. 5. A commitment by management to develop and closer review of a “data concierge” type enterprise- execute a holistic, top-down, process-oriented wide governance mechanism for management and strategy is essential for success in the competitive enforcement of data standardization, delivery and landscape. This will result in accelerating clinical drug handling will lead to a decrease in silo-ed operational development while lowering research and modality. Functional silos have limited information development costs and faster revenue generation. sharing and communication available to discuss any business issues that overlap other departments. This $U S (M illions) view of decision-making results in a system which is supported by diverse, inefficient and fragmented metrics. The lack of cross-functional data 1000 C o st C u rve requirements definition process does not allow 800 proper leveraging of good practices among its 600 affiliates and partners. This results in an inability to 400 support the changes necessary to address strategic 200 R e ve n u e C u rve influences and opportunities. An appropriate cross- functional governance mechanism for strategic I II III IV architecture framework development and P h ases C ost C urv e C h a n g e maintenance should drive operational efficiency. R ev e n u e C urve C h a n g e Process C h an g e s in R e ven u e an d C o st C u rve D u e to D ru g D e ve lo p m en t A c c e leratio n Unclear process definitions and complex data loading processes can lead to inefficiencies in the clinical Figure 6: Changes in Revenue and Cost Curve Due to Drug development process. A global process alignment Development Acceleration based on core competencies can lead to a focus on process ownership rather than a system ownership. Vision and Strategy This can define data flow processes to address the One of the first stages of a strategic framework future needs of modeling and simulation, medical involves the development of a top-down, process- analysis, and biostatistics data needs. New decision centric vision and strategy which leads to a roadmap criteria can be incorporated on new trials and a sustained movement towards a Plan, Build and implementing patient bedside EDC as part of a Operate Model. This requires process-based scalable implementation plan. A technology organizational alignment and change management. A evaluation and selection process is required to migration toward architectural simplification and a manage introduction and retirement of applications. data integration framework will streamline data In order to streamline the process, an initial step is to processing and discrepancy management resulting in consolidate the application portfolio into a few application consolidation. strategic applications and implement a generic, A strategic plan is necessary for future data flexible data processor for external partner data management in which the development of an overall transformation needs. Furthermore, quality checking information management strategy will meet future of data in data loading processes is required to needs, along with a three- to five-year roadmap will ensure lesser number of discrepancies downstream. create an advantageous long-term strategy. Another Conducting an on-going analysis of the process for key factor is the examination of the industry and data review should eliminate organizational, process government initiatives to determine how these will and data repository redundancies. A continuous affect the industry and the steps needed to remain evaluation of impact from strategic influencers, competitive. leveraging new trends and examination of the entire value chain for clinical data management will lead to Governance an efficient processing system. Companies lack an enterprise-wide governance mechanism for the management and enforcement of Relationships its initiatives. A necessary step is to determine an Expanding beyond an external partnership that is appropriate cross-functional decision-making transactional in nature to one that is a strategic authority for strategic roadmap approval, execution partnership can enhance the clinical information and oversight. This involves incorporating management process. Key competencies can be development towards a strategic architecture with enhanced by leveraging strategic partners. For enterprise-wide data handling and standardization. A example, the lab data management process can be | The ADD Effect in Clinical Development | 5
  6. 6. conducted with a lower number of central labs which Other initiatives such as EDC are supported by deliver data in one format. A critical review of lab reallocation of existing workers. An examination of partnerships and CRO contracts is essential in the data custodianship will lead to process ownership process in order to get the data transformed into rather than system ownership. Finally, an evaluation is usable data. necessary to evaluate core competencies to decide which ones will be kept in-house. This assessment will In addition, knowledge from other partners and determine its culture and organizational readiness for affiliates can be beneficial as a learning tool. Also, strategic change. there should be a determination whether it is advantageous to promote an external vendor’s EDC Applications and Technology product strategy and development. An external Another part of the operating framework is the vendor’s strategy might not meet the strategic focus incorporation of data standardization utilizing new of the company. Another benefit of relationships is applications and technology. All incoming data can the alignment of internal capability building plans to be set to use XML and these standards can be external opportunities by participating in external established depending on the analysis needs. There industry and government initiatives (NAHIT). has to be an enforcement of global standards and increased knowledge and utilization of CRF templates CROs can decrease costs and increase savings which which would alleviate the problem of CRF disparity can be utilized for strategic initiatives by the and non-standardization. The consolidation of several company. Companies can concentrate their resources functionality-aligned tools into fewer, enterprise-wide toward core competencies to create a competitive data review tools for data searching, discrepancy advantage while outsourcing their non-core skills. management, and patient data review would create This can lead to dramatic cost savings along with sharable and scalable solutions with less human access to expertise-level staff leading to productivity interface. A business process management layer gains and process improvements. A recent study by could decouple workflows from data storage and Tufts Center for the Study of Drug Development integration layers. shows the increasing reliance on CROs by drug companies. CROs offer an advantage to companies Implementation of role-based access to decision- while providing new insight who do not have recent making information allows the designated users to experience in a specific therapeutic area. They help look at all trial data and safety signaling. If there is reduce R&D costs and utilize the rise in global ambiguity in documentation outlining end-to-end capacity needs. The study states that companies that process/architectural relationships and impacts, there extensively use CROs result in completing projects needs to be a development of technical faster during study close-out period while realizing documentation writing guidelines. comparable quality to companies that don’t rely on Regarding database options, a single reference CROs. Also, the FDA receives submissions more than database is ideal which can also import converted 30 days earlier than the projected date than those lab data from outsourced study data. This will allow who have low CRO usage. easier access to all clinical data in the system and CROs are involved in 23,000 Phase I – IV trials. In provide standard information to end users for 2004, $5.5 billion of global R&D spending went to analysis. A review of in-house data models could lack clinical CROs. CROs are becoming critical for cost the benefits that a standard CDISC would provide savings for companies to focus on their core such as interoperability between its external partners. competencies (Getz, 2006). An industry standard would allow easier data management and integration needed for managing Organization/People/Skillsets data and satisfy needs for medical review and A movement toward the Plan, Build and Operate planning. Model creates a new strategic “plan” function (through reallocation of existing workers) supporting Furthermore, SaaS can allow users to access data in a strategy toward development and management of real-time with low initial activation costs and enterprise architecture. This will be a separate group resources that avoid the high costs of purchasing and mandate with appropriate budgeting and hardware needed to set up an infrastructure needed funding. Furthermore, there is management of for an application. The timeframe for implementing organizational change through all enterprise-wide systems for clinical trials management is much initiatives. Workers have clearly defined roles and smaller leading to faster access and analysis of data. responsibilities while training and matching of skill set Furthermore, management of the system is pushed to to applications. the vendor so companies can focus on the core skills. | The ADD Effect in Clinical Development | 6
  7. 7. Finance Conclusion The annual budget needs to be driven by a strategic The Research and Development process is a very vision and not just break-even goals and be costly process with limited upside potential weighing accounted for its data management practices. Multi- heavily on a FDA-approved drug. Strategic change year budget planning that is conditional upon and organization of the Clinical Information achieving strategic milestones is clearly understood Management capabilities can lead to operational by workers and should have attainable goals and efficiencies and realized cost savings for endpoints. In order to properly judge the economic Pharmaceutical companies. A Plan, Build and Operate impact of a data transformation system, companies Model created, supported by process-based can conduct financial impact assessments of the non- organizational alignment and change management, is standard data models and measure the costs for a key driver to create a foundational framework for maintaining a set of inefficient data management enabling future capabilities. This model will sustain a processes and nonstandard data repositories. The long-term information management strategy and end result could push a need for standardization due communications while permitting strategic enterprise to the cost savings calculated from the assessment. planning and project prioritization. Furthermore, it will create a cross-functional governance model for Location clinical data standardization, management and reuse With the growing trend of firms located in different functionality. This will enhance the existing resources parts of the world, there is an issue of location- and create additional value to reach long-term goals. specific processes and tools which create inefficiencies as there are separate instances of tools utilized in each global location and the lack of global consistency. There are also performance issues within global locations due to architectural and application limitations leading to global issues. One way to alleviate this issue is to investigate and pilot other database architectures and outline performance Service Line Agreements to enhance investigator satisfaction while ensuring less discrepancy management by data managers. | The ADD Effect in Clinical Development | 7
  8. 8. Abbreviations 21CFR 11 Title 21 Code of Federal Regulations CDISC Clinical Data Interchange Standards Consortium CDM Clinical Data Management CDMS Clinical Data Management System CRF Case Report Form EDC Electronic Data Capture FDA Food and Drug Administration HL7 Health Level Seven ICH International Conference on Harmonization M&S Modeling and Simulation NAHIT National Alliance for Health Information Technology NME New Molecular Entity R&D Research and Development RIM Reference Information Model SAIC Science Applications International Corporation XML Extensible Markup Language SaaS Software as a Service | The ADD Effect in Clinical Development | 8
  9. 9. References Smith, Laura. 2006. The Six Sigma Cure. Quality Acharya, Satish. 2006. The Productivity Tiger — Time Digest. and Cost Benefits of Clinical Drug Development in http://www.qualitydigest.com/mar06/articles/01_artic India. Pharmalicensing. le.shtml. http://pharmalicensing.com/features/disp/1153412098 Whiting, Rick. 2004. Standards May Speed Approval _44bfac02291f1. of New Drugs. InformationWeek. Brolund, Greg. 2002. Food and Drug Administration. http://www.informationweek.com/story/showArticle.jh Drug Approvals. tml?articleID=21700481. http://www.adobe.com/showcase/casestudies/fda/cas Wirenga, Dale and Eaton, C Robert. 2004. Phases of estudy.pdf. Product Development. Brooks, Kristen. 2006. CRO Update- Growth, http://www.allp.com/drug_dev.htm.. Expansion, and New Opportunities. Zisson, Steve. 2006. Time to Embrace Paperless http://www.contractpharma.com/articles/2006/05/cr Clinical Trials. o-industry-update.php. http://64.233.187.104/search?q=cache:n4npTkuYzloJ:w Getz, Ken. 2006. CROs Usage Associated With Faster ww.centerwatch.com/professional/cw_commentary.ht Drug Development Speed At Comparable Quality, ml+EDC+drug&hl=en&gl=us&ct=clnk&cd=10. According To Tufts Center For The Study Of Drug Development. Tufts CSDD. DiMasi, J. et al. 2002. Returns on Research and Development for 1990s Drug Introductions. Pharmoeconomics 20. Suppl. 3:11-29. Numerof, Rita and Nightingale, Jack. 2005. Guest Opinion: R&D Prioritization — Going Beyond Decision Analysis. http://www.eyeforpharma.com/search.asp?news= 47331. Roner, Lisa (1). 2006. Guest Feature — Industry At a Crossroads. Eyeforpharma. http://www.eyeforpharma.com/search.asp?news= 51888 . Roner, Lisa (2). 2006. Is Pharma R&D productivity turning the corner? Eyeforpharma. http://www.eyeforpharma.com/search.asp?news= 50963. Roner, Lisa (3). 2006. R&D productivity in the pharma industry is on the cusp of improving, says the Tufts Center for the Study of Drug Development. EyeforPharma. http://www.eyeforpharma.com/search.asp?news= 49520. Roner, Lisa (4). 2006. Driving R&D Innovation and Value With Technology. EyeforPharma. http://www.eyeforpharma.com/search.asp?news= 47099. Roner, Lisa (5). 2006. Improving Drug Safety With IT. EyeforPharma. http://www.eyeforpharma.com/search.asp?news= 48215. 9
  10. 10. 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, Sciences R&D solutions encompass: it 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 • Adaptive Clinical Trials — We provide consulting our 14 years of expertise in this arena help our and industry expertise to reduce dead time clients 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, CROs, 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. productivity improvements for the R&D We provide the program management, organization quantitative measures to reduce time and costs, and proven process that enables clients to conduct more trials effectively. We currently For more information, visit manage 11 such trials www.csc.com/lifesciences. • In-Licensing — We implement strategies and CSC cutting-edge solutions to help pharmaceuticals Life Sciences Practice and biotechs take full advantage of in-licensing 1160 West Swedesford Road, Suite 200 to augment their pipelines. Our structured Berwyn, Pennsylvania 19312 solutions ensure that no licensing opportunity is Unites States 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 | The ADD Effect in Clinical Development | 10
  11. 11. 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. | The ADD Effect in Clinical Development | 11
  12. 12. 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_0524

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