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SPECIAL FEATURE DIA 44TH ANNUAL MEETING
Representing more than 20,000 members worldwide involved in discovery, development, regulation, and marketing of bio/phar maceutical and related products, the Drug Information Association (DIA) each year has the significant task of designing an annual meeting that is timely,topical,and transforming. This year we received the largest ever number of abstracts for the annual meeting, indicative of the fact that attendees truly want to talk andhear about a wide range of topics. We have a number of hot topics as identified by past annual meeting attendees. One is “The Impact of FDAAA on Drug Safety,”which will be held onTuesday, June 24, from 8:00 a.m. to 9:30 a.m. Safety is always going to be a hot topic, and with the FDA and EMEA both paying increased attention to the issue, it is espe cially so today. The Food and Drug Administration Amendments Act of 2007 (FDAAA) will have a global impact in this area. In the plenary session, we expect to hear exactly what this impact might be. Speakers from U.S. and European regulatory agencies, the Reagan Udall Foun dation, PhRMA, and other organizations will discuss their goals and experiences with implementation of the FDAAA and its impact on drug safety. Attendees can submit questions to the panel by e mail through Friday, June 20, to fdaaaondrugsafety firstname.lastname@example.org. Other hot topics that will be addressed include: adaptive clinical design; the critical path initiative; patient recruitment;combinationproducts;multination al clinical trials; biotechnology, especially gene therapy; orphandrugs;personalized medicine and its clinical and regulatory considerations;and pediatric trials. The almost 40 tutorials offer the opportunity to study an area in depth.The sessions are 90 minutes long but the tutorials can last as long as a day. They are for people at all stages in their careers, from beginners to experts,and they cover a huge variety of topics andpro vide basic grounding through advanced training. The Keynote Presentations In drug development, there are four key groups that need to come together: regulators, industry (pharma, biotechs,and CROs),academia,and patients.Each group is integral to the drugdevelopment process. Industry and regulators have always been well represented at the DIA Annual Meeting. In Boston, we are trying to bring all of these groups together. The selection of the keynote presenters is a case in point.Dr.Dennis Ausiello is the Jackson professor of clin ical medicine at Harvard Medical School and chief of medicine at Massachusetts General Hospital, one of the world’s premier medical institutions. And Kathy Giusti is founder and CEO of the Multiple Myeloma Research Foundation (MMRF) and the Multiple Myeloma Research Consortium (MMRC) and is a graduate of Har vard Business School.And again, the links to Boston are very clear. At DIA,we view the collaboration between all stake holders in drug development as being very important. Indeed, Ms. Giusti is a great example of what can be done through such collaboration. Ms. Giusti was inspired by her personal situation — having been diag nosed with multiple myeloma — to draw on her phar maceutical industry experience to foster links between research institutions and industry to speed the devel opment of new treatments for myeloma. Making the Most of the Meeting Scheduling your time around the more than 360 ses DRUG SAFETY ISSUES ARETOPOFMIND JeffreyW.Sherman,M.D.,FACP,Chief Medical Officer and Senior VP, Research and Development, IDMPharma Inc., is program chairman for the 44th Annual Meeting in Boston.Hegives a sneak peekat the upcomingmeeting. Annual DIA Preview Showcase Feature PharmaVOICE is pleased to once again publish this Special Feature showcasing the new products, services, tools, as well as analysis and trends from dozens of clinicalservices companies that will be exhibiting at the DIA 44th Annual Conference in Boston, June 2226, 2008. For your convenience, we have divided the briefs into sections, including Trends, ESolutions, What’s New, and People. We would also like to extend special thanks to Jeffrey W. Sherman, M.D., FACP, DIA 44th Annual Meeting Program Chairperson, for providing an insider’s view about what it takes to produce a successful DIA Annual meeting that meets the needs of attendees, exhibitors, and thought leaders. We look forward to seeing you in Boston. Please stop by the PharmaVOICE Booth — No. 1200 — to learn about what’s happening in the clinicalservices arena. Special thanks to Managing Editor, Denise Myshko, for compiling the information for this DIA Preview. Regards, Taren Grom, Editor Jeffrey Sherman 2008 44th DIA Annual Meeting Program Chairperson R 60 J un e 2 008 PharmaVOICE PV0608 Layout FINAL2 5/20/08 12:46 AM Page 60 SPECIAL FEATURE DIA 44TH ANNUAL MEETING sions offered at the annual meeting can be overwhelming. We’ve taken steps to help you maximize your time in Boston and advance your education about drug development and clinical research throughout the world. The city of Boston has influenced much of this year’s program. For example, Tutorial 36 on the “financing of pharmaceutical and biotech startups,” on Sat., June 21, along with the ven turecapital roundtable:biotechnologyandphar maceutical/healthcare IT on Wed., June 25, will beof interest to manyBostonbased companies. Also, the FDA Center for Drug Evaluation and Review (CDER) will hold its Annual Town Hall,an interactive session where attendees can submit questions to senior CDER leaders, on Thurs., June 26. As always,global drug development is a key focus of this year’s annual meeting. This year’s event will include more than 100 ses sions on issues affecting key regions of the world, including: # Western Europe — 27 sessions # Japan — 23 sessions # China — 18 sessions # India — 12 sessions # Latin America — 11 sessions # Taiwan — 4 sessions # Canada — 4 sessions # Eastern Europe — 2 sessions # Vietnam — 1 session In addition,speakers from the following reg ulatory agencies will present at the annual meeting: # ANMAT Ministry of Health (Argentina) # ANMAT Ministry of Health (Brazil) # Center for Drug Evaluation (Taiwan) # EMEA (Europe) # FDA MOPH (Thailand) # Health Canada # MHRA (UK) # MHLW (Japan) # Ministry of Health, Welfare and Sport (Netherlands) # PMDA (Japan) # SFDA (China) # State Institute for Drug Control (Czech Republic) # FDA (US) # WHO (Switzerland) A significant development to this year’s annual meeting program is the formation of the Clinical Research and Information Technol ogy “megatracks.” One of the things we have done this year is to try to minimize areas of overlap between tracks so that the program is more efficient. In creating megatracks, we have brought all relevant tracks together so that overlap is avoided. Megatracks also make it more efficient for attendees. For example, those in clinical research and IT can more easily identify the sessions that meet their requirements. Networking Events Networking remains a hallmark of the DIA annual meeting, from the daily continental breakfasts and afternoon refreshment breaks to the more formal networking receptions. This year we have expanded some of these opportunities to allow attendees to reap all of the benefits of a complete annual meeting experience. # Networking Reception at the Museumof Science — June 22, 7:00 p.m. to 9:00 p.m. This year, in addition to enjoying great food byWolfgang Puck Catering and a host bar, DIA guests will have exclusive access to the Blue and Green Wings of the Boston Museum of Science. # Extended Luncheon Hours — Tuesday, June 24, 11:30 a.m. to 2:00 p.m. Back by popular demand, expanded lun cheon hours on Tuesday will provide an addi tional networking opportunity and allow atten dees to reap all of the benefits of a complete annual meeting experience. For more information about the annual DIA meeting,visit diahome.org. THE FORUM FOR THE INDUSTRY EXECUTIVE Gaining a COMPETITIVE ADVANTAGE www.pharmavoice.com MEETING REGULATORY REQUIREMENTS with Pamela Williamson Joyce ALZHEIMER’S Market Update IMPROVING the Detail P L I I O Target PharmaVOICE Readers with your DIRECT MAIL or EMAIL Marketing Campaign 35,000+ direct mail addresses 60,000+ Email addresses # # To rent the PharmaVOICE mail or email list, call 2153218656 to speak with Marah Walsh, (email@example.com). Read. Think. Participate. PV0608 Layout FINAL2 5/20/08 12:46 AM Page 61 SPECIAL FEATURE DIA 44TH ANNUAL MEETING Aris Introduces Planning Module for RegulatoryTracking Aris Global has announced the availability of Regis ter 5, an enhanced version of its Webbased tool for tracking all facets of global product registration and enabling compliance with regulatory requirements. The latest version of Register includes an integrated prod uct planning component that automates the tracking of registrations against global and local project plans, helping lifesciences organizations meet the challenge of managing the numerous activities and resources associated with global regulatory submissions. The Register 5 planning module provides functionality that enables companies to: # Link project plans with registrations and updates. # Automate definition and distribution of reporting of project plans. # Create planning templates that are definable for each regulatory procedure type. # Establish and reuse plan templates: define depen dencies; assign owners, roles, resource types, and more; specify highlevel and granular activities. # Create and publish local plans for each country with the single click of a button. # Intelligently update various activities within Regis ter, based on defined business rules. # Access productivityrelated metrics. # Run generic and productivity reports to track actu al versus planned milestones and export project plans to other Microsoft applications. “In the face of manual and errorprone processes that exhaust a company’s planning and resource staff, management is discovering that it’s nearly impossible to track the progress of regulatory submissions on a global and affiliate level,” says Wim Cypers, VP, product management, Aris Global. “They are looking for proven mechanisms to better manage their limited resources to ensure they determine the correct priorities regard ing registration submissions. With this newest release, Register improves visibility across the globe and enables faster, informed decision making at a lower cost.” For more information, visit arisglobal.com, or stop by Booth No. 834. ClinPhone Updates Combined EDCIVR Solution ClinPhone has released the latest version of its electronic data capture (EDC) software, DataLabs by ClinPhone v4.2. Continuing to build on its hybrid tech nology incorporating EDC and paper data management in a single platform, DataLabs v4.2 now offers advance ments in managing work flow at the item level, case report form (CRF) routing and messaging, event notifi cations, and improvements in its userfriendly interface and design. In addition, DataLabs now enables sponsors and CROs to take advantage of the industry’s only EDC solution fully integrated with interactive voice and Web response (IVR/IWR) system, ClinPhone Randomiza tion and Trial Supply Manage ment. DataLabs v4.2 incorporates a notification system, which allows study designers to sched ule custom messages and alerts for important study events. The upgraded software also has an integrated internal messaging system, which enables secure communication among study personnel. Data verification and itemlevel work flowmanage ment capabilities have improved significantly, which streamlines source data verification activity and saves time. Advanced capabilities include the ability to define whether status flags need to be collected at either the item or CRF level. David Stein, VP of product management at Clin Phone comments, “The new features and enhance ments are in direct response to customer and market requirements.” In other company news, ClinPhone and invivodata have formed a global partnership to provide electronic patient reported outcomes (ePRO) solutions. As part of this collaboration, ClinPhone joins invivo data’s PROPartner Program, which enables invivodata customers to leverage the strengths of its roster of affil iate technology and service companies whose offer ings have been identified as bestinclass in their respective market areas. For more information, visit clinphone.com, or stop by Booth No. 217. For more information, visit invivodata.com, or stop by Booth No. 600. CRF Offers Ediary for Tablet PCs CRF now provides TrialMax suite of ePRO software solutions for tablet PCs running the Microsoft Windows Vista operating system. Tablet PCbased ediaries provide investigators with the ability to obtain better data, by designing com prehensive patient questionnaires that take advantage of the tablet’s larger display area and the stylus or touch screen flexibility for more natural information entry and navigation ease. CRF’s full TrialMax platform capabilities are intend ed for TrialMax Tablet PCs: the ediary designer tool, TrialStudio, can be used to design Tablet PCbased solutions. TrialManager, CRF’s Webbased trial report ing tool, provides constant realtime and controlled access to study data. “We have seen how the portability and conve nience of our PDA and smartphone ediaries increase compliance and provide sponsors and investigators with reliable, contemporaneous, highquality data,” says Pamela McNamara, CEO of CRF. “For particular patient populations, the added capabilities that a tablet PC provides can make a real difference in the compli ance rate and therefore the success of the trial. For example, patients with tremors or visual impairment benefit from larger screen objects with which to inter act.” For more information, visit crfhealth.com, or visit Booth No. 241. DrugLogic Introduces Pharmacovigilance Solution DrugLogic has unveiled SafeStart Hosting for its QscanERM drugsafety management system, offering companies secure and fully configurable workflow management for individuals and departments that par ticipate in drug safety surveillance across the entire enterprise. Drugsafety workflow is an emerging need as drug companies set up standard operating procedures (SOPs) for pharmacovigilance, both the signaling of possible issues and the managing of these issues through resolution. With QscanERM in a hosted environment, cus tomers have immediate access to a fully validated workflow system with roles management, workflow and task management, advanced statistical analysis, and reporting functions for AERS, WHO, and VAERS data in a full audit trail vendorhosted environment. “With several major installations over the past two years, we have seen the need to explore different workflow approaches,” says Steve Wordham, Drug Logic’s VP of client operations and chief technical offi cer. “Handling workflow and internal data transitions separately, without having to exercise SOPs on exten sive internal report volumes, would greatly simplify implementations. Departments such as epidemiology, regulatory affairs, and drug safety can explore and even provide partial production capability without having to commit to an internal infrastructure upgrade.” For more information, visit druglogic.com, or stop by Booth No. 141. eCast Launches CT Select to Change Patient Selection for Clinical Trials Developed by eCast, CT Select uses emerging data sources, including electronic medical records and practice management data, along with lab and medica tion data to select highly targeted candidates that match trial protocols. The results equate to proven enrollment, saving ESOLUTIONS The following briefs include information about new ebased clinically related solutions. The companies in this section are presented in alphabetical order. The new features and enhancements are in direct response to customer and market requirements, says David Stein, VP of Product Management at ClinPhone. 62 J un e 2 008 PharmaVOICE PV0608 Layout FINAL2 5/20/08 12:46 AM Page 62 SPECIAL FEATURE DIA 44TH ANNUAL MEETING time and potentially millions of dollars during a prod uct’s life cycle. These emerging data sources help populate the company’s clinical data repository (CDR), which is a robust, contentrich source of HIPAAcompliant, de identified patient data. It can be accessed for the rapid identification of specific research populations and their locations within the CT Select network of investi gators. The CDR receives data from numerous sources resulting in a comprehensive collection of information that can be used to identify specific patient types as defined by the inclusion/exclusion criteria in a clinical protocol. “We have access to HIPAAsecure CDR data,” says Peter Bechtel, president and CEO of eCast. “We only use it for inclusion/exclusion criteria for our CRO and pharma customers. The data that come into the CDR come from the EMR. We supply the EMR as part of this system, so that we get the highest quality data pos sible.” When a clinical trial is placed with CT Select, the company’s team identifies the most qualified research sites across multiple therapeutic areas from within its site network. With a site network representing hun dreds of trained and credentialed research investiga tors throughout the United States and Europe, CT Select is able to rapidly target the most qualified research subjects for clinical trials directly from the patient population within each practice. For more information, visit ecastcorp.com, or stop by Booth No. 811. eResearchTechnology and nSpire Health to Deliver Integrated Cardiac Safety Services eResearchTechnology and nSpire Health have agreed to provide integrated cardiac safety and pul monary core lab services to clinical researchers. nSpire Health and eRT have a combined solution to meet the increased demand for cardiopulmonary safe ty and efficacy services during clinical trials, in part caused by an increased interest in using inhaled thera peutics. The partnership offers integrated services from project planning and set up through study con duct, management, and data delivery for primary and secondary cardiac and respiratory clinicaltrial end points. nSpire Health is providing eSP Core Lab Data Man agement software, QA services, HDpft, KoKo, PiKo, and PiKoLogic (electronic diary) respiratory diagnostic measuring instruments. eRT is performing digital col lection, measurement, interpretation, review, and distri bution of cardiac safety data through its EXPeRT 2.0 workflowenabled data management system. “This alliance addresses a growing need in clinical research to offer comprehensive, bestinclass ser vices in these two closely related areas of clinical study,” says Michael McKelvey, president and CEO of eRT. “While many sponsors recognize and source each company for its respective area of expertise, cus tomers increasingly seek consolidation and streamlin ing in all phases of a clinical trial.” For more information, visit ert.com, or stop by Booth No. 800. For more information, visit nspirehealth.com, or stop by Booth No. 1947. Medidata Broadens Partner Program Medidata Solutions is expanding it ASPire to Win part ner program for contract research organizations (CRO), consultancies, and other service providers. Medidata has broad ened the program to offer vari ous levels of training and support for a wide range of partner activ ity. Medidata offers a flexible program to equip CROs and ser vice providers with various Rave skills to help them optimize their services revenue around the technology. Medidata’s ASPire to Win Program is a nonexclu sive enablement and accreditation program that sup ports selected CROs and other organizations, position ing them to create new services revenue around the implementation of Medidata Rave. Medidata first announced the ASPire to Win pro gram in April 2005 to help CROs meet growing sponsor demand for Medidata Rave. Since then, ASPire to Win has grown to include 11 partners, ranging from smaller clinical consultancies to large, global CROs. “We value the contributions that CROs and other service organizations are making to the EDC growth trend and understand that each organization has a unique set of goals and requirements for EDC,” says Graham Bunn, VP of global CRO partnerships at Medi data. “As a result, we’ve moved away from a onesize fitsall approach and expanded our program to enable our global network of business partners to choose the plan that best meets the needs of their customers and complements their unique capabilities as well as grow their business with Medidata Rave.” For more information, visit mdsol.com, or stop by Booth No. 1220. OmniComm and Logos Partner for Phase I EDC OmniComm Systems is partnering with Logos Tech nologies to create an integrated solution with Alphadas, an electronic data capture solution designed specifically for Phase I clinical trials. The combined technologies are available to customers using the Trial Master, First in Functionality, EDC solution. The collaboration allows customers that are con ducting clinical research in Phase I to take advantage of a clinical study management and fully mobile elec tronic data capture system to capture data directly from the patient’s bedside. For those clients running Phase I to Phase IV clinical studies, the combination unifies the capture, reporting, exporting, and archival of clinical data into a common, costeffec tive, Webbased userinterface. The final warehouse for data may reside in SQL, Oracle Clini cal database tables, or in SAS. “The interface between Logos Technologies and Omni Comm offers a dynamic EDC solution for customers that are focused on Phase I clinical trials and delivers an excellent addi tion to our suite of targeted, inte grated solutions,” says Stephen Johnson, chief operating officer for OmniComm. “The integration of OmniComm’s TrialMaster and Logos Technologies’ Alphadas extends the capabilities for data collected from Alphadas to be combined with clinical data imported from other outside sources. These combined data may then be exported, archived, and made avail able in various reports and reporting formats.” For more information, visit omnicomm.com, or stop by Booth No. 1014. For more information, visit logostechnologies.com, or stop by Booth No. 1647. Oracle Provides ClosedLoop Marketing Solution Oracle is now offering Ora cle’s Siebel Personalized Content Delivery, a comprehensive closedloop marketing (CLM) solution that helps lifesciences organizations plan, develop, and execute more effective customer communication strategies that deliver increased value for cus tomers. Siebel Personalized Content Delivery offers a powerful solu tion for closing the loop at multi ple levels using a customercen tric approach that helps gather unique, actionable insight. The application makes it easier for sales representatives to deliver highimpact presentations that are tailored to individual cus tomer needs by leveraging multimedia visualization content provided by marketing teams. Siebel Personalized Content Delivery leverages Siebel Life Sciences CRM capabilities such as work flow, business rules, and realtime decision technology while offering superior marketing measurement through crossenterprise analytics. Siebel Personalized Content Delivery combines CRM and closedloop marketing capabilities into a sin gle product. This reduces the need for duplicate infras tructure, costly integration, and ongoing maintenance of custom code. We’ve expanded our program to enable our global network of business partners to choose the plan that best meets the needs of their customers and complement their unique capabilities, says Graham Bunn, VP of Global CRO Partnerships at Medidata. Today’s competitive environment is forcing life sciences organizations to transform their commercial models and redefine sales and marketing processes to maximize the value of every interaction with customers, says Rajan Krishnan, VP, Product Strategy, Oracle Life Sciences. The interface between OmniComm and Logos Technologies offers a dynamic EDC solution for customers that are focused on Phase clinical trials, says Stephen Johnson, Chief Operating Officer for OmniComm. # 63 PharmaVOICE J un e 200 8 PV0608 Layout FINAL2 5/20/08 12:46 AM Page 63 SPECIAL FEATURE DIA 44TH ANNUAL MEETING “Today’s competitive environment is forcing life sciences organizations to transform their commercial models and redefine sales and marketing processes to maximize the value of every interaction with cus tomers,” says Rajan Krishnan, VP, product strategy, Oracle Life Sciences. “Siebel Personalized Content Delivery offers companies a complete closedloop marketing solution to dramatically improve the quality of customer interactions and help grow revenue and market share.” For more information, visit oracle.com, or stop by Booth No. 230. Perceptive Informatics Improves Clinical Site Monitoring Perceptive Informatics now provides its clinical site manage ment and monitoring software, Impact MySites, on a portable USB drive. Clinical monitors can now securely upload site visit information onto the USB drive, without carrying their laptop computers with them. The MySites monitoring solu tion is a part of the Impact suite, Perceptive Informatics’ clinical trial management system (CTMS). The Impact MySites module supports online and offline mon itoring activities and the collec tion of associated data during site visits by clinical monitors in the field. As the entire MySites module is housed on the USB drive, information col lected by clinical monitors is securely stored and later synchronized with the Impact database. Perceptive’s software interfaces with interactive voice and Webresponse systems, as well as electron ic data capture (EDC) and data management applica tions, in addition to financial reporting. “We expect that clinical monitors will benefit from increased flexibility, productivity, and efficiency with the option to easily and securely capture site visit infor mation from anywhere in the world at any time, using the new portable functionality of the Impact MySites USB drive,” says Todd Joron, corporate VP and gener al manager of Perceptive Informatics. “This capability represents an important step toward a truly mobile e clinical environment.” For more information, visit perceptive.com, or stop by Booth No. 903. Phase Forward Delivers Enhanced InForm Solution Phase Forward has introduced a new Japanese version of its electronic data capture (EDC) solution, InForm J Integrated Trial Management (ITM). The new Japanese version offers comprehensive, realtime trial management reporting and analysis capabilities embedded directly into the product, provid ing clinical organizations with the ability to help enhance the execution and management of clinical tri als, as well as improve and accelerate clinical decision making. Since 2003, Phase Forward’s InForm J solution has been used by lifesciences companies of all sizes to help efficiently collect, manage, and clean clinical data and has been leveraged in more than 110 trials in Japan. New product features include: . Comprehensive Reporting and Analysis Capabili ties. With its intuitive draganddrop interface, InForm J provides a robust and flexible set of outofthebox reporting and analysis tools. The InForm J solution also has powerful ad hoc reporting tools, enabling end users to create and publish reports easily without the need for extensive report customization or IT assis tance, unlike competitive offerings that require addi tional software, strong technical expertise, or custom report development from the EDC solution vendor. . Productivity Enhancements Across All Clinical Roles. For monitors, remote access to detailed and up totheminute site status allows for better visit plan ning to minimize travel and maximize effectiveness while on site. A monitor can run reports on data entry, query rates and response times, form completion, and signature status, as well as plan for an upcoming site visit. With InForm J ITM, project managers are able to gain a realtime view of critical clinical events, such as adverse events or protocol violations, and can proac tively monitor patient recruitment to identify slow enrollment or high dropout levels or track and trigger payment milestones. “Our customers require innovative, sophisticated clinical data capture and management tools to support today’s increasingly complex trials and the benefits afforded by improved clinicaltrial productivity and effi ciencies,” says Steve Powell, senior VP, worldwide sales, at Phase Forward. “InForm J meets that require ment by offering realtime visibility into data and the ability to more effectively analyze the data, process reports, and ultimately take appropriate action.” For more information, visit phaseforward.com, or stop by Booth No.422. PHT Launches SitePadTablet “PHT Corp. has launched its SitePad Tablet, which is designed to change the quality of sitebased ePRO data capture worldwide. The largescreen mobile device uses the Samsung Q1 Ultra Mobile PC and resides at the investigative site. It is not sent home with the subjects participating in clinical studies. The SitePad Tablet eliminates those inefficiencies by offering an easytouse device with a large 7inch diagonal touch screen. “The screen is about half the size of a piece of paper, so it is easy to see and large enough to accom modate complex questionnaires,” says Phil Lee, presi dent and CEO of PHT. Subjects who are using the SitePad Tablet for the first time can practice on a sam ple questionnaire, which includes multiplechoice ques tions and questions with visual analogue scales. Data collected by the SitePad Tablet are transmitted to a hosted central server in real time using an integrated Ether net port, without relying on wire less networks. The information on each patient then becomes available to the site through a Web portal. For more information, visit phtcorp.com, or stop by Booth No. 1309 and 1409. PPD Enhances its Portfolio of EDC Services PPD has integrated Oracle’s newest electronic data capture (EDC) solution into its suite of clinical trial management appli cations, providing clients and investigators easier, faster navi gation to collect and report real time data for largescale, global clinical trials. Oracle Remote Data Capture Onsite 4.5.3, the latest version of Oracle Remote Data Capture (RDC), is one of two fullservice EDC technologies that PPD offers clients. PPD GlobalView, the company’s propri etary EDC technology, is available for global registries and postapproval studies. An entirely Webbased system, RDC Onsite 4.5.3 requires no software download or installation. With a zero footprint, HTML data entry window, the application can be accessed globally with only an Internet con nection and includes a 128bit encryption to ensure data security. This version features case report forms that are easytonavigate, search, and sort, as well as a robust system of edit checks to ensure data accuracy. Fur thermore, PPD has integrated its interactive voice response system with the RDC platform. Investigators can now enroll and/or randomize patients while trans mitting enrollment data into the Oracle Clinical RDC system, all during the same phone call. “Ease of use is critical when incorporating EDC technology into clinical trials,” says Susan Atkinson, senior VP, biostatistics and data management. “Designed for use by investigators and clinical research associates, Oracle Remote Data Capture Onsite 4.5.3 offers a simple interface with cleaner, faster data entry, enabling our clients to complete clin ical trials faster and accelerate time to market of new therapies.” For more information, visit ppdi.com, or stop by Booth No. 814 and No. 1447. The industry still overwhelmingly uses paper to collect patient reported outcomes, typically citing the cost of providing each subject with his or her own ePRO device as a reason for sticking with paper, says Phil Lee, President and CEO of PHT. Ease of use is critical when incorporating EDC technology into clinical trials, says Susan Atkinson, Senior VP, Biostatistics and Data Management, PPD. We expect that clinical monitors will benefit from increased flexibility, productivity, and efficiency with the option to easily and securely capture site visit information from anywhere in the world at any time, says Todd Joron,Corporate VP and General Manager of Perceptive Informatics. 64 J un e 2 008 PharmaVOICE PV0608 Layout FINAL2 5/20/08 12:47 AM Page 64 SPECIAL FEATURE DIA 44TH ANNUAL MEETING Take Solutions Expands Submissions Assurance Program The lifesciences division of Take Solutions is expanding its Submission Consulting Services unit to include North America, Europe, Asia/Pacific, and Aus tralia. The newly redesigned services unit is in response to market demand for its highvalue submis sions consulting services to provide direction and assistance in compiling errorfree submissions. Take Solutions’ submissions assurance programs now offer two uniquely targeted submission assurance delivery models. One submissions assurance offering is available to Take Solutions’ customers that license Take Solutions’ PharmaReady eCTD software solution. A separate submissions assurance delivery model is available to customers that want to fully outsource this service without the requirement of licensing any soft ware. “The FDA mandate for regulated lifesciences organizations to submit INDs and NDAs electronically is requiring these fastmoving organizations to seek assistance from trusted partners,” says Robert Mac Dougall, executive VP, sales and marketing. “Now adding to this, EMEA requirements for electronic sub missions beginning in 2009 have created even greater demand for submission assurance services.” For more information, visit takesolutions.com, or stop by Booth No. 406. Thomson Introduces Solutions for the Generics Market The scientific business of Thomson Reuters has introduced two new products, Newport Horizon Premi um and Newport Vision Premium, both of which are intended to give customers a competitive advantage in the global generics marketplace. The Newport products are designed to enable pro fessionals working in product selection, business development, competitive intelligence, and active pharmaceutical ingredient (API) sourcing to find the most appropriate product development opportunities more quickly, and to allow innovators to conduct deep er analysis on emerging generic competition. Newport Horizon Premium focuses on helping generic, overthecounter (OTC), and API companies build deals faster and accelerate time to market. Newport Vision Premium assists branded pharma ceutical companies to evaluate the earliest signs of generic competition and identify backup or alternative sources of API supply. “We recognize that there is a need for authorita tive generics market information to give pharmaceuti cal companies a clear competitive advantage over their competitors,” says Claude Basset, VP, Pharma Chem specialty markets, at Thomson. “We developed Newport Horizon Premium and Newport Vision Premi um to help customers improve productivity, accelerate time to market, and gain that competitive edge in the generics marketplace.” Newport Horizon Premium and Newport Vision Premium combine sales, launch, patent, patent chal lenge, exclusivity, chemistry, prescribing, and regulato ry information for more than 10,000 molecules, 18,000 companies, 67 markets, and 90 patent countries world wide with early API development and manufacturing intelligence. In other company news, Vertical*i and Thomson, the scientific business of Thomson Reuters, have announced the availability of the Vertical*iThomson Webservice, an interface between Vertical*i’s Applica tion Suite and Thomson Pharma. The Vertical*i Thomson Webservice combines the drug pipeline information of Thomson Pharma and the business process optimization capabilities of the Verti cal*i Application Suite. The combination provides phar maceutical companies with an endtoend solution for streamlining their business development operations. The Vertical*i Thomson Webservice consists of technology components from each company, and pro vides a connection that allows Vertical*i users to initi ate a search for drugs in the Thomson Pharma pipeline of information from within the Vertical*i application, and then directly import the data into a business devel opment opportunity. For more information, visit thomson.com, or stop by Booth No. 438. M E N T I O N P R I O R I T Y C O D E F C P A 0 5 1 9 A N D S A V E $ 4 0 0 ! R E G I S T E R N O W ! T O R E G I S T E R C A L L T O L L F R E E 8 0 0 8 1 7 8 6 0 1 O R R E G I S T E R O N O U R W E B S I T E A T W W W . C B I N E T . C O M OU T S TAND I NG SU P PORT P RO V I D E D B Y : Adhere to Regulatory Guidelines to Ensure Compliant Relationships with Foreign Officials and Build Global AntiBribery and Corruption Procedures Foreign Corrupt Practices Act (FCPA) For Bio/Pharmaceuticals and Medical Devices C B I ‘ S F O R U M O N T H E *Earn CLE Credits (Pending Approval) J U L Y 1 5 1 6 , 2 0 0 8 . T H E R I T Z C A R L T O N , P E N T A G O N C I T Y . A R L I N G T O N , V A G O V E R N M E N T E N F O R C E M E N T P A N E L : “Enforcement Trends within the Jurisdiction of the FCPA” Moderator: Michael B. Schwartz, Principal, KPMG Forensic, KPMG LLP Panelists: Kathleen M. Hamann, Trial Attorney (FCPA), Fraud Section, Criminal Division, U.S. Department of Justice David Rauser, Special Agent, Federal Bureau of Investigation Cheryl J. Scarboro, Associate Director, Division of Enforcement, U.S. Securities and Exchange Commission I NDUS T RY P E RSP E C T I V E S F ROM : . Abbott . Biogen Idec . BristolMyers Squibb . Covidien . Ferring Pharmaceuticals Inc. . GlaxoSmithKline . Johnson & Johnson . Medtronic, Inc . Mylan Laboratories, Inc. . Pfizer . ScheringPlough Corporation . St. Jude Medical . TAP Pharmaceutical Products . Zimmer PLUS! CHOOSE FROM TWO PRECONFERENCE WORKSHOPS — TUESDAY, JULY 15, 2008 A. Align Compliance Practices with International Codes of Conduct B. Prepare for International Investigations and Respond to Inquiries O R G A N I Z E D B Y : PV0608 Layout PROOFS 5/22/08 11:37 AM Page 65 SPECIAL FEATURE DIA 44TH ANNUAL MEETING Abt Associates Clinical Trials Changes Name Abt Associates Clinical Trials has changed its name to Abt Bio Pharma Solutions (ABS), a whol ly owned subsidiary of Abt Asso ciates Inc. The company continues to provide customized strategic research and commu nications solutions for the phar maceutical, biotechnology, med icaldevice, and diagnostics industries using a team approach that blends decades of experience with wideranging technical and therapeutic area expertise. ABS offers a wide range of integrated services across the product life cycle, including health economics and outcomes research, registries, and other realworld studies, clinical trials, biometrics, and marketing con sulting and research. “ABS helps sponsors achieve success for their products in a very competitive marketplace,” says Steven Fosburg, executive VP and managing director of ABS. “We are leveraging the increased flexibility that our new organization affords to invest in staff and resources to meet the expanding needs of our global client base without sacrificing any of the scientific rigor or timeliness that we are known for.” For more information, visit abtbiopharma.com, or stop by Booth No. 1557. BioImagingTechnologies Acquires Phoenix Data Systems BioImaging Technologies has acquired privately held Phoenix Data Systems, a global clinical data ser vices provider of electronic data capture (EDC) ser vices. The acquisition is a cash and stock transaction val ued at $24 million, payable at closing, consisting of $7 million of cash and 2,287,582 shares of BioImaging stock, valued at $17 million. Together BioImaging and Phoenix Data Systems can offer a broader set of clinicaltrial services to their pharmaceutical and biotechnology customers. Phoenix Data Systems is growing rapidly and gen erated $12 million in revenue and an operating profit in 2007. The acquisition is expected to be accretive to Bio Imaging’s fully diluted earnings per share for fiscal 2008. Phoenix Data Systems will retain its name and continue to be managed by Dr. William Claypool, its current president. For more information, visit bioimaging.com, or stop by Booth No. 1444. For more information, visit phoenixdatasystems.net, or stop by Booth No. 948. Chiltern Opens a New Office in Russia Chiltern has opened a new office in St. Petersburg, Russia, following the recent appointment of Alexey V. Kornilov, M.D., as general manager of its Russian operations. This office is expected to grow rapidly under the leader ship of Dr. Kornilov and is primar ily focused on supporting the company’s global clinical devel opment brand. Over the last few years, Chiltern has conducted many trials in Russia to fulfill sponsors’ demands in the region and to take advantage of highly qualified inves tigator sites generating highquality data. “The opening of our St. Petersburg office is a logi cal next step in Chiltern’s continued growth in Central and Eastern Europe,” says Armand Czaplinski, M.D., MBA, Chiltern general manager, CEE. “Today, with an ever higher number of competing trials, the pharma ceutical industry increasingly recognizes the potential of CEE countries to meet enrollment goals. The avail ability of trained staff and the quality of the data pro duced have resulted in an increased number of FDA and EMEA approved clinical trials.” For more information, visit chiltern.com, or stop by Booth No. 724. Clinsys Launches NewDivision Clinsys Clinical Research has launched Clinsys Alterna, a new division that uses its Global Project Solution (Clinsys GPS) to augment clinical resource services. The new division demonstrates Clinsys’ com mitment to aligning its service offerings with its spon sors’ and the lifesciences industry’s continuously evolving staffing needs. Clinsys Alterna provides customized Phase I to Phase IV clinical trial alternative solutions to the con ventional outsourcing model. The division is a core ele ment of Clinsys GPS, an integrated project manage ment solution that brings the sponsor and the Clinsys project teams together to collaborate and agree on all aspects of the clinical study to ensure the project’s suc cess. “Clinsys Alterna provides a targeted and flexible clinical resourcing model that adapts to best serve a sponsor’s trial management needs,” says David Williams, CEO of Clinsys. “We devoted the time and energy required to approach the evolution of resourc ing in an innovative way that both maximizes efficien cies and decreases deliverable timelines.” Clinsys Alterna delivers a customdesigned, time sensitive clinical solution that enables sponsors to engage its services in site management, clinical moni toring, project management, drug safety, regulatory, and medical writing on a contract basis. In other news, Clinsys has introduced its therapeu tically aligned program strategists (TPS), a concept for the evaluation and execution of clinical trials. The TPS teams are comprised of highly skilled and experienced professionals with defined therapeutic expertise who evaluate, create, and execute all sponsor projects, from clinical development plans and clinicaltrial design through protocol finalization, leading to suc cessful trial conduct. Each TPS team consists of M.D.s, Ph.D.s, and a clinical operations program director with expertise in a specific therapeutic area. These strategists apply a researchoriented approach to clinicaltrial strategy, design, and execution to either deliver a comprehen sive clinical development plan or protocol, or review and critique client synopses and protocols. The TPS team also provides analysis of the competitive environ ment, the current standards of care, and market poten tial. TPS services extend to design and implementation of generic and bioavailability/bioequivalence (BA/BE) trials. For more information, visit clinsys.com, or stop by Booth No. 1041. DSG Establishes Subsidiary in India DSG has opened a wholly owned subsidiary, India Document Solutions Private Ltd., located in Noida, Uttar Prudesh, India, a suburb of New Delhi. The subsidiary employs software engineers focused on research and development and quality control for DSG’s software. DSG has conducted business in India for the past three years with several partner companies in the lifesci ences industry. DSG has developed proven processes and proce dures to ensure that workflows are seamless across offices in the United States and India. The subsidiary employs 30 people and plans to add another 30 people by yearend. DSG continues to operate and staff its 24/7 help desk out of its U.S. offices. “Our subsidiary in India enables us to better meet the needs of our global customers by providing innova tive product solutions more cost effectively,” says Tony Varano, president and CEO of DSG. “With aroundthe clock product development, we are able to reduce the time required to bring new products to market. Having conducted business in India over the past three years, WHAT’S NEW The following briefs include company news about new clinically related operations.The companies in this section are presented in alphabetical order. We are leveraging the increased flexibility that our new organization affords to invest in staff and resources to meet the expanding needs of our global client base without sacrificing any of the scientific rigor or timeliness that we are known for, says Steven Fosburg, Executive VP and Managing Director of Abt BioPharma Solutions. Dr. Alexey Kornilov has been appointed General Manager of Chiltern’s Russian operations. 66 J un e 2 008 PharmaVOICE PV0608 Layout FINAL2 5/20/08 12:47 AM Page 66 SPECIAL FEATURE DIA 44TH ANNUAL MEETING we realized the tremendous amount of talent this region has to offer. The opening of our India office is a natural progression of our planned business expansion and international growth.” DSG continues to investigate more global expan sion opportunities and is currently developing plans to open an office in Japan later this year. For more information, visit dsgus.com, or stop by Booth No. 400. Global Research Services Expands in China Global Research Services (GRS) has launched a wholly owned subsidiary in China, Glob al Medical Consulting Services (Shanghai) Co. Ltd. (GMCS), and has expanded its capabilities to offer fullservice clinical trial management. The company has increased its services to offer full manage ment to both Western and Asian pharmaceutical, biotech, and medicaldevice companies intending to conduct clinical tri als in China. Services include protocol and case report form development, site selection, site monitoring, safety monitoring, project management, data management, and biostatistics. “Our purpose is to offer both Western and Asian clients the ability to perform their clinical trials in China,” says Jillian Lin, general manager, GMCS. “We also intend to extend our clinical vaccine development services into the Asian market. With the world’s increasing interest in China, vaccines, and drug devel opment in general, we find our services in these emerging markets to be both extremely timely and rel evant.” For more information, visit grscro.com, or stop by Booth No. 462. i3 Offers LatePhase Research Services i3 Innovus has launched comprehensive and cus tomized latephase research services, offering cus tomers increased efficiency and access to data and expertise in positioning their products for commercial success. i3’s latephase service offering integrates and expands on the group’s postlaunch realworld research competencies and includes: registry studies (product, disease and safety); postmarketing safety studies; Phase IV interventional trials; prospective, observation al, and naturalistic studies; health economic outcomes research, including burden of illness, patient reported outcomes, and health economic piggyback trials; as well as expanded access programs. “Efficient execution of latephase research requires a multifaceted capability: demographic data mining, scientific study design and analysis, therapeutic exper tise, epidemiology and pharma covigilance, risk management, and global regulatory affairs expertise, as well as deep knowl edge of realworld research,” says Glenn Bilawsky, CEO of i3. “i3’s latephase research encompasses all of these areas with an intricate specialization that drives a competitive advan tage for our customers. Our data assets can assess protocol design and feasibility, as well as optimize patient and physician recruitment.” The latephase research group is led by Cynthia Verst, Pharm.D., MS, as senior VP. Dr. Verst offers experience design ing and conducting latephase programs for maximum operational efficiency, costeffectiveness, speed, and reliability. In other company news, i3 has acquired the Rus sian clinical research organization (CRO) Lege Artis, strengthening its business in the global clinical trials market. The addition of Lege Artis and its capabilities in Belarus and Ukraine provide i3 Research customers with enhanced access to experienced investigators in Russia and the neighboring states of the former Soviet Union. With headquarters in Moscow, Lege Artis is being integrated into i3 Research, which is led by i3 Research President Nigel Page. Its founder and CEO, Tatjana Zwereva, M.D., Ph.D., leads the new Russian company. “Russia has become a strategic geographic area in the drugdevelopment process, with welleducated and experienced medical doctors and a vast population of patients who are interested in participating in clinical trials,” Mr. Bilawsky says. For more information, visit i3global.com, or stop by Booth No. 434. inVentiv Clinical Expands to Latin American Region inVentiv Clinical Solutions, a division of inVentiv Health, has established operations in Latin America, a growing region for drug development. The new location is based in Sao Paulo, Brazil; the company has plans to expand operations to other Latin American countries. inVentiv Clinical’s Latin American operation is led by Ana Paula Ruenis, Ph.D., recently appointed director of clinical operations, Latin America. “Having already established full offshore operations in India, the expansion of our clinical operations into Latin America is an important next step in our goal to become a global clinical ser vices provider,” says Mike Hlinak, president and CEO of inVentiv Clinical. For more information, visit inventivhealth.com, or stop by Booth No. 917. Lifetree Clinical Offer Bioanlytical Services Lifetree Clinical Research has addedbioanalytical services to its portfolio of services. Lifetree Bio analytical is a fullservice, good laboratory practice (GLP)compli ant bioanalytical facility that sup ports Lifetree Clinical Research and its clients during every phase of drug development. “By adding bioanalytical ser vices, we’re ensuring seamless sample transfer and rapid turnaround of critical data to our clients at a competitive rate,” says Lifetree Clinical Research CEO Alice Jackson. “Lifetree Clinical Research continues to broaden our scope of turnkey solutions for our clients’ clinical development needs from protocol writing through final clinical study report with PK analysis and results integration.” For more information, visit lifetreeresearch.com, or stop by Booth No. 1547. Parexel Expands Global Clinical Capabilities Parexel has completed the expansion of three clinical phar macology research units located in Baltimore, Md.; London; and Berlin, Germany, to meet grow ing client demand for expertise based studies in the early phases of clinical development. “Continued expansion of local capabilities combined with an integrated global clinical pharmacology presence has been a cornerstone of Parexel’s leadership in early clinical devel opment,” says Herman Scholtz, M.D., head of international clini cal pharmacology, Parexel. “As biopharmaceutical companies have been conducting more Phase I and proofofconcept studies with increasing complexity, Parexel has been wellpositioned to meet their needs.” In Baltimore, Parexel’s clinical pharmacology research unit has been expanding capabilities and capacity for client programs since 2001, when the unit opened. With the world’s increasing interest in China, vaccines, and drug development in general, we find our services in these emerging markets to be both extremely timely and relevant, says Jillian Lin, General Manager of Global Research Services. Efficient execution of latephase research requires a multifaceted capability: demographic data mining, scientific study design and analysis, therapeutic expertise, epidemiology and pharmacovigilance, risk management, and global regulatory affairs expertise, as well as deep knowledge of realworld research, says Glenn Bilawsky, CEO of i3. By adding bioanalytical services, we’re ensuring seamless sample transfer and rapid turnaround of critical data to our clients at a competitive rate, says Lifetree Clinical Research CEO Alice Jackson. Biopharmaceutical companies have been conducting more Phase I and proofofconcept studies with increasing complexity, and Parexel has been wellpositioned to meet their needs, says Dr. Herman Scholtz, Head of International Clinical Pharmacology, Parexel. Having established full offshore operations in India, the expansion of our clinical operations into Latin America is an important next step to become a global clinical services provider, says Mike Hlinak, President and CEO of inVentiv Clinical. # 67 PharmaVOICE J un e 200 8 PV0608 Layout FINAL2 5/20/08 12:47 AM Page 67 SPECIAL FEATURE DIA 44TH ANNUAL MEETING With its most recent expansion, the unit now has 90 beds, representing the largest such facility in the region. The unit has deep specialization in many clinical areas such as vaccine and immunology, pulmonary, and oncology studies. The Parexel clinical pharmacology research unit in London, established more than 15 years ago, has been expanded to a 64bed capacity. The unit has experience with all types of Phase I studies, including pharmacokinetic and pharmacody namic studies, and has the ability to conduct PET stud ies, as well. Parexel has two longestablished clinical pharma cology research units in Berlin. With the recent expan sion, the units now have 160 total beds. The two sites have dedicated medical teams that use identical equip ment and systems to assure harmonized procedures and workflow. For more information, visit parexel.com, or stop by Booth No. 803. PharmaNet Subsidiary Enters Into Consortium PharmaNet Development Group’s Anapharm sub sidiary has entered into a consortium with BCF Certifi cation Inc., a member of the BCF LLP group, to provide turnkey services to lifesciences ventures. The combined organizations are targeting the medicaldevice and nutraceutical industries to assist clients in commercializing their products in global mar kets. Through this combined entity, BCF Certification assists Canadian and international companies in meet ing regulatory, quality, and clinical requirements. In turn, Anapharm complements the offering by providing clinical development consulting, clinicaltrial, and laboratory services. Through realizing synergies, the consortium pre sents a onestopshop for fullservice trial processes, including due diligence, risk exposure management, and assessment. The consortium is continuing to work to add new partner companies and expand its service offerings to other lifesciences ventures. For more information, visit pharmanet.com, or stop by Booth No. 1020. PRAOpensNewOffice in India To accommodate rapid growth and further enhance its ability to deliver clinical services, PRA International has moved its Mumbai, India, office to a larger, more centrally located facility. The new Mumbai office expands upon the services PRA is able to offer its clients in India, the surrounding regions, and around the globe. With an anticipated staff of up to 50 clinical team members by the end of 2008, PRA India can potentially increase its service capacity by 150% in comparison with September 2007. For more information, visit prainternational.com, or stop by Booth No. 830. Premier Research and Octagon Research Agree to Partner Premier Research Group and Octagon Research Solutions have agreed to a partnership to provide a broader solution set. This new partnership combines Octagon’s expertise in electronic submissions with Premier Research’s clinical expertise across a wide array of therapeutic areas. The partnership enables Premier Research to offer Octagon’s electronic sub mission capabilities as part of its regulatory affairs ser vices and for Octagon to offer Premier’s regulatory development and scientific strategy. James Ottinger, VP of global consulting and compli ance for Premier Research says, “Our partnership with Octagon broadens our services by offering Octagon’s proven expertise in the technical aspects of electronic submissions while we continue to focus on our core strengths of regulatory strategy and consulting.” For more information, visit premierresearch.com, or stop by Booth No. 1617. For more information, visit premierresearch.com, or stop by Booth No. 1617. Quintiles Provides Central Services in Japan Quintiles Transnational has established an agreement with Medca Japan to provide central laboratory services, further extending the Quintiles global network of laboratories certified by the College of American Pathologists (CAP). Quintiles is fielding its own staff at the CAPcertified Medca Japan laboratory in Saitama, a city in the greater Tokyo area. The lab supports clinical trials in Japan. “Recent changes in legisla tion are allowing Japanese phar maceutical companies to extend clinical trials normally conducted in Japan to other countries in Asia, but these companies have had difficulty finding central lab services that are harmonized throughout the region,” says Tom Wollman, senior VP, Quintiles Global Central Laboratories. “With CAPcerti fied labs in Beijing, Singapore, Mumbai, and now Japan, we can provide wellcontrolled processes and harmonized testing services throughout the AsiaPacif ic region to customers in Japan as well as our multina tional customers. This lab, along with all labs in our net work, follows the same standard operating procedures, and data are available on our QNET database.” In other news, Quintiles has expanded its Quintiles Consulting business, which provides pharmaceutical, biotech, and medicaldevice companies with strategic guidance to maximize potential and minimize risk from early discovery through commercialization. Quintiles Consulting is expanding its current ser vices and building a global consulting organization to provide strategic, operational, and technical advice to pharmaceutical, biotechnology, and medicaldevice companies. The organization is focusing on market leading issues and addresses client needs in three practice areas: product development and commercial ization, regulatory and quality, and market access. Additionally, Quintiles has agreed to acquire Eidet ics, a privately held decisionanalytics and market research consulting firm located in Boston as part of its consulting business. The acquisition of Eidetics strengthens Quintiles’ core consulting offerings in the areas of product devel opment, commercialization, and market access. For more information, visit quintiles.com, or stop by Booth No. 1406 and 1606. Thomson Expands Web of Science The scientific business of Thomson Reuters has added 162 regional social science journals to Web of Science. The newly identified collection contains journals that typically target a regional rather than international audience by approaching sub jects from a local perspective or focusing on particular topics of regional interest. For more than two years, Thomson has reviewed thou sands of regional journals in all areas of science, social science, and arts and humanities. Although selection criteria for a regional journal are fundamental ly the same as for an international journal, the importance of the regional journal is mea sured in terms of the specificity of its content rather than in its citation impact. The recently added regional social science journals include 49 titles from the AsiaPacific region and 91 from the European Union. “As the global distribution of Web of Science expands into virtually every region on Earth, the impor tance of regional scholarship to our emerging regional user community also grows,” says Jim Testa, senior director, editorial development and publisher relations at Thomson. “We hope to be instrumental in expanding the audience for these journals and bringing attention to their scholarship.” Throughout 2008, Thomson is expected to expand the current collection of journals to include a more diverse coverage of regional literature. All journals added to the Web of Science go through a rigorous selection process. Regional journals, specifically, must be publishing on time, have Englishlanguage biblio graphic information (title, abstract, keywords), and cited references must be in the Roman alphabet. For more information, visit thomson.com, or stop by Booth No. 438. Recent changes in legislation are allowing Japanese pharmaceutical companies to extend clinical trials normally conducted in Japan to other countries in Asia, but these companies have had difficulty finding central lab services that are harmonized throughout the region, says Tom Wollman, Senior VP of Quintiles Global Central Laboratories. As the global distribution of Web of Science expands into virtually every region on Earth, the importance of regional scholarship to our emerging regional user community also grows, says Jim Testa, Senior Director, Editorial Development and Publisher Relations, at Thomson. 68 J un e 2 008 PharmaVOICE PV0608 Layout FINAL2 5/20/08 12:47 AM Page 68