e-solutions the companies in this section are presented in ...€¦ · elsevier partners with...

SPECIAL FEATURE DIA 45TH ANNUAL MEETING

e all share in the responsibility to worktogether to strengthen the science usedin pharmaceutical product develop-

ment, evaluation, and review,” says Program ChairNancy Smith, Ph.D., former director of the Office ofTraining and Communications, CDER, at the U.S.Food and Drug Administration. “We must find newtools to detect safety issues from preclinical testingthrough postmarketing and to improve communi-cations about the safe use of medicines to patients,physicians, and other interested parties.”

This year’s meeting, which has the theme, “Better

Medicines: Improving Safety with Every Step,”convenes more than 8,900 professionals, includ-ing representatives from more than 50 coun-tries. Additionally, the meeting features morethan 1,100 speakers, including representativesfrom FDA, EMEA, and other global regulatoryagencies. More than 800 exhibiting companieswill showcase their products and services in theinteractive exhibit hall.

STRENGTHENING SCIENCE AND SAFETY

Once again this year, the safety of medicines is top of mind at the Drug Information and Association’s 45th Annual Conference.

Annual DIA Preview Showcase Feature

PharmaVOICE is pleased to once again pub-lish this Special Feature showcasing the newproducts, services, tools, and executiveappointments and promotions from dozens ofclinical-services companies that will beexhibiting at the DIA 45th Annual Conferencein San Diego, June 21-25, 2009. For your con-venience, we’ve divided the briefs into sec-tions, including E-Solutions, What’s New, andPeople. We also encourage you to log ontoour digital edition at www.pharmavoice.comto view even more news and technologiesfrom exhibiting companies.

We look forward to seeing you in San Diego. Please stop by the PharmaVOICEbooth — No. 1300 — to learn about what’shappening in the clinical-services arena.

Nancy Smith, Ph.D., former director of the Office of Training and Communications, CDER, at the U.S. Food and

Drug Administration, is program chair for the Drug Information and Association’s 45th Annual Conference.W

Elsevier Partners with Communispace to Launch GlobalOnline Community

Elsevier, in partnership withCommunispace, has launchedInnovation Explorers, an onlinecommunity of 300 researchersfrom 69 countries to help identi-fy, design, and deliver relevantproducts and services that res-onate with and inspire researchscientists around the world.

Communispace, which hascreated more than 325 onlinecommunities for the world’slargest brands, is actively lead-ing member activity and thedelivery of insights.

“As a company, we’re com-mitted to finding innovative ways to better involve ourusers and buyers in our business, while providing themwith a global platform to engage with one another,”says Jay Katzen, managing director, academic andgovernment products, at Elsevier.

In other moves, Elsevier has acquired the assets ofProfessional Development Software (PDS), theprovider of Softwarefornurses.com online learningeducation products. PDS has been integrated intoElsevier’s Evolve Testing and Remediation productsuite, bringing additional content to Elsevier’s total cur-

riculum solution for nursing.For more information, visit elsevier.com, or stop by Booth No. 529.

Web-Based i3Cube Simplifies Clinical-Trial Process

i3’s recently launchedi3Cube is a Web-based clinicaltrial and data management tech-nology that leverages i3’s ser-vices and proprietary data toaccelerate the clinical-trial pro-cess through automation andconnectivity, allowing cus-tomers to make more rapid,informed decisions about theirproducts.

i3Cube replaces the need formultiple systems and applica-tions to manage study activities

with an integrated solution that centralizes study infor-mation into a single location throughout the entire clin-ical trial process. The solution features intuitive dash-boards that deliver real-time reporting and access tostudy information to sponsors and investigative sitestaff. Additionally, i3Cube provides greater speed andefficiencies through streamlined communicationacross the entire study team, study-specific automatedworkflow, and an integrated study library with versioncontrol, including an electronic trial master file.

“We brought together our use of proprietaryhealthcare claims data with our clinical researchexpertise and developed i3Cube to create time andcost efficiencies for our customers,” says GlennBilawsky, CEO of i3.For more information, visit i3global.com, or stop by Booth No. 107.

Medidata Rave Monitor Helps Manage Site Visits

Rave Monitor is an extensionof Medidata Solutions’ MedidataRave EDC and CDM solution thatoffers research sponsors andCROs a more efficient, compli-ant, and cost-effective way tomanage site visits.

Site-monitoring activitiesrepresent one of the largest costdrivers in clinical researchtoday, increasing the impor-tance of improving the efficiencyand effectiveness with whichmonitors or CRAs perform tasks.The addition of Rave Monitor

further extends the set of capabilities available to CRAs

E-SOLUTIONS The following briefs include information about new e-based clinically related solutions. The companies in this section are presented in alphabetical order.

Our goal for Innovation Explorers is to discover, in partnership with theresearchers themselves, howElsevier can helpimprove theirresearch outcomes,says Jay Katzen of Elsevier.

i3Cube wasdesigned to provideour clients and clinical investigators with asimple, easy-to-use,and streamlinedexperience, saysGlenn Bilawsky of i3.

The introduction ofRave Monitorenables us to provide researchsponsors and CROswith even moreways to work effectively with theirsites, says Medidata’s Glen de Vries.

To access a Free Demo featuring i3Cube, go toi3global.com/solutions/i3Cube.

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SPECIAL FEATUREDIA 45TH ANNUAL MEETING

by providing a new tool that makes a key part of theirjob –– reporting on-site visits –– more efficient.

“Medidata is committed to enhancing our cus-tomers’ competitive advantage by providing the toolsand services that enable operational excellenceacross their entire clinical development team,” saysPresident Glen de Vries.

Rave Monitor enhances cross-study operationalvisibility for study managers by providing users withonline and offline visit report capture, approval work-flow, and inter-study and cross-study status reporting,all within the context of their existing Rave deployment. For more information, visit mdsol.com, or stop by Booth No. 701.

Nextrials Expands Prism’s ReportGeneration Functionality

Nextrials has increased thereport generation functionalityof its Prism data capture andclinical trial management plat-form to deliver more powerfuldata mining capabilities to cus-tomers.

With its improved ad hocreporting feature, Prism userscan now collect, summarize, andexport data from tables within asingle study or across multiplestudies, creating efficienciesthat save time and lower study

costs. Its user-friendly graphical interface alsoincludes advanced interactive data view formats, suchas heat maps, in addition to bar graphs, pie charts, andother standard visual templates.

“Prism’s enhanced reporting capabilities make iteasier to both compile trial data and drill down on datapoints of interest, providing better visibility of studyresults and reducing the opportunity for error,” notesChief Technology Officer Robert Barr.For more information, visit nextrials.com, or stop by Booth No. 1302.

Octagon Research Links ContentManagement Systems

Octagon Research Solutions’ ViewPoint Connectorprovides a way to link multiple data repositories eitheras a module to Octagon’s own ViewPoint process man-agement solution or as stand-alone software that linksto popular content management systems from compa-nies such as Oracle and Microsoft.

ViewPoint Connector’s document and data integra-tion features facilitate two-way communication withcontent management repositories, respect securitydefined within the content management system, andprovide a fundamental building block for applications

that are integrating with contentmanagement systems.Octagon’s ViewPoint solutionuses the optional Connectormodule to access content man-agement systems while manag-ing and controlling content-driv-en enterprise processes such asglobal regulatory submissions.

“The ViewPoint Connectormodule goes beyond existingtechnologies on the market byenabling a higher degree of inte-gration and supporting routinely

requested actions between applications,” says AaronMiller, chief technology officer. For more information, visit octagonresearch.com, or stop by Booth No. 513.

SAS Launches Physician Targeting Solution

SAS’ recently introducedphysician targeting solutionhelps organizations apply pre-dictive analytics to sales, CRM,and other customer data to gobeyond deciling and targetphysicians based on profitability,retention, and future probabilityto prescribe.

Using a broad range of pre-dictive modeling techniques,SAS for Physician Targetingenables organizations to under-stand the rules and characteris-

tics surrounding why physicians have prescribed in thepast and apply those rules to predict who will be theprescribers of the future. Analytics can glean high-value targets from previously non-target populations.

“The SAS solution can mine prescription data withother data points, such as CRM data, managed care,health plan, and patient-level data to predict whichphysicians are responsible for the prescribing activityand segment accordingly,” says Jason Burke, globaldirector of health and life sciences.For more information, visit sas.com, or stop by Booth No. 301.

Thomson Reuters Adds to Liquent,IDRAC Product Lines

The healthcare and science business of ThomsonReuters has unveiled a number of additions and

upgrades to its family of Liquentsolutions.

The recently introducedLiquent PublishPerfect is anenterprise publishing productthat enables the efficient, inte-grated, and compliant publishingof reports from compilation toapproval.

“In a market where time is ofthe essence, Liquent Publish-Perfect allows users to remain inone program instead of goingbetween several,” says JeffHuntsman, VP, global sales, ser-vices and software solutions atThomson Reuters.

Liquent PublishPerfectequips each unique documentmanagement system to createPDF documents that are fullycompliant with the specifica-tions of the regulatory authori-ties. Other features of the solu-tion include a separatestand-alone publishing processoutside of submission publish-ing; an entirely Web-based solu-tion requiring no software instal-lation; compliant outputs; andthe capability to provide addi-

tional information publishing such as watermarks,overlays, and bookmarks.

Thomson Reuters also has launched LiquentInSight Publisher Select, a new tool that enablessmall and emerging life-sciences companies toquickly create, review, amend, and submit regulatorydossiers.

“We are confident that Publisher Select willempower smaller and start-up life-sciences compa-nies by streamlining their filing processes, therebyreducing their time to market,” says Jim Nichols, VP,Liquent software.

In other moves, Thomson Reuters has issued anupgrade to Liquent InSight Manager that offers moreflexibility and usability for day-to-day processes, suchas regulatory submissions.

Users can now plan and track submission activityin alignment with their own regulatory strategy with theGlobal Project Planning (GPP) wizard, which greatlyreduces the data entry needed for the submission pro-cess.

Thomson Reuters also has launched IDRAC Notes,an add-on commenting feature that allows IDRAC tocreate, update, and share comments attached toIDRAC PDF documents. For more information, visit thomsonreuters.com, or stop by Booth No. 821.

To access a Free Demo featuring ViewPoint Connector,go to octagonresearch.com/viewpoint-connector.html

It’s important forresearchers to beable to generatereports customizedfor numerous audiences, rangingfrom safety analyststo clinicians, saysRobert Barr.

ViewPoint Connectorenables the integration of contentfrom disparate repositories intostandardized processes, saysOctagon’s Aaron Miller.

As more pharmaorganizationsrestructure theirapproach to sales,the need forenhanced targetingtools increases,says Jason Burke of SAS.

The resultingreports are generated to thePDF specificationas required by regulatory authorities, savingtime and money,says Jeff Huntsmanof ThomsonReuters.

To help our customers bestapply LiquentInSight PublisherSelect to their filingneeds, we are offering PublisherSelect customersproduct training atno additional cost,says Liquent’s Jim Nichols.

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Almac and PHT Team Up toImprove Clinical-Trial Productivity

Almac Clinical Technologiesand PHT have forged an allianceto improve clinical-trial produc-tivity through a variety of educa-tion initiatives and data integra-tion efforts that will reduceclinical-trial site burdens whileimproving study data collectionand reporting.

PHT and Almac have agreedto provide consultation with clin-ical-trial sponsors on the difficultquestion of choosing the appro-priate technology for studiesinvolving electronic patient-reported outcomes (ePROs). Thefirst joint data initiative involvesintegration of Almac’s patient

screening and randomization data with PHT’s handhelddevices for ePRO studies.

“Our customers are constantly looking for ways tointegrate multiple streams of e-clinical data andreduce the data entry burden on sites,” says PHT CEOPhilip Lee. “Our partnership with Almac offers addedvalue for both sponsors and sites with one less datasource to reconcile and the removal of a manual dataentry step.”For more information about Almac Clinical Technologies, visit almacgroup.com, or stop by Booth No. 1301. For more information about PHT, visit phtcorp.com, or stop by Booth No. 1124 and 1125.

BBK Establishes Osaka LocationBBK Worldwide has opened

BBK Worldwide — Osaka, whichis committed to supportingJapanese pharmaceutical,biotech, and medical-devicecompanies, as well as CROs andSMOs, to more rapidly and effec-tively enroll and retain patients asparticipants in clinical studies.

“Osaka seemed the idealplace to establish the opera-tional base for our building ofbridges — between recruitmentbarriers and enrollment solu-tions, and between cultures and

business practices,” says Jeremy Buchman, whoheads up the Osaka office. For more information, visit bbkworldwide.com, or stop by Booth No. 1221.

Charles River Acquires Piedmont Research Center

Charles River LaboratoriesInternational has agreed toacquire the business and assetsof Piedmont Research Center(PRC), a wholly owned sub-sidiary of PPD, for $46 million incash, significantly expanding theoncology expertise offeredthrough Charles River’s discov-ery and imaging services.

PRC provides preclinical dis-covery services focused on effi-cacy studies in oncology andother therapeutic areas forpharmaceutical and biotechnol-ogy clients, as well as non-GLP(good laboratory practice) pre-clinical efficacy testing serviceswith expertise in the key thera-peutic area of oncology. The

company also offers a range of other in vivo, in vitro,and analytical services to supplement its core phar-macology offering.

PRC continues to operate from its North Carolinaheadquarters as part of Charles River’s Discovery andImaging Services business.

“The addition of PRC’s expertise, particularly inoncology, expands Charles River Discovery and Imag-ing Services’ portfolio of efficacy testing services tobetter support our clients’ needs,” says James Foster,chairman, president, and CEO of Charles River.For more information, visit criver.com, or stop byBooth No. 1731.

Chiltern Acquires Brazil-Based CRO Vigiun

Chiltern International has acquired Vigiun, a full-service CRO located in Sao Paulo, Brazil. Vigiun hasexperience conducting clinical trials in a variety oftherapeutic areas, in particular, infectious disease,oncology, and respiratory.

The acquisition of Vigiun enhances Chiltern’sgrowing presence in Latin America, which was estab-lished a year ago when the company began operationsin Argentina under the leadership of Oscar Podesta,general manager for Latin America.

Two Vigiun staff have assumed new roles atChiltern.

Dr. Eduardo Forleo has been appointed countrymanager for Brazil, and Elisa Halker serves as directorof clinical operations for Brazil. For more information, visit chiltern.com, or stop by Booth No. 203.

ERT Launches New Identity, Website

ERT, the new identitylaunched by the former eResearchTechnology, reflectsthe company’s proactive organi-zation that is committed toredefining and setting new stan-dards of how clinical trials aresuccessfully conducted.

ERT’s brand strategy bringsan enhanced visual identity tomarket as well as sharpenedproduct positioning, a new Web-site, messaging, and corporatecollateral. The ERT Website pro-

vides an enhanced online experience detailing infor-mation on ERT’s portfolio of clinical-trial solutions aswell as all company news and events, which serve toeducate customers and facilitate inquiries.

As part of its new branding, ERT has introduced anew global platform of products and services that con-sists of four sub-brands: Cardiac Safety Solutions; EDCSolutions; ePRO Solutions; and ERT Clinical ResearchConsulting Group.

“Our new brand identity reflects ERT’s dynamismand passion while continuing to instill the confidenceand trust that the industry has in our products and ser-vices,” says Michael McKelvey, president and CEO ofERT. For more information, visit ert.com, or stop by Booth No. 507.

Icon, MedAvante Forge CNS Partnership

Icon and MedAvante haveentered an alliance that aims toenhance precision and reducehigh-failure rates in CNS trials.

“MedAvante has developeda platform that addresses amajor cause of clinical-trial fail-ure in CNS development: vari-ability in both clinical diagnosisof the disorder being studied andongoing assessment of theseverity of the patient’s symp-toms in a consistent and stan-dardized fashion,” says JohnHubbard, Ph.D., president, Icon

Clinical Research. “This alliance extends our ability to offer our ser-

vices across the industry and across the globe,” addsPaul Gilbert, CEO of MedAvante. “Most importantly,however, is what this alliance provides to CNS drug

WHAT’S NEW The following briefs include company news about new clinically related operations. The companies in this section are presented in alphabetical order.

Together, PHT andAlmac are helpingsponsors and sitesremove time- consuming datacleaning tasks tofocus on what theycare about most:the health and safety of patientsand conducting rigorous scientificresearch, saysPHT’s Philip Lee.

Osaka is an optimallocation from whichto operationalizeour patient recruitment effortson behalf of ourclients throughoutthe Asia-Pacificregion, says BBK’sJeremy Buchman.

As pharmaceuticaland biotechnologycompanies increasingly choose strategic outsourcing as themeans to accelerate theirdrug-developmentefforts, they need torely on their servicepartners to providescientific depth and expertise in therapeutic areas,says James Fosterof Charles River.

We see the changeas a move forwardin establishing thecompany as a reliable partner inproducts and services for clinicaltrials, says ERT’sMichael McKelvey.

Icon is constantlystriving to offer ourpharmaceutical andbiotechnology partners innovativeclinical-trial solutions toenhance the drug-developmentprocess, says Icon’sJohn Hubbard.


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developers, the ability on a larger scale to reduce thehigh rate of failed CNS clinical trials, which the indus-try recognizes as unacceptable in terms of cost andlost time.”For more information about Icon, visit iconclini-cal.com, or stop by Booth No. 1307. For more information about MedAvante, visit medavante.net, or stop by Booth No. 1822.

Lionbridge, Open Text Join Forces to Streamline Regulatory Compliance Solutions

Lionbridge Technologies andOpen Text have entered analliance designed to ensure effi-cient, reliable integration of reg-ulatory compliance and docu-ment management solutions forpharmaceutical companies andother organizations.

“By delivering a completesolution, we are helping our cus-tomers increase their processefficiency, improve productivity,and address compliancerequirements while reachingnew global markets,” says

Satish Maripuri, chief operating officer of Lionbridge.For more information about Lionbridge, visit lionbridge.com, or stop by Booth No. 730. For more information about Open Text, visit opentext.com, or stop by Booth No. 2024.

PharmaNet Establishes Clinical HR Business

PharmaNet Development Group has establishedPharmaNet Resource Solutions, a new clinical develop-ment human resourcing business that offers extensiveindustry experience in both clinical operations and con-tract staffing management. PharmaNet Resource Solu-tions provides several contract resourcing services,including on-demand staffing, strategic alliances, func-tional service staffing, and quality control services.

“We offer a strong management team and experi-enced clinical research professionals who provideclients practical, customized resource strategies toensure their requirements are delivered on time andwith the appropriate level of experience,” says SusanSeroskie, R.N., who heads the unit as VP, PharmaNetResource Solutions. Ms. Seroskie joins PharmaNetfrom The Clinical Resource Network, where sheserved as senior VP, managed services.

In other expansion moves, PharmaNet has openeda new office in Sao Paulo, Brazil, to further enhance itsLatin American presence. The company has been pro-viding clinical-trial support in Latin America since 2002.For more information, visit pharmanet.com, or stop by Booth No. 320 and 321.

Premier Research Expands MedicalDevice Operations to United States

Premier Research Group hasexpanded its medical-deviceoperations to include full cover-age in the United States. Thecompany’s medical device grouphas been offering clinical-trialservices in Europe since 1997.

“Providing U.S. and EU ser-vices is a strategic focus for ourcompany, and this strengthensour ability to respond to cus-tomers’ needs,” says PremierResearch Chief Operating OfficerTroy McCall, Ph.D.

Premier’s U.S. medical-device operations are over-seen by Efraim Roe Kozorovitsky, executive director,medical devices. For more information, visit premier-research.com, orstop by Booth No. 827.

Quintiles’ Argentina Facility Earns CAP Accreditation

Quintiles Transnational’scentral laboratory in BuenosAires, Argentina, was recentlyaccredited by the College ofAmerican Pathologists (CAP),giving Quintiles the largest CAP-accredited central laboratorynetwork in the world and settinga standard for patient safety andfaster drug development.

All nine Quintiles central labsare now CAP-accredited, includ-ing wholly owned facilities inChina, India, Singapore, Scot-land, South Africa, and the UnitedStates; and subcontractor labs inArgentina, Brazil, and Japan.

“We offer a combination ofglobal resources, state-of-the-art buildings and equipment,staff experience and expertise,and high-quality and accurateservice,” says Tom Wollman,senior VP, Quintiles Global Cen-tral Laboratories.For more information, visitquintiles.com, or stop by Booth No. 329.

Radiant Research Partners with India-Based Spectrum Clinical Research

Radiant Research has established a strategic part-nership with India-based Spectrum Clinical Research,

allowing Radiant to provide CRO and site servicesacross both North America and India.

Both Radiant and Spectrum share expertise in awide range of therapeutic areas, as well as a proactiverecruitment approach to trials, using health screeningcampaigns to build databases in anticipation of enroll-ment.For more information, visit radiantresearch.com, or stop by Booth No. 1904.

Smith Hanley Consulting Establishes Business Intelligenceand Analytics Practice

Smith Hanley Consulting Group (SHCG), an inVentivHealth company, has launched a strategic businessintelligence, data warehousing, and analytics practiceas a complement to its staffing organization. The newpractice assists SHCG clients in improving fact-baseddecision-making in their operations, financial manage-ment, and regulatory compliance areas.

As part of the launch, SHCG has appointed BharatChitnavis as director, business intelligence and analyt-ics, with responsibility for leading the practice. Mr.Chitnavis reports to Managing Director Shelley Muhs,who has overall accountabilities of SHCG with theexpanded business.For more information, visit smithhanleyconsult-ing.com, or stop by Booth No. 722.

WCC Service Supports Early-Stage Clinical Studies

WorldCare Clinical (WCC) is now offering a newservice, Collect, Ready, Hold, which supports sponsorsconducting early-stage and Phase II clinical trials. Theservice helps to save time and money by allowingimaging data to be collected and standardized accord-ing to the imaging protocol, then held in a single,secure database until a central review of the data isrequested.

Collect, Ready, Hold builds upon the company’sextensive operational and regulatory expertise andemploys WCC’s WorldPro image management technol-ogy to acquire and prepare imaging data and store it allin a single, secure database. This gives sponsors com-plete control of the images acquired and helps themrespond to the FDA or other regulatory agencies,streamlining review processes if needed.

“Sponsors conducting Phase II trials many timeseither don’t have the funding in place or have yet toreceive a request from the FDA to conduct a centralreview of their imaging data,” says Richard Walovitch,WCC’s chief medical officer. “Collect, Ready, Hold wasdeveloped in response to these challenges as a cost-effective and preemptive approach for sponsors to col-lect, QC, and store images in a central database until itis determined if a central review of the imaging data isrequired.”For more information, visit wcclinical.com, or stop by Booth No. 1501.

Together, Lionbridgeand Open Text provide our customers life-sciences regulatoryexpertise and reliable contentmanagement solutions, says Lionbridge’s Satish Maripuri.

Our clients haverequested expanded medical-device services, and weare committed toresponding to theseneeds, says Dr.TroyMcCall of PremierResearch.

CAP accreditationvalidates the high-quality centrallab services we offerat each of our sitesaround the world,says Quintiles’Marina Travacio.

As the pharmaindustry adapts to a changing environment, Quintiles is well-positioned toremain the providerof choice for laboratory services,says Tom Wollmanof Quintiles.


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T H E F I N E A R T O F S C I E N T I F I C E X C E L L E N C E

UNDER STAND ING R E SOURC ING

Chiltern is an equal opportunityemployer and we ensure thatwe give full consideration toindividual needs for work lifebalance, personal fulfillmentand growth. We are constantlylooking for talented individualsat all levels of experience. If youwant more information or wouldlike to register your details withus please visit the Careerssection of our website.

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You need all sorts of peopleto form a great research teamWeknow that the range of skills, talent and experience required to deliver a successfulclinical study can vary widely by project. Therapeutic area, study type, geography,scale and other factors all influence your needs.

We also know that more than ever you need the full range of people availableto you in a flexible and responsive way, while at the same time taking good careof your budget.

This is why Chiltern Resourcing Solutions is structured to deliver you the ideal mixof dedicated clinical research professionals, be they CRAs, Project Managers, DataManagers, Statisticians, Physicians or others. And whether you are looking for afunctional service provider, an individual or a team, we will get outstanding peopleto you when, for how long and where in the world you want them.

To give your study the best possible chance of success – or to be part of a greatteam – simply contact us.Com

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Dr. Theresa Bromley Dr. Howard Goldberg Dr. Marian Ormont

ePharmaSolutions Expands CNS Department

ePharmaSolutions (ePS), a provider of clinical ser-vices and trial management technologies, hasannounced the addition of three key industry veterans,in part to support the expansion of its global CNS raterservices department.

ePS has named Theresa Brom-ley, Ph.D., associate director ofrater training, with responsibility forsupporting the development anddeployment of several Web-basedtechnologies that support the train-ing, certification, and ongoing mon-

itoring of raters in every continent for more than 100psychometric scales.

Dr. Bromley was most recently with UnitedBioSource.

Dr. Bromley is a licensed psychologist with morethan 15 years of private practice and pharmaceuticalindustry experience.

Howard Goldberg, Pharm.D., has joined ePS assenior VP of business development, after 10 years asthe president of ClinPhone, which was acquired byParexel International in August 2008.

Marian Ormont, M.D., has beenappointed medical director. Like Dr.Bromley, she is responsible for sup-porting ePS’ global rater-monitoringtechnology, and joined ePS fromUnited BioSource.

Dr. Ormont is a board-certifiedpsychiatrist with more than six years of industry expe-rience managing rater services for CNS studies on aglobal scale.

Before joining the industry, Dr. Ormont was a prin-ciple investigator and had a private practice.For more information, visit epharmasolutions.com, orstop by Booth No. 1712.

Dr. E. James (Jim) Emerson etrials Hires Consultant as Tech Development VP

etrials Worldwide, a provider ofadaptive e-clinical software and ser-vices designed to optimize clinicaltrial management, has named E.James (Jim) Emerson, Ph.D., VP oftechnology and development. In thisrole, Dr. Emerson is focusing on the

development of new, innovative, and viable productsdesigned to drive quick and sustained revenue streams.

Dr. Emerson previously served as a consultant toetrials. He has an MBA from Seton Hall University anda Ph.D. in computer science from the New York Poly-technic Institute.For more information, visit etrials.com, or stop by Booth No. 1321.

Bill Gwinni3 Names Clinical Informatics VP

i3 has appointed Bill Gwinn VP ofthe clinical informatics team housedwithin its Pharma Informatics busi-ness. Mr. Gwinn joins i3 as an expertin quantitative analysis for selectingthe best clinical trial sites and findingnew patients. His past experience

includes positions at Inclinix and The Medstat Group atThomson Reuters. i3, a global Ingenix company, pro-vides integrated scientific strategies and solutions.For more information, visit i3global.com, or stop by Booth No. 107.

James KirkRichard (Rich) Pilnik

Quintiles Strengthens Businesses UnitsIn the wake of Quintiles Transnational’s 2008

acquisition of Eidetics, James Kirk has been namedpractice leader for Eidetics, which has become themarket intelligence and decision analytics practice ofQuintiles Consulting.

Mr. Kirk was one of Eidetics’ original partners andhas been with the firm since 1988. He holds a master’sdegree from Stanford University.

In this new role, Mr. Kirk leads the team of Eideticsprofessionals on projects that address complex busi-ness challenges in nearly every disease category, frompreclinical go/no-go decisions to post-launch marketdefense.

In other moves, QuintilesTransnational has named Richard(Rich) Pilnik to serve as president ofInnovex, a Quintiles company thathelps pharmaceutical and biotechcompanies maximize commercialsuccess across a product’s life

cycle.Mr. Pilnik has 25 years of experience in the phar-

maceutical commercial sector, most recently as groupVP and chief marketing officer for Eli Lilly.

He received an MBA from the Kellogg School ofManagement at Northwestern University.

Quintiles provides development, financial, andcommercialization solutions to the pharmaceutical andbiotechnology industries.For more information, visit quintiles.com, or stop by Booth No. 329.

WHO’S WHO The following briefs include personnel news, new appointments, and promotions in the clinical arena.

Almac Clinical Technologies specializes ininteractive technology and service solutionsto increase the quality and efficiency of theclinical-trial process. For more information,visit almacgroup.com or Booth No. 1301.BBK Worldwide is a patient recruitment ande-business solution company for clinical R&Dand product marketing segments. For moreinformation, visit bbkworldwide.com or BoothNo. 1221. Charles River Laboratories International Inc.provides products and services to accelerateresearch and drug-development efforts. Formore information, visit criver.com or BoothNo. 1731.Chiltern International Ltd. is a global contractresearch organization with experience in con-ducting and staffing global Phase I to Phase IVclinical trials across a broad therapeuticrange. For more information, visit chiltern.comor Booth No. 203.Elsevier is a publisher of scientific, technical,and medical information products and ser-

vices. For more information, visit elsevier.com orBooth No. 529.ePharmaSolutions (ePS) is a provider of tech-nology-based clinical services that help improvethe way sites are selected, trained, activated,and supported. For more information, visitepharmasolutions.com or Booth No. 1712.ERT provides centralized ECG and e-clinicaltechnology, ePRO, and other services designedto support clinical trials. For more information,visit ert.com or Booth No. 507.Etrials Worldwide Inc. is a provider of adaptivee-clinical software and services to optimize clin-ical-trial management. For more information,visit etrials.com or Booth No. 1321.i3, a global Ingenix company, provides integrat-ed scientific strategies and solutions through-out the pharmaceutical product life cycle. Formore information, visit i3global.com or BoothNo. 107.Icon Plc. is a global provider of outsourceddevelopment services to the pharmaceutical,biotechnology, and medical-device industries.

FEATURED DIA EXHIBITING COMPANIES AT A GLANCE


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Redefining the CROThought Leader: Bob Burford Ph.D.,

Managing Director, Aptuit ConsultingFor more information, visit aptuit.com, or stop by Booth No. 1606.

The Next Generation of ClinicalOperations

Thought Leaders: Nagaraja Srivatsan, Head of Life Sciences, North America, and Kaushik Bhaumik, Global Practice Leader, Consulting and BPO, CognizantFor more information, visit cognizant.com, or stop by Booth No. 211.

Better Standards and Metricsfor CROs and Sponsors

Thought Leaders: Gregg Dearhammer, i3 Statprobe, and Karen Goss, i3 Drug SafetyFor more information, visit i3global.com, or stop by Booth No. 107.

Late-Phase Research Success:Leveraging Secondary Data

Thought Leader: Cyndi Verst, Pharm.D., M.S.,Senior VP, Global Late Phase, i3 Innovus

PharmaVOICE Webcast Network – Podcasts, Videocasts, and Webseminars The following is a list of archived Podcasts and WebLinx Interactive Webseminars and Videocasts related to the clinical research and services arenas that PharmaVOICE and industry thought leaders have conducted throughout the year. To access any of PharmaVOICE’s archived episodes, please visit pharmavoice.com.

For more information, visit i3global.com, or stop by Booth No. 107.

Named Patient Programs: A Three-Part Series

Thought Leaders: Natalie Douglas, CEO, MariaKempshall, Head of Regulatory Affairs and QualityAssurance, and John Lagus, VP of Business and Corporate Development For more information, visit idispharma.com, or stop by Booth No. 235

E-Clinical Moves Into the Mainstream

Thought Leader: Stacey Arrambide, VP, Statistics andData Management, inVentiv Clinical SolutionsFor more information, visit inventivclinical.com, or stop by Booth No. 621.

Procuring and Managing ClinicalStaffing Resources

Thought Leader: Stephen Cottrell, Executive VP,Operations and Business Development, inVentivClinical SolutionsFor more information, visit inventivclinical.com, or stop by Booth No. 621.

Planning for Electronic PatientRecorded Outcomes: A Guide

to Global Clinical Trials SuccessSponsored by: LionbridgeThought Leaders: Hannah O’Gorman, ClinPhone,and Mark Wade, LionbridgeFor more information about Lionbridge, visit lionbridge.com, or stop by Booth No. 730.

Making PharmacovigilanceWork

Thought Leaders: Uwe Maennl, M.D., Ph.D., andGadi Saarony, Parexel ConsultingFor more information, visit parexel.com, or stop by Booth No. 1701

Making Headway in ShiftingWinds by Maximizing Value: A

Three-Part SeriesThought Leaders: Michael Hagan and James C.Kirk, Quintiles Consulting; James Featherstone,Bruce E. Johnson, and Heidi Hunter, Quintiles;and John Doyle, Dr.P.H., and Geoff Garabedian,Quintiles ConsultingFor more information, visit quintiles.com, or stop by Booth No. 329.

For more information, visit iconclinical.com orBooth No. 1307.Lionbridge Technologies Inc. is a provider oftranslation, development, and testing servicesfor the pharmaceutical and biotechnologyindustries. For more information, visit lion-bridge.com or Booth No. 730.MedAvante Inc. is a global provider of central-ized expert psychological rating services. Formore information, visit medavante.net or BoothNo. 1822.Medidata Solutions Worldwide provides hostede-based and clinical-development solutions forpharmaceutical and biotechnology companies.For more information, visit mdsol.com or BoothNo. 701.Nextrials Inc. provides Web-based softwaresolutions and tools for clinical research. Formore information, visit nextrials.com or BoothNo. 1302.Octagon Research Solutions Inc. provides regu-latory, clinical, and process software and ser-vices to the life-sciences industry. For more

information, visit octagonresearch.com or BoothNo. 513.Open Text Corp. provides enterprise contentmanagement solutions. For more information,visit opentext.com or Booth No. 2024.PharmaNet Development Group Inc. providesclinical development services to the life-sci-ences industry. For more information, visit pharmanet.com or Booth No. 320.PHT Corp. provides electronic patient reportedoutcome (ePRO) solutions used in biopharma-ceutical clinical trials. For more information, visitphtcorp.com or Booth No. 1124. Premier Research Group Ltd. provides special-ized outsourced services for the global health-care community. For more information, visit premier-research.com or Booth No. 827.Quintiles Transnational Corp. provides develop-ment, financial, and commercialization solutionsto the pharmaceutical and biotechnology indus-tries. For more information, visit quintiles.com orBooth No. 329.Radiant Research Inc. is a clinical research

company offering study conduct, develop-ment, and centralized patient recruitmentservices. For more information, visit radi-antresearch.com or Booth No. 1904.SAS provides business analytics softwareand services. For more information, visitsas.com or Booth No. 301.Smith Hanley Consulting Group LLC, aninVentiv Health company, is a specializedrecruiting services organization. For moreinformation, visit smithhanleyconsulting.comor Booth No. 722.Thomson Reuters provides information andknowledge to accelerate research, discov-ery, and innovation for life-sciences compa-nies. For more information, visit thomson-reuters.com or Booth No. 821.WorldCareClinical (WCC) is an imaging con-tract research organization that supportsclinical trials. For more information, visitwcclinical.com or Booth No. 1501.


SEE DIGITAL EDITION FOR BONUS CONTENTWWW.PHARMAVOICE.COM

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The keynote speaker is Dr. Nancy Sny-derman, chief medical editor at NBCNews. Dr. Snyderman has reported on

wide-ranging medical topics affecting bothmen and women and has traveled the worldextensively, reporting from many of the world’smost troubled areas. She is Associate Professorof Otolaryngology, Head and Neck Surgery, atthe University of Pennsylvania.

One highlight is a multitrack plenary ses-sion titled Improving Safety with Every Step: Pil-lars of the Pharmaceutical Landscape. This ses-sion will feature industry, regulatory agencies,academia, and patient groups as they sharetheir perspectives on how to enhance patientsafety. With increased awareness on drug safe-ty due to drug withdrawals and the FDAAA of2007, this session will discuss the importance ofcollaboration among the various groups, whatis currently being done, and what needs tohappen in the future to ensure that patientsget the necessary information to makeinformed health decisions.

One featured session is Pharma in the NewAge of Transparency, where experts in health-care policy will discuss how public scrutiny ofthe industry will impact the industry and pub-lic policy as the nation debates major changesin healthcare delivery.

Another featured session looks at the manychallenges confronting the life-sciences industrytoday. High-quality management of researchand development is critical to the future of the

entire industry. Based on the results of a surveyrecently completed to investigate best projectmanagement practices in R&D drug develop-ment, a perspective will be provided on howproject management can meet these chal-lenges and provide huge competitive advan-tage to companies willing to embrace the cul-tural and process changes required.

Making the Most of the Meeting

The Annual Meeting features more than350 sessions and 34 preconference tutorialsfocusing on issues affecting global drug dis-covery and development, including hot topicsessions. Hot topics include: • Accelerated Development Time• Adaptive Trial Design• Biomarkers • Clinical Safety and Pharmacovigilance• Critical Path Initiative• Lean Six Sigma• Pharmacogenomics and Personalized

Medicines• Pharmacovigilance and Risk Management

New this year is the creation of three mega-tracks designed to enhance the quality of thepresentations, minimize overlap of similar ses-sion topics in different tracks, and promotebroader discussion and a fuller understanding ofthe topics presented. Megatracks include: Infor-mation Technology, Clinical Research, and Adver-tising/Marketing/Medical Communications.

Global drug development is also a key focusof the meeting. This year’s event will includesessions on issues affecting key regions of theworld, including: Asia Pacific, Australia, Emerg-ing Markets, Europe, India, and Latin America

The Asia-Pacific region, in particular, will be akey focus. The meeting will provide the oppor-tunity to speak face to face with representa-tives from more than 30 international regula-tors in attendance, such as:• Australia Therapeutic Goods Administration• China State Food and Drug Administration

(SFDA)• India Directorate of Drugs Control• Japan Pharmaceuticals and Medical Devices

Agency (PMDA)• Taiwan Center for Drug Evaluation• Korean Food and Drug Administration• Korean Ministry for Health, Welfare and

Family Affairs• Taiwan Department of Health• Vietnam Ministry of Health

Another new feature this year is that all paidregistrants of the Annual Meeting receive freeonline access to all available sessions, capturedin digital audio with synchronized PowerPointpresentations through the DIA Live LearningCenter. This access allows attendees to reviewthe sessions they attended or those theymissed. Attendees will be able to access thevaluable professional development contentfrom the Annual Meeting for a period of sixmonths after the event.

THE KEYNOTE AND FEATURE PRESENTATIONS

T

Acorn CRO Introduces Site Tracking and Recruitment Tool

Acorn CRO has launched STAR (Site Tracking andRecruitment), a tool aimed at accelerating the siteselection and patient recruitment process for clinicalstudies, increasing the accuracy and transparencyof the site feasibility/selection process, and savingvaluable time during the clinical study start-upphase.

STAR uses a dedicated technology tool to speedthe process of selecting study sites, as well as siterepositories based on sponsor requirements. Thesolution also automates the study feasibility process,seamlessly sends reminder notifications, and gener-ates site feasibility metrics in real time. For more information, visit acorncro.com, or stop by Booth No. 2039.

ISI Solution Streamlines Regulatory Submissions onMicrosoft Software Platform

Image Solutions (ISI) has expanded its relationshipwith Microsoft to offer a SharePoint-compatible ver-sion of its ISI Regulatory Solutions Suite (RSS).

Through the integrated solution, ISI’s RSS —which includes ISI’s flagship products eCTDXPressand ISIPublisher — is now built upon and seamlesslyintegrates with Microsoft Office SharePoint Server2007, offering several new features that removeadministrative burdens from regulatory departmentsto accelerate timelines for bringing drug therapies tomarket.

“SharePoint Server allows us to create a familiarcollaboration environment that enables life-sciencescompanies to easily deploy our proven solutions,” says

Jinsoo Kim, CEO and president of ISI.For more information, visit imagesolutions.com, or stop by Booth No. 851.

MDS Pharma Services LaunchesOncoPredictor for Cancer DrugDevelopment

Through a strategic collaboration with CompendiaBioscience, MDS Pharma Services has deliveredOncoPredictor, a solution designed to improve thedevelopment of drugs to treat cancer.

OncoPredictor combines MDS Pharma Services’OncoPanel with Compendia Bioscience’s Oncominefor a solution that helps identify cancer patient popu-lations most likely to respond to a new or existing can-cer therapy. As a result, research is more efficient and

E-SOLUTIONS Additional DIA exhibiting companies that have new technologies related to the clinical arena. The companies in this section are presented in alphabetical order.

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therapies can be targeted to those most likely to ben-efit.

“Our pharmaceutical and biotechnology clientsseek to determine the efficacy of their compoundsacross cancer genotypes and patient phenotypes,”says MDS Pharma Services President David Spaight.“OncoPredictor helps provide the answer with tech-nology for information-based lead selection, predictivein vivo study design, and biomarker development.”For more information, visit mdsps.com, or stop by Booth No. 721.

Microsoft Targets Discovery of Personalized Medicines

Microsoft’s recently launched software system,Amalga Life Sciences, is designed to transform health-care and life-sciences research data into the criticalknowledge needed for the discovery of new personal-ized treatments.

Amalga Life Sciences helps organizations achievethe next level of research capability by connectingdata and investigators in new ways through novel stor-age capabilities, ontology management functions, and

a semantic query environment powered by a next-gen-eration reasoning engine. For more information, visit microsoft.com, or stop by Booth No. 931.

Updated Relsys System IncludesProductivity Enhancements

The latest version of Relsys International’s ArgusSafety Suite drug safety and risk management systemfeatures productivity, performance, and usabilityenhancements that help pharmaceutical clients rapid-ly process and manage all of their reporting obligation.

Argus Perceptive 5.0 enables powerful risk assess-ments with greater data accuracy, ensuring that medi-cal reviewers get advanced notice of signals, poten-tially leading to earlier risk identification. For more information, visit relsys.net, or stop by Booth No. 1621.

Wolters Kluwer Partners with QlikTech, Netezza on Solution

Wolters Kluwer Health has deployed a new prod-

uct application that combines its database resourcewith QlikView’s software for information providers andNetezza’s data warehouse appliance, offering brandmanagers and other executives quick, cost-effectiveaccess to key market data and customized dash-boards.

Wolters Kluwer Health’s Source market databasecaptures drug prescription data from pharmacies,hospitals, and healthcare providers. These data deliv-er insights into the drivers of a brand’s market perfor-mance.

The new application provides an on-demand Webportal to access the Source database directly, provid-ing clear visibility into the real-time performance ofsales and marketing programs.

“We can quickly design customized dashboardsfor clients, enabling us to more efficiently meet clientneeds,” says Peter Demogenes Sr., director, productmanagement, for Wolters Kluwer Health. “QlikView’sability to merge data from multiple sources allows usto provide updates to the database faster thanbefore.”For more information, visit wkhealth.com, or stop byBooth No. 1842.

WHAT’S NEW The following briefs include company news about new clinically related operations. The companies in this section are presented in alphabetical order.

AAIPharma Forms Alliance WithDrug-Delivery Firm Emisphere

AAIPharma has partnered with Emisphere Tech-nologies to extend the application of Emisphere’s Eli-gen delivery technology to AAIPharma’s drug develop-ment services.

Emisphere’s proprietary Eligen technology is a deliv-ery method for therapeutic molecules and nutritionalsupplements that improves the ability of the body toabsorb small and large molecules by means other thaninjection. AAIPharma currently provides drug productformulation development services to Emisphere.

“This strategic alliance with Emisphere is withinour strategy to offer drug delivery options to our phar-maceutical and biotech customers,” says L. Lee Kar-ras, senior VP of AAIPharma’s pharmaceutical ser-vices business. “The combination of the EmisphereEligen technology and AAIPharma’s drug developmentservices is of tremendous value to customers seekingproprietary and unique oral drug delivery options.”For more information, visit aaipharma.com, or stop by Booth No. 445.

ACM Global Central Partners WithChindex to Provide Central Lab Services in China

ACM Global Central Laboratory is partnering withChindex International to provide central lab services in

China at Chindex’s United Family Hospitals in Beijing.ACM Global Central Lab’s global operations extend tomore than 60 countries, including the Americas,Europe, Australia, Asia, Israel, South Africa, and India,with all tests conducted and managed from central labfacilities with seamless data management providing asingle database. For more information, visit acmgloballab.com, or stop by Booth No. 726.

Covance Expands Operations inEurope, South America

Covance has made a number of expansions to itsfacilities in Europe and South America, including theacquisition of a clinical research company in Switzer-land.

The acquisition of Swiss Pharma Contract, a 50-bed clinical research company based in Basel, signifi-cantly increases Covance’s early clinical developmentfootprint in Europe and gives clients access to specialpatient populations for Phase I/IIa clinical studies.

Covance also has made a significant expansion ofits biotechnology services facility in Harrogate, UnitedKingdom, and has become one of a few CROs to receivea cGMP manufacturing license from the U.K.’sMedicines and Healthcare Products Regulatory Agency(MHRA). The expanded Harrowgate services facilityincludes upgraded infrastructure and equipment for

biopotency, molecular biology, and protein chemistryservices. As a cGMP-licensed manufacturer in the Unit-ed Kingdom, Covance now offers fully cGMP-compliantbiotechnology studies to help customers fulfill globalregulatory requirements for biotechnology studies.

In South America, Covance has opened clinicaldevelopment offices in Santiago, Chile, and Lima, Peru,and expanded its existing office in Buenos Aires,Argentina. These openings further extend the compa-ny’s global clinical development presence to increasepatient access and reduce clinical development time-lines. The new clinical offices located in Santiago andLima support staff in Chile and Peru, including Cov-ance’s regional network of field-based clinicalresearch associates throughout Latin America.For more information, visit covance.com, or stop by Booth No. 1515.

J&J Pharma R&D Opens Facilities inShanghai and Mumbai

Johnson & Johnson Pharmaceutical Research andDevelopment (J&JPRD), a unit of Johnson & Johnson,has expanded its global research network with newfacilities in China and India.

J&JPRD has established a new research anddevelopment center in Shanghai that also serves asJ&JPRD’s Asia R&D headquarters, with Dr. Lily Leeheading the business’ Asia/Pacific R&D efforts.

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The Shanghai site embraces the company’s philoso-phy of open innovation and collaboration by developing abroad regional network and combining internal research,expertise, and capabilities with external knowl-edge/innovation, expertise, or approaches to accelerateinnovation in product and technology development.

J&JPRD has also opened a late-phase new chem-ical entity (NCE) analytical and pharmaceutical devel-opment center (APDC) based in Mumbai. The APDC,the first of its kind in India, plays a key role in address-ing major global healthcare challenges, many of whichalso address key issues facing India and the region.NCEs to be developed by the facility include a potentialnew treatment for tuberculosis, a late-stage HIV com-pound, and a number of products designed to treatmultidrug-resistant bacteria.For more information, visit jnjpharmarnd.com, or stop by Booth No. 216.

Medifacts Partners with Suzukenfor Cardiac Safety Services in Japan

Medifacts International has formed a strategicalliance with Suzuken, one of Japan’s largest cardiacsafety services providers, to deliver advanced technol-ogy and centralized services to the biopharmaceuticaland medical-device industry in Japan.

“Our strategic alliance sets a new standard in theservice delivery of Japanese as well as global studies;we are now able to provide our global clients with full-service cardiac safety support operating from hubs inJapan, China, Europe, and the Americas,” saysMichael Woehler, president and CEO of Medifacts.For more information, visit medifacts.com, or stop by Booth No. 2125.

Perceptive Informatics AddsJapanese Kanji to Web ResponseSystem

Perceptive Informatics has expanded the numberof languages supported by its ClinPhone InteractiveWeb Response System (IWRS), by including Japanesekanji, the Chinese characters used in the Japanesewriting system. With this latest enhancement, IWRSnow supports more than 80 languages via the Web,including Chinese, Greek, Hebrew, Hungarian, Korean,Polish, Romanian, Russian, Slovak, Thai, Turkish, andUkrainian.

The Perceptive Informatics’ data center provides24/7 global support for clinical trials involving multiplecountries, time zones, and languages.For more information, visit perceptive.com, or stop by Booth No. 1707.

Phase Forward Purchases Clinical Data Solutions ProviderWaban Software

Phase Forward has acquired privately held WabanSoftware, a provider of platform solutions for theautomation and compliance of clinical data analysisand reporting, for $14 million in cash.

Waban, based in Cambridge, Mass., and withoperations in Mumbai, India, has become the WabanSoftware Group within PhaseForward, extending itsportfolio of clinical data solutions and enabling an inte-grated end-to-end solution from study setup throughanalysis and submission. For more information, visit phaseforward.com, or stop by Booth No. 729.

PPD Acquires Magen BioSciencesand AbCRO

PPD has purchased Magen BioSciences, abiotechnology company focused on dermatologic ther-apies, for $14.5 million in cash, expanding its compoundpartnering program into dermatology, initially in theindications of psoriasis, atopic dermatitis, and acne.

With the acquisition, PPD gains compounds throughMagen’s exclusive license to develop and commercial-ize preclinical compounds discovered by Eli Lilly for der-matologic therapeutics.

PPD CEO Fred Eshelman notes that the market isgrowing for dermatologic products, which generallypresent fewer development hurdles than other thera-peutics and have a more straightforward path to regu-latory approval.

Sandra Luikenhuis, Ph.D., who was integral in found-ing and growing Magen, has joined PPD with the acqui-sition and is overseeing development of these com-pounds in her role as executive director, dermatology.

PPD also has acquired AbCRO, expanding its CROoperations in central and eastern Europe and strength-ening its ability to provide a broad range of clinical trialmanagement and monitoring, patient recruitment, siteidentification, and regulatory affairs services to itsgrowing client base in the Balkans and surroundingcountries. More than 230 employees have joined PPDwith the AbCRO acquisition, including Co-foundersDana Leff, CEO, and Chairman Christa Pleasants.

In other moves, PPD has opened an office in Tokyo,expanding its Phase II to Phase IV development servicesin response to growing client demand in eastern Asia. For more information, visit ppdi.com, or stop by BoothNo. 546.

WHO’S WHO The following briefs include personnel news, new appointments, and promotions in the clinical arena.

Ardy Arianpour Ambry Genetics Chooses Business Development Director

Ambry Genetics, a commercial clinical laboratoryproviding genetic services focused on clinical diag-nostics, pharmacogenomics, and research support,has hired Ardy Arianpour as director of business devel-opment for genomic services. He was most recentlymanager of business development for Cogenics. For more information, visit ambrygen.com, or stop by Booth No. 2047.

Bill Baxter CIS Adds Government Programs Consultant

Pharmaceutical compliance consulting firm Com-pliance Implementation Services (CIS) has added BillBaxter as a consultant to its management team. In thisrole, Mr. Baxter is responsible for helping to guide CIS’continued growth, specifically in the government pro-grams area.

Mr. Baxter has almost four decades of diversepharmaceutical industry experience in areas such asMedicaid contracting, government affairs, sales, salesmanagement, and training. Before joining CIS, heserved as chairman of State Health Care Policy Coun-cil, an organization tasked with providing a forum forJohnson & Johnson’s operating company manage-ment to review emerging healthcare issues and devel-oping policy. He was also a participating member ofJ&J’s Medicaid and Medicare task forces.For more information, visit cis-partners.com, or stop by Booth No. 2242.

William Broucek Velos Adds Senior Director

Velos, a provider of clinical-trial management infor-mation systems, has appointed William Broucek assenior director, professional services. Mr. Broucek isresponsible for ensuring that superior customer ser-vice is sustained amid the continued expansion of

Velos’ business. Before joining Velos, Mr. Broucek heldsenior positions in professional services and imple-mentation management with Bay Area companies.For more information, visit velos.com, or stop by Booth No. 1840.

John Chiminski David Guelzow John Kay Kevin Tilley Catalent Makes Executive Appointments

Catalent Pharma Solutions, a provider of advancedtechnologies, and development, manufacturing, andpackaging services for pharmaceutical, biotechnology,and consumer healthcare companies, has named anew CEO and announced a number of additions to theprinted components business of its packaging servicessegment.

Catalent has appointed John Chiminski to succeed

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George Fotiades as president and CEO. Mr. Fotiades,who had been serving as president and CEO on aninterim basis, continues as Catalent’s chairman.

Mr. Chiminski joins Catalent after more than twodecades at GE, most recently serving as president andCEO of the GE Medical Diagnostics division of GEHealthcare. He received an M.S. in electrical engi-neering from Purdue University and a Master of Man-agement degree from the Kellogg School of Manage-ment at Northwestern University.

In the printed components business of Catalent’spackaging services segment, David Guelzow has beennamed account director responsible for Midwest busi-ness development and support. Before joining Catal-ent, Mr. Guelzow worked for several years as salesmanager for Amcor Flexibles Healthcare. He earned anMBA from the University of St. Thomas.

Catalent has promoted John Kay to director ofoperations for the printed components business of itspackaging services segment. Mr. Kay was previouslydirector of technical operations for Catalent. He holdsa master’s degree in industrial administration with aconcentration in operations management and financefrom Carnegie Mellon University.

Kevin Tilley has joined Catalent’s printed compo-

nents business as account manager, with responsibilityfor the sales of printed components to new and existingcustomers in the pharmaceutical, life-sciences, andmedical- device markets. Mr. Tilley most recently wasan account executive for MeadWestvaco.For more information, visit catalent.com, or stop by Booth No. 1349.

Robert Fetterman WCC Hires Associate Director of Imaging

WorldCare Clinical (WCC), an imaging CRO for clin-ical trials in the pharmaceutical, biotechnology, andmedical-device industries, has appointed Robert Fet-terman associate director of imaging services.

Mr. Fetterman has more than two decades of expe-rience developing and managing imaging trial pro-cesses in clinical, academic, and industry laboratories.He most recently served as associate director of imag-ing science at Acusphere. For more information, visit wcclinical.com, or stop by Booth No. 1501.

John Foster ProTrials Research Expands Executive Team

John Foster has joined specialized CRO ProTrials

Research as director of business development. In thisnewly created position, Mr. Foster leads ProTrials’strategic business and sales initiatives to manage thecompany’s accelerating growth within the pharma-ceutical, biotechnology, and medical device indus-tries.

Before joining ProTrials, Mr. Foster was with Cov-ance.For more information, visit protrials.com, or stop by Booth No. 1215.

Douglas VanOort NeoGenomics Taps Chairman, Interim CEO

NeoGenomics, a provider of cancer genetics test-ing services, has appointed Douglas VanOort execu-tive chairman and interim CEO. Mr. VanOort’s 30-yearcareer includes more than 10 years in healthcare ser-vices, including stints as executive VP and chief finan-cial officer of Corning Life Sciences and senior VP,operations, at Quest Diagnostics. He currently servesas operating partner for Summer Street Capital Part-ners and managing director of Conundrum CapitalPartners.For more information, visit neogenomics.org, or stopby Booth No. 1848.

AAIPharma Inc. is a global company providingservices that span the entire drug developmentspectrum. For more information, visit aaipharma.com or Booth No. 445.ACM Global Central Laboratory offers a flexibleapproach and a focus on precision to keep clini-cal research studies on schedule. For more infor-mation, visit acmgloballab.com or Booth No. 726.Acorn CRO is a full-service, oncology-focusedcontract research organization. For more infor-mation, visit acorncro.com or Booth No. 2039.Ambry Genetics Corp. is a clinical laboratoryproviding genetic services focused on clinicaldiagnostics, pharmacogenomics, and researchsupport. For more information, visit ambry-gen.com or Booth No. 2047.Catalent Pharma Solutions Inc. is a provider ofdevelopment, manufacturing, and packagingservices. For more information, visit catal-ent.com or Booth No. 1349.Compliance Implementation Services special-izes in establishing a culture of compliance forcompanies. For more information, visit cis-partners.com or Booth No. 2242.Covance Inc. is a comprehensive drug-develop-ment services companies. For more information,visit covance.com or Booth No. 1515.

Image Solutions Inc. is a provider of software andservices to streamline the regulatory approval pro-cess in the life-sciences industry. For more infor-mation, visit imagesolutions.com or Booth No. 851. Johnson & Johnson Pharmaceutical Research &Development LLC leverages drug discovery anddevelopment in a variety of therapeutic areas toaddress unmet medical needs. For more informa-tion, visit jnjpharmarnd.com or Booth No. 216.MDS Pharma Services offers a full spectrum ofresources to meet drug-discovery and develop-ment needs. For more information, visit mdsps.comor Booth No. 721.Medifacts International Inc. supports cardiovas-cular safety and efficacy data collection. For moreinformation, visit medifacts.com or Booth No. 2125.Microsoft Corp. provides software, services, andsolutions. For more information, visitmicrosoft.com or Booth No. 931.NeoGenomics Inc. s a CLIA-certified clinical labo-ratory that specializes in cancer genetics diagnos-tic testing. For more information, visit neoge-nomics.org or Booth 1848.Perceptive Informatics, a subsidiary of ParexelInternational Corp., is a provider of e-clinical solu-tions. For more information, visit perceptive.com orBooth No. 1707.


Phase Forward provides integrated data collec-tion and data management solutions for clinicaltrials and drug safety. For more information, visitphaseforward.com or Booth No. 729.PPD Inc. is a global CRO providing discovery,development, and post-approval services andcompound partnering programs. For moreinformation, visit ppdi.com or Booth No. 546.ProTrials Research Inc. is a clinical operationsfirm that provides qualified professionals to clin-ical research and development programs. Formore information, visit protrials.com or BoothNo. 1215.Relsys International provides pharmacovigi-lance and risk management solutions to thelife-sciences industry that improve productsafety and ensure ongoing compliance withglobal regulations. For more information, visitrelsys.net or Booth No. 1621.Velos Inc. is a provider of next-generationhealthcare software. For more information, visitvelos.com or Booth No. 1840.Wolters Kluwer Health is a provider of informa-tion for professionals and students in medicine,nursing, allied health, pharmacy, and the phar-maceutical industry. For more information, visitwkhealth.com or Booth No. 1842.

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