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There is a continual demand for knowledge and understanding of industry standards and best practices in pharmaceutical clinical development. Pharmaceutical professionals are tasked to evaluate the various aspects of the clinical development process within their firms so they can implement improvement measures. This conference provides professionals with the right knowledge and tools to help drive improved performance and efficiency throughout the course of their clinical development process.At ExL Pharma’s 6th Annual Clinical Performance Metrics & Benchmarking Summit, leading industry experts discuss how the implementation and application of performance metrics can improve your clinical trials, expedite development and enhance quality. Sessions offer both large and small pharmaceutical companies the opportunity to discuss and learn the different types of metrics used in clinical development, how to manage and successfully gain internal buy-in of a metrics program, discuss lessons learned on choosing the right benchmarking company, and the techniques on deriving meaningful conclusions from this benchmarking data to measure productivity. This year’s summit also provides attendees the opportunity to gain first hand knowledge when selecting available technologies for efficient data collection and analysis, and a detailed case study example on the use of metrics to help prioritize the impact efforts when managing timelines and deliverables. This is a must attend educational summit and an excellent networking opportunity.We look forward to greeting you in September!
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To RegisTeR Call 866-207-6528 oR visiT us aT www.exlphaRma.Com
PROUDLY PRESENTS
6th Annual Clinical Performance Metrics & Benchmarking Summit
Register by august 6, 2010 for maximized savings
SePteMBer 20-21, 2010, HyAtt At tHe Bellevue,
PHilAdelPHiA, PA
measuring and improving Clinical performance to maximize efficiency and Reduce operational Costs
post-Conference workshop on BalaNCeD sCoReCaRDs utilizing the Balanced Scorecard Method to Convert value drivers into Metrics and Align Performance Goals with Overall Business Strategy
· Astellas· AstraZeneca· Bristol-Myers Squibb· Eli Lilly · Genentech· Genzyme · GlaxoSmithKline· Merck & Co· sanofi-aventis· And More!
Industry PartIcIPants Include:
Featured Sessions include:IDENTIFYING CLINICAL METRICS strategies for selecting Clinical Development metrics and analyses to ensure optimal performanceNancy dynes, Consultant, Portfolio Management Systems, ELI LILLY
INTERNAL PERFORMANCE gaining internal Buy-in of Your Clinical metrics program to improve an organization’s processesrandy Krauss, Associate Director, Therapeutic Portfolio Management, GENzYME
METRICS IMPLEMENTATION Finding value in Data acquired through previously implemented Clinical performance measurement and assessments, to avoid unnecessary and Costly New initiatives Karen Brooks, MS, CCRA, Associate Director, Therapeutic Operations, SANOFI-AVENTIS
CRO METRICS identifying metrics and Tools to measure CRo and sponsor performance and Continuous improvement in Clinical outsourcing Collaborations Jan Matsson, Director Clinical Outsourcing,ASTRAzENECA
6th Annual Clinical Performance Metrics & Benchmarking Summitseptember 20-21, 2010, hyatt at The Bellevue, philadelphia, pa
Hyatt at the Bellevue, Philadelphia, PA200 South Broad StreetPhiladelphia, Pennsylvania 19102 USATel: (215) 982-4900 · Fax: (215) 982-4922Email: [email protected]
Hotel information
Professionals from pharmaceutical, biotechnology and medical device companies with responsibilities in the following departments:
• ProcessImprovement/Enhancement• MetricsandBenchmarkingDevelopment• PerformanceManagement• ClinicalOperations• ClinicalDevelopment&Planning• ClinicalTrials&Studies• ResourceManagement• Research&Development/R&DOperations• DataManagement• ProjectManagement&Planning• ProcessPlanning• MedicalAffairs• BusinessDevelopment/Operations• TechnologyDevelopment• CapacityPlanning/Management• DrugDevelopmentandSafetyManagement
This conference is also of interest to:
• CROs• TechnologyProviders• Consultants
Discovertruegrandeur,unrivaledstyleandserviceatouriconicdowntownPhiladel-phiahotel.SituatedonthefamousAvenueoftheArts,HyattatTheBellevue(formerlyParkHyattPhiladelphiaattheBellevue)blendsold-worldarchitecturewithmodernamenities.Unwind in our luxuriously oversized guestroomswith posh amenities.AllowourEuropean-style,Conciergetopersonallyrecommendandmakearrange-mentsattoprestaurants,showsandevents.DineatXIX(NINETEEN)atopourPhila-delphialuxuryhotel,withsweepingcityviews.Peruseworld-classshopswithinourlandmarkbuilding.Workoutinourremarkable93,000squarefoothealthclub.SeewhythiseliteCenterCityPhiladelphiahotelhasearnedtheHyattdistinction.
rOOM reServAtiONS:Ifyourequireovernightaccommodations,pleasecontactthehotelandstatethatyouarewithExLPharma’sAnnualClinicalPerformanceMetrics&BenchmarkingSum-mitconferencebySunday, August 29, 2010.WeencourageconferenceparticipantstomakereservationswithourdesignatedvenuetotakeadvantageofExLPharma’sdiscountedroomratebytheaforementioneddate.
Thereisacontinualdemandforknowledgeandunderstandingofindus-trystandardsandbestpracticesinpharmaceuticalclinicaldevelopment.Pharmaceuticalprofessionalsaretaskedtoevaluatethevariousaspectsoftheclinicaldevelopmentprocesswithintheirfirmssotheycanimplementimprovementmeasures.Thisconferenceprovidesprofessionalswiththerightknowledgeandtoolstohelpdrive improvedperformanceandeffi-ciencythroughoutthecourseoftheirclinicaldevelopmentprocess.
AtExLPharma’s6thAnnualClinicalPerformanceMetrics&BenchmarkingSummit, leading industry expertsdiscusshow the implementationandapplicationof performancemetrics can improve your clinical trials, ex-peditedevelopmentandenhancequality. Sessionsofferbothlargeandsmall pharmaceutical companies the opportunity to discuss and learnthedifferenttypesofmetricsusedinclinicaldevelopment,howtoman-ageandsuccessfullygain internalbuy-inofametricsprogram,discusslessons learnedonchoosing therightbenchmarkingcompany,and thetechniquesonderivingmeaningfulconclusionsfromthisbenchmarkingdata tomeasure productivity. This year’s summit also provides attend-eestheopportunitytogainfirsthandknowledgewhenselectingavailabletechnologiesforefficientdatacollectionandanalysis,andadetailedcasestudyexampleontheuseofmetricstohelpprioritizetheimpacteffortswhenmanagingtimelinesanddeliverables.Thisisamustattendeduca-tionalsummitandanexcellentnetworkingopportunity.
WelookforwardtogreetingyouinSeptember!
MaryRuggiero KristenHunterConferenceDirector TeamLeader,[email protected] ExLPharma
who shoulD aTTeND
To RegisTeR Call 866-207-6528 oR visiT us aT www.exlphaRma.Com
september 20-21, 2010, hyatt at The Bellevue, philadelphia, pa
Conference AgendaDay One · September 20th
8:00 Continental Breakfast & Conference Registration
9:00 Chairperson’s Welcome & Opening Remarks David Zuckerman, president, CusTomiZeD impRovemeNT sTRaTegies
9:15 IDENTIFYING CLINICAL METRICSStrategies for Selecting Clinical Development Metrics and Analyses to Ensure Optimal Performance• Gainingknowledgeofthedifferenttypesofmetricsusedinclinicaldevelopment
• Understandingspecificperformanceevaluations: trialmetrics,countrymetrics,sitemetrics
• Methodsforensuringthemetricschosenarebothvalidandrel-evant
• Evaluatingtheirimpactonclinicaldevelopmentperformance• Discussiononspecialmetricstoimproveprocesses:qualitymet-rics,financialmetrics
Nancy Dynes, Consultant, portfolio management systems, eli lillY
10:00 INTERNAL PERFORMANCEGaining Internal Buy-in of Your Clinical Metrics Program to Improve an Organization’s Processes• Learnhowtoteachpeoplewhattheyneedtodoasanorganizationtohelpthemunderstandhowmetricswillbeused
• Howtocommunicatemetricsresultseffectivelythroughouttheorganization
Randy Krauss, associate Director, Therapeutic portfolio management, geNZYme
10:45 Networking & Refreshment Break
11:15 METRICS IMPLEMENTATIONFinding Value in Data Acquired through Previously Implemented Clinical Performance Measurements and Assessments, to Avoid Unnecessary and Costly New Initiatives • Identifyappropriatemetricsforstudyperformance• Utilizemetricstoacceleratetimelinesbydecreasingbottlenecks• AnalyzemetricscontinuouslyforguidingfutureperformanceKaren Brooks, ms, CCRa, associate Director, Therapeutic operations, saNoFi-aveNTis
12:00 Lunch
1:15 Understanding How Performance Metrics can Contribute to Improved Business Processes• Theuseofmetricstohelpprioritizeimpacteffortswhenmanagingtimelinesanddeliverables
• Comparingdifferentmetricstoidentifywhichareasofimprove-mentwouldgarnerthegreatestrevenueimpact
sean gharpurey, principal project manager- product Development operations, geNeNTeCh
2:00 BENCHMARKINGHow to Obtain and Utilize Benchmarking Data to Predict and As-sess Clinical Trial Performance • Overviewofbenchmarkingandactivitiesundertakentoparticipateinbenchmarkingsurveys
• Wheretogofortheinformationtobenchmarkagainst• Howtointerpretbenchmarkingdataanddeterminerelevancetoyourbusiness
• Incorporatingbenchmarkingintoclinicaltrialexecutiondecisions• Derivingmeaningfulconclusionsfromthisdatatomeasurepro-ductivity
otis Johnson, manager, global Clinical Trial operations, meRCK & Co
Nancy Trewhella, Business performance management, meRCK & Co
3:00 Networking & Refreshment Break
3:30 CASE STUDY- INDUSTRY PERSPECTIVEUnderstanding and Applying New Metrics for Measuring R&D Performance to Optimize Efficiency and Cost - a GSK Approach • ExaminationofthecurrentR&Dpractices• Discussionofnewmetrics/approachesusedforoptimumclinicalperformance
• TheimpactthishasoncostoptimizationDongzhou (Jeffery) liu, phD, ms, mBa, medical lead/principle Clinical investigator, medical affairs/Clinical Research, glaxosmiThKliNe
4:15 ROUNDTABLE DISCUSSIONSChoosefromoneofthefollowingtablesdiscussingaspecificclinicalperformancemetric,andhowtheycanindicatestrongperformance
1) Site Performance & Patient Recruitment Metrics: Identifying, applyingandutilizingmetricstooptimizesiteperformance, productivityandquality
2) Protocol Metrics: Learnhowtoobjectivelyscoreaprotocol. Howgoodisthisdocument?Howlikelywillpeopleenrollinthis? Howisitwritten?
3) Quality Metrics: How to successfullydefinequalitymetrics, understandingwhattheyare,andif theresultsof thequality metricscanbeeffectivelyused
4) M&A Metrics: How to manage setting metrics targets in operationsduringandafteramergerandacquisition,whatto anticipate,avoid,andexpect
5) Outsourcing Benefits and Challenges:Understandingtheroleof outsourcinginimprovingthesponsor-vendorrelationshipand best practices used inmanaging cost & increasing supplier productivity
moDeRaToRs:maggie ayers, B.sc., Director, Clinical studies, asTellas
Nancy Dynes, Consultant, portfolio management systems, eli lillY
Cheryl Fiedler, pharmD, executive Director, study strategy & planning, BRisTol-mYeRs sQuiBB
gretchen e. goller, msw, patient Recruitment/Compliance strategist-operations, saNoFi-aveNTis
Jan matsson, Director Clinical outsourcing, asTRaZeNeCa R&D
5:15 Day One Concludes
To RegisTeR Call 866-207-6528 oR visiT us aT www.exlphaRma.Com
Conference AgendaDay Two · September 21st
8:00 Continental Breakfast
9:00 Chairperson’s Introduction of Day TwoDavid Zuckerman, president, CusTomiZeD impRovemeNT sTRaTegies
9:05 Moderator’s Summary of Roundtable Discussions Briefoverviewandkeypointsfromroundtablediscussions
9:30 CRO METRICSIdentifying Metrics and Tools to Measure CRO and Sponsor Per-formance and Continuous Improvement in Clinical Outsourcing Collaborations• Identifyingmetricsandtoolstomeasurethepartnershipandcol-laborationbetweenpharmaceuticalcompaniesandCROs
• Theimportanceofrelationshipgovernance• Casestudy:TheAstraZeneca/QuintilesClinicalPharmacologyAl-liance
Jan matsson, Director Clinical outsourcing, asTRaZeNeCa
10:15 Networking & Refreshment Break
10:45UPDATE FROM THE MCCUnderstanding How Pharmaceutical, Biotechnology and CROs Develop Standardized Metrics to Drive Process Improvement and Boost Partnership Performance in Clinical Trials • Developingandimplementingstandardizedperformancemetricswithagoalofimprovingefficiencyanddeliveryofclinicaltrialop-erations
• Buildinganindustrybenchmarkingdatabaseforclinicaltrialmetrics• Pilotingqualityassessmenttoolsforsiteselectionandprotocoldevelopment
linda sullivan, vice president of operations, meTRiCs ChampioN CoNsoRTium
11:15 PANEL DISCUSSIONExamining Available Technologies for Performance Metrics Data Collection and Analysis• Howarepharmaceutical companiesdeciding andprioritizingwhichtypesofperformancedatatoobtainandanalyze?
• Discussingtheissuespharmaceuticalcompanieshavetoaddresssuchasdatastandardizationandhowtheyaremakingthebuildorbuyperformancemeasurementstechnologydecisions
• Understandingthechallengesforimplementationandadoptionofthesenewsystemsandprocesses
moDeRaToR:scott Ballenger, president, TRial aCCeleRaTioN iNsTiTuTe
paNelisT:alex lancksweert, Business lead, simplifying Clinical information en-vironment (sCie), glaxosmiThKliNe
Cheryl Fiedler, pharmD, executive Director, study strategy & planning, BRisTol-mYeRs sQuiBB
edward mannello, Director, study Recruitment, asTRaZeNeCa
12:15 Main Conference Concludes Lunch for Workshop Participants
POST-CONFERENCE WORKSHOP1:15 Utilizing the Balanced Scorecard Method to Convert Value Drivers into Metrics and Align Performance Goals with Overall Business Strategy
• Whatisthebalancedscorecardmethod?• Definition–combiningmeasuringandmanaging• Casestudyexamplesofprocessimprovement• Whatotheroptionsareoutthere?
• Examiningtheorganizationfrom4differentperspectives• Financial• Learning&Growth• Customer• InternalBusinessProcesses
• Outliningthebenefitsofutilizingascorecardtotrackmetrics• Visibility• Efficiency• Communication• Accountability
• Casestudyexamplesofscorecardsuccess
4:15 Post-Conference Workshop Concludes
“Well organized summit and great speakers” ALCON RESEARCH
“Great discussion! Loved the group involvement. Very helpful and excellent content. Exactly what I came for!” PDL BIOPHARMA
“Very informative learning experience about metrics & benchmarking” SANOTI-AVENTIS
6th Annual Clinical Performance Metrics & Benchmarking Summit
Do you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the op-portunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. exl pharma will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact:
steve Decker, Business Development manager212-400-6234, [email protected]
Sponsorship and exhibiting OpportunitiesMedia Partners
Five ways to RegisterFax: 888-221-6750 Phone: 866-207-6528Mail: ExLEvents,Inc. Online: www.exlpharma.com 5558thAve,Ste310 Email: [email protected] NewYork,NY10018
Registration Fees for Attending ExL Pharma’s 6th Annual Clinical Performance Metrics & Benchmarking SummiteaRlY BiRD pRiCiNgRegisterbyFriday,August6,2010toTakeAdvantageofEarly-BirdPricing:Corporate Rate: Conference+Workshop $1995 ConferenceOnly $1695sTaNDaRD pRiCiNgRegisterAfterFriday,August6,2010:Corporate Rate: Conference+Workshop $2195 ConferenceOnly $1895oNsiTe pRiCiNgCorporate Rate: Conference+Workshop $2295 ConferenceOnly $1995
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To Reg
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PROUDLY PRESENTS
6th A
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Industry PartIcIPants Include:
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strategies for selectin
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