29th - 30th September 2011, Thistle City Barbican, London, UK

Organised By

Anticipating and overcoming management and delivery challenges

To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/clinical-trial-logistics-and-supply

Vladimir Anisimov, Senior Director, Research Statistics Unit, QSci, GlaxoSmithKline

Martin Simán, Clinical Information Science Director, AstraZeneca

Uwe Gudat, Medical Director, Office of the Chief Medical Officer, Merck Serono

Maria Eugenia Giribets Parra, Clinical Supply Chain Coordinator, Boehringer-Ingelheim Pharma

Justin Doel, Clinical Supplies Manager, Novartis Vaccines & Diagnostics, Global Clinical Research & Development

Penelope Ward, Senior Director, Experimental Medicine, UCB New Medicines

Sean Smith, Vice President, Clinical Supply Chain, Fisher Clinical Services

Bassam Hallis, Project Manager, Health Protection Agency

Annegret Van der Aa, Clinical Trial Manager, Galápagos

Stuart McGuire, Executive Director Global Business Development, Chiltern

Angus Cameron, Director & Senior Vice President, Business Development, Pharmarama International

Lewis Cameron, Chief Executive Officer, Clearstone Laboratories

Key Speakers

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Clinical Trial Logistics & Supply

Driving the Industry Forward | www.futurepharmaus.com

Media Partners

Associate Sponsors

Silver Sponsors

Diagnostics SciencesClinicalTechnologies

ClinicalServices

PharmaServices

Conference IntroductionClinical Trial Logistics & Supply

29th - 30th September 2011, London, UK

Dear Colleague, Cuttingoverheadsandimprovingsupplychainsintoday’smarketisaspressinganeedas

ever.Withthewholedrugdevelopmentprocessheavilydependantonclinicaltrialefficiency,logisticandsupplychainoptimisationarenowintegraltocostsaving.

Effectivelytransportingclinicaltrialmaterialstoinvestigatorsites,andpatientsamplesbacktocentrallaboratoriesarecriticalifaproductistobelaunchedontimeandwithinbudget.Inaworldwheretimeismoney,evenaweek’sdelaycanpotentiallycostmillions.

Moreover,therelentlesspressuretobringdrugstomarketquicklyandcheaplymeansmanystudiesarenowoutsourcedtoEasternEuropeanandotheremergingmarkets.Witheachcountryhavinguniqueguidelines,understandingthecomplexitiesofshippingmaterialstoavarietyofdestinationsiscrucial.Opportunitiesforstrategicandadaptiveplanninginclude:regulatory compliance, multi-language labeling, risk-based modelling, and secure, co-ordinateddistribution.Whicheverstageyou’reat,maximisingvaluedemandsanintegratedandwellorganisedsupplychain.

Visiongain’s Clinical Trial Logistics and Supply conference addresses your concerns, enabling you to efficiently resolve challenges at regional, national and international levels. In addition to providing the latest developments in security, forecasting, partnering and outsourcing, you will also leave empowered to: •Optimisedrugpoolingforclinicaltrialsupplies •Ensurebioequivalencewhenundertakingcomparativetrials •Integratenationalregulatoryrequirementsintoprotocoldesign •Improvepatientmanagementforstudiesconductedinemergingmarkets •Labelinvestigationalmedicinalproductscountry-specificallytomeetcustomsapproval •Forecastsupplydemandtoeliminatewastage •Optimisesamplemanagement •Implementasecurecoldchainstrategyand reduce temperaturedeviationanddelivery

timeduringshipping •EvaluateimprovedGPSandRFIDtemperature-monitoringdevicestominimizeriskduring

transportation •Maximiseyourdepotsupplyanddistributionpractices •ImplementlessonsgleanedfromcasestudiesfromEasternEurope,theFarEastandAsia •UtiliseIVRandIWRtosavetimeandmoney Ilookforwardtomeetingyouattheconference Bestregards

John Shah Senior Conference Producer

Who should attend?Presidents, Chief Executive Officers, VPs, Global Heads, Chief Scientific Officers, Directors, Principal Scientists, Franchise Heads and Investigators in:• Clinical Research• Clinical Operations• Clinical Logistics Planning/Distribution• Clinical Trial Process Implementation• Drug Formulation• Chemistry, Manufacturing & Controls• Drug Supply Planning/Management• Clinical Trial Support• Global Clinical Outsourcing• Clinical Packaging• Labelling• Supply Chain Management/Integrity• Cold Chain Technology• Transportation Operations• Business Development• Quality Assurance• Research Statistics• Regulatory Affairs

Silver Sponsors:Incorporatedin1998,DGPIntelsiusspecializesinthedesign,manufactureandsupplyoftemperature-controlledpackagingandregulatory-compliantsampletransportsolutions.Withastrongfocus

ondevelopingenvironmentallysustainableproductsandprocedures,weofferclientsaneco-friendlywaytoensuretheintegrityoftheirproducts.DGPIntelsiushasagrowingglobalpresence,withmanufacturingfacilities,distributionhubsandlocalofficessituatedthroughouttheworld,includingNorthAmerica,EuropeandAsia.Wearededicatedtoprotectinglife’smostpreciouscargo.For further information please visit: www.intelsius.comDurbinisagloballeaderinclinicaltrailsupply,specialisinginComparators,StandardofCaremedicationsandAncillarysupplies.Basedonitsfoundations,heritageandexperienceDurbinbringsadifferencefortheClinicalTrialsupplymarket.Thisdifference–TheDurbinDifference–canbesummarisedas1)Globalsourcingcapability–frequentlysourcingfromover100countries,2)Globalcustomdistribution–customdistributionsolutionsto180countries3)Transparentpricing–fulldisclosureofallpurchasecostsandinvoices.Formoreinformationpleasecontactclinicaltrialsupply@durbin.co.ukor+442088696517.Provenreliability.It’sinourDNA.For further information please visit: www.durbin.co.uk

TheHauptPharmaGroupisoneofthelargest,fullyintegratedcontractdevelopmentandmanufacturingorganisationsinEuropewithnineproductionsitesinGermany,France,ItalyandJapan.Ourservicescoverthecompleteprocesschainfromlabscaleformulationdevelopmentviaprocess

developmentandvalidationtocommercialscaleproduction.Aportfolioofstandardpharmaceuticaldosageformsisroundedoffbylyophilizedformulations.InadditiontoconventionalAPIs,HauptPhamahandlescytotoxics,hormonesandcontrolleddrugs.Ourcorporatedevelopmentorganisationprovidesasinglecustomerinterfacefordevelopment,analyticsandclinicaltrialsupplies.For further information please visit: www.haupt-pharma.deAssociate Sponsors:

Sofrigam,coldchainexpert.RelyonSofrigam’sexpertise,packagingandservicestowarrantyyourcoldchainsecurity.Sofrigamdesignsandqualifiesisothermalandrefrigeratedpackagingenablingthetransportofheatsensitiveproducts(fresh

orfrozen)innon-refrigeratedvehicles.ThematerialsusedassociatedwiththeexpertiseofourengineersandourpartnershipwithAterMetrologieLaboratory,meansourproductsaresuitableforsectorsthatareVERYdemandingwithregardtoqualityandsafety,suchasthepharmaceutical,chemical,biotechnologyindustries.Weofferourclientsarangeofstandardormade-to-measureproductsandservicesenablingthemtoestablishsecure,economicalandecologicalcoldchainlogistics.For further information please visit: www.sofrigam.com

BasedinFrance,EuromedexisanexperiencedpartnerforCROsandpromotersinvolvedinclinicaltrials.Euromedexorganizesandfollowsallthelogisticsofclinicaltrials,frommanufacturingtodeliveryofthedrugtotheinvestigators.

Servicesprovidedareinstrictcompliancetolawsandregulatory;EuromedexhasaQualityAssuranceSystemallowingtofulfillmostdemandingpharmaceuticalrequirementsandespeciallyGMP/GDP.Euromedexoffersservicesofalogisticcentreandacentralpharmacyforalllogisticoperations:reception,checking,storageanddeliveryunderdifferenttemperatureconditions.Weproposeshortdeliverytimetothesites(forFranceinoneday).Goodsflowsaretracedandfollowupisavailable.For further information please visit: www.euromedex.com

AlmacClinicalServices,partoftheAlmacGroup,hasover20yearsexperiencedeliveringafullrangeofglobalclinicaltrialsupplyandinnovativetechnologysolutionstoPharmaceuticalandBiotechCompaniesworldwide.Wearethemosttrustedand

stablenameintheclinicalsupplymarketplace.WearedifferentiatedbyourexceptionalclientservicepoweredbyexperiencedandknowledgebasedProjectManagement.Ourclinicalsupplyservicesinclude:Globalcomparatorsourcing,Blindingandover-encapsulation,Packagingandlabellingoftrialsupplies,OnlineLabelApprovalSystem,Globaldistributionanddepotnetwork,ShippingTemperatureMonitoring(STEMS),ProjectManagementandQualifiedPersonconsulting,rangeofanalyticalservicesanddrugsupplymanagement.For further information please visit: www.almacgroup.com

Media Partners:PharmiWeb.comistheleadingindustry-sponsoredportalforthepharmaceuticalsector.Supportedbymostoftheleadingpharmaceuticalcorporations,PharmiWeb.comprovidesdynamicreal-timenews,features,

eventslistingsandinternationaljobstoindustryprofessionalsacrossEuropeandtheUS.For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGYEUROPEisownedbyBIOTECHNOLOGYWORLD.ItisbasedandlocatedinWarsaw,Poland.BiotechnologyWorldwasfoundedin2007toprovidetheworld’sbiotechandpharmainformationandmarkettomakeituniversally

accessibleandusefulforscientificandbusinessprocesses.ItsfirststeptofulfillingthatmissionwasbuildingtheBIOTECHNOLOGYEUROPEplatformthatwillallowaquickspreadofinformationindifferentchannels.BIOTECHNOLOGYEUROPEofferscompaniescompletedinternetpublicrelations,publicationandmarketingsolutions.OneofthemainsgoalsofBIOTECHNOLOGYEUROPEistointegratetheBiotechandPharmaSectorinEuropetoglobalbiotechnology,pharmaceuticalandlifescienceactivities.For further information please visit: www.biotechnology-europe.com

FuturePharmaceuticalshasforgedpowerfulrelationshipswithkeyindustryleaderstoprovideaplatformforsuccessfulbrandrecognition,andforseniordecision-makerstohavethemeanstoprocureandplan

implementationstrategiesbasedonthetopicscovered.Positionedtobeanauthoritativeresourcewithintoppharmacompaniesaswellassmall,specialty,andbiotech,FuturePharmaceuticalsmagazineisgearedtocreateadeeppenetrationintoahighlytargetedandresponsiveaudience,bridgingthegapbetweentheindustries’topissuesandthesolutionstop-tiervendorscanprovide.For further information please visit: www.futurepharmaus.com

InPharmistheonlineplatformforexclusivepharmaceuticalnews,comment,contracts,services,jobsandeventsandishometoInPharmjobs.com,PharmafileandPharmafocus.

For further information please visit: www.inpharm.comWelcometoPharmaceuticalOutsourcing,thejournaldedicatedtopharmaceuticalandbiopharmaceuticalcontractservices.Withregularsectionsoncontractmanufacturing,contractresearch,contractpackaging,formulation/development

services,contractanalyticaltesting,APIs,stabilitytesting,clinicalresearchandotherareas,webringthemostcompletecoverageoftrendsandissuesintheindustrytoour15,000readersinNorthAmerica.For further information please visit: http://pharmoutsourcing.com

Driving the Industry Forward | www.futurepharmaus.com

Sponsorship and exhibition opportunitiesThiseventoffersauniqueopportunitytomeetanddobusinesswithsomeofthekeyplayersinthepharmaceuticalandbiotechindustries.Ifyouhaveaserviceorproducttopromote,youcandosoatthiseventby:•Hostinganetworkingdrinksreception•Takinganexhibitionspaceattheconference•Advertisinginthedelegatedocumentationpack•Providingbrandedbags,pens,gifts,etc.Ifyouwouldlikemoreinformationontherangeofsponsorshiporexhibitionpossibilitiesforvisiongain'sClinicalTrialLogistics&SupplyConference,pleasecontactus:Damian Gorman, +44 (0)20 7549 9934 damian.gorman@visiongainglobal.com

Diagnostics SciencesClinicalTechnologies

ClinicalServices

PharmaServices

09:00 Registration and refreshments

09:30 Opening address from the Chair

09:40 Designing a clinical programme

•Understandingcorporateandclinicalresearchgoals

•Planningandimplementingasuitableprogramme

•Casestudyexamples

Uwe Gudat MedicalDirector,OfficeoftheChiefMedicalOfficerMerck Serono

10:20 Coordinating complex clinical information flow phase III

•AligningclinicalinformationfrommultipleCROsandbigpharma

•Managingchallengestoevolveintosuccess

•LessonslearnedfromanalliancephaseIIIdevelopmentprogramme

Martin Simán ClinicalInformationScienceDirectorAstraZeneca

11:00 Morning refreshments

11:20 Quality considerations for audit compliance

•OverseeingtrialprogressandensuringitmeetsGCPguidelinesandsponsorSOPs

•Therolesofthesponsorofaclinicalinvestigation,theIRB,orindependentethicscommittee

•Therolesandresponsibilitiesoftheclinicaltrialinvestigator

12:00 Strategic considerations for patient recruitment, retention and compliance in multinational trials

•Recruitmentpracticesacrosscultures;thegood,thebadandtheugly

•Minimisingdropout;enhancingpatientretention

•Violationsanddeviations;strategiestoimprovecompliance

Penelope Ward SeniorDirector,ExperimentalMedicineUCB New Medicines

12:40 Networking lunch

13:40 Predictive drug supply modelling in clinical trials (statistical methodology and software)

•MainuncertaintiesandrisksinCTsupplychainprocesses

•Predictivepatientrecruitmentandrisk-basedsupplymodellingtools

•Softwaretoolsfordrugsupplymodelling

Vladimir Anisimov SeniorDirector,ResearchStatisticsUnit,QSciGlaxoSmithKline

14:20 Presentation to be announced

Robert Donnell BusinessDevelopmentManagerDurbin

14:40 Bioequivalence and strategic comparator sourcing

•Benefitsofasinglecomparatorforaworldwidetrial

•Bioequivalence:ifitwalkslikeaduckandquackslikeaduck…

•FDAWaivers

Angus Cameron DirectorandSeniorVicePresidentPharmarama International

15:20 Afternoon refreshments

15:40 Drug pooling as a clinical supply strategy

•Definitionandregulatorybackgroundofdrugpooling

•Possibledrugpoolingapproaches,benefitsandchallenges

•Casestudy:poolingatsitesacrossstudies

Maria Eugenia Giribets Parra ClinicalSupplyChainCoordinatorBoehringer-Ingelheim Pharma

16:20 Assay development and sample management

•Samplehandling

•Sampleloggingandtrackingthroughtheanalysiscycle

•Reducinguncertaintythroughqualityassurance

Bassam Hallis ProjectManagerHealth Protection Agency

17:00 Closing remarks from the Chair

17:10 Networking drinks

Take your discussions further and build new relationships in a relaxed and informal setting.

Day 1Clinical Trial Logistics & Supply

Thursday 29th September 2011

Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

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Day 2Clinical Trial Logistics & Supply

Friday 30th September 2011

09:00 Registration and refreshments

09:30 Opening address from the Chair

Justin Doel ClinicalSuppliesManagerNovartis Vaccines & Diagnostics, Global Clinical Research & Development

09:40 Personalised medicine – it’s always about YOU, isn’t it?

•Importanceofstratification

•Impactonclinicaltrials

•Aglimpseofthefuture

Angus Cameron DirectorandSeniorVicePresidentPharmarama International

10:20 Customs requirements in Eastern Europe

•Settingqualityagreements

•Decidingcontractualpartners

•EssentialGMP/GDPcontents

11:00 Morning refreshments

11:20 Essential steps towards successful clinical trial supplies in Eastern European countries - case study

•RationaleforconductingstudiesinEEUcountries

•AdditionalregulatorychallengesinEEUcountries

•Casestudy:real-lifeexperience&lessonslearned

Annegret Van der Aa ClinicalTrialManager,DevelopmentGalápagos

12:00 Presentation to be announced

•Identifyingtherighttransportstrategyforyourclinicaltrialwithfocusoncentrallab

•Managingrisksonclinicaltrialsampletransportation

•Rightsizingyourbatchshipmentfrequency

Stuart McGuire ExecutiveDirectorGlobalBusinessDevelopmentChiltern

Lewis Cameron ChiefExecutiveOfficerClearstone Laboratories

12:40 Networking lunch

13:40 Management and supply challenges in emerging markets

Optimisingprocurement,distributionandthird-partydeliveriesareamongthemanychallengesencounteredwhenrunningtrialsinBRICKandEEUcountries.Panelistswilldiscussstrategiestoovercometheseandotherhurdles,aswellascomplyingwithregulatory,QAstandardsandlabellingguidelines,choosingandsupplyinginvestigatorsites,andmeetingnationalinspectionstandards.Selectingtherighttransportstrategyandrealistictimelinesforobtainingimportlicenseswillalsobeconsidered.Pleaseemailyourquestionsforthepaneltojohn.shah@visiongainglobal.com.

Chair: Angus Cameron, DirectorandSeniorVicePresident,Pharmarama International

Annegret Van der Aa, ClinicalTrialManager,Development,Galápagos

Stuart McGuire, ExecutiveDirectorGlobalBusinessDevelopment,Chiltern

Lewis Cameron, ChiefExecutiveOfficer,Clearstone Laboratories

Robert Donnell, BusinessDevelopmentManager,Durbin

14:20 Managing time and temperature sensitive supply chains

•Planninginadvance:fromdepottosite

•Understandinglocaldistributioninfrastructure

•Customsandregulatorycompliance

Sean Smith VicePresident,ClinicalSupplyChainFisher Clinical Services

15:00 Afternoon refreshments

15:20 Piloting RF-enabled technology for temperature monitoring in clinical trails

•PotentialofRFenabledtechnologyfortemperaturemonitoring

•Pilotingexperience(setup,conduct,dataanalysis)

•ConsiderationswhenimplementingRF-technologyfortemperaturemonitoring

16:00 Minimising risk in low-temperature maintenance

•Ensuringintegrityofpackagingcontainers

•Riskassessmenttechniquesinthesupplychain

•Integratedfeedbackprocesses

16:40 Chair’s closing remarks

16:50 End of conference

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Registration FormClinical Trial Logistics & Supply

29th - 30th September 2011, London, UK

www.visiongain.com/clinical-trial-logistics-and-supply

Clinical Trial Logistics & Supply 29th - 30th September 2011Location:ThistleCityBarbican

Address:CentralStreet,ClerkenwellLondonEC1V8DSUK