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1st - 2nd December 2011, Visiongain Conference Centre, London, UK Organised By From characterisation and discovery, through to clinical trials and patient safety – your complete guide to biomarkers To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biomarkers Claudio Carini, Translational Medicine, Pfizer Harsukh Parmar, Global Head of Early Clinical Development, Respiratory & Inflammation Therapy Area, AstraZeneca Laura K. Richman, Vice President, MedImmune Ge Ruigt, Director Experimental Medicine Neuroscience, Merck Ian Hudson, Director of Licensing Division, MHRA David Brooks, Acting Head of the Depart of Clinical Neuroscience, Imperial College London Peter Parker, Professor of Cancer Cell Biology, King’s College, University of London Christian Czech, Group Leader Translational Biomarkers, Roche Theresa Zhang , Research Fellow, Merck Parag Acharya, R&D Manager, Unilever R&D Anna-Christine Bay-Jensen, Group Manager, Cartilage Biology and Biomarkers, Nordic Bioscience Maarten Van Roy, Associate Scientist, Pharmacology, Ablynx Sharmilee Gnanapavan, Neurology Specialist Registrar, Barts and the London NHS Trust Hayley Whitaker, Research Associate, Cancer Research UK Cambridge Research Institute Key Speakers BOOK NOW! 4th Annual Biomarkers Driving the Industry Forward | www.futurepharmaus.com Media Partners

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Page 1: 4th Annual Biomarkers (2011) Pp

1st - 2nd December 2011, Visiongain Conference Centre, London, UK

Organised By

From characterisation and discovery, through to clinical trials and patient safety – your complete guide to biomarkers

To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biomarkers

Claudio Carini, Translational Medicine, Pfizer

Harsukh Parmar, Global Head of Early Clinical Development, Respiratory & Inflammation Therapy Area, AstraZeneca

Laura K. Richman, Vice President, MedImmune

Ge Ruigt, Director Experimental Medicine Neuroscience, Merck

Ian Hudson, Director of Licensing Division, MHRA

David Brooks, Acting Head of the Depart of Clinical Neuroscience, Imperial College London

Peter Parker, Professor of Cancer Cell Biology, King’s College, University of London

Christian Czech, Group Leader Translational Biomarkers, Roche

Theresa Zhang , Research Fellow, Merck

Parag Acharya, R&D Manager, Unilever R&D

Anna-Christine Bay-Jensen, Group Manager, Cartilage Biology and Biomarkers, Nordic Bioscience

Maarten Van Roy, Associate Scientist, Pharmacology, Ablynx

Sharmilee Gnanapavan, Neurology Specialist Registrar, Barts and the London NHS Trust

Hayley Whitaker, Research Associate, Cancer Research UK Cambridge Research Institute

Key Speakers

BOOK NOW!

4th Annual Biomarkers

Driving the Industry Forward | www.futurepharmaus.com

Media Partners

Page 2: 4th Annual Biomarkers (2011) Pp

Conference Introduction4th Annual Biomarkers

1st - 2nd December 2011, London, UK

Dear Colleague,

In2010,theglobalbiomarkersmarketwasanestimatedvalueof$13.5billion1.Forecasters predict significant growth in the years ahead with estimates of$33.3 billion by the end of 2015.This growth will most certainly be drivenby the current demand for biomarkers in drug discovery and other areas ofR&D.Theuseofbiomarkersduringearly stagesofaproductdevelopment isalready saving costs and time in the industry by indicating the possibility offailureatanearlierstageintheresearchprocess.CROshavenowrecognisedthecommercialopportunitiesofbiomarkersandareformingpartnershipswithprovidersandbuildingin-housecapabilities.

Visiongain’s 4th Biomarkers Conference will provide attendees with an in-depthunderstandingof theuseofbiomarkers inR&Dandwillexplore recentdevelopmentsinthisfastgrowingsector.Industryexpertswillalsoaddressunmetneeds,challengesanddiscusspracticalaspectsofbiomarkerimplementation.

Why you should attend this conference

•Heartheregulatoryperspective–biomarkersindrugdevelopment

•Reviewnoveltargetsinbiomarkerdiscovery

•Discusshowbiomarkerscanaccelerateyourclinicaldevelopment

•See how improvements in technologies are leading to better efficiency ofbiomarkers

•Analysebiomarkersandtheirroleindrugdevelopment

•Assesspreclinicalsafetyconsiderations

•Discusspredictivebiomarkerdiscoveryanddevelopmentforcancertreatment

•UnderstandtheroleofEEGasabiomarkerinpsychiatry

•Evaluatebiomarkersdiscoveryusingnon-invasivemetabolomics&challenges

Ilookforwardtomeetingyouattheconference Bestregards

Koos Mohammed Conference Producer

Who should attend this conference?Senior VPs, Chief Scientific Officers, Directors, Managers, Professors, Scientists, and Principal Investigators in:• Biomarker Development Programmes • Clinical Pharmacology • Clinical Research • Drug Discovery and Development • Recombinant DNA technology • Medical imaging • Safety Assessment • Assay Development • Proteomics/ Genomics Programmes • Metabolomics • Epigenomics • Molecular toxicology • Regulatory Affairs • Translational Medicine • Oncology • CNS • Inflammation and Immunology • Biological Sciences • Diagnostics • Bioanalysis • Pharmacokinetics & Drug Metabolism • Genomics Business Development • Cellular & Molecular Development • Clinical Discovery Technologies • Pharmacogenomics & Human Genetics • Discovery Research • Bioengineering

Media Partners:PharmiWeb.comistheleadingindustry-sponsoredportalforthepharmaceuticalsector.Supportedbymostoftheleading

pharmaceuticalcorporations,PharmiWeb.comprovidesdynamicreal-timenews,features,eventslistingsandinternationaljobstoindustryprofessionalsacrossEuropeandtheUS.For further information please email: [email protected]

BIOTECHNOLOGYEUROPEisownedbyBIOTECHNOLOGYWORLD.ItisbasedandlocatedinWarsaw,Poland.

BiotechnologyWorldwasfoundedin2007toprovidetheworld’sbiotechandpharmainformationandmarkettomakeituniversallyaccessibleandusefulforscientificandbusinessprocesses.ItsfirststeptofulfillingthatmissionwasbuildingtheBIOTECHNOLOGYEUROPEplatformthatwillallowaquickspreadofinformationindifferentchannels.BIOTECHNOLOGYEUROPEofferscompaniescompletedinternetpublicrelations,publicationandmarketingsolutions.OneofthemainsgoalsofBIOTECHNOLOGYEUROPEistointegratetheBiotechandPharmaSectorinEuropetoglobalbiotechnology,pharmaceuticalandlifescienceactivities.For further information please visit: www.biotechnology-europe.com

FuturePharmaceuticalshasforgedpowerfulrelationshipswithkeyindustryleaderstoprovideaplatformforsuccessful

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

InPharmistheonlineplatformforexclusivepharmaceuticalnews,comment,contracts,services,jobsandeventsandis

hometoInPharmjobs.com,PharmafileandPharmafocus.For further information please visit: www.inpharm.com

Driving the Industry Forward | www.futurepharmaus.com

Sponsorship and exhibition opportunities

Thiseventoffersauniqueopportunitytomeetanddobusinesswithsomeofthekeyplayersinthepharmaceuticalandbiotechindustries.Ifyouhaveaserviceorproducttopromote,youcandosoatthiseventby:

•Hostinganetworkingdrinksreception•Takinganexhibitionspaceattheconference•Advertisinginthedelegatedocumentationpack•Providingbrandedbags,pens,gifts,etc.

Ifyouwouldlikemoreinformationontherangeofsponsorshiporexhibitionpossibilitiesforvisiongain's4thAnnualBiomarkersConference,pleasecontactus:

Piyush Patel, +44 (0)20 7549 9961 [email protected]

1Biomarkers:TechnologiesandGlobalMarkets(BCCResearch,March2011)

Poster PresentationAtabusyconferenceitishardtomakesureeveryonewhosharesyourinterestsknowswhatyouaredoing.MaximiseyourtimeatVisiongain’s4thAnnualBiomarkersmeetingbysharingyourresultsinaposterpresentation.Withaplethoraofkeydecisionmakers,takeadvantageofthisseniornetworkingopportunity.Pleasesendyour200wordabstract,inEnglish,to:info@visiongainglobal.comforapproval.ThedeadlineforsubmissionsisMonday14thNovember,2011.Pleaseincludecontactdetailsforthecorrespondingauthor(s).Academicinstitutionswillnotbechargedafeeifbookedasfull-pricedelegates.Posterssubmittedbypharmaceuticalandbiotechnologyfirmswillbechargedafeeof£199.Posterssubmittedbyserviceproviders/vendorsarewelcomeandwillbesubjecttoevaluation.Uponapprovalafeeof£500willapply.Twodelegatesfromyourorganisationmustbebookedatfullpricetopresentaposter.PleasenotethatallposterswillbedisplayedatthediscretionofVisiongainLtdandaresubjecttoapproval.Duetolimitedspace,pleaseregisteryourinterestearly.

Page 3: 4th Annual Biomarkers (2011) Pp

09:00 Registration and refreshments

09:30 Opening address from the Chair

Claudio Carini TranslationalMedicinePfizer

09:40 Biomarkers in drug development – regulatory perspective

•Regulatoryacceptanceofnewbiomarkers

•Strategiesforincreasingthenumberofqualifiedbiomarkers

•Challengingissues

Ian Hudson DirectorofLicensingDivisionMHRA and CHMP Member

10:20 Precision Medicine critically affects innovation in clinical development strategy and drug therapy

•Biomarkersaspartofanewparadigm

•Newstudydesignsandre-definingthetraditionalpathwayofdrugdevelopment

•Needforamorecollaborativeapproachbetweenbasicandclinicalresearch

•Embracingnewinnovativetechnologies

Claudio Carini TranslationalMedicinePfizer

11:00 Morning refreshments

11:20 Predictive biomarker discovery and development for cancer treatment

•Discoveryofbiomarkerspredictiveofresponsetooncologydrugcandidates

•Developmentofassaystoassessbiomarkersinhumantumorspecimens

•Useofbiomarkerassaysinoncologyclinictrials

Theresa Zhang ResearchFellowMerck

12:00 Biomarkers: discovery strategies and technologies

•Strategiesforprovidingtrulypersonalisedpredictivebiomarkersandproximalbiomarkersinrespectofthecurrenttrancheofdrugsinuseandindevelopment

•Reviewofemergingnewtechnologiesforgeneratingsophisticatedreadoutsdirectlyinformativeondrugactionandthepredictionofdrugresponsiveness

Peter Parker ProfessorofCancerCellBiologyKing’s College, University of London

12:40 Networking lunch

13:40 Biomarker strategy for successful non-clinical to clinical translation

•Developmentofbiomarkerstrategy

•Selectionofspeciesforsafetyandefficacytesting

•Dispositionofdrug-targetcomplexassafetymarker

•TranslationofPDeffectfromnonclinicalspeciestoman

Maarten Van Roy AssociateScientist,PharmacologyAblynx

14:20 EEG as a biomarker in psychiatry

Ge Ruigt SeniorDirectorTranslationalMedicineNeuroscienceMerck

15:00 Afternoon Refreshments

15:20 Biomarkers target in validation and discovery in early development

•Strategiesforacceleratingdevelopment

•Reducingtherisksoffailuresatlaterstagesofresearch

Harsukh Parmar GlobalHeadofEarlyClinicalDevelopment,Respiratory&InflammationTherapyAreaAstraZeneca

16:00 Selecting the right drug for patients

•Demonstrationofcost-effectiveness

•Adoptionoftestsinclinicalpractise

•Teststoreducesideeffects

16:40 Closing remarks from the Chair

16:50 Networking drinks

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

Day 14th Annual Biomarkers

Thursday1st December 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

CA

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Day 24th Annual Biomarkers

Friday 2nd December 2011

09:00 Registration and refreshments

09:30 Opening address from the Chair

Hayley Whitaker ResearchAssociateCancer Research UK Cambridge Research Institute

09:40 Rational biomarker strategies in drug development

•Useofbiomarkersinearlystagesofdrugdevelopment

•Maximisingutilityofpharmacodynamicmarkersindrugdevelopment

•Examplesofbiomarkerstrategiesindrugdevelopment

Laura K. Richman VicePresidentMedImmune

10:20 Biochemical markers of ongoing joint damage in arthritis - current and future biomarkers of prognosis and efficacy measurements

•Targetingpathologyspecificmarkers

•Examplesofnovelbiochemicalmarkersofextracellularmatrixremodelling,Neo-Epitopes

•Useofapathologicalrelevantbiochemicalmarkersforprognosisandtreatmentefficacyinrheumatoidandjointdegenerativediseases

Anna-Christine Bay-Jensen GroupManager,CartilageBiologyandBiomarkersNordic Bioscience

11:00 Morning refreshments

11:20 Biomarkers discovery using non-invasive metabolomics & challenges

•Metabolomics-what’snew?

•Non-invasivemetabolomics-why,where&how

•Metabolomicsbasedbiomarkerdiscovery-currentstatus,emergingscope&futurechallenges

Parag Acharya R&DManagerUnilever R&D

12:00 Sponsor Spotlight Session

Takethisuniqueopportunitytobeapartoftheconferencetheme,network,shareideasandprovideanoverviewofyourproduct/servicestotheaudience.Formoreinformationpleasecontactpiyush.patel@visiongainglobal.com

12:40 Networking lunch

13:40 Neurofilament heavy chain in multiple sclerosis: from bench to bedside

•MultipleSclerosis(MS)–whatweknowandtheroleforbiomarkers

•Thestagesofbiomarkervalidationtowardsaviablesurrogateend-point

•Neurodegenerationandevaluationofaxonalpathologyusingneurofilamentheavychain

•Neurofilamentsinclinicaltrial:cannabiniodsinCREAEandLamotrigineinSecondaryProgressiveMS

•Thefuture:BioMS-euconsortiumforbiomarkerresearch

Sharmilee Gnanapavan NeurologySpecialistRegistrarBarts and the London NHS Trust

14:20 The role of molecular imaging for drug development in CNS disorders

•MIcan:

-Supportclinicaldiagnosisandaidscreeningfortrials

-Followdiseaseprogression

-Helpunderstanddiseasemechanisms

-Helpunderstanddrugmechanisms

-Allowdose-receptor/enzymeoccupancyprofilestobegeneratedfornoveltherapeutics

David Brooks ActingHeadoftheDepartofClinicalNeuroscienceImperial College London

15:00 Afternoon refreshments

15:20 Biomarkers for CNS diseases: Of Mice and Men

•ChallengeofIdentifyingCNSbiomarkers

•Technologiesforbiomarkeridentificationandtheirapplication

•ExamplesfornewCNSbiomarkersandhowtheyhavebeenidentified

Christian Czech GroupLeaderTranslationalBiomarkersRoche

16:00 Biomarker data management and analysis

•Newtechnologiesaroundbiomarkersandtheirinterplaywithdrugdevelopment

•Minimisingrisks:emergingtechnologiesandtheirimplications

16:40 Chair’s closing remarks

16:50 End of Conference

Page 5: 4th Annual Biomarkers (2011) Pp

How to bookEmail:[email protected]:http://www.visiongain.com/biomarkers

UK Office:Tel: +44(0)207549 9961Fax:+44(0)2075499932 VisiongainLtdBSGHouse226-236CityRoadLondonEC1V2QYUK

General informationVenue:VisiongainConferenceCentre230CityRoad,London,EC1V2TT.UnitedKingdom.ClosesttubestationisOldStreet(NorthernLine).Accommodation:ThistleCityBarbican,CentralStreet,Clerkenwell,London,EC1V8DS,Phone:08713769004/+448453058304,Fax:08713769104/+448453058343http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.htmlTravelodgeLondonCityRoadHotel,7-12CityRoad,London,EC1Y1AE,Tel:08719846333,Fax:02076282503,http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340

Payment terms:Visiongainrequirethefullamounttobepaidbeforetheconference.VisiongainLtdmayrefuseentrytodelegateswhohavenotpaidtheirinvoiceinfull.Acreditcardguaranteemayberequestedifpaymenthasnotbeenreceivedinfullbeforetheevent.VisiongainLtdreservestherighttochargeinterestonunpaidinvoices.

Substitutions/name changes or cancellations: Thereisa50%liabilityonallbookingsoncemade,whetherbypost,fax,emailorweb.Thereisanorefundpolicyforcancellationsreceivedonorafteronemonthbeforethestartoftheevent.Shouldyoudecidetocancelafterthisdate,thefullinvoicemustbepaid.Conferencenoteswillthenbesenttoyou.Unfortunately,weareunabletotransferplacesbetweenconferences.However,ifyoucannotattendtheconference,youmaymakeasubstitution/namechangeatanytime,aslongasweareinformedinwritingbyemail,faxorpost.Namechangesandsubstitutions must be from the same company or organisation and are not transferable betweencountries.Pleasenotethatdiscounteddelegatesplacesatavisiongaineventarenonrefundable.

Invoice alterations:Therewillbeanadministrationchargeof£50foranychangestoaninvoice,excluding substitutions/name changes, requested by the customer. This will be charged to thecustomerbycreditcardpriortothechangesbeingmade.

Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executivebriefingcontent,timing,speakersorvenuewithoutnotice.TheeventmaybepostponedorcancelledduetounforeseeneventsbeyondthecontrolofvisiongainLtd.Ifsuchasituationarises,wewilltrytorescheduletheevent.However,visiongainLtdcannotbeheldresponsibleforanycost,damageorexpenses,whichmaybeincurredbythecustomerasaconsequenceoftheeventbeingpostponedorcancelled.Wethereforestronglyadviseallourconferenceclientstotakeoutinsurancetocoverthecostoftheregistration,travelandexpenses.

Data Protection: Visiongain Ltd gathers and manages data in accordance with the DataProtectionAct1988.YourpersonalinformationcontainedinthisformmaybeusedtoupdateyouonvisiongainLtdproductsandservicesviapost,telephone,faxoremail,unlessyoustateotherwise.Wemayalsoshareyourdatawithexternalcompaniesofferingcomplementaryproductsorservices.Ifyouwishforyourdetailstobeamended,suppressedornotpassedontoanyexternalthirdparty,pleasesendyourrequesttotheDatabaseManager,visiongainLtd,BSGHouse,226-236CityRoad,London,EC1V2QY.Alternatively,youcanvisitourwebsiteatwww.visiongain.comandamendyourdetails.Pleaseallowapproximately30daysforyourremovalorupdaterequesttobeappliedtoourdatabase.Followingyourremovalorupdaterequest,youmayreceiveadditionalpiecesofcommunicationfromvisiongainLtdduringthetransitionalperiod,whilstthechangesarecomingintoeffect.

Fee: Theconferencefeeincludeslunch,refreshmentsandconferencepapersprovidedontheday.This feedoesnot include travel, hotel accommodation, transfersor insurance, (whichwe stronglyrecommendyouobtain).

VAT: VATwillbechargedatthelocalrateoneachconference.DelegatesmaybeabletorecoverVATincurredbycontactingEurocashCorporationplc+44(0)1273325000,eurocash@eurocashvat.com.Eurocashspecialiseinrecoveringcross-borderVAT.

How we will contact you: VisiongainLtd’spreferredmethodofcommunicationisbyemailandphone.Pleaseensurethatyoucompletetheregistrationforminfullsothatwecancontactyou.

Unable to attendObviouslynothingcomparestobeingtherebutyouneednotmissout.Simplyticktheboxandsendwithyourpayment.YouwillreceivespeakertalksinPDFstwoweeksaftertheevent.

Yes, please send me speaker talks Price£550 VAT:£110 Total:£660

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Registration Form4th Annual Biomarkers

1st - 2nd December 2011, London, UK

www.visiongain.com/biomarkers

4th Annual Biomarkers 1st - 2nd December 2011Location:VisiongainConferenceCentre

Address:230CityRoadLondonEC1V2TTUK

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