ClinicalProgrammingWorkshop

October10,2009

SinoAmericanPharmaceuticalProfessionalsAssociation

PerspectivesonClinicalProgrammingWorkChallenges

Sino-American Pharmaceutical Professionals Association

Clinical Programming Workshop

Agenda

Perspectives on Clinical Programming Work Challenges

Mingde Xia, Ph.D., SAPA President (2008-2009) Jisong Cui, Ph.D., SAPA President (2009-2010) Ing-Ming Pan, Workshop Chair Workshop Executive Committee Members: Danny Chaing, Varsha Chhatre, Cynthia He, Wenli Hu, Sarah Shiue, Ron Simpson, Mike Todd, Tricia Yeh, Aatiya Zaidi www.sapaweb.org

Saturday, October 10, 2009 (8:00 AM to 5:00 PM)

Jadewin Fine McDonnell Building McDonnell Hall A01/02, Princeton University, 76 Washington Road, Princeton, New Jersey 08540 Registration and Breakfast (8:00 AM to 9:00 AM) Morning Session (9:00 AM to 12:30 PM) 9:00 AM 9:05 AM Opening Remarks Mingde Xia, Ph.D., and Jisong Cui, Ph.D. SAPA President (2008-2009), SAPA President (2009-2010) Welcome and Meeting Agenda Ing-Ming Pan, Workshop Chair Johnson & Johnson

9:05 AM 9:15 AM

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Morning Parallel Discussions Discussion 2
Drug Development Process Session Chair: Tricia Yeh 9:15 AM 10:45 AM Clinical Trials: Basic Regulatory and Statistical Considerations Mary Johnson, Ph.D., PharmaNet 10:45 AM 11:00 AM, Coffee Break 11:00 AM 12:00 PM Fundamentals of Investigational New Drug Application Andrew Chang, Ph.D., PharmaNet 12:00 PM 12:30 PM Philadelphia University SAS Certificate Program Carol Matthews, United BioSource Co

9:15 AM - 12:30 PM Discussion 1

CDISC / eSubmission Session Chair: Sarah Shiue / Varsha Chhatre 9:15 AM 9:45 AM Taste of SDTM Changhong Shi, Beilei Xu, Merck 9:45 AM 10:15 AM SDTMIG 3.1.2 vs SDTMIG 3.1.1, What Are the Major Differences Fugui Dong, Ph.D., PharmaNet 10:15 AM 10:45 AM Insights into ADaM Matt Becker, PharmaNet 10:45 AM 11:00 AM, Coffee Break 11:00 AM 11:30 AM Introduction to CDISC ADaM V2.1 and ADaMIG V1.0 John Troxell, Merck 11:30 AM 12:00 PM CDISC Pilot II SDTM/ADaM Implementation Issues Yuguang Zhao, and Sarah Shiue Eisai, and Merck 12:00 PM 12:30 PM Electronic Submission Process Denis Michel, Johnson & Johnson

Lunch (12:30 PM to 1:30 PM)

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Agenda
Afternoon Session (1:30 PM to 5:00 PM)

1:30 PM 2:45 PM Discussion 1

Afternoon Parallel Discussions Discussion 2

1: 30 PM 2:15 PM Panel Discussion: Career Path for a SAS Programmer Session Chair: Aatiya Zaidi Panelists: Jaishri Alladi, Johnson & Johnson Denis Michel, Johnson & Johnson Peter Ouyang, Celgene Sarah Shiue, Merck ***************************************** 2:15 PM 2:45 PM Market Your Talent Wenmei Ge, Johnson & Johnson

Programming Technical / Process Tips Session Chair: Cynthia He 1:30 PM 2:00 PM Using Google to Solve SAS Problems Mike Todd, Nth Analytics 2:00 PM 2:20 PM A Complete Derivation of Duration and Display in ISO 8601 Using SAS Program Joyce Gui, Helen Wang, and Sandy Wang Independent Consultant, Merck, and Rutgers 2:20 PM 2:40 PM Verifying Changes in Output Eric Carleen, PharmaNet

2:45 PM 3:00 PM 3:00 PM 4:45 PM

3:00 PM 3:45 PM 3:45 PM 4:15 PM 4:15 PM 4:45 PM

Coffee Break Soft Skills Session Chair: Danny Chaing

Business Communication Skills: A Powerful Factor for Your Career Judy West, English That Works, Inc Communication Skills: Techniques You Can Apply Lisa Lyons, Johnson & Johnson Panel Discussions Danny Chaing, Barry Schwab, Lisa Lyons, Judy West and Tricia Yeh Johnson & Johnson, English That Works, and PharmaNet

4:45 PM 4:50 PM

Conclusion of the Event Ing-Ming Pan

5:00 PM 8:00 PM, Dinner and Fellowship (optional)

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AbstractandBiography

WorkshopChairIngMingPan:Ms.PanhasbeenwithJohnson&Johnsoncompaniesfor over20years.ShejoinedOrthoPharmaceuticalCompanyin1988asaProgrammingConsultant andin1989movedtoJohnson&JohnsonP.R.D.asaScientificProgrammer.Sincethen,she hadincreasedresponsibilitiesindatamanagement,programming,andprojectmanagementin Johnson&JohnsonPharmaCompanies.SheiscurrentlymanagingateamofSASprogrammers intheInternalMedicineandCardiovasculartherapeuticareasatJohnson&Johnson. PriortojoiningJohnson&JohnsonsheworkedattheUniversityofTexasMedicalSchoolin HoustonandattheHunterdonMedicalCenterinFlemington,NJ. AfterreceivingaBSdegreeandanMSdegreefromNationalTaiwanUniversity,Ms.Panthen movedtotheUSwhereshereceivedanMSdegreeinHumanNutritionandBiochemistryfrom MississippiStateUniversity.SheisalsoacertifiedMedicalTechnologist(ASCP).

CDISC/eSubmission
SessionChair:SarahShiue,Merck/VarshaChhatre,Novartis
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CDISCSessionChairSarahShiue:Ms.ShiueistheDirectorofScientificProgramming responsiblefortheMerckscientificprogramminggroupinRahway,NewJersey.Shehasbeen inthePharmaceuticalIndustryformorethan20yearsmostlyatJohnson&Johnsonandwasat AventispriortojoiningMerckin2005.Shehasbroadexperiencesinreportingandglobal regulatorydossiersubmissionsinseveraltherapeuticareasandhadinvolvedcloselyin developingstandardsystemsandprocessesatJohnson&JohnsonandAventis.Ms.Shiuewas amemberoftheCDISCSDSandADaMworkinggroupsin20002007representingJohnson& Johnson,AventisorMerckrespectivelyandhadparticipatedinthefirsttwoCDISCFDASDTM pilots. eSubmissionSessionChairVarshaChhatre:Ms.Chhatrehasbeenworkingintheapplications ofStatisticsandtheStatisticalProgrammingareasformorethan20years.CurrentlyasaSr. PrincipalProgrammeratNovartisPharmaceuticals,sheissupportingtheEarlyClinical Development(ED)studiesinalltherapeuticareas.ShehasbeenaSASuserformorethan10 yearsandeSubmissionisoneofherinterests.CurrentlyatNovartis,sheisresponsiblefor coordinatingandreviewingEDdeliverables,mostlyCRTsrequiredforallNovartisesubmissions. Ms.ChhatrehasaMasterdegreeinAppliedStatisticsfromIndia,aMasterdegreeinStatistics fromUniversityofVictoria,CanadaandaMasterscertificateinProjectManagementfrom GeorgeWashingtonUniversity.
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TasteofSDTM
ChanghongShiandBeileiXu,Merck Abstract: TheStudyDataTabulationModel(SDTM)isaClinicalDataInterchangeStandardsConsortium (CDISC)standard.AtMerck,pilotstudieshavebeencompletedinwhichSDTMisimplemented tothecollecteddataupfrontwiththefollowingprovenadvantagesfromSDTM: 1.standardizationacrossstudies. 2.facilitationofdataintegritychecking. 3.tabulationdatastructuresreadilyleveragedforADaM(AnalysisDatasetModel)datasetup. Thispaperwilldescribethesethreeadvantagesindetail. Biography: Ms.ChanghongShiisaScientificProgrammingAnalystatMerck&Co.,Inc.Shehasworkedas aSASprogrammerfor8.5years.BeforejoiningMerck,Ms.Shihadworkedasaninformation specialistinStatisticsCanadaforoneandhalfyears.HerareasofexpertiseincludetheBaseSAS, SASMacroLanguage,SAS/CONNECT,VisualBasic,JavaandOracle. Ms.BeileiXuhasabout12yearsexperienceinSASprogramming.Ms.Xucurrentlyworksin MerckScientificProgramminggroup.
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SDTMIG3.1.2vsSDTMIG3.1.1,WhatAretheMajorDifferences
FuguiDong,Ph.D.,Manager,DatabaseProgramming,PharmaNet Abstract: CDISChasofficiallyreleasedtheStudyDataTabulationModel,Version1.2(SDTMv1.2)andthe SDTMImplementationGuideforHumanClinicalTrials(SDTMIGv.3.1.2)atMarch2009.Once theupdatedsoftwareisavailable,FDAwillmoveto3.1.2.Thispresentationwilldiscusssomeof themajorchangesintroducedin3.1.2release. Biography: Dr.DongisaDatabaseProgrammingManageratPharmaNet.HereceivedhisPh.D.in MolecularBiologyin1997andMSinSystemAnalysisin2000fromMiamiUniversity.Dr.Dongis anOraclecertifiedOracle8iand9iprofessionalandSASCertifiedAdvancedSAS9programmer. HehasbeeninvolvedintheSDTMconversioninthepast3years.

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InsightsintoADaM
MattBecker,PharmaNet Abstracts: ADaM(AnalysisDatasetModel)ismeanttodescribethedataattributessuchasstructure, content,andmetadatathataretypicallyfoundinclinicaltrialanalysisdatasets.TheADaM modelsarebuiltfromtheCDISCSDTMbaseline.Inthispresentation,Mr.Beckerwillbriefly covertheCDISCSDTM3.1.1modelandthenmoveintoanindepthreviewofADaM.Thegoal istoprovidetheattendeesknowledgeoftheADaMmodel,howitrelatestotheCDISCSDTM base,andhowitmayhelpinreducingFDAreviewtime. Biography: Mr.MattBeckerhastwentyyearsofexperienceincontractdrugdevelopment,specializingin statisticalprogrammingandrelatedsoftwaredevelopment.Hehasbeeninstrumentalinthe developmentanddeploymentofnumerousstatisticalprogrammingplatforms.Arecognized leaderinstatisticalprogramminginSAS,Mr.Beckerisafrequentspeakerandleaderatindustry conferencessuchasPharmaSUGandSUGI.
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IntroductiontoCDISCADaMV2.1andADaMIGV1.0
JohnTroxell,AssociateDirector,ScientificProgramming,Merck Abstracts: TheAnalysisDataModel(ADaM)teamoftheClinicalDataInterchangeStandardsConsortium (CDISC)hasdraftedanADaMImplementationGuide(IG).TheIGdescribesrequirementsfor thesubjectlevelanalysisdatasetADSL.TheIGalsodescribesandprovidesrequirementsfor thenewstandarddatasetstructureforanalysisdatasetsthatcontainmultiplerecordsper subject.Thisnewstandardstructuresupportsmostcommonstatisticalanalyses,including,but notlimitedto,changefrombaseline,categorical,andtimetoeventanalyses.Thepresentation willprovideanoverviewofADaMandtheIG,andanintroductiontothenewstandard structureforanalysisdatasets. Biography: Mr.JohnTroxellwrotehisfirstSASprogramin1977.HehasdegreesinEnglish,Horticulture, andStatistics.Mr.TroxellcurrentlyholdspositionofAssociateDirector,ScientificProgramming, atMerck,andhasbeentheCDISCAnalysisDataModel(ADaM)teamleadsinceFebruary2008.

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CDISCPilotIISDTM/ADaMImplementationIssues
YuguangZhao,Eisai SarahShiue,Merck Abstracts: ThemissionoftheCDISC/FDAIntegratedDataPilotwastodemonstratethatadatasubmission createdusingCDISCharmonizedstandardswillmeettheneedsandexpectationsofFDA reviewersinconductinganintegratedsafetyreviewofdatafrommultiplestudiesand compounds.Thepilotwastobeutilizedtoevaluatedataintegration,workflowandprocess, semanticinteroperabilityandstandardanalysisandreporting.Thispresentationwillgivean overviewofacasestudyofexperiencesimplementingtheCDISCmodelsandprovidethe industrywithfeedbackonissuesinimplementingSDTM/ADaM. Biography: Mr.YuguangZhaooriginallycamefromInnerMongoliaofChina.HegraduatedfromUniversity ofNevadaRenowithMSdegree.Hehasbeenworkinginthepharmaceuticalindustryforover 10years.HepreviouslyworkedatSanofiAventis.Atpresent,Mr.ZhaoisworkingatEisai MedicalResearchasthedirectorforglobalstatisticalanalysis,essentiallythestatistical programminggroup.HeusedtobeintheCDISCSDSteamandparticipatedintheCDISCfirst pilotasapilotchair. Ms.SarahShiueistheDirectorofScientificProgrammingresponsiblefortheMerckscientific programminggroupinRahway,NewJersey.ShehasbeeninthePharmaceuticalIndustryfor morethan20yearsmostlyatJohnson&JohnsonandwasatAventispriortojoiningMerckin 2005.Shehasbroadexperiencesinreportingandglobalregulatorydossiersubmissionsin severaltherapeuticareasandhadinvolvedcloselyindevelopingstandardsystemsand processesatJohnson&JohnsonandAventis.Ms.ShiuewasamemberoftheCDISCSDSand ADaMworkinggroupsin20002007representingJohnson&Johnson,AventisorMerck respectivelyandhadparticipatedinthefirsttwoCDISCFDASDTMpilots.

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ElectronicSubmissionProcess DenisMichel,Johnson&Johnson
Abstract: Globalhealthauthoritiesrequireclinicalinformationinelectronicformatforthepurposeof reviewingapplicationstomarketdrugsandbiologics.Electronicsubmissionshaveevolvedover time,withincreasingregulatoryguidanceanddatastandards.Thispresentationexploresthe processofelectronicsubmission,regulatoryreviewissues,andlessonslearnedforfuture submissions. Biography: Mr.Michelhasworkedinclinicaldatamanagementandstatisticalprogrammingat pharmaceuticalcompaniesandContractResearchOrganizationssince1982.HehasbeenaSAS usersince1985,andhaspresentedpapersatlocalandglobalusergroups.Heiscurrently managingateamofSASprogrammersintheneurosciencetherapeuticareaatJohnson& Johnson.Hisfocusareasincludedictionarymanagementandelectronicsubmissions. Mr.MichelhasaBSinBiologicalSciencesfromStateUniversityofNewYorkatStonyBrookand MBAfromSetonHallUniversity.

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Clinical Programming Workshop

AbstractandBiography DrugDevelopmentProcess
SessionChair:TriciaYeh,VicePresident,Biostatistics,PharmaNet

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SessionChairTriciaYeh:Ms.Yehhasover30yearsexperienceinthepharmaceuticaland CROindustry.SheprovidesstatisticalinputinthedevelopmentofprotocolsandCRFsand managesbiostatisticalactivitiesinthepreparationofclinicaltrialreportsandNDA/PLA submissions.Shehasworkedinawidevarietyoftherapeuticareas,notablycardiovascular, oncology,neurology,andendocrine/metabolicindications,andhasextensiveexperiencewith integrationoflegacydatabasesandperforminginterimanalysesfordatamonitoringboards. ShehasaMSdegreeinBiostatisticsfromUniversityofCincinnatiandaMSdegreeinBotany fromMiamiUniversity.

ClinicalTrials:BasicRegulatoryandstatisticalConsiderations
MaryJohnson,Ph.D.,ExecutiveVicePresident,Biostatistics,PharmaNet Abstract: PartIAnoverviewofhowexperimentalmedicalproducts(drug,biologics,devices)are developedandtestedtodetermineiftheyaresafeandeffectiveforuseinhumans. PartIIAnoverviewofstatisticalprinciplesinclinicaltrials(includingbias,blinding, randomization,andtrialdesignissues). Biography: Dr.Johnsonhasservedasastatisticalconsultanttopharmaceuticalclientsforover20years, assistingindesignofdrugdevelopmentprogramsandadvisingclientsonstatisticaland regulatoryaspectsofNDA/PLAsubmissionsforawidevarietyoftherapeuticindications.Dr. Johnsonalsospent8yearsasastatisticalreviewerandgroupleaderintheDivisionof BiometricsattheFDA.Sheisfamiliarwithregulatoryguidelinesandprocesses,andhashelped numerousclientsdevelopefficientandstatisticallysoundresearchprogramstogainrapid markingapproval.ShereceivedherPhDinBiostatisticsatYaleUniversity.

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FundamentalsofInvestigationalNewDrugApplication
AndrewC.Chang,Ph.D.,ExecutiveDirector,PharmaNetConsulting Abstract: Thefollowingtopicswillbepresented: GeneralintroductionoftheFDA WhatisanIND Clinicaltrialregulations INDreviewprocess(focusontheprocessusedinCBER). Biography: Dr.Changhasmorethan19yearsofexperienceinthedevelopmentofbiologicsand pharmaceuticals.AthiscurrentcapacityasanExecutiveDirector,PharmaNetConsulting,Dr. Changhasadvisedclientsontoplevelstrategicplanningandevaluationsrelatedtobiological productdevelopmentintheUS,Europe,andAsiatoefficientlybringproductsfromR&Dto marketingapproval.HehasconsultedonregulatorysubmissionsfrompreINDtomarketing applications;regulatorypathwaysincludingassessingthepossibleregulatoryjurisdiction, orphandrugdesignation,andfasttrackandacceleratedapproval;FDAandEMEArequirements onchemistry,manufacturingandcontrol(CMC);immunogenicityriskassessmentfor therapeuticproteinproducts;viralsafetyfornaturallyderived(includingbloodproducts)or recombinantproteinproducts;comparabilitystudiesinsupportingmanufacturingchanges duringeitherproductdevelopmentorpostmarketing;andstrategicplanningfordeveloping biosimilars.Hehascreatedanddeliveredtrainingprogramstoclientsonqualityrelatedissues (e.g.,specification,stability,qualitybydesign,processvalidation,potencystandardandassays, andimpurities),andoncurrentGoodManufacturingPractices(cGMP).Dr.Changprovided mockpreapprovalinspectionstoassesswhetherclientswereincompliancewithcGMPand theirreadinessfortheFDAinspection.Hisconsultingservicesassistedclientsontheirproduct approvalsafterfirstcyclereviewbyregulatoryauthorities. PriortojoiningPharmaNetin2006,Dr.Changservedmorethan11yearsatUSFDA,most recentlyasanAssociateDirectorforPolicyandRegulationandSeniorRegulatoryScientistin theDivisionofHematology,OfficeofBloodResearchandReview(OBRR),CenterforBiologics EvaluationandResearch(CBER).Heisknownnationallyandinternationallyforhissignificant scientificandregulatorycontributionstothedevelopment,approvalandpostmarket surveillanceofrecombinantandnaturallyderivedproducts.DuringhistenureattheFDA,Dr. Changhadservedastheprimaryproductrevieweronover40originalINDsubmissionsand hundredsofamendments.Hehadservedasthereviewcommitteechairpersonforthe
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licensuresoffournewandnovelrecombinantandnaturallyderivedproducts,andforthe approvalofhundredsofpostmarketingsupplements.In2002,FDArecognizedDr.Changasthe FDAregulatoryexpertintheregulationofnewandnovelrecombinantproductsaswellas naturallyderivedbiologicalproducts.Heclearlyisconsideredoneoftheforemostregulatory expertsinrecombinantandnaturallyderivedproteinproducts. WhileatFDA,Dr.ChangwasknownasaleadingFDAandCBERspokespersonandhas presentedtheFDAperspectiveatmanynationalandinternationalmeetings.Inaddition,hehas servedonnumerouscommittees,suchasFDACommitteeforFollowOnProtein Pharmaceuticals,CBERsChemistry,ManufacturingandControl(CMC)CoordinatingCommittee (CMCCC),CBERrepresentativeatCDERManufacturingScienceWorkingGroup,CMCReview TemplateWorkingGroup,FDAComparabilityWorkingGroup,andCBERWorkingGroupfor ManufacturingChanges.Dr.ChangalsoservedastheFDAdeputytopicleaderforICHQ5E guideline,andtheFDAobserverforEuropeanandUSPharmacopeiasExpertGroupsonBlood andBloodDerivedProducts.Furthermore,heworkedcloselywithCBERsOfficeofCompliance andBiologicsQualityonFDAinspectionprogramincludingTeamBioandCBERpre license/approvalinspections. HisformalscientifictrainingincludesaDoctorofPhilosophydegreeinBiochemistryfromthe StateUniversityofNewYork,1991,andaBachelorofSciencesdegreeinPharmaceutical ChemistryfromtheChinaPharmaceuticalUniversity,1982.Supplementinghisacademic degrees,Dr.ChangalsostudiedattheNationalInstituteofAllergicandInfectiousDiseases, NationalInstitutesofHealthasapostdoctoralfellowfrom1991untilhejoinedCBERin1995. ConsultingExpertise:Regulatoryconsiderationsfornatural,recombinant,andcombination products,productcomparability,followon/biosimilarproteinproducts,viralsafety, immunogenicity,cGMPaudit,andinterpretationofFDAregulations,policies,andguidances. AndrewC.Chang,Ph.D. ExecutiveDirector,PharmaNetConsulting PharmaNetDevelopmentGroup 504CarnegieCenter,Princeton,NJ08540 Tel:6095808218or2402460296 Cell:2025529518 Fax:6095142188 achang@pharmanet.com

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PhiladelphiaUniversitySASCertificateProgram
CarolMatthews,Sr.Director,ClinicalProgramming,UnitedBioSourceCorporation Abstract: Thereareseveralkeycomponentstobeingasuccessfulstatisticalprogrammerinthe pharmaceuticalindustrythatgobeyondjustunderstandinghowSASworks.WhileSASoffers greatcoursesthatteachhowtousethelanguage,PhiladelphiaUniversityhastheonlyprogram intheareathatcarefullyscreensapplicantsandprovidesindepthtrainingspecificallytargeted tothepharmaceuticalindustry. Biography: Ms.CarolMatthewsiscurrentlyaSeniorDirectorofClinicalProgrammingforUnitedBioSource Corporation,BiotechnologySolutions.ShehasbeenanadjunctfacultymemberinPhiladelphia UniversitysSASProgrammingcertificationprogramsince1998,haspresentedaudio conferencesthroughFDANews,andhaspresentedseveralseminarsoneffectiveclinical programmingpracticesattheannualPharmaceuticalIndustrySASUser'sGroupconference.Ms. MatthewsrecentlycoauthoredthebookValidatingClinicalTrialDataReportingWithSASwith BrianShilling.

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AbstractandBiography ProgrammingTechnical/ProcessTips
SessionChair:CynthiaHe,ScheringPlough

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SessionChairCynthiaHe:Ms.HeisamanagerinGlobalScientificProgrammingDepartment atScheringPloughResearchInstitute.Shehasover20yearsofSASprogrammingexperience and8yearsofmanagementexperienceinCROandPharmaceuticalcompaniesincluding Covance,PharmaNet,Merck,andScheringPlough.Shehasamaster'sdegreeinStatisticsfrom RutgersUniversity.

UsingGoogletoSolveSASProblems
MikeTodd,NthAnalytics Abstract: SAShasalonghistoryasthelanguageforstatisticalprogramminginthepharmaceutical industry.Inthepast30+years,most,ifnotall,oftheproblemsstatisticalprogrammersfaceon adaytodaybasishavebeensolvedbysomebody.Usuallythereisapapersomewhereonthe Internetaboutit.UsingGooglequeries,statisticalprogrammerscanleveragethevastSAS knowledgebaseontheInternet,andgetquickanswerstoavarietyofproblems,suchas: Differentalgorithmsforsubjectagecalculations Findingrowdifferences(i.e.simulatingthelagfunction)inPROCSQL. MethodsforprintingPage1ofninRTFoutputs HowtousehexadecimalcodesinSASstatements ReadingaChineseencodedSASdataset Biography: Mr.MikeToddisthePresidentofNthAnalytics,aClinicalBiometricsServicesfirm.Hehasover 25yearsofpharmaceuticalexperiencewithanextensivebackgroundinstatisticalanalysis,and isarecognizedexpertonCDISCSDTM.Mr.ToddhasaB.A.inEnglishLiteraturefromPenn State,aM.A.inExperimentalPsychologyfromtheUniversityofSouthCarolina,andaM.S.in StatisticsfromRutgersUniversity.

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ACompleteDerivationofDurationandDisplayinISO8601UsingSASProgram
JoyceGui,IndependentConsultant HelenWang,DepartmentofScientificProgramming,Merck SandyWang,Rutgers,theStateUniversityofNewJersey Abstract: Inclinicaltrials,anadverseevent(AE)canoccuranytimeduringthecourseofthestudy.Indata analysis,itiscommontorelateAEinformationwithstudymedicationwhichisreferredtoas timesincelastdose.Ifthedurationvariableisincludedforregulatorysubmission,itmustfollow theISO8601durationformatsasdescribedintheCDISCSDTMImplementationGuide(Version 3.1.1)section4.1.4.3.Thispaperwilluseadverseexperiencestartdate/timeandthestudy medicationstartdate/timetoderivethetimesincelastdosebasedondefinedrulesusingSAS programs,anddisplaythedurationinISO8601durationformat. Biography: Ms.JoyceGuiholdsM.S.degreesinSystemEngineeringandStatistics.Sheworkedinthe financialindustryasaSASprogrammerforafewyearsbeforejoiningMerck.AtMerck,Joyce workedfor5yearsinthedatamanagementdepartment,and3yearsintheBiostatisticsand ResearchDecisionSciencesdepartmentprovidingSASprogrammingfordataanalysisand reportingtobiostatisticiansforclinicaltrialsandNDAsubmissions.SheleftMerckinJuly2009, andnowworksasanindependentconsultanttoprovidetable,listingandpatientprofilesfor theneedofclinicaltrialdevelopmentandregulatorysubmissionforpharmaceuticalcompanies. Ms.HelenWangholdsaM.S.degreeinStatistics.ShehasextensiveexperiencesinSAS programmingandstatisticalanalysis.Ms.WanghasbeenusingSASforstatisticalanalysisand reportingfor15yearsindifferentindustriesincludingpharmaceutical,financial,telecom,and banking. Ms.SandyWangworksasaStatisticalProgrammer(contract)inBiostatisticsandResearch DecisionSciencesDept.atMercksinceJan.2009.ShesalsoaparttimeM.S.studentin Statistics&BiostatisticsatRutgers,theStateUniversityofNewJersey.Ms.WangholdsaM.S. degreeinMechanicalEngineeringfromtheUniversityofToledo.

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VerifyingChangesinOutput
EricCarleen,AssociateDirector,PharmaNet Abstract: Oftenduringastudyaminorchangeismadetoaprogram,anditisexpectedthattheresult willchangeonlyasmallnumberoftablesandlistingsinasmallway.Thistalkwillpresent methodstoverifythatexpectationprogrammaticallybyautomatinga100%comparisonofthe beforeandafteroutput.ThismethodworksonLSTandRTFfilesproducedby SAS.Hundredsoftablescanbevalidatedinfewminutes.

Biography: Mr.EricCarleenisanAssociateDirectoratPharmaNet,wherehehasbeenprogrammingsince 2003.HealsospenttenyearsatCarterWallaceasastatistician,programmer,andassociate directorofUNIXandWindowssystemsandnetworking;oneyearasaprogrammeratSterling Drug;andnineyearsattheUniversityofRochesterdoingNIHresearchandpharmaceutical workasastatistician,SASprogrammer,anddatabaseprogrammer.Mr.CarleenhasaMasters degreeinStatisticsfromtheUniversityofRochester.

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AbstractandBiography PanelDiscussion:CareerPathforaSASProgrammer
SessionChair:AatiyaZaidi,NovoNordisk

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SessionChairAatiyaZaidi:Ms.ZaidiistheSeniorManagerofStatisticalProgrammingat NovoNordiskInc.Shehas17yearsofSASprogrammingexperienceand10yearsof managementexperienceinCROandpharmaceuticalcompaniesthatincludeCovance,Wyeth AyerstResearch,andNovoNordiskInc."

BiographyofPanelists:
JaishriAlladi,Johnson&Johnson Ms.Alladihas20yearsofStatisticalProgrammingexperiencespanningavarietyoftherapeutic areasintheCRO/Pharmaceuticalindustry.Shehasheldfunctionalareamanagement responsibilitiesforthelast13years. InthelastnineyearsatJohnson&Johnson,Ms.Alladihasprovidedprogrammingleadership acrossseveralregulatorysubmissionsintheareaofRheumatology.Sheiscurrentlyresponsible foroverseeingprogrammingoperationsfortheVirologytherapeuticareaandearly developmentstudies(bothsmallandlargemolecules)inthetherapeuticareasofImmunology andOncology. DenisMichel,Johnson&Johnson Mr.Michelhasworkedinclinicaldatamanagementandstatisticalprogrammingat pharmaceuticalcompaniesandContractResearchOrganizationssince1982.HehasbeenaSAS usersince1985,andhaspresentedpapersatlocalandglobalusergroups.Heiscurrently managingateamofSASprogrammersintheneurosciencetherapeuticareaatJohnson& Johnson.Hisfocusareasincludedictionarymanagementandelectronicsubmissions. Mr.MichelhasaBSinBiologicalSciencesfromStateUniversityofNewYorkatStonyBrookand MBAfromSetonHallUniversity.

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BiographyofPanelists(cont.):
PeterOuyang,Ph.D.,VicePresident,BiostatisticsandSASProgramming,CelgeneCorporation Dr.OuyangreceivedhisPh.D.inStatisticsfromSUNYatStonyBrookin1982,andisamember ofASA,ENAR,ICSA,andDIA.Hehasextensiveexperienceinstatisticaldesign,analysis,and reportinginthepreclinicalareaandallphasesofclinicaldrugdevelopmentinmany therapeuticareas.Hisleadershiphasresultedinseveralsuccessfuldrugapplicationsinallergy, antiinfective,CNS,diabetes,painandoncology.Hehasorganizedmanyshortcoursesand professionalmeetings.Hisresearchinterestsincludeadaptiveclinicaltrialdesign,group sequentialmethods,multiplecomparisons,analysisoflongitudinaldata,computerassistedtrial design,andPK/PDmodeling.HealsocoauthoredtheSOPtogoverntheconductofinterim analysisviaaDataMonitoringCommitteeinJohnson&JohnsonP.R.D.. SarahShiue,DirectorofScientificProgramming,Merck Ms.ShiueistheDirectorofScientificProgrammingresponsiblefortheMerckscientific programminggroupinRahway,NewJersey.ShehasbeeninthePharmaceuticalIndustryfor morethan20yearsmostlyatJohnson&JohnsonandwasatAventispriortojoiningMerckin 2005.Shehasbroadexperiencesinreportingandglobalregulatorydossiersubmissionsin severaltherapeuticareasandhadinvolvedcloselyindevelopingstandardsystemsand processesatJohnson&JohnsonandAventis.Ms.ShiuewasamemberoftheCDISCSDSand ADaMworkinggroupsin20002007representingJohnson&Johnson,AventisorMerck respectivelyandhadparticipatedinthefirsttwoCDISCFDASDTMpilots.

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AbstractandBiography MarketYourTalent
WenmeiGe,Johnson&Johnson

Abstract: AreyouinterestedinlearningmoreaboutNetworking101,howtowriteagreatresumeorhow toprepareforaphone&facetofaceInterview?Ingoodtimesorbad,especiallyinatime whenchangecomessofast,weneedtobereadywhenopportunitiesknockonthedoor.Inthis presentation,Ms.WenmeiGewillbesharingsometipsonhowtomarketyourtalentinthis fastchangingworld.

Biography: Ms.WenmeiGeiscurrentlyaProgrammingManagerintheProcessSupportgroupatJohnson &JohnsonPharmaceuticalResearch&Development.Inherrole,sheisresponsibleforthe internalDMCandIAsupports.WenmeibeganhercareerwiththeJohnson&Johnson organizationin2005.PriortojoiningJohnson&JohnsonP.R.D.,sheservedasaleadsenior statisticalprogrammeratAdvancedBiologicsLLC.WenmeiholdsaMastersdegreein ComputerSciencefromSt.JosephsUniversityandaBachelorofScienceinEngineeringfrom ShanghaiUniversity.Ms.GechairstheTitusvilleA.S.I.A(theAsianSocietyforInnovation& Achievement)andwasnamedrecipientofthe2006and2008Johnson&JohnsonA.S.I.AImpact Awards.

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AbstractandBiography SoftSkills
SessionChair:DannyChaing,Johnson&Johnson

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SessionChairDannyChaing:Mr.ChaingstartedhispharmaceuticalcareerinStatisticsat HoechstRousselPharmaceutical,Incin1977.Inthe12yearsatAmericanHomeProducts Corporation(19791991),heleddatamanagement,statistics,andprogrammingworkin multipleapprovedNDAs,andRxtoOTCconversions.Mr.ChaingconcentratedonComputer AssistedNDA(CANDA)technologieswhileworkingforRhonePoulencRorer(RPR)from1991to 1995.HejoinedJanssenResearchFoundationofJohnson&Johnsonin1995andhadincreased responsibilitiesindatamanagement,andprogramminginJohnson&JohnsonPharma Companies.HiscurrentpositionisHead,StatisticalProgrammingCNS/Internal Medicine/Virology,Biostatistics&ProgrammingCenterofExcellence(CoE),GlobalDrug Development(GDO)ofJohnson&Johnson.DannyhasbeenactiveinSAPA,ICSA,andPhRMA (BDMTG). Mr.ChaingearnedhisBachelorofScienceinStatisticsfromFuJanUniversity,Taiwan.Hehasa MasterdegreeinStatisticsandaMasterdegreeinComputerSciencefromRutgersUniversity.

BusinessCommunicationSkills:APowerfulFactorforyourCareer
JudyWest,EnglishThatWorks,Inc Abstract: Todayscorporationsemploymanymultinationalswhosetechnicalandscientificexpertiseis crucialintodaysglobalmarketplace.Amajorjobrequirementistheabilitytocommunicate clearlyandconfidentlyandtopresentonesideasappropriatelyandeffectively.Whenthisis accomplished,employeescansignificantlyleveragetheirknowledgeandskillsascredibleand contributingmembersoftheteamandorganization. Whatarethebusinesscommunicationandculturalawarenessskillsnecessaryfor successintodaysbusinessenvironment? Howcanyouimproveyourprofessionalvisibilityandcredibilityatwork? Findoutwhymanyexecutivessaythatcommunicationskillsarethenumberonefactorthat determinedtheirrisetothetop.Learnwhywhatyouknow,whoyouknow,andwhoknows youcanmakeamajordifferenceinyourcareer.
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AbstractandBiography

Biography: JudyWest,founderandpresidentofEnglishThatWorks,Inc.hasthirtyyearsofsuccessful experiencedeveloping,andteachingcourses,trainingprograms,workshops,andprivate coachingsessionsthatimprovetheoralandwrittenperformanceofprofessionalswhospeak Englishastheirsecondlanguage.ShehasprovidedservicesatBristolMyersSquibb,Johnson andJohnson,Ethicon,Janssen,andWyethaswellasotherresearch,technical,manufacturing, andservicecorporations,governmentoffices,colleges,andcommunitybasedorganizations. TrainingprovidedbyMs.Westfocusesonimmediatelyusefullanguageandculturalawareness skillsneededforcommunicativeandinterpersonalsuccessinbusinessandsocialsettings. CourseofferingsincludeAmericanEnglishPronunciation,SpeakingSolutions,Assertive Communication,WritingforMultinationals,andcustomizedindividualcoaching. Participantsconsistentlyreportthefollowingpositiveresults: Greaterabilitytocommunicateeffectivelyandpersuasively Moreproductiverelationshipsandgreaterparticipationonteamsandinmeetings Enhancedprofessionalimage ExpandedactiveEnglishvocabulary Decreasedmisunderstandingsduetoorallanguage/accent IncreasedunderstandingofAmericanidiomsandculture Heightenedselfconfidence Ms.WestisaMagnaCumLaudegraduateoftheUniversityofPennsylvaniawheresheearneda BachelorofArtsinSociologyandaMasterofScienceinEducation.

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AbstractandBiography

CommunicationSkills:TechniquesYouCanApply
LisaLyons,Johnson&Johnson Abstract: Effectivecommunicationrequiresbringingtogetherdifferentpointsofviewandrelayingthat informationwithoutlosingclarity.Regardlessifitisafacetofaceconversationoranemail exchange,ameaningfulmessageentailsestablishingaconnectionthatleavesapowerful impression.ThispresentationwillbuilduponthekeyconceptspresentedinBusiness CommunicationSkills:APowerfulFactorforYourCareerandprovidetheaudiencewith techniquestheycanapplyineverydaysituations. Biography: Ms.LisaLyonshasovertenyearsexperienceinstatisticalprogrammingforthepharmaceutical industry.CurrentlysheisaManageratJohnson&Johnsonwheresheisresponsiblefor managementofEstablishedProductsstatisticalprogrammingteam.Shehasexcellent communicationskillsandherresponsibilitiesincludecoaching,developingandmentoringstaff forprofessionalgrowth. Ms.LyonsisagraduateofDrexelUniversityinPhiladelphia,PAwheresheearnedaMSin ClinicalResearch.Ms.LyonsalsoholdsaSASCertificationfromPhiladelphiaUniversityin Philadelphia,PAandaBSinPsychologyfromCollegeofNewJersey,Trenton,NJ.

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AbstractandBiography
PanelDiscussions:SoftSkills

BiographyofPanelists:
BarrySchwab,Ph.D.,Johnson&Johnson Dr.SchwabisVicePresidentandHeadofClinicalStatisticsfortheNeuroscience,Pain,Anti infectives/MetabolismandCV/UrologyprogramsatJohnson&Johnson. Dr.SchwabhasbeenwithJohnson&Johnsonfor25years.Hehasprovidedstatisticalexpertise andstrategicdirectiontomanyofJohnson&Johnsonsinvestigationalcompounds,with contributionstoproductapprovalsinpsychiatry,neurology,pain,dermatology,antiinfectives andhematology/oncology.DuringhistenurewithJohnson&Johnson,Dr.Schwabspent2 yearsworkingintheZurich,SwitzerlandofficeofJohnson&JohnsonPRI(19911992). Dr.Schwabisactiveinstatisticalprofessionalsocietyactivities.HeservedonthePhRMA BiostatisticsandDataManagementTechnicalGroupfrom20002002.In2003hewasChairof thePhRMA/FDAWorkshoponRiskDetection.HehasbeenaProgramSteeringCommittee memberandSessionChairfortheASA/BiopharmFDAWorkshop,theDIAStatisticalWorkshop andtheBASSStatisticalconferencesince2004.Forthepast3years,Dr.Schwabhasbeenthe industryCoChairoftheAnnualFDA/DIAStatisticsForum,anopenmeetingtodiscuss regulatoryandscientificissuesassociatedwiththedevelopmentandreviewoftherapeutic drugsandbiologics.Dr.SchwabisanEditorialAdvisoryBoardMemberforPharmaceutical Statistics,TheJournalforAppliedStatisticiansinthePharmaceuticalIndustry. Dr.SchwabreceivedhisPh.D.inBiostatisticsfromtheMedicalCollegeofVirginia. TriciaYeh,VicePresident,Biostatistics,PharmaNet Ms.TriciaYehhasover30yearsexperienceinthepharmaceuticalandCROindustry.She providesstatisticalinputinthedevelopmentofprotocolsandCRFsandmanagesbiostatistical activitiesinthepreparationofclinicaltrialreportsandNDA/PLAsubmissions.Shehasworked inawidevarietyoftherapeuticareas,notablycardiovascular,oncology,neurology,and endocrine/metabolicindications,andhasextensiveexperiencewithintegrationoflegacy databasesandperforminginterimanalysesfordatamonitoringboards.ShehasaMSdegreein BiostatisticsfromUniversityofCincinnatiandaMSdegreeinBotanyfromMiamiUniversity.

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Direction to the workshop: The workshop will be held in McDonnell Building, Princeton University, Princeton, New Jersey. See below the map for the building and the parking lot information. There will be SAPA signs available to direct you to the parking lot and McDonnell building. McDonnell Building and parking:

Directions

Jadewin Fine

McDonnell Building (76 Washington Rd Princeton, NJ 08540)

Parking Lot 21

(Fitzrandolph Rd)

1 3
Additional parking (Ivy Ln)

4
Parking under

construction

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Directions

Direction to dinner at Supper Star East Buffet: The optional dinner will be in Super Star East Buffet, located right off the Route 1,about 4.6 mile / 7 minutes from the McDonnell Building. The address and the driving direction is provided below Super Star East Buffet Phone: 609.987.9168 311 Nassau Park Blvd. Princeton/West Windsor (In The Same Shopping Center as Wal-Mart and The Home Depot, Next To Sam's Club) Dinner Buffet Adult (3-6) (7-11) Price $16 $7 $8

The driving directions from Princeton University to Super Star East Buffet: Total: 4.6 mi about 7 mins 1. Head southeast on Washington Rd toward Faculty Rd 2. Turn right at Brunswick Pike/US-1 3. Slight right toward Quakerbridge Rd 4. Take the ramp onto Quakerbridge Rd 5. Turn right at Nassau Park Blvd 331 ft Destination will be on the right 0.4 mi 0.2 mi 2.8 mi 1.2 mi

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Thanks
Volunteers
ChaChiLo EugeniaWaslin SherryMeeh ZhenhongBao JayeetaGhosh JiminZhang RuiDing YingZhang ShaoyouWang Han,Jia He,Jieru Miao,Wei Sheng,Silu Wu,Zheqiong Johnson&Johnson Johnson&Johnson Johnson&Johnson RUBiotech RUBiotech RUBiotech RUBiotech RUBiotech NJITCSSA NJITCSSA NJITCSSA NJITCSSA NJITCSSA NJITCSSA

SAPA
BaoGuoHuang CaiLi HelenaFeng JianZhu JiangfanLi JianjiWang JisongCui JiwenChen KevinChen LianHuang MingdeXia XiaohuiMei XiaoyingZhang XingLi YanXia SanofiAventis Merck SAPA Novartis Johnson&Johnson BMS Merck BMS ScheringPlough Johnson&Johnson Johnson&Johnson BoehringerIngelheim Alpharma ISPOR SheringPlough
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