2014 ASA Biopharmaceutical Section/ FDA - Industry .

Transcription

2014 ASA Biopharmaceutical Section/ FDA - Industry Statistics WorkshopRegistrants List as of 9-22-14Last t FDA-CDRHArray BioPharmaGE HealthcareCytel Inc.Merck & Company, Inc.FDAVirtu Stat, Ltd.FDAShionogi Inc.AmgenHines VA Cooperative StudyCoordinating CenterFDAAbbVieNovartis PharmaceuticalsPPD DevelopmentFDA, Center for VeterinaryMedicineBayer HealthCareStevenR.E.MylanBerry ConsultantsAlnylam PharmaceuticalsBristol-Meyers SquibbMerck & Company, Inc.FDACDRH, FDAPiramal Enterprises LimitedH. Lundbeck A/SCDRH/FDANovartis Pharma AGMylan Pharmaceuticals Inc.Boehringer IngelheimLawrence Vetmedica, Inc.CitySilver SpringWayneCollege ParkSilver SpringLongmontPrincetonSan JoseNorth BrunswickNorth WalesSilver SpringNorth WalesSilver SpringFlorham ntryUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesHinesSilver ILPANJTXUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesRockvilleBethelWhippanyMDCTNJUnited StatesUnited StatesUnited StatesSandwich, KentAustinCambridgePenningtonRahwaySilver SpringGermantownMumbai 400063LundGlenelgHarleysvilleSilver SpringBasel 4002MorgantownSt. JosephWVUnited KingdomUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesIndiaSwedenUnited StatesUnited StatesUnited StatesSwitzerlandUnited StatesMOUnited StatesTXMANJNJMDMDMDPAMD

thKlineAbbVieIDDI, Inc.FDAGenentechFDA, Center for Devices &Radiological HealthPfizer, Inc.King of PrussiaNorth ChicagoCupertinoRockvilleSan FranciscoPAILCAMDCAUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesSilver SpringGrotonMDCTUnited StatesUnited StatesUniv of Minnesota, Biostatistics,School of Public HealthMinneapolisPPDWilmingtonMNNCUnited StatesUnited StatesBillericaPotomacNorth WalesCambridgePittsburghRedwood CitySouth San FranciscoSilver SpringBridgewaterSilver SpringNew WalesRaritanMAMDPAMAPACACAMDNJMDPANJUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesSilver SpringSilver SpringShanghaiRockvilleMDMDUnited StatesUnited StatesChinaUnited uStephenYu-LinJanelleArkenduSomeshCongFeiEMD Serono Inc.FDA/CDERG.Siu Fung Merck & Co., Inc.Genocea BioscienceUniv of PittsburghH.Portola PharmaceuticalsF.Onyx Pharmaceuticals, IncFDAK.Sekhar Novartis PharmaceuticalsFDAMerck and Company, Inc.Johnson & JohnsonChenChenChenChenHuanyuHuifangHuifangJieFood and Drug AdministrationFDAAstraZenecaNational Cancer nrongFu-ChihYuYue-MeiVaishaliMerck Serono (Beijing) R&D Hub Chaoyang, Beijing 100022GaithersburgMDFMD K&LFt. WashingtonPAMedpace Inc.CincinnatiOHSouth San Francisco CACelgeneWestfieldNJDaiichi SankyoEdisonNJFDASilver SpringMDFDASilver SpringMDHCRIBelmontMAFDASilver SpringMDFDASilver SpringMDGilead SciencesFoster CityCAUniversity of dex TherapeuticsHamptonNJMDChinaUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited States

loDarbyDaviDede Amgen Inc.Sanofi-AventisCelgeneJinJinJ.V.AgensysPfizer IncFDAPharmacyclicsAxio ResearchACADIA PharmaceuticalsEli LillyBerry ConsultantsFDA/CDER/OTS/OBInstitut De RecherchesInternationales ServierConsultantEli Lilly and Co.FDA (Food & DrugAdministration)Alexion Pharmaceuticals, Inc.Ortho-McNeil JanssenPharmaceutical, LLCFDAMedImmuneH.L.ChanC.L.A.A.FDAFDAAlkermes, Inc.Boston Biomedical AssociatesJanssen PharmaceuticalCompanySunovionGilead SciencesFDA/CDER/OTS/OB/DB4MPI ResearchAbbVie Inc.Taiho Pharma U.S.A., Inc.AstraZenecaQuintilesMedtronic, Inc.FDAFDACACANJNJNJCAMIMDCACOCAINFLMDUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesSuresnesNorwalkIndianapolisCTINFranceUnited StatesUnited StatesSilver SpringMDUnited StatesCheshireDouglassvilleCTPAUnited StatesUnited StatesRaritanSilver SpringPotomacLa PlataSilver SpringSilver SpringWinchesterNJMDMDMDMDMDMAUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesMarlboroMAUnited StatesRaritanFort LeeFoster CitySilver rland ParkMemphisSilver SpringSilver SpringSharonNJNJCAMDMIILNJMDKSTNMDMDMAUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesThousand OaksMoorparkBridgewaterBridgewaterKendall ParkSanta MonicaKalamazooSilver SpringSunnyvaleThorntonSan DiegoIndianapolisOrlandoSilver Spring

thelCynthiaR.Flower Valley Consulting, IncC.Pfizer rGellerElizabethYangMary JaneNancyGenevois-Marlin tPeterSharonUC San DiegoJanssen R&DGlaxoSmith KlineP.OracleH.FDAUniversity of California, SanDiegoD.University of Pennsylvania School of MedicineS.Richard Merck & Co., Inc.Tilahun FDAA.La JollaSpring HouseRTPMiamiWoodbineCAPANCFLMDUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesLa JollaCAUnited StatesPhiladelphiaNorth WalesSilver SpringPAPAMDUnited StatesUnited StatesUnited StatesRockvilleLundCollegevilleSilver SpringRedwood CitySilver SpringSilver SpringMorrisvilleHerndonMDPAMDCAMDMDNCVAUnited StatesSwedenUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesMDCACAMAILNJUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesSilver SpringFraminghamWayneSilver SpringSilver SpringMDMAPAMDMDUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesCharlestonNorth WalesTarrytownBethesdaSCPANYMDUnited StatesUnited StatesUnited StatesUnited StatesFDAFDAPharmaLinkFHISciLucent LLCNational Institutes of Allergy andInfectious DiseasesBethesdaMedivationSan FranciscoGenentechSan FranciscoLexingtonAbbVieNorth ChicagoNovartisEast HanoverFDA/CDER/OBL.Shire Development Inc.FDA, CDEROBE/CBER/FDAMedical University of SouthCarolinaMerck & Co. Inc.RegeneronOffice of Biostat ResearchB.Sanofi Aventis R&DWestatChilly-Mazarin 91385HoustonTXFranceUnited StatesNIDA Center for Clinical TrialsSAMSI/NCSUPfizerBethesdaRTPPearl RiverRockvilleUnited StatesUnited StatesUnited StatesUnited StatesJosephKumarMDNCNYMD

HongMartinStevenV.M.W.J.B.PhiladelphiaPAUnited StatesFood and Drug AdministrationSilver SpringColumbiaMDMDUnited StatesUnited StatesNovartis PharmaceuticalsPPD DevelopmentStatistical SolutionsFDA, CDRHMedImmuneTheorem Clinical ResearchReagan-Udall Foundation for theFDAMorris PlainsCaryCorkSilver SpringGermantownLansdaleNJNCUnited StatesUnited StatesIrelandUnited StatesUnited StatesUnited StatesCambridgeFlorham ParkGaithersburgSilver SpringWestfieldBellevueSilver SpringSan DiegoBethesdaSilver SpringRedwood CityRockvilleSeoul, 138-724D-88400, ster SpringCambridgeRahwayHillsboroughYardleySan CarlosSilver SpringChevy ChaseHennigsdorf 16761NagoyaMANJMDMDNJWAMDCAMDMDCAMDWalthamSilver SpringSilver SpringMAMDMDFDAForest LabR.M.R.FDAHackett & Associates, Inc.The EMMES CorporationFDA/CDER/DB2Hanmi Pharm. Co., Ltd.M.DavidH.H.P.Astex Pharmaceutical IncDeloitteAbbVieShionogi & Co., Ltd.Quintiles TransnationalFujirebio Diagnostics, Inc.NovartisMerck Research LabCelldex TherapeuticsBristol-Myers SquibbBioMarinFDAJohns Hopkins UniversityBrahms GmbHFresenius Medical Care AMDMDUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesSouth KoreaGermanyUnited StatesUnited StatesUnited StatesJapanUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesGermanyJapanUnited StatesUnited StatesUnited States

uyckImmermannW.DaleCancer Research andBiostatisticsAbbVieBrown UniversityAmgenFDAIncyte CorporationH. Lundbeck A/SFDAOtsukaSunovion Pharma Inc.J&JFDACelgene CorpFDASynteract HCR, Inc.Millennium Pharmaceuticals,Inc.FDA/CDERSt Jude Children's ResearchHospitalPfizer Oncology StatisticsFDASeattleAbbott ParkProvidenceRockvilleSilver SpringWilmingtonDK-2500 ValbySilver SpringRockvilleFort LeeMendhamSilver SpringBasking RidgeSilver SpringCarlsbadWAILRIMDMDDEMDMDNJNJMDNJMDCAUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesDenmarkUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesQuincySilver SpringFremontMAMDCAUnited StatesUnited StatesUnited StatesTNCAMDWAMDUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesJamesFDAMemphisSan DiegoSilver SpringBellevueSilver SpringTinaMohammadSusanFrederickD.F.CTI Clinical Trials & ConsultingFDAMerckPfizerCincinnatiSilver SpringRahwayPearl RiverOHMDNJNYUnited StatesUnited StatesUnited StatesUnited StatesIronyTelbaZ.Silver SpringMDUnited StatesIvanovaAnastasiaFood and Drug AdministrationUniversity of North Carolina,Chapel HillChapel HillNCUnited jiQiXiaopingFood and Drug AdministrationNovartis VaccinesJanssen PharmaceuticalsQuintilesAstraZenecaMedImmuneAmgen Inc.Forest Research InstituteSilver rsburgSo. San FranciscoJersey CityFairfaxThousand OaksSilver SpringMDMAPAMDMDMDCANJVACAMDUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesW.E.DanielAmgen, Inc.FDA

ZhenFengbinJessica /CBERSunovion, Inc.Genentech, Inc.FDA/CDER/OTS/OB/DBIKangL.FDA\CDRHTheorem Clinical ResearchKrogGlaxoSmithKlineH. Lundbeck ers CompanyCelgeneBioinformedica, Inc.Genentech, Inc.Merck & Co., Inc.Food and Drug AdministrationFDA/CDER/DB2MedivationPharmaceutical ProductDevelopmentY.Food and Drug AdministrationL.FDA/CDERFDAFDAMoffitt Cancer CenterHanmi Pharmaceutical, LtdZoetisSamumed, LLCAbbott LaboratoriesB.T.D.M.M.FDABristol-Myers SquibbFDAFDAAxio Research LLCFDAFDAFDASilver SpringFort LeeSouth San FranciscoSilver SpringSilver SpringSilver SpringCherry HillDublinCollegevilleValby 2500WarrenCarlsbadSilver SpringLaPlataCheshireShort HillsSouthamptonSouth San FranciscoRahwayThousand OaksMDNJCAMDMDMDNJCAPANJCAMDMDCTNJPACANJCAUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesDenmarkUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesSilver SpringSilver SpringArlingtonSan FranciscoMDMDVACAUnited StatesUnited StatesUnited StatesUnited StatesWilmingtonNCUnited StatesSilver SpringBethesdaSilver SpringSilver SpringSilver SpringTampaSeoul 138-N24KalamazooSan DiegoAbbott ParkWyckoffSilver SpringPrincetonSilver SpringSilver SpringSeattleSilver SpringSilver SpringSilver SpringMDMDMDMDMDFLUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesSouth KoreaUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesMICAILNJMDNJMDMDWAMDMDMD

sannePamelaLisaJohnDavidH.S.LeeLeeLeeJamesJoo YeonKyung M.M.Merck Research LaboratoriesUltragenyx PharmaceuticalGlaxo Smith Kline, Inc.Univ of KentuckyEli Lilly & CompanyBayer Pharma AGRahwayNJNovatoCAResearch Triangle ParkNCLexingtonKYIndianapolisIN13342 BerlinTDW Pharmaceuticals, Inc.Merck & Co., Inc.Food & Drug AdministrationJazz PharmaceuticalsBiostatHaven, Inc.Taipei 11492RahwaySilver SpringPalo AltoCroton On HudsonNJMDCANYUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesGermanyTaiwan,Republicof ChinaUnited StatesUnited StatesUnited StatesUnited StatesTakeda Pharmaceuticals U.S.A.Boston ScientificFDADeerfieldMarlboroughSilver SpringDoylestownPlainwellSilver SpringNorth PotomacWadsworthILMAMDPAMIMDMDILUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesEdisonSilver SpringSilver SpringNJMDMDUnited StatesUnited StatesUnited StatesCollege ParkSilver SpringSilver SpringSouth San FranciscoPacificaSan CarlosSilver SpringMDMDMDCACACAMDUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesSilver SpringRockvilleLake Forest ParkSeattleThousand OaksSilver SpringBethesdaCollegevilleSilver SpringSilver SpringMorrisvilleSilver SpringDaytonMDMDWAWACAMDMDPAMDMDNCMDNJUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesM.M.P.J.L.F.S.LaurenJ.PPD, Inc.FDA CDERFDACMCStatsDaiichi Sankyo ersity of Maryland AtCollege ParkFDA/CBERFDAGenentech Inc.FDA/CDERFood and Drug AdministrationFDASeattle GeneticsGilead SciencesAmgen OTS/OB/DBG

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ManukyanMaoMarchenkoMarkovtsovaMartellMartinez joengIndraniMarthaV.S.E.W.B.R.L.D.PfizerIntegra LifeSciences, Inc.QuintilesGenzymeH. Lundbeck A/SCBER-Vaccine EvaluationBranch/FDAFDA/OTS/OBBioCSLDepartment of Biostatistics,Nagoya UniversityThe EMMES CorporationPPDFDAFDA/CDER/DB2TigermedCytel Inc.Myraqa, IncFDA/CDER/OBAlkermes, IncSanofi-AventisAccovion GmbHKitasato UniversityInVentiv Health ClinicalR.Chandra Food & Drug AdministrationBiomedical SystemsJCOG Data CenterBaxterJanssen Research &DevelopmentGenentech IncTakeda Global Research andDevelopment, Inc.L.J.Food and Drug AdministrationMerck & Co.Asubio Pharmaceuticals, Inc.FDANIAIDLexingtonAustinSalineWest WindsorDorchesterValby DK 2500MATXMINJMAUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesDenmarkRockvilleSilver SpringParkville, VictoriaMDMDUnited StatesUnited StatesAustraliaNagoya 4668550RockvillePenningtonChesterSilver SpringSilver SpringGaithersburgCambridgeSilver SpringSilver mouth MeetingPrincetonNorth PotomacSt. LouisMorrisvilleSaitama 332-0034TokyoWestlake ited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesGermanyJapanUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesJapanJapanUnited StatesSouth San Francisco CASouth San Francisco CARockvilleMDUnited StatesUnited StatesUnited StatesDeerfieldILUnited StatesSilver SpringKenilworthEdisonSilver SpringChapel HillBethesdaMDNJNJMDNCMDUnited StatesUnited StatesUnited StatesUnited StatesUnited StatesUnited States

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Connor Jason Berry Consultants Orlando FL United States . Geller Nancy L. Office of Biostat Research Bethesda MD United States . Hardison C. David Deloitte Irvine CA United States Hartford A