About FDA

CBER Key Staff Directory

DIRECTORPeter W. Marks, MD, PhDWO-717232240-402-8000
fax 301-595-1310
Deputy DirectorVacantWO-717230240-402-8000
fax 301-595-1310
Special AssistantAnne E. WilcoxWO-717234240-402-8183
fax 301-595-1310
Senior Scientist for Emerging & Pandemic Threat PreparednessDavid S. Cho, PhDWO-717246240-402-8036
fax 301-595-1310
Special AssistantGopa RaychaudhuriWO-717250240-402-8147
Associate Director for MedicineBarbara D. Buch, MDWO-717224240-402-8000
fax 301-595-1310
Associate Director for Quality AssuranceSheryl L. Lard-Whiteford, PhDWO-717240240-402-7912
fax 301-595-1310
Associate Director for PolicyDiane Maloney, JDWO-717242240-402-8113
fax 301-595-1310
Associate Director for ResearchCarolyn A. Wilson, PhDWO-716316240-402-6705
Associate Director for Review ManagementChristopher C. Joneckis, PhD (Acting)WO-717334240-402-8083
fax 301-595-1310
Senior Advisor for Chemistry, Manufacturing, & ControlChristopher C. Joneckis, PhDWO-717334240-402-8083
fax 301-595-1310
Senior Advisor for International AffairsJoan Wilmarth BlairWO-717226240-402-8022
fax 301-595-1310
Senior Advisor for Counterterrorism/Medical CountermeasuresCynthia L. Kelley, MSWO-717204240-402-8089
fax 301-595-1310
Executive Operations StaffAnne E. WilcoxWO-717234240-402-8183
fax 301-595-1310
Document Control CenterJules M. MeislerWO-71G102240-402-8384
fax 301-594-0149
DIRECTOR Steven A. Anderson, PhD, MPPWO-711220240-402-8577
Deputy DirectorDavid Martin, MD (Acting)WO-711224240-402-8710
Associate Director for Risk AssessmentMark O. Walderhaug, PhDWO-711059240-402-8812
Associate Director for ResearchRichard A. Forshee, PhDWO-711226240-402-8631
Associate Director for PolicyJawahar Tiwari, PhDWO-711234240-402-8804
Division of BiostatisticsEstelle Russek-Cohen, PhD
Vaccine Evaluation BranchA. Dale Horne, PhDWO-711246240-402-8653
Therapeutics Evaluation BranchBoguang Zhen, PhDWO-711240240-402-8844
Division of EpidemiologyDavid Martin, MDWO-711224240-402-8710
Deputy Division DirectorCraig Zinderman, MD (Acting)WO-711325240-402-8845
Pharmacovigilance BranchChristopher Jankosky, MDWO-711310240-402-8664
Analytic Epidemiology BranchWei Hua, MD, MS, MHS, PhD (Acting)WO-711306240-402-8658
DIRECTOR Lorrie H. McNeillWO-714120240-402-7800 
Deputy DirectorJoanne C. BinkleyWO-713120240-402-7800
Division of Manufacturers Assistance and TrainingDonna L. LipscombWO-711008240-402-7800
Career Development and Directed Training BranchEris MackeyWO-714128240-402-7800
Manufacturers Assistance & Technical Training BranchFaye VigueWO-713128240-402-7800
Division of Disclosure and Oversight ManagementSusan C. Frantz-BohnWO-713126240-402-7800
Congressional and Oversight BranchMatthew D. LyonsWO-714116240-402-7800
Access Litigation & Freedom of Information BranchBeth Brockner-RyanWO-711114240-402-7800
Division of Communication and Consumer AffairsDiane BartellWO-714130240-402-7800
Communication Technology BranchKristin ShazorWO-713118240-402-7800
Consumer Affairs BranchWalter GardnerWO-713004240-402-7800
DIRECTOR James M. SiggWO-716234240-402-7990
Deputy DirectorDeirdre P. HusseyWO-716230240-402-7990
Special AssistantAnn M. JenkinsWO-716232240-402-7990
Regulatory Information Management StaffJeffrey M. AndersonWO-716104240-402-8004
Planning and Performance Management StaffMark Thompson (Acting)WO-716222240-402-8174
Division of Program ServicesDawn WhiteWO-716308240-402-3184
Assistant Director for SafetyTanya PittasWO-716310240-402-9093
Program Operations BranchDawn WhiteWO-716308240-402-3184
Program Services BranchJason P. RubinoWO-716304301-796-1948
Division of Budget and Resource ManagementMary Pat Leary (Acting)WO-716260240-402-8108
Resource Management BranchPatricia CarrWO-716248240-402-8171
Budget Analysis and Formulation BranchAngela MoyWO-716258240-402-8127
Division of Scientific Advisors & ConsultantsPrabhakara AtreyaWO-716216240-402-8006
DIRECTOR Jay S. Epstein, MDWO-714230240-402-8280
Deputy DirectorGinette Y. Michaud, MDWO-714234240-402-8331
Associate Director for Medical AffairsBasil Golding, MD (Acting)WO-714056240-402-8300
Senior Advisor for Scientific AffairsMark J. Weinstein, PhDWO-714229240-402-8365
Associate Director for Regulatory AffairsAlan E. Williams, PhDWO-714250240-402-8448
Associate Director for ResearchChintamani D. Atreya, PhDWO-714236240-402-8009
Associate Director for Policy and CommunicationsJennifer B. Scharpf, MPHWO-714248240-402-8437
Associate Deputy Director for Quality AssuranceJoseph GiglioWO-714220240-402-8295
Regulatory CounselMartin Ruta, PhDWO-714238240-402-8435
Special Assistant to the DirectorJacqueline Little, PhDWO-714237240-402-8416
Administrative StaffMichelle SalvettiWO-714218240-402-8436
Regulatory Project Management StaffIliana Valencia, M.S.WO-714252240-402-8444
Division of Emerging & Transfusion Transmitted Diseases - I.O.D.Hira L. Nakhasi, PhDWO-714266240-402-8209
Deputy Director(Vacant)   
Deputy Director for Medical Issues and Policy(Vacant)   
Associate Director for Regulatory PolicySayah Nedjar, PhDWO-714262240-402-8334
Product Review BranchPradip Akolkar, Ph.D.WO-714334240-402-8247
Laboratory of Bacterial & Transmissible Spongiform Encephalopathy AgentsDavid Asher, MDWO-52/724332240-402-9367
Laboratory of Molecular VirologyIndira K. Hewlett, PhDWO-52/724308240-402-9587
Laboratory of Emerging PathogensSanjai KumarWO-52/725304240-402-9652
Division of Hematology Clinical ReviewPaul D. Mintz, MDWO-714044240-402-8332
Deputy DirectorHoward Chazin, MDWO-714040240-402-8271
Hematology Product Review Branch(Vacant)   
Clinical Review BranchNisha Jain, MDWO-714054240-402-8408
Division of Hematology Research and ReviewBasil Golding, MDWO-714056240-402-8300
Deputy DirectorMahmood Farshid, PhDWO-714050240-402-8400
Laboratory of Cellular HematologyJaroslav G. Vostal, MD, PhDWO-52/724212240-402-8222
Laboratory of HemostasisTimothy K. Lee, PhD (Acting)WO-714028240-402-8415
Laboratory of Plasma DerivativesDorothy E. Scott, MDWO-52/724214240-402-8236
Laboratory of Biochemistry and Vascular BiologyAbdu Alayash, PhDWO-52/724106240-402-9350
Division of Blood Components and DevicesRichard J. Davey, MDWO-714068240-402-8103
Deputy DirectorOrieji Illoh, MDWO-714074240-402-8457
Blood and Plasma Branch(Vacant)  
Devices Review BranchTeresita C. MercadoWO-714072240-402-8420
DIRECTOR Marion F. Gruber, PhDWO-713230301-796-1856
Deputy DirectorPhillip R. Krause, MDWO-713234301-796-1862
Associate Director for ResearchKonstantin Chumakov, PhDWO-52/721128240-402-9440
Associate Director, Scientific AffairsErik A. Henchal, PhDWO-713242301-796-1853
Associate Director for Regulatory PolicyTheresa M. Finn, PhDWO-713236301-796-1859
Associate Director for Medical Policy & Vaccine SafetyKaren Farizo, MDWO-713238301-796-1448
Special Assistant for CommunicationMaureen A. Hess, MPHWO-713240301-796-1866
Special AssistantLinda H. ShoneWO-713226301-796-1864
Division of Viral ProductsJerry P. Weir, PhDWO-52/721306240-402-7473
fax 301-595-1070
Deputy DirectorRobin Levis, PhDWO-52/721208240-402-9665
Laboratory of Hepatitis VirusesMarian MajorWO-52/721210240-402-9720
Laboratory of Vector Borne DiseasesLewis J. Markoff, MDWO-52/725336240-402-9725
Laboratory of RetrovirusesHana Golding, PhDWO-714056240-402-8300
Laboratory of DNA VirusesKeith Peden, PhDWO-52/721220240-402-7312
Laboratory of Pediatric & Respiratory Viral DiseasesJerry P. Weir, PhD (Acting)WO-52/721306240-402-7473
Laboratory of Method DevelopmentSteven Rubin, PhDWO-52/721118240-402-7357
Laboratory of ImmunoregulationIra J. Berkower, MD, PhDWO52/721212240-402-9393
Division of Bacterial, Parasitic & Allergenic ProductsJay E. Slater, MDWO-52/723336240-402-7396
fax 301-595-1125
Deputy DirectorDrusilla Burns, PhDWO-52/723334240-402-9414
Laboratory of ImmunobiochemistryRonald L. Rabin, MDWO-52/723332240-402-7333
Laboratory of Bacterial PolysaccharidesWillie F. Vann, PhDWO-52/72G317240-402-7438
Laboratory of Mycobacterial Diseases & Cellular ImmunologySheldon L. Morris, PhDWO-52/725324240-402-9765
Laboratory of Respiratory & Special PathogensMichael Schmitt, PhDWO-52/723320240-402-7366
Laboratory of Enteric & Sexually Transmitted DiseasesEarl Stibitz, PhDWO-52/723304240-402-7401
Division of Vaccines & Related Products ApplicationsWellington Sun, MDWO-713056301-796-2640
fax 301-827-3532
Deputy DirectorLoris D. McVittie, PhDWO-713266301-796-2640
CMC Review
Branch 1
Paul G. Richman, PhDWO-713254301-796-2640
CMC Review
Branch 2
Rakesh Pandey, PhDWO-713248301-796-2640
CMC Review
Branch 3
Elizabeth M. Sutkowski, PhDWO-713050301-796-2640
Clinical Review
Branch 1
Jeffrey Roberts, MD (Acting)WO-713304301-796-2640
Clinical Review
Branch 2
Andrea Hulse (James)WO-713308301-796-2640
Review Management Support BranchLaraine S. HenchalWO-713264301-796-2640
DIRECTOR Mary Anne MalarkeyWO-715030240-402-9008
Deputy DirectorMark Schwartz, JDWO-715028240-402-9078
Special Assistant to the DirectorThomas J. AdamsWO-715044240-402-8873
Special Assistant for OperationsKerry BrendelWO-715022240-402-8897
Associate Director for PolicyAnita F. RichardsonWO-715038240-402-9065
Associate Director for Regulatory PolicyDiane AlexanderWO-715042240-402-8877
Associate Director for Manufacturing ScienceEdward PattenWO-715027240-402-9049
Associate Director for Safety and CommunicationJean MakieWO-715040240-402-9007
Associate Director for BioinformaticsSujay Pandey, PhDWO-715050240-402-9043
Special Assistant for Imports & Product AvailabilityJoseph P. ManikWO-715046240-402-9010
Special Assistant for Manufacturing and PolicyLinda E. Silvers, DVM, MPHWO-715048240-402-9089
Division of Case ManagementRobert A. SausvilleWO-715004240-402-9076
Advertising & Promotional Labeling BranchLisa StockbridgeWO-715056240-402-9115
Biological Drug and Device Compliance BranchMaria AndersonWO-715072240-402-8883
Blood and Tissue Compliance BranchStephany J. WesleyWO-715068240-402-9115
Division of Inspections & SurveillanceGilliam B. ConleyWO-715118240-402-8914
Bioresearch Monitoring BranchPatricia A. HolobaughWO-715133240-402-8906
Program Surveillance BranchLillian Ortega (Acting)WO-715128240-402-9041
Division of Manufacturing and Product QualityJohn A. Eltermann, Jr., PharmD, MSWO-716038240-402-9508
fax 301-595-1306
Deputy DirectorLaurie P. NorwoodWO-716046240-402-9778
Product Release BranchJoseph Quander, IIIWO-75G706240-402-7332
Manufacturing Review Branch ICarolyn A. RenshawWO-716042240-402-7343
Manufacturing Review Branch IIMarion MichaelisWO-716060240-402-9748
Application Review BranchJames CrimWO-716004240-402-9458
Division of Product QualityWilliam M. McCormick, PhDWO-716068240-402-9735
fax 301-595-1312
Deputy Director(Vacant)   
Laboratory of Analytical Chemistry and Blood Related ProductsLokesh BhattacharyyaWO-75G702240-402-9399
Quality Assurance BranchSuzanne CarterWO-75G646240-402-9420
Laboratory of Microbiology, In-Vivo Testing and StandardsJames KenneyWO-75G704240-402-9629
DIRECTOR Celia M. Witten, PhD, MDWO-715230240-402-8190
fax 301-595-1303
Deputy DirectorStephanie L. Simek, PhDWO-715234240-402-8352
Regulatory Management StaffPatrick S. Riggins, PhDWO-715236240-402-8346
Associate Director for ResearchSuzanne L. Epstein, PhDWO-52/723110240-402-9510
Associate Director for PolicyRichard D. McFarland, PhD, MDWO-715226240-402-8330

Associate Director for Policy (New Legislation)Rachael Strong-Anatol, PhDWO-715242240-402-8249
Associate Director for Information ManagementTheodore R. Stevens, MSWO-715074240-402-8357
Division of Cellular & Gene TherapiesRaj K. Puri, MD, PhDWO-715342240-402-9171
Deputy DirectorKimberly A. Benton, PhDWO-715324240-402-8258
Cell Therapies BranchSteven Oh, PhDWO-715314240-402-8337
Gene Therapies BranchDenise GavinWO-715328240-402-8291
Gene Transfer and Immunogenicity BranchAndrew Byrnes, PhDWO-52/723118240-402-9417
Tumor Vaccines and Biotechnology BranchRaj K. Puri, MD, PhD (Acting)WO-715342240-402-9171
Cellular and Tissue Therapy BranchSteven R. Bauer, PhDWO-52/723208240-402-9385
Division of Clinical Evaluation & Pharmacology / ToxicologyWilson W. Bryan, MDWO-715208240-402-8266
fax 240-402-1303
General Medicine BranchIlan Irony, MDWO-715262240-402-8312
Pharmacology / Toxicology BranchMercedes SerabianWO-715260240-402-8349
Oncology BranchKe Liu, MDWO-715264240-402-8325
Division of Human TissuesEllen F. Lazarus, MDWO-715210240-402-8319
Human Tissue and Reproduction BranchPing He, MDWO-715212240-402-9327


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Page Last Updated: 03/17/2016
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