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CBER Key Staff Directory

DIRECTOR Karen Midthun, MD WO-71 7232 240-402-8000
fax 301-595-1310
Deputy Director Peter W. Marks, MD, PhD WO-71 7230 240-402-8000
fax 301-595-1310
Special Assistant Anne E. Wilcox WO-71 7234 240-402-8183
fax 301-595-1310
Senior Scientist for Emerging & Pandemic Threat Preparedness David S. Cho, PhD WO-71 7246 240-402-8036
fax 301-595-1310
Special Assistant Gopa Raychaudhuri WO-71 7250 240-402-8147
Associate Director for Medicine Barbara D. Buch, MD WO-71 7224 240-402-8000
fax 301-595-1310
Associate Director for Quality Assurance Sheryl L. Lard-Whiteford, PhD WO-71 7240 240-402-7912
fax 301-595-1310
Associate Director for Policy Diane Maloney, JD WO-71 7242 240-402-8113
fax 301-595-1310
Associate Director for Research Carolyn A. Wilson, PhD N29B 5NN20 301-827-0481
fax 301-827-3187
Associate Director for Review Management Christopher C. Joneckis, PhD (Acting) WO-71 7334 240-402-7910
fax 301-595-1310
Senior Advisor for Chemistry, Manufacturing, & Control Christopher C. Joneckis, PhD WO-71 7334 240-402-7910
fax 301-595-1310
Senior Advisor for International Affairs Joan Wilmarth Blair WO-71 7226 240-402-8022
fax 301-595-1310
Senior Advisor for Counterterrorism/Medical Countermeasures Cynthia L. Kelley, MS WO-71 7204 240-402-8089
fax 301-595-1310
Executive Operations Staff Anne E. Wilcox WO-71 7234 240-402-8183
fax 301-595-1310
Document Control Center Jules M. Meisler WO-71 G102 240-402-8384
fax 301-594-0149
DIRECTOR Steven A. Anderson, PhD, MPP WO-71 1220 240-402-8577
Deputy Director David Martin, MD (Acting) WO-71 1224 240-402-8710
Associate Director for Risk Assessment Mark O. Walderhaug, PhD WO-71 1059 240-402-8812
Associate Director for Research Richard A. Forshee, PhD WO-71 1226 240-402-8631
Associate Director for Policy Jawahar Tiwari, PhD WO-71 1234 240-402-8804
Division of Biostatistics Estelle Russek-Cohen, PhD
WO-71 1228 240-402-8771
Vaccine Evaluation Branch A. Dale Horne, PhD WO-71 1246 240-402-8653
Therapeutics Evaluation Branch Boguang Zhen, PhD WO-71 1240 240-402-8844
Division of Epidemiology David Martin, MD WO-71 1224 240-402-8710
Deputy Division Director Craig Zinderman, MD (Acting) WO-71 1325 240-402-8845
Pharmacovigilance Branch Christopher Jankosky, MD WO-71 1310 240-402-8664
Analytic Epidemiology Branch Wei Hua, MD, MS, MHS, PhD (Acting) WO-71 1306 240-402-8658
DIRECTOR Lorrie H. McNeill WO-71 4120 240-402-7800 
Deputy Director Joanne C. Binkley WO-71 3120 240-402-7800
Division of Manufacturers Assistance and Training Donna L. Lipscomb WO-71 1008 240-402-7800
Career Development and Directed Training Branch Eris Mackey WO-71 4128 240-402-7800
Manufacturers Assistance & Technical Training Branch Faye Vigue WO-71 3128 240-402-7800
Division of Disclosure and Oversight Management Susan C. Frantz-Bohn WO-71 3126 240-402-7800
Congressional and Oversight Branch Matthew D. Lyons WO-71 4116 240-402-7800
Access Litigation & Freedom of Information Branch Beth Brockner-Ryan WO-71 1114 240-402-7800
Division of Communication and Consumer Affairs Diane Bartell WO-71 4130 240-402-7800
Communication Technology Branch Francis Orphe WO-71 1113 240-402-7800
Consumer Affairs Branch Walter Gardner WO-71 3004 240-402-7800
DIRECTOR James M. Sigg WO-71 6234 240-402-7990
Deputy Director Deirdre P. Hussey WO-71 6230 240-402-7990
Special Assistant Ann M. Jenkins WO-71 6232 240-402-7990
Regulatory Information Management Staff Jeffrey M. Anderson WO-71 6104 240-402-8004
Planning and Performance Management Staff Mary Pat Leary WO-71 6242 240-402-8099
Division of Program Services Stephanie Hawk WO-71 6306 301-796-4113
Assistant Director for Safety Tanya Pittas N29A 1C02 301-827-1867
Program Operations Branch Dawn White WO-71 6308 240-402-3184
Program Services Branch Jason P. Rubino WO-71 6304 301-796-1948
Division of Budget and Resource Management Martie Louviere WO-71 6260 240-402-8108
Resource Management Branch Connie Giganti WO-71 6262 240-402-8063
Budget Analysis and Formulation Branch Angela Moy WO-71 6258 240-402-8127
Division of Scientific Advisors & Consultants Prabhakara Atreya WO-71 6216 240-402-8006
DIRECTOR Jay S. Epstein, MD WO-71 4230 240-402-8280
Deputy Director Ginette Y. Michaud, MD WO-71 4234 240-402-8331
Associate Director for Medical Affairs Basil Golding, MD (Acting) WO-71 4056 240-402-8300
Senior Advisor for Scientific Affairs Mark J. Weinstein, PhD WO-71 4229 240-402-8365
Associate Director for Regulatory Affairs Alan E. Williams, PhD WO-71 4250 240-402-8448
Deputy Associate Director for Bioinformatics (Vacant) WO-71    
Associate Director for Research Chintamani D. Atreya, PhD WO-71 4236 240-402-8009
Associate Director for Policy and Communications Jennifer B. Scharpf, MPH WO-71 4248 240-402-8437
Associate Deputy Director for Quality Assurance Joseph Giglio WO-71 4220 240-402-8295
Regulatory Counsel Martin Ruta, PhD WO-71 4238 240-402-8435
Special Assistant to the Director Jacqueline Little, PhD WO-71 4237 240-402-8416
Administrative Staff Michelle Salvetti WO-71 4218 240-402-8436
Regulatory Project Management Staff Iliana Valencia, M.S. WO-71 4252 240-402-8444
Division of Emerging & Transfusion Transmitted Diseases - I.O.D. Hira L. Nakhasi, PhD N29 222 301-827-3008
fax 301-480-7928
Deputy Director Paul A. Mied, PhD N29 219 301-827-6569
Deputy Director for Medical Issues and Policy Robin M. Biswas, MD N29 225 301-827-3011
Associate Director for Regulatory Policy Sayah Nedjar, PhD WO-71 4262 240-402-8334
Product Review Branch Pradip Akolkar, Ph.D. (Acting) WO-71 4334 240-402-8247
Laboratory of Bacterial & Transmissible Spongiform Encephalopathy Agents David Asher, MD NLRC 236 301-594-6733
Laboratory of Molecular Virology Indira K. Hewlett, PhD N29B 4NN16 301-827-0795
Laboratory of Emerging Agents Sanjai Kumar NLRC 158 301-827-7533
Division of Hematology Clinical Review Paul D. Mintz, MD WO-71 4044 240-402-8332
Deputy Director for Medical Affairs Howard Chazin, MD WO-71 4040 240-402-8271
Hematology Product Review Branch Anne Pilaro, PhD (Acting) WO-71 4044 240-402-8341
Clinical Review Branch Nisha Jain, MD WO-71 4054 240-402-8408
Division of Hematology Research and Review Basil Golding, MD WO-71 4056 240-402-8300
Deputy Director for CMC and Policy Mahmood Farshid, PhD WO-71 4050 240-402-8400
Laboratory of Cellular Hematology Jaroslav G. Vostal, MD, PhD N29 321 301-827-9655
Laboratory of Hemostasis Timothy K. Lee, PhD (Acting) WO-71 4028 240-402-8415
Laboratory of Plasma Derivatives Dorothy E. Scott, MD N29 232 301-827-3016
Laboratory of Biochemistry and Vascular Biology Abdu Alayash, PhD N29 112 301-827-3813
Division of Blood Components and Devices Richard J. Davey, MD WO-71 4068 240-402-8103
Deputy Director Orieji Illoh, MD WO-71 4074 240-402-8457
Blood and Plasma Branch (Vacant) WO-71  
Devices Review Branch Teresita C. Mercado WO-71 4072 240-402-8420
DIRECTOR Marion F. Gruber, PhD WO-71 3230 301-796-1856
Deputy Director Phillip R. Krause, MD WO-71 3234 301-796-1862
Associate Director for Research Konstantin Chumakov, PhD N29B 1H16 301-827-0655
Associate Director, Scientific Affairs Erik A. Henchal, PhD WO-71 3242 301-796-1853
Associate Director for Regulatory Policy Theresa M. Finn, PhD WO-71 3236 301-796-1859
Associate Director for Medical Policy & Vaccine Safety Karen Farizo, MD (Acting) WO-71 3238 301-796-1448
Special Assistant for Communication Maureen A. Hess, MPH WO-71 3240 301-796-1866
Special Assistant Linda H. Shone WO-71 3226 301-796-1864
Division of Viral Products Jerry P. Weir, PhD N29A 1A21 301-827-1930
fax 301-496-1810
Deputy Director Robin Levis, PhD (Acting) N29A 1A21 301-827-1930
Laboratory of Hepatitis Viruses Stephen M. Feinstone, MD N29A 1D14 301-827-1877
Laboratory of Vector Borne Diseases Lewis J. Markoff, MD N29A 1B17 301-827-1886
Laboratory of Retroviruses Hana Golding, PhD N29B 4NN04 301-827-0784
Laboratory of DNA Viruses Keith Peden, PhD N29A 3D08 301-827-1708
Laboratory of Pediatric & Respiratory Viral Diseases Jerry P. Weir, PhD (Acting) N29A 1A21 301-827-1930
Laboratory of Method Development (Vacant) NLRC B-122 301-594-3720
fax 301-827-4622
Laboratory of Immunoregulation Ira J. Berkower, MD, PhD N29 523 301-496-1870
Division of Bacterial, Parasitic & Allergenic Products Jay E. Slater, MD N29 130 301-496-1014
fax 301-402-2776
Deputy Director Drusilla Burns, PhD N29 130 301-496-1014
Laboratory of Immunobiochemistry Ronald L. Rabin, MD N29 111 301-496-4575
Laboratory of Bacterial Polysaccharides Willie F. Vann, PhD N29 103A 301-496-1014
Laboratory of Mycobacterial Diseases & Cellular Immunology Sheldon L. Morris, PhD N29 502 301-496-5978
Laboratory of Respiratory & Special Pathogens Michael Schmitt, PhD N29 124 301-402-3553
Laboratory of Enteric & Sexually Transmitted Diseases Earl Stibitz, PhD N29 526 301-496-1014
Division of Vaccines & Related Products Applications Wellington Sun, MD WO-71 3056 301-796-2640
fax 301-827-3532
Deputy Director Loris D. McVittie, PhD WO-71 3266 301-796-2640
CMC Review
Branch 1
Paul G. Richman, PhD WO-71 3254 301-796-2640
CMC Review
Branch 2
Rakesh Pandey, PhD WO-71 3248 301-796-2640
CMC Review
Branch 3
Elizabeth M. Sutkowski, PhD WO-71 3050 301-796-2640
Clinical Review
Branch 1
Jeffrey Roberts, MD (Acting) WO-71 3304 301-796-2640
Clinical Review
Branch 2
Andrea Hulse (James) (Acting) WO-71 3308 301-796-2640
Review Management Support Branch Laraine S. Henchal WO-71 3264 301-796-2640
DIRECTOR Mary Anne Malarkey WO-71 5030 240-402-9008
Deputy Director Mark Schwartz, JD WO-71 5028 240-402-9078
Special Assistant to the Director Thomas J. Adams WO-71 5044 240-402-8873
Special Assistant for Operations Kerry Brendel WO-71 5022 240-402-8897
Associate Director for Policy Anita F. Richardson WO-71 5038 240-402-9065
Associate Director for Regulatory Policy Diane Alexander WO-71 5042 240-402-8877
Associate Director for Manufacturing Science Edward Patten WO-71 5027 240-402-9049
Associate Director for Safety and Communication Jean Makie WO-71 5040 240-402-9007
Associate Director for Bioinformatics Sujay Pandey, PhD WO-71 5050 240-402-9043
Special Assistant for Imports & Product Availability Joseph P. Manik WO-71 5046 240-402-9010
Special Assistant for Manufacturing and Policy Linda E. Silvers, DVM, MPH WO-71 5048 240-402-9089
Division of Case Management Robert A. Sausville WO-71 5004 240-402-9076
Advertising & Promotional Labeling Branch Lisa Stockbridge WO-71 5056 240-402-9115
Biological Drug and Device Compliance Branch Maria Anderson WO-71 5072 240-402-8883
Blood and Tissue Compliance Branch Stephany J. Wesley WO-71 5068 240-402-9115
Division of Inspections & Surveillance Gilliam B. Conley WO-71 5118 240-402-8914
Bioresearch Monitoring Branch Patricia A. Holobaugh WO-71 5133 240-402-8906
Program Surveillance Branch Janet L. Ishimoto WO-71 5128 240-402-8965
Division of Manufacturing and Product Quality John A. Eltermann, Jr., PharmD, MS NLRC A-217 301-827-3031
fax 301-827-3536
Deputy Director Laurie P. Norwood NLRC A-237 301-827-3031
Product Release Branch Joseph Quander, III NLRC A-209 301-594-6517
Manufacturing Review Branch I Carolyn A. Renshaw NLRC A-252 301-827-3031
Manufacturing Review Branch II Marion Michaelis NLRC A-234 301-827-3031
Application Review Branch James Crim NLRC A-236 301-827-3031
Division of Product Quality William M. McCormick, PhD NLRC 2400 301-594-6299
fax 301-480-9748
Deputy Director Rajesh K. Gupta, PhD NLRC 2401 301-594-6241
Laboratory of Analytical Chemistry and Blood Related Products (Vacant) NLRC 2402 301-594-6242
Quality Assurance Branch Suzanne Carter
NLRC 2412 301-594-6243
Laboratory of Microbiology, In-Vivo Testing and Standards James Kenney NLRC 2405 301-594-6242
DIRECTOR Celia M. Witten, MD, PhD WO-71 5230 240-402-8190
fax 301-595-1303
Deputy Director Stephanie L. Simek, PhD WO-71 5234 240-402-8352
Regulatory Management Staff Patrick S. Riggins, PhD WO-71 5236 240-402-8346
Associate Director for Research Suzanne L. Epstein, PhD N29B 2NN06 301-827-0450
fax 301-827-0449
Associate Director for Policy Richard D. McFarland, MD WO-71 5226 240-402-8330

Associate Director for Policy (New Legislation) Rachael Strong-Anatol, PhD WO-71 5242 240-402-8249
Associate Director for Information Management Theodore R. Stevens, MS WO-71 5074 240-402-8357
Division of Cellular & Gene Therapies Raj K. Puri, MD, PhD N29B 2NN10 301-827-0680
fax 301-827-0449
Deputy Director Kimberly A. Benton, PhD WO-71 5324 240-402-8258
Cell Therapies Branch Keith M. Wonnacott, PhD WO-71 5314 240-402-8371
Gene Therapies Branch Daniel M. Takefman, PhD WO-71 5308 240-402-8358
Gene Transfer and Immunogenicity Branch Andrew Byrnes, PhD N29B 2NN04 301-827-0680
Tumor Vaccines and Biotechnology Branch Raj K. Puri, MD, PhD (Acting) N29B 2NN10 301-827-0680
Cellular and Tissue Therapy Branch Steven R. Bauer, PhD N29B 2NN20 301-827-0680
Division of Clinical Evaluation & Pharmacology / Toxicology Wilson W. Bryan, MD WO-71 5208 240-402-8266
fax 240-402-1303
General Medicine Branch Ilan Irony, MD WO-71 5260 240-402-8349
Oncology Branch Ke Liu, MD WO-71 5262 240-402-8312
Division of Human Tissues Ellen F. Lazarus, MD WO-71 5264 240-402-8325
Human Tissue and Reproduction Branch Melissa Greenwald, MD WO-71 5210 240-402-8319
fax 301-595-1303


Page Last Updated: 11/05/2014
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