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  1. Center for Biologics Evaluation and Research (CBER)

Center for Biologics Evaluation and Research Also referred to as: CBER


OFFICE OF THE CENTER DIRECTOR
DIRECTOR Peter W. Marks, MD, PhD WO-71 7232 240-402-8000
fax 301-595-1310
Deputy Director Celia M. Witten, PhD, MD WO-71 7230 240-402-8000
fax 301-595-1310
Special Assistant Debra Ellison WO-71 7234

240-402-3003

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 WO-71 6316 240-402-6705
Associate Director for Review Management Christopher C. Joneckis, PhD WO-71 7334 240-402-8083
fax 301-595-1311
Senior Science Advisor for Chemistry, Manufacturing, & Controls (Vacant) WO-71 7338 240-402-8115
fax 301-595-1311
Senior Advisor for International Affairs Joan Wilmarth Blair WO-71 7226 240-402-8022
fax 301-595-1310
Senior Advisor for Counterterrorism/Medical Countermeasures (Vacant) WO-71 7204 240-402-8089
fax 301-595-1310
Executive Operations Staff Debra Ellison WO-71 7234 240-402-8183
fax 301-595-1310
Document Control Center Richard D. Thomas WO-71 G104 240-402-8386
fax 301-594-0149
Regulatory Information Management Staff Heather Erdman WO-71  6324 240-402-8055
 
OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY
DIRECTOR Steven A. Anderson, PhD, MPP WO-71 1220 240-402-8577
Deputy Director Telba Z. Irony. PhD WO-71 1216 301-796-6044
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
Associate Director for Regulatory Affairs Alan Williams, PhD WO-71 1236 240-402-8448
Associate Director for Medical Policy (Vacant) WO-71    
Division of Biostatistics John Scott, PhD(Acting) WO-71 1018 240-402-8779
Deputy Division Director (Vacant) WO-71    
Vaccine Evaluation Branch (Vacant) WO-71    
Therapeutics Evaluation Branch Boguang Zhen, PhD WO-71 1240 240-402-8844
Division of Epidemiology Scott Proestel, MD WO-71 1260 240-402-0396
Deputy Division Director (Vacant) WO-71    
Pharmacovigilance Branch Adamma Mba-Jonas, MD WO-71 1027 240-402-8713
Analytic Epidemiology Branch Deepa Arya, MD WO-71 1318 240-402-6284
 
OFFICE OF COMMUNICATION, OUTREACH AND DEVELOPMENT
DIRECTOR Lorrie H. McNeill WO-71 4120 240-402-7800 
Deputy Director Susan C. Frantz-Bohn 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 Manen Bishop WO-71 3133 240-402-8019
Manufacturers Assistance & Technical Training Branch Jeffrey Anderson WO-71 3128 240-402-7800
Division of Disclosure and Oversight Management Suzann Burk WO-71 3126 240-402-8028
Congressional and Oversight Branch Christopher Juenger WO-71 3110 240-402-8086
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 Kristin Shazor WO-71 3118 240-402-7800
Consumer Affairs Branch Walter Gardner WO-71 3004 240-402-7800
 
OFFICE OF MANAGEMENT
DIRECTOR Deirdre P. Hussey WO-71 6230 240-402-7990
Deputy Director (Vacant) WO-71 6230 240-402-7990
Special Assistant Karen Greenfield WO-71 6232 240-402-8068
Planning and Performance Management Staff Mark Thompson(Acting) WO-71 6254 240-402-8174
Division of Program Services Dawn White WO-71 6136 240-402-3184
Assistant Director for Safety Marisa Hickey (Acting) WO-71 6128 240-402-7192
Program Operations Branch Caroline Leake WO-71 6136 301-796-4950
Program Services Branch Jason P. Rubino WO-71 6130 301-796-1948
Division of Budget and Resource Management Mary Pat Leary WO-71 6260 240-402-8108
Resource Management Branch Michael Fischer WO-71 6252 240-402-8014
Budget Analysis and Formulation Branch Angela Granum WO-71 6258 240-402-0376
Division of Scientific Advisors & Consultants Prabhakara Atreya WO-71 6306 240-402-8006
Division of Veterinary Services John Dennis WO-71 6262 240-402-9474
 
OFFICE OF BLOOD RESEARCH AND REVIEW
DIRECTOR Nicole Verdun, MD WO-71 4230 240-402-5100
Deputy Director Anne Eder, MD, PhD (Acting) WO-71 4037 240-402-8398
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 4238 240-402-8437
Associate Deputy Director for Quality Assurance Joseph Giglio, MS WO-71 4242 240-402-8295
Regulatory Counsel Martin Ruta, PhD WO-71 4220 240-402-8435
Special Assistant to the Director Jacqueline Little, PhD WO-71 4237 240-402-8416
Administrative Staff Vacant WO-71 4218  
Regulatory Project Management Staff Sonday Kelly, MS WO-71 4110 240-402-8410
Division of Emerging & Transfusion Transmitted Diseases Hira Nakhasi, PhD WO-71 4038 240-402-8209
Deputy Director Peyton (John) Hobson, PhD WO-71 4040 301-796-5892
Associate Deputy Director for Medical Issues and Policy Development Anne Eder, MD, PhD WO-71 4037 240-402-8398 
Associate Director for Regulatory Policy Sayah Nedjar, PhD WO-71 4042 240-402-8334
Product Review Branch David Leiby, PhD WO-71 4044 240-402-5392
Laboratory of Bacterial & Transmissible Spongiform Encephalopathy Agents David Asher, MD WO-52/72 4332 240-402-9367
Laboratory of Molecular Virology Indira K. Hewlett, PhD WO-52/72 4308 240-402-9587
Laboratory of Emerging Pathogens Sanjai Kumar, PhD WO-52/72 5304 240-402-9652
Division of Blood Components and Devices Orieji Illoh, MD WO-71 4074 240-402-8457
Deputy Director Wendy Paul, MD WO-71 4074

240-402-8747

Blood and Plasma Branch Richard McBride, MS WO-17 4066 240-402-9220
Devices Review Branch Teresita C. Mercado WO-71 4072 240-402-8420
Clinical Review Staff Salim Haddad, MD WO-71 4052 240-402-9313
Laboratory of Cellular Hematology Jaroslav G. Vostal, MD, PhD WO-52/72 4212 240-402-8222
Laboratory of Biochemistry and Vascular Biology Abdu Alayash, PhD WO-52/72 4106 240-402-9350
 
OFFICE OF VACCINES RESEARCH AND REVIEW
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 WO-52/72 1128 240-402-9440
Associate Director, Medical Countermeasures and Scientific Affairs Jeff Roberts, MD WO-71 3242 301-796-0809
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 WO-71 3238 301-796-1448
Special Assistant for Communication Maureen A. Hess, MPH WO-71 3240 301-796-1866
Division of Viral Products Jerry P. Weir, PhD WO-52/72 1306 240-402-7473
Deputy Director Robin Levis, PhD WO-52/72 1208 240-402-9665
Laboratory of Hepatitis Viruses Marian Major, PhD WO-52/72 1210 240-402-9720
Laboratory of Vector Borne Diseases Marian Major, PhD (Acting) WO-52/72 5336 240-402-9725
Laboratory of Retroviruses Hana Golding, PhD WO-71 4056 240-402-8300
Laboratory of DNA Viruses Keith Peden, PhD WO-52/72 1220 240-402-7312
Laboratory of Pediatric & Respiratory Viral Diseases Zhiping Ye, MD, PhD WO-52/72 1306 240-402-7473
Laboratory of Method Development (Vacant) WO-52/72 1118 240-402-7357
Laboratory of Immunoregulation Carol Weiss, MD, PhD WO52/72 1212 240-402-7474
Division of Bacterial, Parasitic & Allergenic Products Jay E. Slater, MD WO-52/72 3336 240-402-7396
fax 301-595-1125
Deputy Director Drusilla Burns, PhD WO-52/72 3334 240-402-9414
Laboratory of Immunobiochemistry Ronald L. Rabin, MD WO-52/72 3332 240-402-7333
Laboratory of Bacterial Polysaccharides Willie F. Vann, PhD WO-52/72 G317 240-402-7438
Laboratory of Respiratory & Special Pathogens Michael Schmitt, PhD WO-52/72 3320 240-402-7366
Laboratory of Mucosal Pathogens & Cellular Immunology Earl Stibitz, PhD WO-52/72 3304 240-402-7401
Division of Vaccines & Related Products Applications (Vacant) WO-71 3056 301-796-2640
fax 301-827-3532
Deputy Director - Clinical Doran Fink, MD, PhD WO-71 3311 301-796-2640
Deputy Director - Regulatory Loris D. McVittie, PhD WO-71 3266 301-796-2640
CMC Review
Branch 1
Jon Daugherty, PhD WO-71 3260 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
Roshan Ramanathan WO-71 3010 301-796-2640
Clinical Review
Branch 2
Andrea Hulse (James), MD WO-71 3308 301-796-2640
Review Management Support Branch Timothy Nelle, PhD WO-71 3264 301-796-2640
 
OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY
DIRECTOR Mary Anne Malarkey WO-71 5030 240-402-9008
Deputy Director Melissa Mendoza WO-71 5028 301-796-8707
Special Assistant to the Director Mona Atkinson WO-71 5039 301-796-4215
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 Safety and Communication Jean Makie WO-71 5040 240-402-9007
Associate Director for Bioinformatics Sujay Pandey, PhD WO-71 5050 240-402-9043
Associate Director for Policy and Legislation Tom Adams WO-71 5044 240-402-8873
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 240-402-9095
Biological Drug and Device Compliance Branch Maria Anderson WO-71 5072 240-402-8883
Blood and Tissue Compliance Branch Stephany J. Kersten WO-71 5068 240-402-9115
Division of Inspections & Surveillance Carrie Mampilly WO-71 5128 240-402-2973
Bioresearch Monitoring Branch Dennis Cato WO-71 5136 240-402-8906
Program Surveillance Branch Jeremy Wally WO-71 5133 240-402-7458
Division of Manufacturing and Product Quality John A. Eltermann, Jr., RPh, MS WO-71 6038 240-402-9508
fax 301-595-1306
Deputy Director Laurie P. Norwood WO-71 6046 240-402-9778
Product Release Branch Joseph Quander, III WO-75 G706 240-402-7332
Manufacturing Review Branch I Carolyn A. Renshaw WO-71 6042 240-402-7343
Manufacturing Review Branch II Qiao Bobo WO-71 6060 240-402-9403
Application Review Branch James Crim WO-71 6004 240-402-9458
Division of Biological Standards and Quality Control Maryna Eichelberger, PhD WO-75 G646 240-402-9505
Laboratory of Biochemistry, Virology and Immunology Muhammad Shahabuddin, PhD WO-75 G664 240-402-7370
Laboratory of Analytical Chemistry and Blood Related Products Lokesh Bhattacharyya, PhD WO-75 G702 240-402-9399
Quality Assurance Branch Suzanne Carter WO-75 G646 240-402-9420
Laboratory of Microbiology, In-Vivo Testing and Standards James Kenney, DSc WO-75 G704 240-402-9629
 
OFFICE OF TISSUES AND ADVANCED THERAPIES
DIRECTOR Wilson Bryan, MD WO-71 5230

240-402-8266

Deputy Director Rachael Anatol, PhD WO-71 5234 240-402-8249
Associate Director for Research Suzanne L. Epstein, PhD WO-52/72 3110 240-402-9510
Associate Director for Policy Richard D. McFarland, PhD, MD WO-71 5226 240-402-8330

 
Associate Director for Policy (New Legislation) (Vacant) WO-71    
Associate Director for Information Management Theodore R. Stevens, MS WO-71 5074 240-402-8357
Associate Director for Regulatory Management Kimberly Benton, PhD WO-71 5324 240-402-8258
Director Division of Regulatory Project Management Ramani Sista WO-71 5328 240-402-8354
Division of Cellular & Gene Therapies Raj K. Puri, MD, PhD WO-71 5342 240-402-9171
Deputy Director Steven Oh, PhD WO-71 5314 240-402-8337 
Cell Therapies Branch Melanie Eacho, PhD WO-71 5326 301-796-0122
Gene Therapies Branch Denise Gavin WO-71 5328 240-402-8291
Gene Transfer and Immunogenicity Branch Andrew Byrnes, PhD WO-52/72 3118 240-402-9417
Tumor Vaccines and Biotechnology Branch Raj K. Puri, MD, PhD (Acting) WO-71 5342 240-402-9171
Cellular and Tissue Therapy Branch Steven R. Bauer, PhD WO-52/72 3208 240-402-9385
Division of Plasma Protein Therapeutics Basil Golding, MD WO-71 4056 240-402-8300
Deputy Director Mahmood Farshid, PhD WO-71 4050 240-402-8400
Hemostasis Branch Timothy K. Lee, PhD(Acting) WO-71 4028 240-402-8415
Plasma Derivatives Branch Dorothy Scott, MD WO-71 4214 240-402-8236
Regulatory Project Management Branch I Patrick Riggins, PhD WO-71 5236 240-402-8346
Regulatory Project Management Branch II Patrick Riggins, PhD(Acting) WO-71 5236 240-402-8346
Division of Clinical Evaluation & Pharmacology / Toxicology Tejashri Purohit-Sheth, MD WO-71 5310 301-796-3402
Deputy Director Ilan Irony, MD WO-71 5304 240-402-8312
General Medicine Branch I Ilan Irony, MD (Acting) WO-71 5304 240-402-8312
General Medicine Branch II Lei Xu, MD, PhD WO-71 4325 240-402-8372
Pharmacology / Toxicology Branch I Mercedes Serabian, MS WO-71 5313 240-402-8349
Pharmacology / Toxicology Branch II Becky Robinson-Zeigler, PhD WO-71 5323 301-796-6532
Clinical Hematology Branch Bindu George, MD WO-71 4312 240-402-8292
Oncology Branch Ke Liu, MD WO-71 4264 240-402-8325
Division of Human Tissues Scott Brubaker WO-71 5210 240-402-8319
Human Tissue and Reproduction Branch Ping He, MD WO-71 5212 240-402-9327