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Resources for You

CBER Key Staff Directory

 

OFFICE OF THE CENTER DIRECTOR
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
OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY
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
(Acting)
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
OFFICE OF COMMUNICATION, OUTREACH AND DEVELOPMENT
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
OFFICE OF MANAGEMENT
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
OFFICE OF BLOOD RESEARCH AND REVIEW
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 PolicySayah Nedjar, PhDWO-714262240-402-8335
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
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
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
OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY
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
(Acting)
NLRC
2412
301-594-6243
Laboratory of Microbiology, In-Vivo Testing and Standards
James Kenney
NLRC
2405
301-594-6242
OFFICE OF CELLULAR, TISSUE AND GENE THERAPIES
DIRECTOR
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