CBER Key Staff Directory

OFFICE OF THE CENTER DIRECTOR
DIRECTOR	Karen Midthun, MD	HFM-1	RKW2	7101	301-827-0372 fax 301-827-0440
Deputy Director	Peter W. Marks, MD, PhD	HFM-6	RKW2	7102	301-827-0372
Special Assistant	Anne E. Wilcox	HFM-1	RKW2	7104	301-827-0371
Senior Scientist for Emerging & Pandemic Threat Preparedness	David S. Cho, PhD	HFM-1	RKW2	7230	301-827-9424 fax 301-827-0440
Special Assistant	Gopa Raychaudhuri	HFM-1	RKW2	7228	301-827-6352
Associate Director for Medicine	Barbara D. Buch, MD	HFM-1	RKW2	7100	301-827-0372 fax 301-827-0440
Associate Director for Quality Assurance	Sheryl L. Lard-Whiteford, PhD	HFM-4	RKW2	7220	301-827-0379 fax 301-827-2920
Associate Director for Policy	Diane Maloney, JD	HFM-10	RKW2	7106	301-827-0372 fax 301-827-0440
Associate Director for Research	Carolyn A. Wilson, PhD	HFM-20	N29B	5NN20	301-827-0481 fax 301-827-3187
Associate Director for Review Management	Robert A. Yetter, PhD	HFM-25	RKW2	7301	301-827-0373 fax 301-827-9434
Senior Advisor for Chemistry, Manufacturing, & Control	Christopher C. Joneckis, PhD	HFM-25	RKW2	7302	301-435-5681 fax 301-827-9434
Senior Advisor for International Affairs	Joan Wilmarth Blair	HFM-30	RKW2	7234	301-827-0639 fax 301-827-0440
Senior Advisor for Counterterrorism/Medical Countermeasures	Cynthia L. Kelley, MS	HFM-6	RKW2	7236	301-827-0636 fax 301-827-0440
Executive Operations Staff	Anne E. Wilcox	HFM-1	RKW2	7104	301-827-0371
Document Control Center	Jules M. Meisler	HFM-99	WOC1	200N	301-827-2863 fax 301-594-0149
OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY
DIRECTOR	Robert Ball, MD, MPH, M.Sc.	HFM-210	WOC1	54S		301-827-3034 fax 301-827-0648
Deputy Director	Steven A. Anderson, PhD, M.P.P.	HFM-210	WOC1	39S		301-827-6026
Associate Director for Risk Assessment	Mark O. Walderhaug, PhD	HFM-210	WOC1	309N		301-827-6028
Associate Director for Research	Richard A. Forsee, PhD	HFM-210	WOC1	308N		301-827-6042
Associate Director for Policy	Jawahar Tiwari, PhD	HFM-220	WOC1	437S		301-827-60476047 fax 301-827-5218
Division of Biostatistics	Estelle Russek-Cohen, PhD (Acting)	HFM-215	WOC1	448S		301-827-9007 fax 301-827-5218
Vaccine Evaluation Branch	A. Dale Horne, PhD	HFM-217	WOC1	409S		301-827-6096
Therapeutics Evaluation Branch	Boguang Zhen, PhD (Acting)	HFM-219	WOC1	424S		301-827-6027
Division of Epidemiology	David Martin, MD (Acting)	HFM-220	WOC1	455S		301-827-9018 fax 301-827-5218
Deputy Division Director	Craig Zinderman, MD (Acting)	HFM-220	WOC1	441S		301-827-6045
Vaccine Safety Branch	Michael Nguyen, MD (Acting)	HFM-222	WOC1	461S		301-827-9027
Therapeutics and Blood Safety Branch	Michael Nguyen, MD (Acting)	HFM-224	WOC1	461S		301-827-9027
Analytic Epidemiology Branch	Wei Hua, MD, MS, MHS, PhD (Acting)	HFM-220	WOC1	323N		301-827-6059
OFFICE OF COMMUNICATION, OUTREACH AND DEVELOPMENT
DIRECTOR	Lorrie H. McNeill	HFM-40	RKWL	601		301-827-2000 fax 301-827-3843
Deputy Director	Joanne C. Binkley	HFM-40	RKWL	601		301-827-2000
Division of Manufacturers Assistance and Training	Donna L. Lipscomb	HFM-42	RKWL	601		301-827-2000 fax 301-827-3079
Career Development and Directed Training Branch	Eris Mackey	HFM-49	RKWL	601		301-827-2000
Manufacturers Assistance & Technical Training Branch	Faye Vigue	HFM-41	RKWL	601		301-827-2000
Division of Disclosure and Oversight Management	Susan C. Frantz-Bohn	HFM-44	RKWL	601		301-827-2000 fax 301-827-3843
Congressional and Oversight Branch	Matthew D. Lyons	HFM-46	RKWL	601		301-827-2000
Access Litigation & Freedom of Information Branch	Beth Brockner-Ryan	HFM-48	RKWL	601		301-827-2000
Division of Communication and Consumer Affairs	Diane Bartell	HFM-43	RKWL	601		301-827-2000 fax 301-827-3843
Communication Technology Branch	Francis Orphe (Acting)	HFM-45	RKWL	601		301-827-2000
Consumer Affairs Branch	Walter Gardner	HFM-47	RKWL	601		301-827-2000
OFFICE OF MANAGEMENT
DIRECTOR	James M. Sigg	HFM-100	RKWL	360		301-827-1320 fax 301-827-1438
Deputy Director	Deirdre P. Hussey	HFM-100	RKWL	360		301-827-1320
Special Assistant	Ann M. Jenkins	HFM-100	RKWL	360		301-827-1320
Regulatory Information Management Staff	Jeffrey M. Anderson	HFM-110	RKWL	375		301-827-6171 fax 301-827-2875
White Oak Planning Team	Maureen E. Sheridan	HFM-118	RKWL	513		301-827-0413 fax 301-827-3137
Planning and Performance Management Staff	Mary Pat Leary	HFM-150	RKWL	420		301-827-1414 fax 301-827-1102
Strategic Human Capital Programs	Lisa M. Durphy	HFM-122	RKWL	350		301-827-9317 fax 301-827-1441
Division of Program Services	David R. Leffler	HFM-115	RKWL	350		301-827-1400 fax 301-827-1441
Assistant Director for Safety	(Vacant)	HFM-114	N29A	1C02		301-827-1867
Building Operations Staff	Catrina M. Posley	HFM-118	RKWL	513		301-827-3502 fax 301-827-3137
Program Operations Branch	Cynthia A. Hart-Smith	HFM-122	RKWL	350		301-827-1400
Program Management Services Branch	Marsha C. Williams	HFM-123	RKWL	350		301-827-1400
Division of Budget and Resource Management	Martie Louviere	HFM-140	RKWL	420		301-827-1414 fax 301-827-1102
Resource Management Branch	Connie Giganti	HFM-145	RKWL	420		301-827-1414
Budget Analysis and Formulation Branch	Richard Kodl	HFM-150	RKWL	420		301-827-1414
Division of Scientific Advisors & Consultants	Prabhakara Atreya	HFM-460	RKW2	1120		301-827-1295 fax 301-827-0294
Division of Veterinary Services	John Dennis, DVM, MS	HFM-22	N29A	1A17		301-827-1847 fax402-2408
OFFICE OF INFORMATION TECHNOLOGY
DIRECTOR	Ginger Leo	HFM-160	RKWL	400		301-827-1368 fax 301-827-3053
Deputy Director	Amy El Naggar	HFM-165	RKWL	400		301-827-1368
Division of Information Operations	Amy El Naggar	HFM-165	RKWL	400		301-827-1368 fax 301-827-3053
Division of Information Development	Nadia O. Davey	HFM-170	RKWL	400		301-827-1368 fax 301-827-3053
OFFICE OF BLOOD RESEARCH AND REVIEW
DIRECTOR	Jay S. Epstein, MD	HFM-300	WOC1	400N		301-827-3518 fax 301-827-3533
Deputy Director for Medical and Scientific Affairs	Ginette Y. Michaud, MD	HFM-300	WOC1	400N		301-827-3518
Associate Director for Medical Affairs	Basil Golding, MD (Acting)	HFM-300	WOC1	400N		301-827-3518
Senior Advisor for Scientific Affairs	Mark J. Weinstein, PhD	HFM-300	WOC1	400N		301-827-3518
Associate Director for Regulatory Affairs	Alan E. Williams, PhD	HFM-300	WOC1	400N		301-827-3518
Deputy Associate Director for Bioinformatics	(Vacant)	HFM-330	WOC1	400N		301-827-6120
Associate Director for Research	Chintamani D. Atreya, PhD	HFM-300	WOC1	400N		301-827-3518
Associate Director for Policy and Communications	Jennifer B. Scharpf, MPH	HFM-350	WOC1	400N		301-827-6128 fax 301-827-2843
Deputy Associate Director for Regulatory Affairs	Betsy Jett, B.S.	HFM-300	WOC1	400N		301-827-6129
Associate Deputy Director for Quality Assurance	Joseph Giglio	HFM-380	WOC1	400N		301-827-9212
Regulatory Counsel	Martin Ruta, PhD	HFM-300	WOC1	400N		301-827-3518
Special Assistant to the Director	Jacqueline Little, PhD	HFM-300	WOC1	400N		301-827-3518
Division of Emerging & Transfusion Transmitted Diseases - I.O.D.	Hira L. Nakhasi, PhD	HFM-310	N29	222		301-827-3008 fax 301-480-7928
Deputy Director	Paul A. Mied, PhD	HFM-310	N29	219		301-827-6569
Deputy Director for Medical Issues and Policy	Robin M. Biswas, MD	HFM-310	N29	225		301-827-3011
Product Review Branch	Elliot P. Cowan, PhD	HFM-394	RKWL2	11100		301-827-6681
Laboratory of Bacterial & Transmissible Spongiform Encephalopathy Agents	David Asher, MD	HFM-313	NLRC	236		301-594-6733
Laboratory of Molecular Virology	Indira K. Hewlett, PhD	HFM-315	N29B	4NN16		301-827-0795
Laboratory of Emerging Agents	Sanjai Kumar	HFM-313	NLRC	158		301-827-7533
Division of Hematology	Basil Golding, MD	HFM-330	N29	326		301-496-4396 fax 402-2780
Deputy Director for CMC and Policy	Mahmood Farshid, PhD	HFM-300	WOC1	400N		301-827-6163
Deputy Director for Medical Affairs	Howard Chazin, MD	HFM-300	WOC1	400N		301-827-6178
Deputy Director for Medical Affairs	Paul Mintz, MD	HFM-300	WOC1			301-827-6112
Laboratory of Cellular Hematology	Jaroslav G. Vostal, MD, PhD	HFM-335	N29	321		301-827-9655
Laboratory of Hemostasis	Timothy K. Lee, PhD (Acting)	HFM-340	WOCI	400N		301-827-6166
Laboratory of Plasma Derivatives	Dorothy E. Scott, MD	HFM-345	N29	232		301-827-3016
Clinical Review Branch	Nisha Jain, MD	HFM-392	WOCI	400N		301-827-6110
Laboratory of Biochemistry and Vascular Biology	Abdu Alayash, PhD	HFM-343	N29	112		301-827-3813
Division of Blood Applications	Richard J. Davey, MD	HFM-370	WOC1	400N		301-827-3524 fax 301-827-3535
Deputy Director	Orieji Illoh, MD	HFM-370	WOC1	400N		301-827-6145
Blood and Plasma Branch	Leslie G. Holness, MD	HFM-375	WOC1	400N		301-827-3524
Regulatory Project Management Branch	Iliana Valencia, M.S.	HFM-380	WOC1	400N		301-827-3524
Devices Review Branch	Teresita C. Mercado	HFM-390	WOC1	400N		301-827-3524
OFFICE OF VACCINES RESEARCH AND REVIEW
DIRECTOR	Marion F. Gruber, PhD	HFM-405	WOC2	3340		301-796-2630 fax 301-402-1290
Deputy Director	Phillip R. Krause, MD (Acting)	HFM-405	WOC2	3340		301-796-1856
Associate Director for Research	Konstantin Chumakov, PhD	HFM-470	N29B	1H16		301-827-0655
Associate Director, Scientific Affairs	Erik A. Henchal, PhD	HFM-405	WOC2	3302		301-796-1853
Associate Director for Regulatory Policy	Theresa M. Finn, PhD	HFM-405	WOC2	3320		301-796-1859
Associate Director for Medical Policy & Vaccine Safety	Karen Farizo, MD (Acting)	HFM-457	WOC2	3234		301-796-1448
Special Assistant for Communication	Maureen A. Hess, MPH	HFM-405	WOC2	3338		301-796-1866
Special Assistant	Linda H. Shone	HFM-405	WOC2	3336		301-796-1864
Division of Viral Products	Jerry P. Weir, PhD	HFM-445	N29A	1A21		301-827-1930 fax 301-496-1810
Deputy Director	Robin Levis, PhD (Acting)	HFM-445	N29A	1A21		301-827-1930
Laboratory of Hepatitis Viruses	Stephen M. Feinstone, MD	HFM-448	N29A	1D14		301-827-1877
Laboratory of Vector Borne Diseases	Lewis J. Markoff, MD	HFM-451	N29A	1B17		301-827-1886
Laboratory of Retroviruses	Hana Golding, PhD	HFM-454	N29B	4NN04		301-827-0784
Laboratory of DNA Viruses	Keith Peden, PhD	HFM-454	N29A	3D08		301-827-1708
Laboratory of Pediatric & Respiratory Viral Diseases	Jerry P. Weir, PhD (Acting)	HFM-460	N29A	1A21		301-827-1930
Laboratory of Method Development	(Vacant)	HFM-470	NLRC	B-122		301-594-3720 fax 301-827-4622
Laboratory of Immunoregulation	Ira J. Berkower, MD, PhD	HFM-466	N29	523		301-496-1870
Division of Bacterial, Parasitic & Allergenic Products	Jay E. Slater, MD	HFM-425	N29	130		301-496-1014 fax 301-402-2776
Deputy Director	Drusilla Burns, PhD	HFM-425	N29	130		301-496-1014
Laboratory of Immunobiochemistry	Ronald L. Rabin, MD	HFM-422	N29	111		301-496-4575
Laboratory of Bacterial Polysaccharides	Willie F. Vann, PhD	HFM-428	N29	103A		301-496-1014
Laboratory of Mycobacterial Diseases & Cellular Immunology	Sheldon L. Morris, PhD	HFM-431	N29	502		301-496-5978
Laboratory of Respiratory & Special Pathogens	Michael Schmitt, PhD	HFM-434	N29	124		301-402-3553
Laboratory of Enteric & Sexually Transmitted Diseases	Earl Stibitz, PhD	HFM-425	N29	526		301-496-1014
Division of Vaccines & Related Products Applications	Wellington Sun, MD	HFM-475	WOC2	2302		301-796-2640 fax 301-827-3532
Deputy Director	Loris D. McVittie, PhD	HFM-475	WOC2	2344		301-796-2640
CMC Review Branch 1	Paul G. Richman, PhD	HFM-481	WOC2	2132		301-796-2640
CMC Review Branch 2	Rakesh Pandey, PhD	HFM-478	WOC2	2120		301-796-2640
CMC Review Branch 3	Elizabeth M. Sutkowski, PhD	HFM-481	WOC2	2238		301-796-2640
Clinical Review Branch 1	Jeffrey Roberts, MD (Acting)	HFM-485	WOC2	2218		301-796-2640
Clinical Review Branch 2	Lewis K. Schrager, MD	HFM-475	WOC2	2114		301-796-2640
Review Management Support Branch	Laraine S. Henchal	HFM-481	WOC2	2312		301-796-2640
OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY
DIRECTOR	Mary Anne Malarkey	HFM-600	RKW2	1039		301-827-6190 fax 301-827-3381
Deputy Director	Mark Schwartz, JD (Acting)	HFM-600	RKW2	1039		301-827-6190
Special Assistant to the Director	Thomas J. Adams	HFM-600	RKW2	1039		301-827-6190
Special Assistant to the Director	Peggy A. Noland	HFM-600	RKW2	1212		301-827-6190
Associate Director for Policy	Anita F. Richardson	HFM-600	RKW2	1201		301-827-6190
Associate Director for Regulatory Policy	Diane Alexander	HFM-600	RKW2	1203		301-827-6190
Associate Director for Manufacturing Science	Edward Patten	HFM-600	RKW2	1039		301-827-6190
Associate Director for Safety and Communication	Jean Makie	HFM-600	RKW2	1201		301-827-6190
Associate Director for Bioinformatics	Sujay Pandey, PhD	HFM-600	RKW2	1201		301-827-6190
Special Assistant for Imports & Product Availability	Joseph P. Manik	HFM-600	RKW2	1039		301-827-6190
Special Assistant for Manufacturing and Policy	Linda E. Silvers, DVM, MPH	HFM-600	RKW2	1201		301-827-6190
Division of Case Management	Robert A. Sausville	HFM-610	RKW2	1000		301-827-6201 fax 301-594-0940
Advertising & Promotional Labeling Branch	Lisa Stockbridge	HFM-602	RKW2	1000		301-827-6201
Biological Drug and Device Compliance Branch	Maria Anderson	HFM-624	RKW2	1000		301-827-6330
Blood and Tissue Compliance Branch	Stephany J. Wesley	HFM-614	RKW2	1000		301-827-6201
Division of Inspections & Surveillance	Gilliam B. Conley	HFM-650	RKW2	1000		301-827-6220 fax 301-827-6748
Bioresearch Monitoring Branch	Patricia A. Holobaugh	HFM-664	RKW2	1000		301-827-6220
Program Surveillance Branch	Janet L. Ishimoto	HFM-654	RKW2	1000		301-827-6220
Program Inspection Branch	(Vacant)	HFM-604	RKW2	1000		301-827-6220
Division of Manufacturing and Product Quality	John A. Eltermann, Jr., PharmD, MS	HFM-670	NLRC	A-217		301-827-3031 fax 301-827-3536
Deputy Director	Laurie P. Norwood	HFM-670	NLRC	A-237		301-827-3031
Product Release Branch	Joseph Quander, III	HFM-672	NLRC	A-209		301-594-6517
Manufacturing Review Branch I	Carolyn A. Renshaw	HFM-675	NLRC	A-252		301-827-3031
Manufacturing Review Branch II	Chiang Syin, PhD	HFM-676	NLRC	A-234		301-827-3031
Application Review Branch	James Crim	HFM-671	NLRC	A-236		301-827-3031
Division of Product Quality	William M. McCormick, PhD	HFM-407	NLRC	2400		301-594-6299 fax 301-480-9748
Deputy Director	Rajesh K. Gupta, PhD	HFM-407	NLRC	2401		301-594-6241
Laboratory of Analytical Chemistry and Blood Related Products	Lokesh Bhattacharyya, PhD	HFM-407	NLRC	2402		301-594-6242
Quality Assurance Branch	Suzanne Carter (Acting)	HFM-407	NLRC	2412		301-594-6243
Laboratory of Microbiology, In-Vivo Testing and Standards	James Kenney	HFM-407	NLRC	2405		301-594-6242
OFFICE OF CELLULAR, TISSUE AND GENE THERAPIES
DIRECTOR	Celia M. Witten, MD, PhD	HFM-700	WOC1	200S		301-827-5102 fax 301-827-9796
Deputy Director	Stephanie L. Simek, PhD	HFM-700	WOC1	200N		301-827-5102
Regulatory Management Staff	Patrick S. Riggins, PhD	HFM-705	WOC1	200N		301-827-5366
Associate Director for Research	Suzanne L. Epstein, PhD	HFM-700	N29B	2NN06		301-827-0449 fax 301-827-9796
Associate Director for Policy	Richard D. McFarland, MD	HFM-700	WOC1	200S		301-827-5102 fax 301-827-9796
Associate Director for Policy (New Legislation)	Rachael Strong-Anatol, PhD	HFM-700	WOC1	200S		301-827-5102 fax 301-827-9796
Associate Director for Information Management	Theodore R. Stevens, MS	HFM-700	WOC1	200S		301-827-9150
Division of Cellular & Gene Therapies	Raj K. Puri, MD, PhD	HFM-710	N29B	2NN10		301-827-0680 fax 301-827-0449
Deputy Director	Kimberly A. Benton, PhD	HFM-720	WOC1	200N		301-827-5102
Cell Therapies Branch	Keith M. Wonnacott, PhD	HFM-715	WOC1	200N		301-827-5102
Gene Therapies Branch	Daniel M. Takefman, PhD	HFM-720	WOC1	200N		301-827-5102
Gene Transfer and Immunogenicity Branch	Andrew Byrnes, PhD	HFM-725	N29B	2NN04		301-827-0680
Tumor Vaccines and Biotechnology Branch	Raj K. Puri, MD, PhD (Acting)	HFM-735	N29B	2NN10		301-827-0680
Cellular and Tissue Therapy Branch	Steven R. Bauer, PhD	HFM-740	N29B	2NN20		301-827-0680
Division of Clinical Evaluation & Pharmacology / Toxicology	Wilson W. Bryan, MD	HFM-755	WOC1	200N		301-827-5102 fax 301-827-9796
General Medicine Branch	Ilan Irony, MD	HFM-755	WOC1	200S		301-827-5102
Oncology Branch	Ke Liu, MD	HFM-755	WOC1	200N		301-827-5102
Division of Human Tissues	Ellen F. Lazarus, MD	HFM-770	WOC1	200S		301-827-6031 fax 301-827-2844
Human Tissue and Reproduction Branch	Melissa Greenwald, MD	HFM-775	WOC1	200N		301-827-2002 fax 301-827-2844