CBER Leadership Directory

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OFFICE OF THE CENTER DIRECTOR
DIRECTOR	Karen Midthun, MD (Acting)	HFM-1	RKW2	7101	301-827-0372 fax 301-827-0440
Deputy Director	Karen Midthun, MD	HFM-6	RKW2	7102	301-827-0372
Special Assistant	Anne E. Wilcox	HFM-1	RKW2	7104	301-827-0372
Medical Director for Emerging & Pandemic Threat Preparedness	Vacant	HFM-1	RKW2	7100	301-827-0372
Senior Scientist and Point of Contact for Emerging & Pandemic Threat Preparedness	Jean Hu-Primmer	HFM-1	RKW2	7230	301-827-6352 fax 301-594-6530
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
Regulations and Policy Staff	Laura A. Rich, JD	HFM-17	RKW2	5116	301-827-3093 fax 301-827-9434
Associate Director for Research	Carolyn A. Wilson, PhD	HFM-20	N29B	5NN20	301-827-0481 fax 301-827-0440
Core Facilities Team	Nga Yen Nguyen, PhD	HFM-23	N29	205	301-402-4996 fax 435-2231
Associate Director for Review Management	Robert A. Yetter, PhD	HFM-25	RKW2	7301	301-827-0373 fax 301-827-9434
Document Control Center	Jules M. Meisler	HFM-99	WOC1	200N	301-827-5940 fax 301-594-0149
Senior Advisor for Chemistry & Manufacturing Controls	Christopher C. Joneckis, PhD	HFM-1	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 301-435-2246
Special Assistant to the Director for Human Subject Protection	Richard D. Diamond, MD, MPA	HFM-6	RKW2	7226	301-496-1864 fax 301-435-2246
Emergency Response Coordinator	(Vacant)	HFM-6	RKW2	7000	301-827-0372
Science Communications Advisor	Marc Kusinitz, PhD	HFM-2	RKW2	7109	301-827-0372 fax 301-827-0440
Senior Regulatory Affairs Advisor	(Vacant)	HFM-25	RKW2	7108	301-827-9424
OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY
DIRECTOR	Robert Ball, MD, MPH	HFM-210	WOC1	200S	301-827-3034 fax 301-827-0648
Deputy Director	Steven A. Anderson, PhD	HFM-210	WOC1	200S	301-827-3034
Associate Director for Risk Assessment	Mark O. Walderhaug, PhD	HFM-210	WOC1	200S	301-827-3034
Associate Director for Research	Steven A. Anderson, PhD	HFM-210	WOC1	200S	301-827-3034
Associate Director for Regulatory Policy	Jawahar Tiwari, PhD	HFM-219	WOC1	200S	301-827-3034 fax 301-827-0648
Division of Biostatistics	Henry S. Hsu, PhD, MPH	HFM-215	WOC1	200S	301-827-3977 fax 301-827-5218
Vaccine Evaluation Branch	A. Dale Horne, DrPH	HFM-217	WOC1	200S	301-827-3977
Therapeutics Evaluation Branch	Ghanshyam Gupta, PhD	HFM-219	WOC1	200S	301-827-3977
Division of Epidemiology	Robert P. Wise, MD, MPH (Acting)	HFM-220	WOC1	200S	301-827-3974 fax 301-827-5218
Vaccine Safety Branch	Andrea R. Sutherland, MD, MSc, MPH (Acting)	HFM-222	WOC1	200S	301-827-3974
Therapeutics and Blood Safety Branch	Carig E. Zinderman, MD (Acting)	HFM-224	WOC1	200S	301-827-3974
Analytic Epidemiology Branch	Hector S. Izurieta	HFM-223	WOC1	200S	301-827-3974
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	Leslie D. Wheelock	HFM-42	RKWL	601	301-827-2000 fax 301-827-3079
Career Development and Directed Training Branch	Laura L. Stewart	HFM-49	RKWL	601	301-827-2000
Manufacturers Assistance & Technical Training Branch	(Vacant)	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	Karen A. Groover	HFM-45	RKWL	601	301-827-2000
Consumer Affairs Branch	Walter Gardner	HFM-47	RKWL	601	301-827-2000
Executive Secretariat Team	Walter Gardner	HFM-5	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	(Vacant)	HFM-100	RKWL	360	301-827-1320
Regulatory Information Management Staff	Roger D. Eastep	HFM-110	RKWL	375	301-827-3503 fax 301-827-2875
White Oak Planning Team	Maureen E. Sheridan	HFM-118	RKWL	513	301-827-0413 fax 301-827-3137
Division of Program Services	David R. Leffler	HFM-115	RKWL	350	301-827-1400 fax 301-827-1441
Assistant Director for Safety	Larry M. Solomon	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 Planning, Evaluation, & Budget	Karen M. O'Brien	HFM-140	RKWL	420	301-827-1414 fax 301-827-1102
Resource Management Branch	Connie Giganti	HFM-145	RKWL	420	301-827-1414
Planning & Evaluation Branch	Mary Pat Leary	HFM-150	RKWL	420	301-827-1414
Division of Scientific Advisors & Consultants	William Freas, PhD	HFM-71	RKW2	1113	301-827-0314 fax 301-827-0294
Division of Veterinary Services	Philip J. Snoy, DVM	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	Alan E. Williams, PhD (Acting)	HFM-300	WOC1	400N	301-827-2861
Associate Director for Medical Affairs	Vacant	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	301-827-2861
Associate Director for Research	Chintamani D. Atreya, PhD	HFM-300	WOC1	400N	301-827-3518
Associate Director for Policy and Communications & Chief, Policy and Publications Staff	Jennifer B. Scharpf, MPH	HFM-350	WOC1	400N	301-827-3514 fax 301-827-2843
Deputy Associate Director for Regulatory Affairs	Sayah Nedjar, PhD	HFM-300	WOC1	400N	301-827-3518
Associate Deputy Director for Medical & Scientific Affairs	Basil Golding, MD (Acting)	HFM-330	N29	326	301-496-4396
Senior Advisor for Medical Affairs	Toby A. Silverman, MD (Acting)	HFM-392	WOC1	400N	301-827-6112
Special Assistant to the Director	Linda M. Alms	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
Product Testing Staff	Robin M. Biswas, MD	HFM-310	N29	225	301-827-3011
Product Review Branch	Elliot P. Cowan, PhD	HFM-394	WOC1	300S	301-827-6681
Laboratory of Bacterial, Parasitic, & Unconventional 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 Hepatitis & Related Emerging Agents	Gerardo Kaplan, PhD	HFM-325	N29	225	301-496-0338 fax 301-480-7928
Division of Hematology	Basil Golding, MD	HFM-330	N29	326	301-496-4396 fax 402-2780
Deputy Director	Mahmood Farshid, PhD	HFM-345	N29	311	301-827-6163
Deputy Director of Operations	Susan L. Abbondanzo, MD	HFM-330	N29	238	301-496-4396
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	N29	311	301-496-4833
Laboratory of Plasma Derivatives	Dorothy E. Scott, MD	HFM-345	N29	232	301-827-3016
Clinical Review Branch	Nisha Jain, MD, PhD (Acting)	HFM-392	WOCI	400N	301-827- 3524
Laboratory of Biochemistry and Vascular Biology	Abdu Alayash, PhD	HFM-343	N29	112	301-827-3813
Division of Blood Applications	Sheryl A. Kochman, (Acting)	HFM-370	WOC1	400N	301-827-3524 fax 301-827-3535
Deputy Director	(Vacant)	HFM-370	WOC1	400N	301-827-3524
Blood and Plasma Branch	Leslie G. Holness, MD	HFM-375	WOC1	400N	301-827-3524
Regulatory Project Management Branch	Jeffrey M. Anderson	HFM-380	WOC1	400N	301-827-3524
Devices Review Branch	Sheryl A. Kochman	HFM-390	WOC1	400N	301-827-3524
OFFICE OF VACCINES RESEARCH AND REVIEW
DIRECTOR	Norman W. Baylor, PhD	HFM-400	N29B	1H16	301-827-0655 fax 301-827-9721
Deputy Director	Marion F. Gruber, PhD (Acting)	HFM-5	WOC1	350N	301-827-5105
Associate Director for Research	Konstantin Chumakov, PhD (Acting)	HFM-400	N29B	1H16	301-827-0655
Associate Director, Management & Scientific Affairs	Erik A. Henchal, PhD	HFM-400	WOC1	372N	301-827- 5105
Associate Director for Regulatory Policy	(Vacant)	HFM-405	WOC1	360N	301-827-5105 fax 301-827-9781
Special Assistant for Communication	Maureen A. Hess, MPH	HFM-405	WOC1	360N	301-827-5105
Special Assistant	Linda H. Shone	HFM-405	WOC1	352	301-827-5407 fax 301-827-0448
Division of Product Quality	William M. McCormick, PhD	HFM-406	NLRC	2400	301-594-6299 fax 301-480-9748
Deputy Director	Rajesh K. Gupta, PhD	HFM-406	NLRC	2401	301-594-6241
Product Quality Laboratory Staff	Rajesh K. Gupta, PhD (Acting)	HFM-406	NLRC	2401	301-594-6241
Quality Assurance Staff	Christopher Bastedo	HFM-407	NLRC	2403	301-594-6243
Validation Staff	Lokesh Bhattacharyya, PhD	HFM-406	NLRC	2400	301-594-6242
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-451	N29A	1A21	301-827-1930
Laboratory of Hepatitis Viruses	Stephen M. Feinstone, MD	HFM-448	N29A	1D14	301-827-1880
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	Andrew M. Lewis, MD	HFM-457	N29A	1B06	301-827-0650
Laboratory of Pediatric & Respiratory Viral Diseases	Jerry P. Weir, PhD (Acting)	HFM-460	N29A	1A21	301-827-1930
Laboratory of Method Development	Konstantin M. Chumakov, PhD	HFM-470	NLRC	B-128	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	Milan S. Blake, PhD	HFM-410	N29	130	301-496-1014 fax 301-402-2776
Deputy Director	Jay E. Slater, MD	HFM-410	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	130	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	Drusilla L. Burns, PhD	HFM-434	N29	124	301-402-3553
Laboratory of Enteric & Sexually Transmitted Diseases	Dennis J. Kopecko, PhD	HFM-440	N29	420	301-496-1893
Laboratory of Methods Development & Quality Control	Vacant	HFM-443	N29	419	301-435-5196
Division of Vaccines & Related Products Applications	Wellington Sun, MD	HFM-475	WOC1	300N	301-827-3070 fax 301-827-3532
Deputy Director	Loris D. McVittie, PhD	HFM-475	WOC1	300N	301-827-3070
CMC Review Branch 1	Paul G. Richman, PhD	HFM-478	WOC1	300N	301-827-3070
CMC Review Branch 2	Rakesh Pandey, PhD	HFM-479	WOC1	300N	301-827-3070
CMC Review Branch 3	Elizabeth M. Sutkowski, PhD	HFM-481	WOC1	300N	301-827-3070
Clinical Review Branch 1	Douglas R. Pratt, MD	HFM-485	WOC1	300N	301-827-3070
Clinical Review Branch 2	Lewis K. Schrager, MD	HFM-486	WOC1	300N	301-827-3070
Review Management Support Branch	Laraine S. Henchal	HFM-488	WOC1	300N	301-827-3070
OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY
DIRECTOR	Mary Anne Malarkey	HFM-600	RKW2	1039	301-827-6190 fax 301-827-3381
Deputy Director	Leslie Kux	HFM-600	RKW2	1039	301-827-6190
Special Assistant to the Director	Thomas J. Adams	HFM-600	RKW2	1039	301-827-6190
Associate Director for Policy	Anita F. Richardson	HFM-600	RKW2	1201	301-827-6190
Associate Director for Regulatory Policy	Jessica A. Tave	HFM-600	RKW2	1201	301-827-6190
Associate Director for Manufacturing Science	Edward Patten	HFM-600	RKW2	1039	301-827-6190
Associate Director for Safety and Communication	Jalena G. Specht	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	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	Ele Ibarra-Pratt, RN, BSN, MPH	HFM-602	RKW2	1000	301-827-6201
Biological Drug and Device Compliance Branch	Diane S. Alexander	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.	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
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	200N	301-827-5102 fax 301-827-9796
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	Raj K. Puri, MD, PhD (Acting)	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 (Acting)	HFM-740	N29B	2NN20	301-827-0680
Division of Clinical Evaluation & Pharmacology / Toxicology	Ashok K. Batra, MD	HFM-750	WOC1	200N	301-827-5102 fax 301-827-9796
Clinical Evaluation Branch	Peter F. Bross, MD (Acting)	HFM-755	WOC1	200N	301-827-5102
Pharmacology / Toxicology Branch	Mercedes A. Serabian, MS, DABT	HFM-760	WOC1	200N	301-827-5102
Division of Human Tissues	Martha A. Wells, MPH (Acting)	HFM-770	WOC1	200S	301-827-6106 fax 301-827-2844
Human Tissue and Reproduction Branch	Martha A. Wells, MPH	HFM-775	WOC1	200S	301-827-6106 fax 301-827-2844