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

OFFICE OF THE CENTER DIRECTOR

DIRECTOR	Peter W. Marks, MD, PhD	240-402-8000 fax 301-595-1310
Deputy Director	Celia M. Witten, PhD, MD	240-402-8000 fax 301-595-1310
Chief, Executive Operations Staff	Debra Ellison	240-402-3003
Associate Director for Preparedness and Response/Senior Advisor for Counterterrorism and Emerging Threats	David S. Cho, PhD	240-402-8036 fax 301-595-1310
Chief of Staff	Sarah Walinsky, JD	240-402-8000
Associate Director for Special Programs	Gopa Raychaudhuri	240-402-8147
Associate Director for Medicine	Barbara D. Buch, MD	240-402-8000 fax 301-595-1310
Associate Director for Products	Sheryl L. Lard-Whiteford, PhD	240-402-7912 fax 301-595-1310
Associate Director for Policy	Diane Maloney, JD	240-402-8113 fax 301-595-1310
Associate Director for Science	Karen Elkins, PhD	240-402-9507
Associate Director for International Affairs	(Vacant)

OFFICE OF REGULATORY OPERATIONS

DIRECTOR	Christopher C. Joneckis, PhD	240-402-8083 fax 301-595-1311
Deputy Director	(Vacant)
Senior Science Advisor for Chemistry, Manufacturing, & Controls	Ingrid Markovic, PhD	240-460-3771 fax 301-595-1311
Division of Informatics and Information Technology	(Vacant)
Data Standards Branch	(Vacant)
Information Technology Branch	Michael Foecking
Records Management Branch	Richard Thomas
Regulatory Information Branch	(Vacant)
Division of Regulatory Operations and Programs	(Vacant)
Regulatory Affairs and Business Operations Branch	Darlene Martin
Regulatory Programs Branch	(Vacant)

OFFICE OF BIOSTATISTICS AND PHARMACOVIGILANCE

DIRECTOR	Steven A. Anderson, PhD, MPP	240-402-8577
Deputy Director	Richard A. Forshee, PhD	301-796-6044
Associate Director for Risk Assessment	Mark O. Walderhaug, PhD	240-402-8812
Associate Director for Research	(Vacant)
Associate Director for Policy	Jawahar Tiwari, PhD	240-402-8804
Associate Director for Regulatory Affairs	(Vacant)
Associate Director for Medical Policy	(Vacant)
Division of Biostatistics	John Scott, PhD	240-402-8779
Deputy Division Director	Shiowjen Lee, PhD
Vaccine Evaluation Branch	Tsai Lien Lin, PhD
Therapeutics Evaluation Branch 1	Boguang Zhen, PhD	240-402-8844
Device and Non-Clinical Evaluation Branch	(Vacant)
Therapeutics Evaluation Branch 2	(Vacant)
Division of Pharmacovigilance	Narayan Nair, MD	240-402-0396
Deputy Division Director	Meghna Alimchandani, MD
Pharmacovigilance Branch 1	Adamma Mba-Jonas, MD	240-402-8713
Pharmacovigilance Branch 2	(Vacant)
Pharmacovigilance Branch 3	(Vacant)

OFFICE OF COMMUNICATION, OUTREACH AND DEVELOPMENT

DIRECTOR	Lorrie H. McNeill	240-402-7800
Deputy Director	Susan C. Frantz-Bohn	240-402-7800
Division of Manufacturers Assistance and Training	Manen Bishop	240-402-7800
Career Development and Directed Training Branch	(Vacant)
Manufacturers Assistance & Technical Training Branch	Jeffrey Anderson	240-402-7800
Division of Disclosure and Oversight Management	Suzann Burk	240-402-7800
Congressional and Oversight Branch	Christopher Juenger	240-402-7800
Access Litigation & Freedom of Information Branch	Beth Brockner-Ryan	240-402-7800
Electronic Disclosure Branch	Jennifer Miller	240-402-7800
Division of Communication and Consumer Affairs	Diane Bartell	240-402-7800
Communication Technology Branch	Juneous Pettijohn	240-402-7800
Consumer Affairs Branch	Paul Richards	240-402-7800

OFFICE OF MANAGEMENT

DIRECTOR	Deirdre P. Hussey	240-402-7990
Deputy Director	Mary Pat Leary	240-402-8099
Special Assistant	Karen Greenfield	240-402-8068
Division of Program Services	Adriana Medina (Acting)	301-348-1934
Safety and Services Branch	Michele Howard	301-796-5955
Program Services Branch	Lauren Wappaus
Division of Management Planning and Analysis	(Vacant)
Planning, Performance, and Formulation Branch	Lidiana Villones
Capacity Planning and Management Analysis Branch	Angela Granum	240-402-0376
Division of Acquisition and Budget Resources	Mary Pat Leary (Acting)
Acquisitions Management Branch	Michael Fischer
Budget Planning and Execution Branch	(Vacant)
Division of Scientific Advisors & Consultants	Prabhakara Atreya	240-402-8006
Division of Veterinary Services	John Dennis	240-402-9474
Division of Human Capital	Adriana Medina
Management Services Branch	Lori White
Workforce Management Branch	Caroline Leake

OFFICE OF BLOOD RESEARCH AND REVIEW

DIRECTOR	Nicole Verdun, MD	240-402-5100
Deputy Director	Anne Eder, MD, PhD	240-402-8398
Associate Director for Research	Chintamani D. Atreya, PhD	240-402-8009
Associate Director for Policy and Communications	Jennifer B. Scharpf, MPH	240-402-8437
Associate Deputy Director for Quality Assurance	Joseph Giglio, MS	240-402-8295
Regulatory Counsel	Janet Goldberg, JD
Special Assistant to the Director	Jacqueline Little, PhD	240-402-8416
Administrative Staff	Lisa Gaskins	240-402-4124
Regulatory Project Management Staff	Sonday Kelly, MS	240-402-8410
Division of Emerging & Transfusion Transmitted Diseases	Hira Nakhasi, PhD	240-402-8209
Deputy Director	Peyton (John) Hobson, PhD	301-796-5892
Associate Deputy Director for Medical Issues and Policy Development	(Vacant)	240-402-8398
Associate Director for Regulatory Policy	Sayah Nedjar, PhD	240-402-8334
Product Review Branch	Nicholas Anderson, PhD	240-402-5392
Laboratory of Bacterial & Transmissible Spongiform Encephalopathy Agents	(Vacant)	240-402-9367
Laboratory of Molecular Virology	Indira K. Hewlett, PhD	240-402-9587
Laboratory of Emerging Pathogens	Sanjai Kumar, PhD	240-402-9652
Division of Blood Components and Devices	Orieji Illoh, MD	240-402-8457
Deputy Director	Wendy Paul, MD	240-402-8747
Blood and Plasma Branch	Richard McBride, MS	240-402-9220
Devices Review Branch	Zhugong Liu, MD, PhD
Clinical Review Staff	Salim Haddad, MD	240-402-9313
Laboratory of Cellular Hematology	Jaroslav G. Vostal, MD, PhD	240-402-8222
Laboratory of Biochemistry and Vascular Biology	Abdu Alayash, PhD	240-402-9350

OFFICE OF VACCINES RESEARCH AND REVIEW

DIRECTOR	Peter W. Marks, MD, PhD (Acting)	240-402-8000 fax 301-595-1310
Deputy Director	Doran Fink, MD, PhD (Acting)	301-796-2640
Associate Director for Research	Konstantin Chumakov, PhD	240-402-9440
Associate Director, Medical Countermeasures and Scientific Affairs	(Vacant)
Associate Director for NCI	Hector Izurieta, MD	240-402-8663
Associate Director for Regulatory Policy	Theresa M. Finn, PhD	301-796-1859
Associate Director for Medical Policy & Vaccine Safety	Karen Farizo, MD	301-796-1448
Special Assistant for Communication	Maureen A. Hess, MPH	301-796-1866
Division of Viral Products	Jerry P. Weir, PhD	240-402-7473
Deputy Director	Robin Levis, PhD	240-402-9665
Laboratory of Hepatitis Viruses	Marian Major, PhD	240-402-9720
Laboratory of Vector Borne Diseases	Marian Major, PhD (Acting)	240-402-9720
Laboratory of Retroviruses	Hana Golding, PhD	240-402-9561
Laboratory of DNA Viruses	Keith Peden, PhD	240-402-7312
Laboratory of Pediatric & Respiratory Viral Diseases	Zhiping Ye, MD, PhD	240-402-7473
Laboratory of Method Development	Konstantin Chumakov, PhD (Acting)	240-402-9440
Laboratory of Immunoregulation	Carol Weiss, MD, PhD	240-402-7474
Division of Bacterial, Parasitic & Allergenic Products	Jay E. Slater, MD	240-402-7396
Deputy Director	Drusilla Burns, PhD	240-402-9414
Laboratory of Immunobiochemistry	Ronald L. Rabin, MD	240-402-7333
Laboratory of Bacterial Polysaccharides	Willie F. Vann, PhD	240-402-7438
Laboratory of Respiratory & Special Pathogens	Michael Schmitt, PhD	240-402-7366
Laboratory of Mucosal Pathogens & Cellular Immunology	Earle Stibitz, PhD	240-402-7401
Deputy Director - Clinical	Doran Fink, MD, PhD	301-796-2640
Deputy Director - Regulatory	Loris D. McVittie, PhD	301-796-2640
CMC Review Branch 1	Jon Daugherty, PhD	301-796-2640
CMC Review Branch 2	Rakesh Pandey, PhD	301-796-2640
CMC Review Branch 3	Elizabeth M. Sutkowski, PhD	301-796-2640
Clinical Review Branch 1	Maria Allende, MD	301-796-2640
Clinical Review Branch 2	Andrea Hulse (James), MD	301-796-2640
Review Management Support Branch	Timothy Nelle, PhD	301-796-2640

OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY

DIRECTOR	Melissa Mendoza (Acting)	240-402-9153
Deputy Director	Anita Ricardson (Acting)	240-402-9153
Special Assistant to the Director	Mona Atkinson	301-796-4215
Special Assistant for Operations	Kerry Brendel	240-402-8897
Associate Director for Policy	Anita F. Richardson	240-402-9065
Associate Director for Regulatory Policy	Diane Alexander	240-402-8877
Associate Director for Safety and Communication	Jean Makie	240-402-9007
Associate Director for Bioinformatics	Sujay Pandey, PhD	240-402-9043
Associate Director for Policy and Legislation	(Vacant)
Special Assistant for Imports & Product Availability	Joseph P. Manik	240-402-9010
Special Assistant for Manufacturing and Policy	Linda E. Silvers, DVM, MPH	240-402-9089
Division of Case Management	Robert A. Sausville	240-402-9076
Advertising & Promotional Labeling Branch	Lisa Stockbridge	240-402-9095
Biological Drug and Device Compliance Branch	Maria Anderson	240-402-8883
Blood and Tissue Compliance Branch	Stephany J. Kersten	240-402-9115
Division of Inspections & Surveillance	Carrie Mampilly	240-402-2973
Bioresearch Monitoring Branch	Dennis Cato	240-402-8906
Program Surveillance Branch	Susan Rogerson
Division of Manufacturing and Product Quality	(Vacant)
Deputy Director	Carolyn A. Renshaw
Product Release Branch	Joseph Quander III	240-402-7332
Manufacturing Review Branch 1	Lori Tull	240-402-7343
Manufacturing Review Branch 2	Anthony Lorenzo	240-402-9403
Manufacturing Review Branch 3	(Vacant)
Application Review Branch	James Crim	240-402-9458
Division of Biological Standards and Quality Control	Maryna Eichelberger, PhD	240-402-9505
Laboratory of Biochemistry, Virology and Immunology	Muhammad Shahabuddin, PhD	240-402-7370
Laboratory of Analytical Chemistry	(Vacant)
Laboratory of Blood Related Products	(Vacant)
Quality Assurance Branch	Varsha Garnepudi
Laboratory of Microbiology, In-Vivo Testing and Standards	James Kenney, DSc	240-402-9629

OFFICE OF TISSUES AND ADVANCED THERAPIES

DIRECTOR	Wilson Bryan, MD	240-402-8190
Deputy Director	Rachael Anatol, PhD	240-402-8190
Associate Director for Research	Suzanne L. Epstein, PhD	240-402-8190
Associate Director for Policy	Carolyn Yong, PhD	240-402-8190
Associate Director for Policy	Anne Rowzee, PhD	301-796-8190
Associate Director for Information Management	Theodore R. Stevens, MS	240-402-8190
Associate Director for Regulatory Management	Kimberly Benton, PhD	240-402-8190
Division of Regulatory Project Management	Ramani Sista, PhD	240-402-8190
Deputy Director	Lori Tull	240-402-8190
Regulatory Project Management Branch 1	Heather Erdman	240-402-8190
Regulatory Project Management Branch 2	Beatrice Kallungal	240-402-8190
Regulatory Project Management Branch 3	Tyree Newman	240-402-8190
Regulatory Project Management Branch 4	Edward Thompson	240-402-8190
Division of Cellular & Gene Therapies	(Vacant)	240-402-8190
Deputy Director	Steven Oh, PhD	240-402-8190
Cell Therapies Branch	Melanie Eacho, PhD	240-402-8190
Gene Therapies Branch	Denise Gavin, PhD	240-402-8190
Gene Transfer and Immunogenicity Branch	Andrew Byrnes, PhD	240-402-8190
Tumor Vaccines and Biotechnology Branch	(Vacant)	240-402-8190
Cellular and Tissue Therapy Branch	Steven R. Bauer, PhD	240-402-8190
Gene Therapies Branch 2	Kimberly Schultz, PhD	240-402-8190
Tissue Engineering Branch	Laura Ricles, PhD	240-402-8190
Division of Plasma Protein Therapeutics	Basil Golding, MD	240-402-8190
Deputy Director	Mahmood Farshid, PhD	240-402-8190
Hemostasis Branch	Timothy K. Lee, PhD	240-402-8190
Plasma Derivatives Branch	Dorothy Scott, MD	240-402-8190
Division of Clinical Evaluation & Pharmacology/Toxicology	Tejashri Purohit-Sheth, MD	240-402-8190
Deputy Director	(Vacant)	240-402-8190
General Medicine Branch 1	Elizabeth Hart, MD	240-402-8190
General Medicine Branch 2	Lei Xu, MD, PhD	240-402-8190
Pharmacology/Toxicology Branch 1	Mercedes Serabian, MS	240-402-8190
Pharmacology/Toxicology Branch 2	Iwen Wu, PhD	240-402-8190
Oncology Branch	Peter Bross, MD	240-402-8190
Malignant Hematology Branch	(Vacant)	240-402-8190
General Medicine Branch 3	(Vacant)	240-402-8190
Benign Hematology Branch	(Vacant)	240-402-8190
Division of Human Tissues	Scott Brubaker	240-402-8190
Human Tissue and Reproduction Staff	Ping He, MD	240-402-8190