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/Chief Executive Operation Staff | Debra Ellison | WO-71 | 7234 |
240-402-3003 |
Associate Director for Preparedness and Response/Senior Advisor for Counterterrorism and Emerging Threats | David S. Cho, PhD | WO-71 | 7204 | 240-402-8036 fax 301-595-1310 |
Chief of Staff | Sarah Walinsky, JD (Acting) | WO-71 | 7236 | 240-402-8000 |
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 | Karen Elkins, PhD (Acting) | WO-71 | 1032 | 240-402-9507 |
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 | Ingrid Markovic, PhD | WO-71 | 7264 | 240-460-3771 fax 301-595-1311 |
Senior Advisor for International Affairs | Joan Wilmarth Blair | WO-71 | 7226 | 240-402-8022 fax 301-595-1310 |
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 | ||||
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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 | Paul Richards | WO-71 | 3004 | 240-402-8153 |
OFFICE OF MANAGEMENT | ||||
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DIRECTOR | Deirdre P. Hussey | WO-71 | 6234 | 240-402-7990 |
Deputy Director | Mary Pat Leary | WO-71 | 6230 | 240-402-8099 |
Special Assistant | Karen Greenfield | WO-71 | 6232 | 240-402-8068 |
Planning and Performance Management Staff | Lidiana Villones | WO-71 | 6250 | 240-402-9848 |
Division of Program Services | Adriana Medina | WO-71 | 6122 | 301-348-1934 |
Assistant Director for Safety | Michele Howard | WO-71 | 6130 | 301-796-5955 |
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 (Acting) | 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 | ||||
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DIRECTOR | Nicole Verdun, MD | WO-71 | 4230 | 240-402-5100 |
Deputy Director | Anne Eder, MD, PhD | 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 | Lisa Gaskins | WO-71 | 4222 | 240-402-4124 |
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 |
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DIRECTOR | Peter W. Marks, MD, PhD (Acting) | WO-71 | 7232 | 240-402-8000 fax 301-595-1310 |
Deputy Director | (Vacant) | WO-71 | ||
Associate Director for Research | Konstantin Chumakov, PhD | WO-52/72 | 1128 | 240-402-9440 |
Associate Director, Medical Countermeasures and Scientific Affairs | (Vacant) | WO-71 | ||
Associate Director for NCI | Hector Izurieta, MD | WO-71 | 3224 | 240-402-8663 |
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 | 1210 | 240-402-9720 |
Laboratory of Retroviruses | Hana Golding, PhD | WO-72 | 1218 | 240-402-9561 |
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 | 1330 | 240-402-7473 |
Laboratory of Method Development | Konstantin Chumakov, PhD (Acting) | WO-52/72 | 1128 | 240-402-9440 |
Laboratory of Immunoregulation | Carol Weiss, MD, PhD | WO52/72 | 1244 | 240-402-7474 |
Division of Bacterial, Parasitic & Allergenic Products | Jay E. Slater, MD | WO-52/72 | 3336 | 240-402-7396 |
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 | Earle Stibitz, PhD | WO-52/72 | 3304 | 240-402-7401 |
Deputy Director - Clinical | Doran Fink, MD, PhD | WO-71 | 3314 | 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 |
Maria Allende, MD | WO-71 | 3304 | 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 | ||||
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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 | ||||
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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 | Carolyn Yong, PhD | WO-71 | 5238 | 240-402-5093 |
Associate Director for Policy | Anne Rowzee, PhD | WO-71 | 5226 | 301-796-3177 |
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 |