> ## Content Index > Fetch the complete content index at: https://www.foodconsumer.org/llms.txt > Use this file to discover other available public pages before exploring further. # CBER Key Staff Directory - FDA - URL: https://www.foodconsumer.org/cber_key_staff_directory_-_fda_0530140340/ - Published: 2014-05-30T16:39:00.000Z - Updated: 2026-09-22T18:42:08.000Z - Description: A staff directory listing names, office locations and phone numbers for key personnel in the FDA's Center for Biologics Evaluation and Research. - Author: Food Consumer - Tags: Miscellaneous, Health News, #vivvo-import | **OFFICE OF THE CENTER DIRECTOR** | | | | | | ------------------------------------------------------------------------ | ------------------------------------- | ----- | ----- | ----------------------------- | | **DIRECTOR** | Karen Midthun, MD | WO-71 | 7232 | 240-402-8000fax 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 | 240-402-8036fax 301-595-1310 | | Special Assistant | Gopa Raychaudhuri | WO-71 | 7250 | 240-402-8147 | | Associate Director for Medicine | Barbara D. Buch, MD | WO-71 | 7224 | 240-402-8000fax 301-595-1310 | | Associate Director for Quality Assurance | Sheryl L. Lard-Whiteford, PhD | WO-71 | 7240 | 240-402-7912fax 301-595-1310 | | Associate Director for Policy | Diane Maloney, JD | WO-71 | 7242 | 240-402-8113fax 301-595-1310 | | Associate Director for Research | Carolyn A. Wilson, PhD | N29B | 5NN20 | 301-827-0481fax 301-827-3187 | | Associate Director for Review Management | Christopher C. Joneckis, PhD (Acting) | WO-71 | 7334 | 240-402-7910fax 301-595-1310 | | Senior Advisor for Chemistry, Manufacturing, & Control | Christopher C. Joneckis, PhD | WO-71 | 7334 | 240-402-7910fax 301-595-1310 | | Senior Advisor for International Affairs | Joan Wilmarth Blair | WO-71 | 7226 | 240-402-8022fax 301-595-1310 | | Senior Advisor for Counterterrorism/Medical Countermeasures | Cynthia L. Kelley, MS | WO-71 | 7204 | 240-402-8089fax 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 | 240-402-8384fax 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. Forsee, 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 | | Division of Veterinary Services | John Dennis, DVM, MS | N29A | 1A17 | 301-827-1847 | | **OFFICE OF INFORMATION TECHNOLOGY** | | | | | | **DIRECTOR** | Ginger Leo | PIFO | 140K | 301-796-7760 | | Deputy Director | Amy El Naggar | PIFO | 150F | 301-796-7345 | | Division of Information Operations | Amy El Naggar | PIFO | 150F | 301-796-7345 | | Division of Information Development | Nadia O. Davey | PIFO | 140H | 301-796-7358 | | **OFFICE OF BLOOD RESEARCH AND REVIEW** | | | | | | **DIRECTOR** | Jay S. Epstein, MD | WO-71 | 4230 | 240-402-8280 | | Deputy Director for Medical and Scientific Affairs | 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 | 4236 | 240-402-8009 | | Associate Director for Research | Chintamani D. Atreya, PhD | WO-71 | 4248 | 240-402-8437 | | Associate Director for Policy and Communications | Jennifer B. Scharpf, MPH | WO-71 | 4220 | 240-402-8295 | | Deputy Associate Director for Regulatory Affairs | Betsy Jett, B.S. | WO-71 | 4238 | 240-402-8435 | | Associate Deputy Director for Quality Assurance | Joseph Giglio | WO-71 | 4237 | 240-402-8416 | | Regulatory Counsel | Martin Ruta, PhD | WO-71 | 4218 | 240-402-8436 | | Special Assistant to the Director | Jacqueline Little, PhD | WO-71 | 4252 | 240-402-8444 | | Administrative Staff | Michelle Salvetti | WO-71 | 4230 | 240-402-8280 | | Regulatory Project Management Staff | Iliana Valencia, M.S. | WO-71 | 4234 | 240-402-8331 | | Division of Emerging & Transfusion Transmitted Diseases - I.O.D. | Hira L. Nakhasi, PhD | N29 | 222 | 301-827-3008fax 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 | | 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 | 301-827-1930fax 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 | 301-594-3720fax 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 | 301-496-1014fax 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 | 301-796-2640fax 301-827-3532 | | Deputy Director | Loris D. McVittie, PhD | WO-71 | 3266 | 301-796-2640 | | CMC ReviewBranch 1 | Paul G. Richman, PhD | WO-71 | 3254 | 301-796-2640 | | CMC ReviewBranch 2 | Rakesh Pandey, PhD | WO-71 | 3248 | 301-796-2640 | | CMC ReviewBranch 3 | Elizabeth M. Sutkowski, PhD | WO-71 | 3050 | 301-796-2640 | | Clinical ReviewBranch 1 | Jeffrey Roberts, MD (Acting) | WO-71 | 3304 | 301-796-2640 | | Clinical ReviewBranch 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 | 301-827-3031fax 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 | 301-594-6299fax 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** | Celia M. Witten, MD, PhD | WO-71 | 5230 | 240-402-8190fax 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 | 301-827-0450fax 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 | 301-827-0680fax 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 | 240-402-8266fax 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 | 240-402-8319fax 301-595-1303 |