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 |
| Deputy Director | Celia M. Witten, PhD, MD | 240-402-8000 fax 301-595-1310 |
| Deputy Director | Julie C. Tierney, JD | 240-402-8000 fax 301-595-1310 |
| Chief, Executive Operations Staff | Debra Fisher, MBA | 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 |
| Associate Director for Special Programs | Gopa Raychaudhuri, PhD | 240-402-8147 |
| Associate Director for Medicine | Barbara D. Buch, MD | 240-402-8000 fax 301-595-1310 |
| Associate Director for Product Management | Sheryl L. Lard-Whiteford, PhD | 240-402-7912 fax 301-595-1310 |
| Associate Director for Policy | James D. Myers, JD | 240-402-5923 |
| Associate Director for Science | Karen Elkins, PhD | 240-402-9507 |
| Associate Director for International Affairs | Michelle Limoli, PharmD | 301-796-8377 |
| Senior Advisor for Translational Science | Scott Steele, PhD | 301-651-9049 |
| Center Ombudsman | Olivia Ziolkowski, JD, MPH | 301-837-7292 |
OFFICE OF REGULATORY OPERATIONS
|
DIRECTOR |
Christopher C. Joneckis, PhD |
240-402-8083 |
|
Deputy Director |
Darlene Martin, MS |
301-796-1663 |
|
Senior Science Advisor for Chemistry, Manufacturing, & Controls |
Ingrid Markovic, PhD |
240-460-3771 |
|
Division of Informatics |
Victor P. Bagwell, MPH-EPI, MAS, MBA, MScIT |
240-402-4046 |
|
Data Standards Branch |
Virginia Hussong |
240-506-4843 |
|
Regulatory Information Branch |
Brien Hampton |
240-402-8070 |
|
Records Management Branch |
Richard Thomas |
240-402-8386 |
|
Division of Information Technology |
Michael Foecking (ACTING) |
301-802-8882 |
|
Program Management & Analysis Branch |
Gladys Rodriguez (ACTING) |
301-796-7288 |
|
Technology Integration & Delivery Branch |
Robert 'Troy' Reisch (ACTING) |
240-506-1011 |
|
Division of Regulatory Operations and Programs |
Sonday Kelly, MS |
240-402-8410 |
|
Regulatory Affairs and Business Operations Branch |
Katie Rivers, MS |
301-796-1818 |
|
Regulatory Programs Branch |
Cherie Ward-Peralta, MS |
240-402-8447 |
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 | Alice Carpenter | 240-402-7800 |
| Manufacturers Assistance & Technical Training Branch | Jeffrey Anderson | 240-402-7800 |
| Division of Disclosure and Oversight Management | Suzann Burk | 240-402-7800 |
| Division of Disclosure and Oversight Management, Deputy Division Director | Beth Brockner-Ryan | 240-402-7800 |
| Congressional and Oversight Branch | Christopher Juenger | 240-402-7800 |
| Access Litigation & Freedom of Information Branch | Elizabeth Sly | 240-402-7800 |
| Electronic Disclosure Branch | Jennifer Miller | 240-402-7800 |
| Division of Communication and Consumer Affairs | Paul Richards | 240-402-7800 |
| Communication Technology Branch | Juneous Pettijohn | 240-402-7800 |
| Consumer Affairs Branch | Paul Richards (ACTING) | 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 |
| Director, Division of Program Services | Jason Rubino | 301-796-1948 |
| Deputy Director, Division of Program Services | Lauren Yamada | 240-402-3975 |
| Safety and Services Branch | Margaret Kemp | 301-796-6639 |
| Program Services Branch | Lorena Moyer (Acting) | 240-205-6990 |
| Director, Division of Management Planning and Analysis | Lidiana Villones | 240-381-6558 |
| Deputy Director, Division of Management Planning and Analysis | Katelyn Wannage | 240-402-1702 |
| Planning, Performance, and Formulation Branch | Katelyn Wannage (Acting) | 240-402-1702 |
| Capacity Planning and Management Analysis Branch | Yanming Chae | 240-402-8035 |
| Director, Division of Acquisition and Budget Resources | Michael Fischer | 301-348-3917 |
| Deputy Director, Division of Acquisition and Budget Resources | Madilyn Gonzalez | 240-762-8617 |
| Acquisitions Management Branch | Lisa Portner | 301-796-3726 |
| Budget Planning and Execution Branch | Junio Colobong | 240-402-8041 |
| Division of Scientific Advisors & Consultants | Prabhakara Atreya | 240-402-8006 |
| Director, Division of Veterinary Services | John Dennis, MS DACLAM | 240-402-9474 |
| Director, Division of Human Capital | Adriana Medina | 301-348-1934 |
| Management Services Branch | Lori White | 240-402-7549 |
| Workforce Management Branch | Zoraly Vega Gonzalez | 240-402-4427 |
OFFICE OF BLOOD RESEARCH AND REVIEW
| DIRECTOR | Anne Eder, MD, PhD | 240-402-8398 |
|
Deputy Director |
(Vacant) | |
|
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 Director for Special Projects |
Carlos Villa, MD, PhD | 301-796-6382 |
|
Associate Deputy Director for Quality Assurance |
Joseph Giglio, MS | 240-402-8295 |
|
Administrative Staff |
Lisa Gaskins | 240-402-4124 |
|
Regulatory Project Management Staff |
Cherry Geronimo | 240-402-9555 |
|
Laboratory of Pathogen Reduction |
(Vacant) | |
|
Division of Emerging & Transfusion Transmitted Diseases |
Hira Nakhasi, PhD | 240-402-8209 |
|
Deputy Director |
Peyton (John) Hobson, PhD | 301-796-5892 |
|
Product Review Branch |
Majda Uskievich, PhD | 301-796-2316 |
|
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 | 240-402-8417 |
|
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 | David Kaslow, MD | 301-796-7114 |
| Deputy Director | (Vacant) | |
| Associate Director for Research | Tod Merkel, PhD | 240-402-9746 |
| Associate Director, Medical Countermeasures and Scientific Affairs | Peter Weina, MD | |
| 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 |
| Health Science Advisor | Maureen Hess, MPH, RD | 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 | Tony Wang, PhD | 240-402-1956 |
| 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 | 240-402-6733 |
| Laboratory of Method Development | (Vacant) | |
| 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 | (Vacant) | |
| 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 |
| Division of Review Management and Regulatory Review | Loris D. McVittie, PhD | 301-796-2640 |
| Deputy Director | (Vacant) | |
| Regulatory Review Branch 1 | Jon Daugherty, PhD | 301-796-2640 |
| Regulatory Review Branch 2 | Rakesh Pandey, PhD | 301-796-2640 |
| Regulatory Review Branch 3 | Elizabeth M. Sutkowski, PhD | 301-796-1536 |
| Review Management Support Branch | Cassandra Overking | 240-402-7302 |
| Division of Clinical and Toxicology Review | (Vacant) | |
| Deputy Director | (Vacant) | |
| Clinical Review Branch 1 | Maria Allende, MD | 301-796-2952 |
| Clinical Review Branch 2 | Andrea Hulse (James), MD | 301-796-2640 |
| Clinical Review Branch 3 | Anuja Rastogi, MD, MHS | 301-796-1544 |
OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY
| DIRECTOR | Melissa Mendoza, JD | 301-796-8707 |
| Deputy Director | Vincent Amatrudo, JD | 301-796-8537 |
| Special Assistant to the Director | Mona G. Atkinson, MS, MBA | 301-796-4215 |
| Special Assistant for Operations | Kerry Brendel | 240-402-8897 |
| Associate Director for Manufacturing Quality | Michele Forster | 616-233-9311x1017 |
| Associate Director for Policy | Anita Richardson | 240-402-9065 |
| Associate Director for Regulatory Policy and Legislation | Diane Alexander | 240-402-8877 |
| Associate Director for Regulatory Policy | Anna Kooser | 301-348-1845 |
| Associate Director for Safety and Communication | Jean Makie | 240-402-9007 |
| Associate Director for Bioinformatics | Sujay Pandey, PhD | 240-402-9043 |
| Special Assistant for Imports & Product Availability | Joseph P. Manik | 240-402-9010 |
| Associate Director for Supply Chain Security and Product Policy | Linda E. Silvers, DVM, MPH | 240-402-9089 |
| Director, Division of Case Management (DCM) | Robert A. Sausville | 240-402-9076 |
| Deputy Director, Division of Case Management (DCM) | Maria Anderson | 240-402-8883 |
| Advertising & Promotional Labeling Branch (DCM) | Lisa Stockbridge, PhD | 240-402-9095 |
| Biological Drug and Device Compliance Branch (DCM) | VACANT | VACANT |
| Blood and Tissue Compliance Branch (DCM) | Cherlita Honeycutt | 240-402-6632 |
| Director, Division of Inspections & Surveillance (DIS) | Carrie M. Mampilly, MPH | 240-402-2973 |
| Bioresearch Monitoring Branch (DIS) | Dennis T. Cato | 240-402-8906 |
| Program Surveillance Branch (DIS) | Beth Rogerson | 240-402-9066 |
| Director, Division of Manufacturing and Product Quality (DMPQ) | Carolyn A. Renshaw | 240-402-7343 |
| Deputy Director, Division of Manufacturing and Product Quality (DMPQ) | Nicole Trudel | 240-402-7432 |
| Product Release Branch (DMPQ) | Joseph Quander, III | 240-402-7332 |
| Manufacturing Review Branch I (DMPQ) | Lori Peters | 240-402-7314 |
| Manufacturing Review Branch II (DMPQ) | Anthony Lorenzo | 240-402-9706 |
| Manufacturing Review Branch III (DMPQ) | Donald Ertel, MS, MT (ASCP) | 240-402-9511 |
| Application Review Branch (DMPQ) | James Crim | 240-402-9458 |
| Director, Division of Biological Standards and Quality Control (DBSQC) | Maryna Eichelberger, PhD | 240-402-9505 |
| Laboratory of Biochemistry, Virology and Immunochemistry Branch (DBSQC) | Muhammad Shahabuddin, PhD | 240-402-7370 |
| Laboratory of Analytical Chemistry Branch (DBSQC) | Kenneth Phillips | 301-796-0238 |
| Quality Assurance Branch (DBSQC) | Varsha Garnepudi | 240-402-9547 |
| Laboratory of Microbiology, In-Vivo Testing and Standards (DBSQC) | James L. Kenney, DSc | 240-402-9629 |
| Laboratory of Blood Related Products Branch (DBSQC) | Kori Francis | 240-402-9528 |
OFFICE OF THERAPEUTIC PRODUCTS
|
SUPER OFFICE DIRECTOR |
Nicole Verdun, MD |
240-402-5100 |
| Deputy Director | Rachael Anatol, PhD | 240-402-8190 |
| Regulatory Operations Staff Chief | Wei Liang | 240-402-8190 |
| Policy & Special Projects Staff Chief | Denise Zavagno, JD (acting) | 240-402-8190 |
| Office of Review Management and Regulatory Review | ||
| Director | Ramani Sista, PhD | 240-402-8190 |
| Division of Review Management & Regulatory Review 1 | Beatrice Kallungal, MS | 240-402-8190 |
| Regulatory Review Branch 1 | Beatrice Kallungal | 240-402-8190 |
| Regulatory Management Support Branch 1 | Tyree Newman, MDiv | 240-402-8190 |
| Division of Review Management & Regulatory Review 2 | Mara Miller, MA | 240-402-8190 |
| Deputy Director, DRMRR2 | Lori Tull | 240-402-8190 |
| Regulatory Review Branch 2 | Colleen Caldwell, MS, MPH | 240-402-8190 |
| Regulatory Management Support Branch 2 | Edward Thompson | 240-402-8190 |
| Office of Cellular Therapy and Human Tissue CMC | ||
| Director | Heather Lombardi, PhD | 240-402-8190 |
| Deputy Director | Steven Oh, PhD | 240-402-8190 |
| Division of Cell Therapy 1 | Melanie Eacho, PhD | 240-402-8190 |
| Cell Therapy Branch 1 | Irina Tiper, PhD | 240-402-8190 |
| Cell Therapy Branch 2 | Matthew Klinker, PhD | 240-402-8190 |
| Cellular & Tissue Therapy Branch | Kyung Sung, PhD | 240-402-8190 |
| Division of Cell Therapy 2 | Laura Ricles, PhD | 240-402-8190 |
| Tissue Engineering Branch 1 | Zehra Tosun, PhD | 240-402-8190 |
| Tissue Engineering Branch 2 | Alyssa Kitchel, PhD | 240-402-8190 |
| Tumor Vaccine & Biotechnology Branch | Nirjal Bhattarai, PhD | 240-402-8190 |
| Division of Human Tissues | Scott Brubaker | 240-402-8190 |
| Human Tissues and Reproduction Staff | Ping He, MD | 240-402-8190 |
| Office of Clinical Evaluation | ||
| Director | Lola Fashoyin-Aje, MD, MPH | 240-402-8190 |
| Division of Clinical Evaluation General Medicine | Lola Fashoyin-Aje, MD, MPH (acting) | 240-402-8190 |
| General Medicine Branch 1 | Elizabeth Hart, MD | 240-402-8190 |
| General Medicine Branch 2 | Rosa Sherafat-Kazemzadeh, MD (acting) | 240-402-8190 |
| General Medicine Branch 3 | Vaishali Popat, MD | 240-402-8190 |
| General Medicine Branch 4 | Gavin Imperato, MD | 240-402-8190 |
|
Division of Clinical Evaluation Oncology |
Asha Das, MD |
240-402-8190 |
| Oncology Branch 1 | Peter Bross, MD | 240-402-8190 |
| Oncology Branch 2 | Jessica Lee, MD | 240-402-8190 |
| Division of Clinical Evaluation Hematology | Lola Fashoyin-Aje, MD, MPH (acting) | 240-402-8190 |
| Benign Hematology Branch | Megha Kaushal, MD (acting) | 240-402-8190 |
| Malignant Hematology Branch | Robert Sokolic, MD | 240-402-8190 |
| Office of Gene Therapy CMC | ||
| Director | Denise Gavin, PhD | 240-402-8190 |
| Division of Gene Therapy 1 | Andrew Byrnes, PhD | 240-402-8190 |
| Gene Therapy Branch 1 | Andrew Harmon, PhD | 240-402-8190 |
| Gene Therapy Branch 2 | Brian Stultz, PhD (acting) | 240-402-8190 |
| Gene Therapy Branch 3 | Andrew Byrnes, PhD (acting) | 240-402-8190 |
| Division of Gene Therapy 2 | Kimberly Schultz, PhD | 240-402-8190 |
| Gene Transfer & Immunogenicity | Andrew Byrnes, PhD (acting) | 240-402-8190 |
| Gene Therapy Branch 4 | Anna Kwilas, PhD | 240-402-8190 |
| Gene Therapy Branch 5 | Graeme Price, PhD | 240-402-8190 |
| Office of Pharmacology/Toxicology | ||
| Director | Iwen Wu, PhD | 240-402-8190 |
| Division of Pharmacology/Toxicology 1 | Allen Wensky, PhD | 240-402-8190 |
| Pharmacology/Toxicology Branch 1 | Abigail Shearin, VMD, PhD | 240-402-8190 |
| Pharmacology/Toxicology Branch 3 | Danielle Brooks, PhD | 240-402-8190 |
| Division of Pharmacology/Toxicology 2 | Alyssa Galaro, PhD | 240-402-8190 |
| Pharmacology/Toxicology Branch 2 | Sandhya Sanduja, PhD | 240-402-8190 |
| Pharmacology/Toxicology Branch 4 | Alyssa Galaro, PhD (acting) | 240-402-8190 |
| Office of Plasma Protein Therapeutics CMC | ||
| Director | Basil Golding, MD | 240-402-8190 |
| Deputy Director | Mahmood Fashid, PhD | 240-402-8190 |
| Division of Hemostasis | Zuben Sauna, PhD | 240-402-8190 |
| Hemostasis Branch 1 | Alexey Khrenov, PhD | 240-402-8190 |
| Hemostasis Branch 2 | Zuben Sauna, PhD (acting) | 240-402-8190 |
| Division of Plasma Derivatives | Dorothy Scott, MD | 240-402-8190 |
| Plasma Derivatives Branch 1 | Dorothy Scott, MD (acting) | 240-402-8190 |
| Plasma Derivatives Branch 2 | Jennifer Reed, PhD | 240-402-8190 |