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 |
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 |
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 | Vacant | |
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 | Jason Rubino | 301-796-1948 |
Safety and Services Branch | Michele Howard | 301-796-5955 |
Program Services Branch | Lauren Yamada (Acting) | 240-402-3975 |
Division of Management Planning and Analysis | Lidiana Villones (Acting) | 240-381-6558 |
Planning, Performance, and Formulation Branch | Katelyn Wannage | 240-402-1702 |
Capacity Planning and Management Analysis Branch | Yanming Chae | 240-402-8035 |
Division of Acquisition and Budget Resources | Michael Fischer | 301-348-3917 |
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 |
Division of Veterinary Services | John Dennis | 240-402-9474 |
Division of Human Capital | Adriana Medina | 301-348-1934 |
Management Services Branch | Lori White | 240-402-7549 |
Workforce Management Branch | Zoraly Vega Gonzalez (Acting) | 240-402-4427 |
OFFICE OF BLOOD RESEARCH AND REVIEW
DIRECTOR |
Anne Eder, MD, PhD (Acting) |
240-402-8398 |
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 | (Vacant) | |
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 |
David Kaslow, MD |
301-796-7114 |
Deputy Director |
(Vacant) |
301-796-2640 |
Associate Director for Research |
(Vacant) |
240-402-9440 |
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 |
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 |
Jerry Weir (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 |
(Vacant) |
301-796-2640 |
Deputy Director - Regulatory |
Loris D. McVittie, PhD |
301-796-2640 |
Division of Vaccines and Related Products Applications | 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 |
Cassandra Overking |
301-796-2640 |
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 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 |
Advertising & Promotional Labeling Branch (DCM) | Lisa Stockbridge, PhD | 240-402-9095 |
Biological Drug and Device Compliance Branch (DCM) | Maria Anderson | 240-402-8883 |
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, M.D. |
240-402-5100 |
Regulatory Operations Staff Chief | Wei Liang (acting) | 240-402-8190 |
Policy & Special Projects Staff Chief | Carolyn Yong, PhD (acting) | 240-402-8190 |
Office of Review Management and Regulatory Review | ||
Director | Ramani Sista, PhD (acting) | 240-402-8190 |
Division of Regulatory Management Review 1 | Ramani Sista, PhD | 240-402-8190 |
Regulatory Review Branch 1 | Heather Erdman | 240-402-8190 |
Regulatory Management Support Branch 1 | Tyree Newman | 240-402-8190 |
Division of Review Management & Regulatory Review 2 | Mara Miller, MA (acting) | 240-402-8190 |
Deputy Director, DRMRR2 | Lori Tull | 240-402-8190 |
Regulatory Review Branch 2 | Beatrice Kallungal, MS | 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 (acting) | 240-402-8190 |
Division of Cell Therapy 1 | Steven Oh, PhD (acting) | 240-402-8190 |
Cell Therapy Branch 1 | Melanie Eacho, PhD | 240-402-8190 |
Cell Therapy Branch 2 | Melanie Eacho, PhD (acting) | 240-402-8190 |
Cellular & Tissue Therapy Branch | Kyung Sung, PhD (acting) | 240-402-8190 |
Division of Cell Therapy 2 | Steven Oh, PhD (acting) | 240-402-8190 |
Tissue Engineering Branch 1 | Laura Ricles, PhD | 240-402-8190 |
Tissue Engineering Branch 2 | Laura Ricles, PhD (acting) | 240-402-8190 |
Tumor Vaccine & Biotechnology Branch | Nirjal Bhattarai, PhD (acting) | 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 | Tejashri Purohit-Sheth, MD (acting) | 240-402-8190 |
Division of Clinical Evaluation General Medicine | Tejashri Purohit-Sheth, MD | 240-402-8190 |
General Medicine Branch 1 | Elizabeth Hart, MD | 240-402-8190 |
General Medicine Branch 2 | Lei Xu, MD, PhD | 240-402-8190 |
General Medicine Branch 3 | Vaishali Popat, MD | 240-402-8190 |
General Medicine Branch 4 | Elizabeth Hart, MD (acting) | 240-402-8190 |
Division of Clinical Evaluation Oncology |
Asha Das, MD (acting) |
240-402-8190 |
Oncology Branch 1 | Peter Bross, MD | 240-402-8190 |
Oncology Branch 2 | Peter Bross, MD (acting) | 240-402-8190 |
Division of Clinical Evaluation Hematology | Tejashri Purohit-Sheth, MD (acting) | 240-402-8190 |
Benign Hematology Branch | Tejashri Purohit-Sheth, MD (acting) | 240-402-8190 |
Malignant Hematology Branch | Tejashri Purohit-Sheth, MD (acting) | 240-402-8190 |
Office of Gene Therapy CMC | ||
Director | Denise Gavin, PhD (acting) | 240-402-8190 |
Division of Gene Therapy 1 | Denise Gavin, PhD (acting) | 240-402-8190 |
Gene Therapy Branch 1 | Denise Gavin, PhD | 240-402-8190 |
Gene Therapy Branch 2 | Andrew Byrnes, PhD (acting) | 240-402-8190 |
Gene Therapy Branch 3 | Denise Gavin, PhD (acting) | 240-402-8190 |
Division of Gene Therapy 2 | Denise Gavin, PhD (acting) | 240-402-8190 |
Gene Transfer & Immunogenicity | Andrew Byrnes, PhD | 240-402-8190 |
Gene Therapy Branch 4 | Kimberly Schultz, PhD | 240-402-8190 |
Gene Therapy Branch 5 | Kimberly Schultz, PhD (acting) | 240-402-8190 |
Office of Pharmacology/Toxicology | ||
Director | Iwen Wu, PhD (acting) | 240-402-8190 |
Division of Pharmacology/Toxicology 1 | Iwen Wu, PhD (acting) | 240-402-8190 |
Pharmacology/Toxicology Branch 1 | Abigail Shearin, DVM (acting) | 240-402-8190 |
Pharmacology/Toxicology Branch 3 | Allen Wensky, PhD (acting) | 240-402-8190 |
Division of Pharmacology/Toxicology 2 | Iwen Wu, PhD (acting) | 240-402-8190 |
Pharmacology/Toxicology Branch 2 | Sandhya Sanduja, PhD (acting) | 240-402-8190 |
Pharmacology/Toxicology Branch 4 | Alyssa Galaro (acting) | 240-402-8190 |
Office of Plasma Protein Therapeutics CMC | ||
Director | Basil Golding, MD (acting) | 240-402-8190 |
Deputy Director | Mahmood Fashid, PhD (acting) | 240-402-8190 |
Division of Hemostasis | Zuben Sauna, PhD (acting) | 240-402-8190 |
Hemostasis Branch 1 | Alexey Khrenov, PhD (acting) | 240-402-8190 |
Hemostasis Branch 2 | Mikhail Ovanesov, PhD (acting) | 240-402-8190 |
Division of Plasma Derivatives | Dorothy Scott, MD (acting) | 240-402-8190 |
Plasma Derivatives Branch 1 | Dorothy Scott, MD | 240-402-8190 |
Plasma Derivatives Branch 2 | Jennifer Reed (acting) | 240-402-8190 |