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  1. Center for Biologics Evaluation and Research (CBER)

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
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
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, MS DACLAM 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

240-402-8398

Deputy Director Anne Eder, MD, PhD (Acting) 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 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 Rachael Anatol, PhD (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 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 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 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 240-402-8190
Cell Therapy Branch 2 Matthew Klinker 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 Laura Ricles, PhD (acting) 240-402-8190
Tissue Engineering Branch 2 Alyssa Kitchel 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 Nicole Verdun, 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 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 Nicole Verdun, MD (acting) 240-402-8190
Benign Hematology Branch Prasad Mathew, MD 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 Tao Pan, 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, DVM 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 240-402-8190
Pharmacology/Toxicology Branch 4 Alyssa Galaro 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 240-402-8190

 

 

 




 
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