Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Center for Biologics Evaluation and Research (CBER)

Center for Biologics Evaluation and Research (CBER)
            
                        CBER Offices & Divisions
          CBER Vision & Mission
          CBER Reports
          CBER Ombudsman
          CBER Product Jurisdiction
          Jobs at the Center for Biologics Evaluation and Research (CBER) Home
          About FDA
          FDA Organization
          Center for Biologics Evaluation and Research (CBER)
          Center for Biologics Evaluation and ResearchCenter for Biologics Evaluation and Research (CBER) Center for Biologics Evaluation and Research
    Also referred to as: CBER

    
Share
    Post
    Linkedin

    Email
    Print**OFFICE OF THE CENTER DIRECTOR**

**DIRECTOR**
			Peter W. Marks, MD, PhD
			240-402-8000
			fax 301-595-1310Deputy Director
			Celia M. Witten, PhD, MD
			240-402-8000
			fax 301-595-1310Deputy Director
			Julie C. Tierney, JD
			240-402-8000
			fax 301-595-1310Chief, Executive Operations Staff
			Debra Fisher, MBA
			240-402-3003Associate Director for Preparedness and Response/Senior Advisor for Counterterrorism and Emerging Threats
			David S. Cho, PhD
			240-402-8036
			fax 301-595-1310Associate Director for Special Programs
			Gopa Raychaudhuri, PhD
			240-402-8147Associate Director for Medicine
			Barbara D. Buch, MD
			240-402-8000
			fax 301-595-1310Associate Director for Product Management
			Sheryl L. Lard-Whiteford, PhD
			240-402-7912
			fax 301-595-1310Associate Director for Policy
			James D. Myers, JD
			240-402-5923Associate Director for Science
			Karen Elkins, PhD
			240-402-9507Associate Director for International Affairs
			Michelle Limoli, PharmD
			301-796-8377Senior Advisor for Translational Science
			Scott Steele, PhD
			301-651-9049Center Ombudsman
			Olivia Ziolkowski, JD, MPH
			301-837-7292**OFFICE OF REGULATORY OPERATIONS**

**DIRECTOR**
			Christopher C. Joneckis, PhD
			240-402-8083Deputy Director
			Darlene Martin, MS
			301-796-1663Senior Science Advisor for Chemistry, Manufacturing, & Controls
			Ingrid Markovic, PhD
			240-460-3771Division of Informatics
			Victor P. Bagwell, MPH-EPI, MAS, MBA, MScIT
			240-402-4046Data Standards Branch
			Virginia Hussong
			240-506-4843Regulatory Information Branch
			Brien Hampton
			240-402-8070Records Management Branch
			Richard Thomas
			240-402-8386Division of Information Technology
			Michael Foecking (ACTING)
			301-802-8882Program Management & Analysis Branch
			Gladys Rodriguez (ACTING)
			301-796-7288Technology Integration & Delivery Branch
			Robert 'Troy' Reisch (ACTING)
			240-506-1011Division of Regulatory Operations and Programs
			Sonday Kelly, MS
			240-402-8410Regulatory Affairs and Business Operations Branch
			Katie Rivers, MS
			301-796-1818Regulatory Programs Branch
			Cherie Ward-Peralta, MS
			240-402-8447**OFFICE OF BIOSTATISTICS AND PHARMACOVIGILANCE**

**DIRECTOR**
			Steven A. Anderson, PhD, MPP
			240-402-8577Deputy Director
			Richard A. Forshee, PhD
			301-796-6044Associate Director for Risk Assessment
			Mark O. Walderhaug, PhD
			240-402-8812Associate Director for Research
			(Vacant)Associate Director for Policy
			Jawahar Tiwari, PhD
			240-402-8804Associate Director for Regulatory Affairs
			(Vacant)Associate Director for Medical Policy
			(Vacant)Division of Biostatistics
			John Scott, PhD
			240-402-8779Deputy Division Director
			Shiowjen Lee, PhDVaccine Evaluation Branch
			Tsai Lien Lin, PhDTherapeutics Evaluation Branch 1
			Boguang Zhen, PhD
			240-402-8844Device and Non-Clinical Evaluation Branch
			(Vacant)Therapeutics Evaluation Branch 2
			(Vacant)Division of Pharmacovigilance
			Narayan Nair, MD
			240-402-0396Deputy Division Director
			Meghna Alimchandani, MDPharmacovigilance Branch 1
			Adamma Mba-Jonas, MD
			240-402-8713Pharmacovigilance Branch 2
			(Vacant)Pharmacovigilance Branch 3
			(Vacant)**OFFICE OF COMMUNICATION, OUTREACH AND DEVELOPMENT**

**DIRECTOR**
			Lorrie H. McNeill
			240-402-7800Deputy Director
			Susan C. Frantz-Bohn
			240-402-7800Division of Manufacturers Assistance and Training
			Manen Bishop
			240-402-7800Career Development and Directed Training Branch
			Alice Carpenter
			240-402-7800Manufacturers Assistance & Technical Training Branch
			Jeffrey Anderson
			240-402-7800Division of Disclosure and Oversight Management
			Suzann Burk
			240-402-7800Congressional and Oversight Branch
			Christopher Juenger
			240-402-7800Access Litigation & Freedom of Information Branch
			Beth Brockner-Ryan
			240-402-7800Electronic Disclosure Branch
			Jennifer Miller
			240-402-7800Division of Communication and Consumer Affairs
			VacantCommunication Technology Branch
			Juneous Pettijohn
			240-402-7800Consumer Affairs Branch
			Paul Richards
			240-402-7800**OFFICE OF MANAGEMENT**

**DIRECTOR**
			Deirdre P. Hussey
			240-402-7990Deputy Director
			Mary Pat Leary
			240-402-8099Special Assistant
			Karen Greenfield
			240-402-8068Division of Program Services
			Jason Rubino
			301-796-1948Safety and Services Branch
			Michele Howard
			301-796-5955Program Services Branch
			Lauren Yamada (Acting)
			240-402-3975Division of Management Planning and Analysis
			Lidiana Villones (Acting)
			240-381-6558**Planning, Performance, and Formulation Branch**
			Katelyn Wannage
			240-402-1702Capacity Planning and Management Analysis Branch
			Yanming Chae
			240-402-8035Division of Acquisition and Budget Resources
			Michael Fischer
			301-348-3917Acquisitions Management Branch
			Lisa Portner
			301-796-3726Budget Planning and Execution Branch
			Junio Colobong
			240-402-8041Division of Scientific Advisors & Consultants
			Prabhakara Atreya
			240-402-8006Division of Veterinary Services
			John Dennis, MS DACLAM
			240-402-9474Division of Human Capital
			Adriana Medina
			301-348-1934Management Services Branch
			Lori White
			240-402-7549Workforce Management Branch
			Zoraly Vega Gonzalez (Acting)
			240-402-4427**OFFICE OF BLOOD RESEARCH AND REVIEW**

**DIRECTOR**
			Anne Eder, MD, PhD
			240-402-8398Deputy Director
			Anne Eder, MD, PhD (Acting)
			240-402-8398Associate Director for Research
			Chintamani D. Atreya, PhD
			240-402-8009Associate Director for Policy and Communications
			Jennifer B. Scharpf, MPH
			240-402-8437Associate Deputy Director for Quality Assurance
			Joseph Giglio, MS
			240-402-8295Regulatory Counsel
			Janet Goldberg, JDSpecial Assistant to the Director
			Jacqueline Little, PhD
			240-402-8416Administrative Staff
			Lisa Gaskins
			240-402-4124Regulatory Project Management Staff
			(Vacant)Division of Emerging & Transfusion Transmitted Diseases
			Hira Nakhasi, PhD
			240-402-8209Deputy Director
			Peyton (John) Hobson, PhD
			301-796-5892Associate Deputy Director for Medical Issues and Policy Development
			(Vacant)
			240-402-8398Associate Director for Regulatory Policy
			Sayah Nedjar, PhD
			240-402-8334Product Review Branch
			Nicholas Anderson, PhD
			240-402-5392Laboratory of Bacterial & Transmissible Spongiform Encephalopathy Agents
			(Vacant)
			240-402-9367Laboratory of Molecular Virology
			Indira K. Hewlett, PhD
			240-402-9587Laboratory of Emerging Pathogens
			Sanjai Kumar, PhD
			240-402-9652Division of Blood Components and Devices
			Orieji Illoh, MD
			240-402-8457Deputy Director
			Wendy Paul, MD
			240-402-8747Blood and Plasma Branch
			Richard McBride, MS
			240-402-9220Devices Review Branch
			Zhugong Liu, MD, PhDClinical Review Staff
			Salim Haddad, MD
			240-402-9313Laboratory of Cellular Hematology
			Jaroslav G. Vostal, MD, PhD
			240-402-8222Laboratory of Biochemistry and Vascular Biology
			Abdu Alayash, PhD
			240-402-9350**OFFICE OF VACCINES RESEARCH AND REVIEW**

**DIRECTOR**
			David Kaslow, MD
			301-796-7114Deputy Director
			(Vacant)
			301-796-2640Associate Director for Research
			(Vacant)
			240-402-9440Associate Director, Medical Countermeasures and Scientific Affairs
			Peter Weina, MD.Associate Director for NCI
			Hector Izurieta, MD
			240-402-8663Associate Director for Regulatory Policy
			Theresa M. Finn, PhD
			301-796-1859Associate Director for Medical Policy & Vaccine Safety
			Karen Farizo, MD
			301-796-1448Health Science Advisor
			Maureen Hess, MPH, RD
			301-796-1866Division of Viral Products
			Jerry P. Weir, PhD
			240-402-7473Deputy Director
			Robin Levis, PhD
			240-402-9665Laboratory of Hepatitis Viruses
			Marian Major, PhD
			240-402-9720Laboratory of Vector Borne Diseases
			Marian Major, PhD (Acting)
			240-402-9720Laboratory of Retroviruses
			Hana Golding, PhD
			240-402-9561Laboratory of DNA Viruses
			Keith Peden, PhD
			240-402-7312Laboratory of Pediatric & Respiratory Viral Diseases
			Zhiping Ye, MD, PhD
			240-402-7473Laboratory of Method Development
			Jerry Weir (Acting)
			240-402-9440Laboratory of Immunoregulation
			Carol Weiss, MD, PhD
			240-402-7474Division of Bacterial, Parasitic & Allergenic Products
			Jay E. Slater, MD
			240-402-7396Deputy Director
			Drusilla Burns, PhD
			240-402-9414Laboratory of Immunobiochemistry
			Ronald L. Rabin, MD
			240-402-7333Laboratory of Bacterial Polysaccharides
			Willie F. Vann, PhD
			240-402-7438Laboratory of Respiratory & Special Pathogens
			Michael Schmitt, PhD
			240-402-7366Laboratory of Mucosal Pathogens & Cellular Immunology
			Earle Stibitz, PhD
			240-402-7401Deputy Director - Clinical
			(Vacant)
			301-796-2640Deputy Director - Regulatory
			Loris D. McVittie, PhD
			301-796-2640Division of Vaccines and Related Products Applications
			Loris D. McVittie, PhD
			301-796-2640CMC Review Branch 1
			Jon Daugherty, PhD
			301-796-2640CMC Review Branch 2
			Rakesh Pandey, PhD
			301-796-2640CMC Review Branch 3
			Elizabeth M. Sutkowski, PhD
			301-796-2640Clinical Review Branch 1
			Maria Allende, MD
			301-796-2640Clinical Review Branch 2
			Andrea Hulse (James), MD
			301-796-2640Review Management Support Branch
			Cassandra Overking
			301-796-2640**OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY**

**DIRECTOR**
			Melissa Mendoza, JD
			301-796-8707Deputy Director
			Vincent Amatrudo, JD
			301-796-8537Special Assistant to the Director
			Mona G. Atkinson, MS, MBA
			301-796-4215Special Assistant for Operations
			Kerry Brendel
			240-402-8897Associate Director for Manufacturing Quality
			Michele Forster
			616-233-9311x1017Associate Director for Policy
			Anita Richardson
			240-402-9065Associate Director for Regulatory Policy and Legislation
			Diane Alexander
			240-402-8877Associate Director for Regulatory Policy
			Anna Kooser
			301-348-1845Associate Director for Safety and Communication
			Jean Makie
			240-402-9007Associate Director for Bioinformatics
			Sujay Pandey, PhD
			240-402-9043Special Assistant for Imports & Product Availability
			Joseph P. Manik
			240-402-9010Associate Director for Supply Chain Security and Product Policy
			Linda E. Silvers, DVM, MPH
			240-402-9089Director, Division of Case Management (DCM)
			Robert A. Sausville
			240-402-9076Advertising & Promotional Labeling Branch (DCM)
			Lisa Stockbridge, PhD
			240-402-9095Biological Drug and Device Compliance Branch (DCM)
			Maria Anderson
			240-402-8883Blood and Tissue Compliance Branch (DCM)
			Cherlita Honeycutt
			240-402-6632Director, Division of Inspections & Surveillance (DIS)
			Carrie M. Mampilly, MPH
			240-402-2973Bioresearch Monitoring Branch (DIS)
			Dennis T. Cato
			240-402-8906Program Surveillance Branch (DIS)
			Beth Rogerson
			240-402-9066Director, Division of Manufacturing and Product Quality (DMPQ)
			Carolyn A. Renshaw
			240-402-7343Deputy Director, Division of Manufacturing and Product Quality (DMPQ)
			Nicole Trudel
			240-402-7432Product Release Branch (DMPQ)
			Joseph Quander, III
			240-402-7332Manufacturing Review Branch I (DMPQ)
			Lori Peters
			240-402-7314Manufacturing Review Branch II (DMPQ)
			Anthony Lorenzo
			240-402-9706Manufacturing Review Branch III (DMPQ)
			Donald Ertel, MS, MT (ASCP)
			240-402-9511Application Review Branch (DMPQ)
			James Crim
			240-402-9458Director, Division of Biological Standards and Quality Control (DBSQC)
			Maryna Eichelberger, PhD
			240-402-9505Laboratory of Biochemistry, Virology and Immunochemistry Branch (DBSQC)
			Muhammad Shahabuddin, PhD
			240-402-7370Laboratory of Analytical Chemistry Branch (DBSQC)
			Kenneth Phillips
			301-796-0238Quality Assurance Branch (DBSQC)
			Varsha Garnepudi
			240-402-9547Laboratory of Microbiology, In-Vivo Testing and Standards (DBSQC)
			James L. Kenney, DSc
			240-402-9629Laboratory of Blood Related Products Branch (DBSQC)
			Kori Francis
			240-402-9528**OFFICE OF THERAPEUTIC PRODUCTS**

**SUPER OFFICE DIRECTOR**
			Nicole Verdun, MD
			240-402-5100Deputy Director
			Rachael Anatol, PhD
			240-402-8190Regulatory Operations Staff Chief
			Wei Liang
			240-402-8190Policy & Special Projects Staff Chief
			Rachael Anatol, PhD (acting)
			240-402-8190**Office of Review Management and Regulatory Review**Director
			Ramani Sista, PhD
			240-402-8190Division of Review Management & Regulatory Review 1
			Beatrice Kallungal, MS
			240-402-8190Regulatory Review Branch 1
			Heather Erdman
			240-402-8190Regulatory Management Support Branch 1
			Tyree Newman
			240-402-8190Division of Review Management & Regulatory Review 2
			Mara Miller, MA
			240-402-8190Deputy Director, DRMRR2
			Lori Tull
			240-402-8190Regulatory Review Branch 2
			Beatrice Kallungal, MS
			240-402-8190Regulatory Management Support Branch 2
			Edward Thompson
			240-402-8190**Office of Cellular Therapy and Human Tissue CMC**Director
			Heather Lombardi, PhD
			240-402-8190Deputy Director
			Steven Oh, PhD
			240-402-8190Division of Cell Therapy 1
			Melanie Eacho, PhD
			240-402-8190Cell Therapy Branch 1
			Irina Tiper
			240-402-8190Cell Therapy Branch 2
			Matthew Klinker
			240-402-8190Cellular & Tissue Therapy Branch
			Kyung Sung, PhD
			240-402-8190Division of Cell Therapy 2
			Laura Ricles, PhD
			240-402-8190Tissue Engineering Branch 1
			Laura Ricles, PhD (acting)
			240-402-8190Tissue Engineering Branch 2
			Alyssa Kitchel
			240-402-8190Tumor Vaccine & Biotechnology Branch
			Nirjal Bhattarai, PhD
			240-402-8190Division of Human Tissues
			Scott Brubaker
			240-402-8190Human Tissues and Reproduction Staff
			Ping He, MD
			240-402-8190**Office of Clinical Evaluation**Director
			Nicole Verdun, MD (acting)
			240-402-8190Division of Clinical Evaluation General Medicine
			Tejashri Purohit-Sheth, MD
			240-402-8190General Medicine Branch 1
			Elizabeth Hart, MD
			240-402-8190General Medicine Branch 2
			Lei Xu, MD, PhD
			240-402-8190General Medicine Branch 3
			Vaishali Popat, MD
			240-402-8190General Medicine Branch 4
			Gavin Imperato, MD
			240-402-8190Division of Clinical Evaluation Oncology
			Asha Das, MD
			240-402-8190Oncology Branch 1
			Peter Bross, MD
			240-402-8190Oncology Branch 2
			Jessica Lee, MD
			240-402-8190Division of Clinical Evaluation Hematology
			Nicole Verdun, MD (acting)
			240-402-8190Benign Hematology Branch
			Prasad Mathew, MD
			240-402-8190Malignant Hematology Branch
			Robert Sokolic, MD
			240-402-8190**Office of Gene Therapy CMC**Director
			Denise Gavin, PhD
			240-402-8190Division of Gene Therapy 1
			Andrew Byrnes, PhD
			240-402-8190Gene Therapy Branch 1
			Andrew Harmon, PhD
			240-402-8190Gene Therapy Branch 2
			Brian Stultz, PhD (acting)
			240-402-8190Gene Therapy Branch 3
			Tao Pan, PhD (acting)
			240-402-8190Division of Gene Therapy 2
			Kimberly Schultz, PhD
			240-402-8190Gene Transfer & Immunogenicity
			Andrew Byrnes, PhD (acting)
			240-402-8190Gene Therapy Branch 4
			Anna Kwilas, PhD
			240-402-8190Gene Therapy Branch 5
			Graeme Price, PhD
			240-402-8190**Office of Pharmacology/Toxicology**Director
			Iwen Wu, PhD
			240-402-8190Division of Pharmacology/Toxicology 1
			Allen Wensky, PhD
			240-402-8190Pharmacology/Toxicology Branch 1
			Abigail Shearin, DVM
			240-402-8190Pharmacology/Toxicology Branch 3
			Allen Wensky, PhD (acting)
			240-402-8190Division of Pharmacology/Toxicology 2
			Iwen Wu, PhD (acting)
			240-402-8190Pharmacology/Toxicology Branch 2
			Sandhya Sanduja, PhD
			240-402-8190Pharmacology/Toxicology Branch 4
			Alyssa Galaro
			240-402-8190**Office of Plasma Protein Therapeutics CMC**Director
			Basil Golding, MD
			240-402-8190Deputy Director
			Mahmood Fashid, PhD
			240-402-8190Division of Hemostasis
			Zuben Sauna, PhD
			240-402-8190Hemostasis Branch 1
			Alexey Khrenov, PhD
			240-402-8190Hemostasis Branch 2
			Zuben Sauna, PhD (acting)
			240-402-8190Division of Plasma Derivatives
			Dorothy Scott, MD
			240-402-8190Plasma Derivatives Branch 1
			Dorothy Scott, MD (acting)
			240-402-8190Plasma Derivatives Branch 2
			Jennifer Reed
			240-402-8190

                                                                                  Content current as of:
      01/24/2024Center for Biologics Evaluation and Research (CBER)
            
          
                        CBER Offices & Divisions
          CBER Vision & Mission
          CBER Reports
          CBER Ombudsman
          CBER Product Jurisdiction
          Jobs at CBER
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop