CBER Expertise
Office of Vaccines Research and Review
Division of Viral Products
Jerry Weir, PhD, Division Director
Philip Krause, MD, Deputy Director
The Division of Viral Products is responsible for the review, evaluation, and regulation of viral vaccines and related products. The research programs of the Division support this mission and focus on critical issues related to the development, evaluation, and regulation of viral vaccines and related biological products.
Laboratory of DNA Viruses
- Andrew Lewis, MD, Chief - Development of Assays of Defined Sensitivity for the Regulatory Management of Novel Cell Substrates
- Jerry Weir, PhD - DNA Virus Vaccine Protective Immunity
- Michael Merchlinsky, PhD - Development and Evaluation of New-Generation Smallpox Vaccines
- Philip Krause, MD - DNA virus vaccine safety issues: contamination and viral latency
- Alonzo Garcia, PhD - Identifying biomarkers of smallpox vaccine efficacy: Immune responses to the extracellular enveloped antigens of smallpox
Laboratory of Hepatitis Viruses
- Stephen Feinstone, MD, Chief - Hepatitis C vaccines: Development of in vitro and in vivo systems for HCV replication and evaluation of vaccine efficacy
- Marian Major, PhD - Studies of efficacy, safety and potency assay development for prophylactic and therapeutic vaccines against hepatitis viruses
Laboratory of Methods Development
- Konstantin M. Chumakov, PhD, Acting Chief - Evaluation of safety and potency of viral vaccines based on analysis of molecular consistency
- Kathryn Carbone, MD - Developing tests to evaluate virus vaccine safety for the nervous system
- Vladimir Chizhikov, PhD - Microarray-Based Evaluation of Purity and Safety of Biological Products
Laboratory of Pediatric and Respiratory Viral Diseases
- Zhiping Ye, MD, PhD - Development and Evaluation of Influenza Vaccines Using Molecular Approaches
- Judy Beeler, MD - Developing tests to detect biomarkers of vaccine efficacy (e.g., protective immune responses) to respiratory viruses that infect infants, children and the elderly
- C.D. Atreya, PhD - Methods for improving the safety of rotavirus and rubella vaccines
Laboratory of Retrovirus Research
- Hana Golding, PhD, Chief - HIV and smallpox vaccines: Development of new assays and animal models for evaluation of vaccine safety and efficacy
- Marina Zaitseva, PhD - Development of animal models and in vitro assays to test efficacy of immune reconstitution following administration of anti-HIV-vaccines and immunotherapies
- Arifa Khan, PhD - Biological Product Safety: Assay development for latent viruses in vaccine cell substrates and risk assessment of retrovirus transmission
- Keith Peden, PhD - Development of Quantitative Assays to Evaluate the Safety of Cell Substrates and Vaccines
Laboratory of Vector Borne Viral Diseases
- Lewis Markoff, MD, Chief - Methods for improving the safety and efficacy of vaccines against emerging virus pathogens
Laboratory of Immunology
- Ira Berkower, MD, Chief - Improving vaccine potency through particle formation or by using live attenuated vectors to generate vaccines for HIV and select agents
- Carol Weiss, MD - Evaluating Viral Antigens and Efficacy in Vaccines for HIV/AIDS and Smallpox