1. Overview of the Division of Viral Products
Jerry P. Weir, Ph.D. Director
Division of Viral Products/OVRR/CBER/FDA

2. Mission
Regulate viral vaccines and related biological products, ensuring their safety and efficacy for human use
Facilitate the development, evaluation, and licensure of new viral vaccines that positively impact the public health

3. Division of Viral Products Responsibilities
Investigational New Drug (IND) and Biologics License Application (BLA) review, and other pre-marketing activities (e.g., pre-IND)
BLA supplement review, lot release review and testing, and other post-marketing activities (e.g., Biological product deviations)
Manufacturer inspections (pre- and post-licensure)
Consultation with other public health agencies (e.g., WHO, CDC, NIBSC)
Conduct research related to the development, manufacturing, evaluation, and testing of viral vaccines

4. Licensed Viral Vaccines
Hepatitis Viruses
Hepatitis A
Hepatitis B
HepA/HepB
HepB-Hib
DTaP-HepB-IPV
Vector-Borne Viral Diseases
Yellow Fever
Japanese Encephalitis Virus
DNA Viruses
Varicella Virus
Smallpox
Childhood Viruses
Inactivated poliovirus
Measles, Mumps, rubella
Rotavirus
Respiratory Viruses
Inactivated Influenza
Live attenuated influenza
Other Viral Vaccines
Rabies

5. Viral Vaccines Under Development
Hepatitis Viruses
Hepatitis C
Hepatitis E
Vector-Borne Viral Diseases
Dengue
West Nile Virus
DNA Viruses
Human Papillomavirus
Herpes Simplex
Cytomegalovirus
New smallpox vaccines
Childhood Viruses
New Rotavirus vaccines
HIV
Respiratory Viruses
New Influenza vaccines
Pandemic influenza vaccines
Respiratory Syncytial Virus
Parainfluenza virus
Vaccines for Emerging Diseases and agents of Bioterrorism
Ebola and other hemorrhagic fevers
Venezuelan Equine Encephalitis Virus and other encephalitis causing viruses

6. Division of Viral Products Snapshot
7 Laboratories
17 Tenured Principal Investigators
67 Full-time equivalent staff (April 2006)
> 50 Contract staff (e.g., post-doctoral fellows)
~ 140 publications (last 2 years)
> $3,000,000 grants and contracts (FY05)
Researcher/Reviewer Model
Review workload (e.g., INDs, BLAs, post-marketing)
Mission-relevant research
Outreach and collaboration (e.g., expert consultants to WHO)

7. Division of Viral Products Research Priorities
Develop methods and models to assess and predict viral vaccine safety and efficacy
development and evaluation of novel vaccination strategies and technologies
identification of correlates of protection
development of animal models predictive of efficacy
Facilitate the development and evaluation of vaccines for high priority viral diseases including emerging diseases and agents of bioterrorism
influenza vaccine reagent preparation
issues related to vaccine development for high priority diseases (e.g., RSV, HepC), emerging diseases (e.g., pandemic influenza, HIV, West Nile virus) and Bioterrorism agents (e.g., smallpox)
Evaluate novel approaches to improve vaccine quality
evaluation of cell substrates
Development and evaluation of new methods and assays for product characterization

8. Division of Viral Products Laboratories
Jerry P. Weir, Ph.D., Director
Phil Krause, M.D., Deputy Director
Laboratory of Hepatitis Viruses
Steve Feinstone, M.D., Chief
Laboratory of Vector-Borne Viral Diseases
Lewis Markoff, M.D., Chief
Laboratory of Retroviruses
Hana Golding, Ph.D, Chief
Laboratory of DNA Viruses
Andrew Lewis, M.D., Chief
Laboratory of Respiratory Viral Diseases
Chief - Vacant
Laboratory of Immunoregulation
Ira Berkower, M.D., Chief
Laboratory of Methods Development
Konstantin Chumakov, Ph.D., Chief

9. Laboratory of Vector Borne Viral Diseases
Areas of Research
Characterization of candidate live, attenuated dengue and West Nile virus vaccines.
Mechanism by which flaviviruses repair attenuating 3'terminal deletions of genome RNA.
Virion morphogenesis.
Effect of quasi-species character on phenotype.
Development of an ELISA-based potency assay for rabies vaccines.

10. Laboratory of Hepatitis Viruses
Areas of Research
Vaccine strategies to prevent HCV infection
Development of mouse models for HCV infection to replace the chimpanzee
Development of in vitro culture systems to study antibody neutralization of HCV
Biomarkers for HCV protection and HBV/HCV related hepatocellular carcinoma

11. Laboratory of Immunoregulation
Areas of Research
Structure-function analysis of HIV envelope glycoproteins
Vaccination strategies to enhance vaccine immunogenicity
Dissecting the neutralizing antibody response to vaccinia virus
gp120 particles HBsAg particles

12. Laboratory of Respiratory Viral Diseases
Areas of Research
Prepare and distribute influenza virus reagents to determine purity and strength of influenza vaccines
Perform serology studies in support of influenza strain selection
Develop new high growth influenza virus strains for vaccines and determine properties for optimal growth in eggs and tissue culture
Evaluate new vaccine strategies
Identify cellular receptors for respiratory syncytial virus (RSV) and determine antigenic structure of RSV glycoproteins
Develop serological methods for vaccine trial evaluation

13. Laboratory of Method Development
Areas of Research
Microarrays and other molecular methods for analysis of pathogens
Genotyping of viruses and bacteria
Identification of Mycoplasmas
Genetic stability of live viral vaccines
Immunological test methods development
New animal model development
Neurotoxicity assay development

14. Laboratory of Retrovirus Research
Areas of Research
Development of assays for HIV and smallpox clinical trial evaluation
Identification and characterization of adjuvants
Activity and safety of DNA vaccines and CpG oligodeoxynucleotides
Safety and evaluation of cell substrates used for vaccine production
Retrovirus transmission

15. Laboratory of DNA Viruses
Areas of Research
Evaluation of cell substrates used for vaccine manufacture
Developing methods to evaluate the risks posed by the use of neoplastic cells for production of viral vaccines
Detection of adventitious agents
Mechanisms of viral latency
Immunogenicity and pre-clinical efficacy of new-generation smallpox vaccines
Evaluation of novel herpesvirus vaccination strategies

16. Summary
The research programs and laboratory activities in the Division of Viral Products support the regulatory mission of the Office of Vaccines and CBER
Ensures the safety and efficacy of regulated viral vaccine products, and
Facilitates the development and evaluation of new virus vaccine products