1. Office of Vaccines Research and Review
Konstantin Chumakov, PhD
Associate Director for Research, OVRR

2. Office of Vaccines Research and Review
Director
Marion Gruber, Ph.D. (acting)
Deputy Director
Philip Krause, M.D. (acting)
Associate Director for Research
Konstantin Chumakov, Ph.D.
Associate Director for Medical Policy
and Vaccine Safety
Philip Krause, M.D.
Associate Director For
Management and Scientific Affairs
Erik Henchal, Ph.D.
Associate Director
for Regulatory Policy
Theresa Finn, Ph.D.
Division of Bacterial, Parasitic and Allergenic Products
Director: Jay Slater, M.D.
Deputy: Drusilla Burns, Ph.D.
Division of Viral Products
Director: Jerry Weir, Ph.D.
Deputy: Robin Levis, Ph.D.
Division of Vaccines and Related Products Applications
Director: Wellington Sun, Ph.D.
Deputy: Loris McVittie, Ph.D.

3. Division of Viral Products
Director: Jerry Weir, Ph.D.
Deputy: Robin Levis, PhD.
Lab of Pediatric and
Respiratory Viral Diseases
Jerry Weir, Ph.D (acting)
Zhiping Ye
Maryna Eichelberger
Judy Beeler
Lab of Retroviruses
Hana Golding, Ph.D
Hana Golding
Keith Peden
Arifa Khan
Lab of Vector
Borne Diseases
Lew Markoff, M.D
Lew Markoff
Lab of Immunoregulation
Ira Berkower, M.D
Ira Berkower
Carol Weiss
Lab of Hepatitis
Stephen Feinstone, M.D
Stephen Feinstone
Marian Major
Lab of DNA Viruses
Andrew Lewis
Philip Krause
Jerry Weir
Lab of Method Development
Konstantin Chumakov, Ph.D
Konstantin Chumakov
Steven Rubin (acting)
Vladimir Chizhikov

4. OVRR Mission Statement
Protect and enhance the public health by assuring the availability of safe and effective vaccines, allergenic extracts, and other related products.

5. OVRR activities
Review, evaluate, and take appropriate actions on INDs, BLAs, amendments and supplements to these applications for vaccines and related products, conducting inspections, etc.
Develop policies and procedures governing the pre- market review of regulated products
Conducting research related to the development, manufacture, and evaluation of vaccines and related products

6. The role of FDA Research
FDA research occupies a well-defined critical niche at the end of product development pipeline
FDA scientists are uniquely positioned to address scientific issues related to safety and efficacy of medicinal products
The results remain in public domain and benefit the entire industry

7. The purpose of OVRR research program is to:
contribute to regulation of vaccines and related products by addressing scientific aspects of critical regulatory issues
develop and maintain a scientific base for establishing methods and standards designed to ensure the continued safety, purity, potency and effectiveness of vaccines and related products
recruit and maintain highly trained scientists who possess the expertise necessary for review of regulatory submissions and development of regulatory policies and guidance documents
provide scientific expertise and leadership to vaccine industry to facilitate the development and introduction of new vaccines and related products

8. The purpose of research management
To reconcile investigator-initiated research model with the needs dictated by FDA mission

9. OVRR Research Management Process
Research Management Committee
Division research portfolio
Lab Chief
Division Director
OVRR
CBER
Principal Investigator
Site visit, Advisory committee recommendations
Regulatory Division
Proposal
Current priorities
Laboratory projects
Current regulatory issues
Budget projection
Annual Research Plan

10. Research is conducted in three major areas with special emphasis on products of high public health importance and visibility
Safety
To study factors affecting safety of regulated products,
create and validate appropriate methods and standards
Efficacy
To study biomarkers and introduce new methods and
standards to evaluate and improve vaccine efficacy
Availability
To develop new concepts and methods opening novel
regulatory pathways to improve availability of vaccines and
related products

11. 1. Safety
Evaluate purity of components used in manufacture of vaccines, including cell substrates, and develop methods for detection of adventitious agents
Study the utility of novel scientific technologies based on genomics, proteomics, etc., for comprehensive evaluation of vaccines and related products and ensuring their consistency
Create methods and models to study potential toxic effects of vaccine antigens, adjuvants, and other components of vaccines
Determine biomarkers of pathogenicity and develop new methods to evaluate and ensure safety of live vaccines and related products
Study the mechanisms of vaccine-related adverse events, ways to mitigate them, and biomarkers of predisposition

12. 2. Efficacy
Study pathogenesis to identify correlates of protection and biomarkers of vaccine efficacy, including studies in special populations
Create methods for evaluation and improvement of immunogenicity, potency, and protectivity of vaccines
Study the mechanisms of innate and adaptive immunity against viral and bacterial diseases and mechanisms of immunopathology, including allergy
Study the mechanism of action of adjuvants and create methods for predicting their effectiveness

13. 3. Availability
Create new approaches to inducing protective immunity, including synthetic and DNA vaccines, modifications of antigen presentation and vaccine delivery routes
Create and evaluate methods for monitoring and controlling the manufacturing process
Evaluate novel scientific technologies for manufacture of vaccines, including use of novel cell substrates, plants, and other innovative platforms
Create methods for evaluation of vaccines that lead to refinement, reduction, and replacement of tests in laboratory animals
Conduct studies to facilitate the development and regulation of probiotics for preventive and therapeutic use

14. Rating of Research Projects
PUBLIC HEALTH SIGNIFICANCE
Public health need — dealing with high priority issue
Immediate regulatory relevance — pending applications exist
Strategic regulatory relevance — resolving general regulatory challenge of major importance
Office/Division needs — fills a gap in the overall research program
SCIENTIFIC MERIT
Scientific rationale
Originality and innovation
Feasibility of research approach
Budget (affordability)
QUALIFICATIONS AND PRODUCTIVITY
Necessary qualifications
Past productivity of investigator/impact