office of vaccines research and review
DESCRIPTION
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.TRANSCRIPT
Office of Vaccines Research and ReviewKonstantin Chumakov, PhD
Associate Director for Research, OVRR
Office of Vaccines Research and Review
Office of Vaccines Research and ReviewDirector
Marion Gruber, Ph.D. (acting)Deputy Director
Philip Krause, M.D. (acting)
Associate Director for ResearchKonstantin 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 Directorfor Regulatory PolicyTheresa 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.
Division of Viral ProductsDivision of Viral Products
Director: Jerry Weir, Ph.D.Deputy: Robin Levis, PhD.
Lab of Pediatric and Respiratory Viral DiseasesJerry Weir, Ph.D (acting)
Zhiping YeMaryna Eichelberger
Judy Beeler
Lab of RetrovirusesHana Golding, Ph.D
Hana GoldingKeith PedenArifa Khan
Lab of Vector Borne Diseases
Lew Markoff, M.D
Lew Markoff
Lab of ImmunoregulationIra Berkower, M.D
Ira BerkowerCarol Weiss
Lab of HepatitisStephen Feinstone, M.D
Stephen FeinstoneMarian Major
Lab of DNA VirusesKeith Peden
Andrew LewisPhilip Krause
Jerry Weir
Lab of Method DevelopmentKonstantin Chumakov, Ph.D
Konstantin ChumakovSteven Rubin (acting)Vladimir Chizhikov
OVRR Mission StatementProtect and enhance the public health by assuring the availability of
safe and effective vaccines, allergenic extracts, and other related products.
OVRR activitiesReview, 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
The role of FDA ResearchFDA 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
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
The purpose of research management
To reconcile investigator-initiated research model with the needs dictated by FDA
mission
OVRR Research Management ProcessProposal
Laboratory projects
Budget projection
Annual Research
Plan
Current priorities
Research Management Committee Division research portfolio
Lab Chief
Division
Director
OVRRCBER
Principal Investigat
or
Site visit, Advisory committee recommendations
Regulatory Division
Current
regulatory issues
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
EfficacyTo study biomarkers and introduce new methods andstandards to evaluate and improve vaccine efficacy
AvailabilityTo develop new concepts and methods opening novelregulatory pathways to improve availability of vaccines andrelated products
1. Safety
A. Evaluate purity of components used in manufacture of vaccines, including cell substrates, and develop methods for detection of adventitious agents
B. Study the utility of novel scientific technologies based on genomics, proteomics, etc., for comprehensive evaluation of vaccines and related products and ensuring their consistency
C. Create methods and models to study potential toxic effects of vaccine antigens, adjuvants, and other components of vaccines
D. Determine biomarkers of pathogenicity and develop new methods to evaluate and ensure safety of live vaccines and related products
E. Study the mechanisms of vaccine-related adverse events, ways to mitigate them, and biomarkers of predisposition
2. Efficacy
A. Study pathogenesis to identify correlates of protection and biomarkers of vaccine efficacy, including studies in special populations
B. Create methods for evaluation and improvement of immunogenicity, potency, and protectivity of vaccines
C. Study the mechanisms of innate and adaptive immunity against viral and bacterial diseases and mechanisms of immunopathology, including allergy
D. Study the mechanism of action of adjuvants and create methods for predicting their effectiveness
3. Availability
A. Create new approaches to inducing protective immunity, including synthetic and DNA vaccines, modifications of antigen presentation and vaccine delivery routes
B. Create and evaluate methods for monitoring and controlling the manufacturing process
C. Evaluate novel scientific technologies for manufacture of vaccines, including use of novel cell substrates, plants, and other innovative platforms
D. Create methods for evaluation of vaccines that lead to refinement, reduction, and replacement of tests in laboratory animals
E. Conduct studies to facilitate the development and regulation of probiotics for preventive and therapeutic use
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