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