u s food and drug administration l.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
U.S. Food and Drug Administration PowerPoint Presentation
Download Presentation
U.S. Food and Drug Administration

Loading in 2 Seconds...

play fullscreen
1 / 15

U.S. Food and Drug Administration - PowerPoint PPT Presentation


  • 120 Views
  • Uploaded on

U.S. Food and Drug Administration. Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated. . Office of Vaccines Research and Review.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'U.S. Food and Drug Administration' - graham


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
u s food and drug administration
U.S. Food and Drug Administration

Notice: Archived Document

The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

office of vaccines research and review

Office of Vaccines Research and Review

Konstantin Chumakov, PhD

Associate Director for Research, OVRR

ovrr mission statement
OVRR Mission Statement

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

ovrr activities
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
organizational structure of ovrr
Organizational Structure of OVRR

Office of Vaccines Research and Review

Director

Norman Baylor Ph. D

Deputy Director

Marion Gruber, Ph.D.

Associate Director

for Regulatory Policy

Theresa Finn, Ph.D

Associate Director For

Management and Scientific Affairs

Erik Henchal, Ph.D

Associate Director for Research

Konstantin Chumakov, Ph.D

Associate Director for Medical Policy

and Vaccine Safety

Philip Krause, M.D. (acting)

Division of Bacterial, Parasitic and Allergenic Products

Director: Milan Blake, Ph.D

Deputy: Jay Slater, M.D

Division of Viral Products

Director: Jerry Weir, Ph.D

Deputy: Robin Levis, PhD (acting)

Division of Vaccines and Related Products Applications

Director: Wellington Sun, Ph.D

Deputy: Loris McVittie, Ph.D

Division of Product Quality

Director: William McCormick, Ph.D

Deputy: Rajesh Gupta, Ph.D

division of viral products

Division of Viral Products

Director: Jerry Weir, Ph.D

Deputy: Robin Levis, PhD (acting)

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 DNA Viruses

(vacant)

Andrew Lewis

Philip Krause

Jerry Weir

Lab of Vector

Borne Diseases

Lew Markoff, M.D

Lew Markoff

Lab of Method Development

Konstantin Chumakov, Ph.D

Konstantin Chumakov

Steven Rubin (acting)

Vladimir Chizhikov

Lab of Hepatitis

Stephen Feinstone, M.D

Stephen Feinstone

Marian Major

Lab of Immunoregulation

Ira Berkower, M.D

Ira Berkower

Carol Weiss

Division of Viral Products
the purpose of ovrr research program is to
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 establishingmethods 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 objective of research management
The objective of research management

To reconcile investigator-initiated research model with the needs dictated by FDA mission

ovrr research management process

Principal Investigator

Lab Chief

Proposal

Site visit, Advisory committee recommendations

Current priorities

Laboratory projects

Research Management Committee

Current regulatory issues

Regulatory Division

Division Director

Division research portfolio

Annual Research Plan

Budget projection

OVRR

CBER

OVRR Research Management Process
slide11
Research is conducted in three major areas with special emphasis on priority products of high public health importance
  • 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

1 safety
1. Safety
  • Purity of components, including cell substrates
  • Novel scientific technologies for evaluation of consistency
  • Toxic effects of vaccine antigens, adjuvants, etc.
  • Biomarkers of pathogenicity, safety of live vaccines
  • Vaccine-related adverse events, biomarkers of predisposition, prevention
2 efficacy
2. Efficacy
  • Correlates of protection and biomarkers of vaccine efficacy
  • Improvement of immunogenicity, potency, and protectivity of vaccines
  • Mechanisms of innate and adaptive immunity, immunopathology, including allergy
  • Mechanism of action of adjuvants and predicting their effectiveness.
3 availability
3. Availability
  • Novel vaccines (e.g. synthetic, DNA vaccines), new ways of antigen presentation and vaccine delivery
  • Methods for monitoring and controlling the manufacturing process
  • New vaccine platforms, novel cell substrates, plant vaccines, etc
  • Refinement, reduction, and replacement of tests in laboratory animals
  • Probiotics for preventive and therapeutic use
the role of site visits
The role of Site Visits
  • To evaluate scientific merits and regulatory relevance of OVRR research programs
    • Must be on par with standards in the field
    • In line with recommendations of previous Site Visits
  • To review proposed long-term research plans
    • Similar to NIH study section
  • To assess progress of individual investigators and review proposed conversions and promotions
    • To provide input for CBER Promotion and Conversion Evaluation (PCE) Committee