U.S. Food and Drug Administration

1. 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 It was current when produced, but is no longer maintained and may be outdated.

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

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

4. 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

5. 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

6. 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

7. OVRR Research Budget in FY2009 $9,664,000

8. 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

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

10. 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

11. 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

12. 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

13. 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.

14. 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

15. 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