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Office of Vaccines Research and Review

Office of Vaccines Research and Review. Konstantin Chumakov, PhD Associate Director for Research, OVRR. Office of Vaccines Research and Review. Office of Vaccines Research and Review Director Norman Baylor Ph. D Deputy Director Marion Gruber, Ph.D. Associate Director for Research

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Office of Vaccines Research and Review

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

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

  3. Division of Bacterial, Parasitic, and Allergenic Products Division of Bacterial, Parasitic, and Allergenic Products Director: Jay Slater, M.D. (acting) Deputy: Drusilla Burns, PhD (acting) Lab of Respiratory and Special Pathogens Drusilla Burns, Ph.D. Tod Merkel Erich Keller Michael Schmitt Juan Arciniega Lab of Bacterial Polysaccharides Willie Vann, Ph.D. John Cipollo Mustafa Akkoyunlu Daron Freedberg Margaret Bash Wei Wang Lab of Immunobiochemistry Ronald Rabin, M.D. Jay Slater Lab of Mycobaterial Diseases and Cellular Immunology Sheldon Morris, Ph.D Karen Elkins Siobhan Cowley Lab of Enteric and Sexually Transmitted Diseases Scott Stibitz, PhD Dennis Kopecko

  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 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

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

  9. 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

  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

  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 • To assess progress of individual investigators and review proposed conversions and promotions • To provide input for CBER Promotion and Conversion Evaluation (PCE) Committee

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