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Division of Bacterial, Parasitic and Allergenic Products

Division of Bacterial, Parasitic and Allergenic Products. Jay E. Slater, MD Director, DBPAP. Division of Bacterial, Parasitic and Allergenic Products (DBPAP). Merger (1999) of Division of Bacterial Products (DBP) and Division of Allergenic Products and Parasitology (DAPP) Leadership

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Division of Bacterial, Parasitic and Allergenic Products

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  1. Division of Bacterial, Parasitic and Allergenic Products Jay E. Slater, MD Director, DBPAP

  2. Division of Bacterial, Parasitic and Allergenic Products (DBPAP) • Merger (1999) of • Division of Bacterial Products (DBP) and • Division of Allergenic Products and Parasitology (DAPP) • Leadership • Drusilla Burns, PhD (Acting) 1999-2000 • Richard Walker, PhD 2000-2008 • Milan Blake, PhD 2008-2010 • Jay Slater, MD 2010-present

  3. Immediate Office of the Director Jay Slater, MD – Director Drusilla Burns, PhD – Deputy Director (Acting) Regulatory Staff Jennifer Bridgewater – Assoc. Dir. Regulatory Policy Tina Roecklein – Regulatory Coordinator 5 FTE Laboratory of Bacterial Polysaccharides Willie Vann, PhD – Chief Mustafa Akkoyunlu , PhD Margaret Bash, MD Wei Wang, PhD John Cipollo , PhD Daron Freedberg , PhD 16 FTE, 11 ORISE Laboratory of Respiratory and Special Pathogens Drusilla Burns, PhD - Chief Juan Arciniega, D Sci James Keller, PhD Tod Merkel, PhD Michael Schmitt, PhD 16 FTE, 7 ORISE Laboratory of Enteric and Sexually Transmitted Diseases Scott Stibitz, Ph.D. – Chief Dennis Kopecko, PhD 7 FTE, 13 ORISE Laboratory of Mycobacterial Diseases & Cellular Immunology Sheldon Morris, Ph.D. – Chief Siobhan Cowley, PhD Karen Elkins, PhD 10 FTE, 9 ORISE Laboratory of Immunobiochemisty Ron Rabin, M.D. – Chief 9 FTE, 7 ORISE Division of Bacterial, Parasitic and Allergenic Products (DBPAP) As of 15 April 2011

  4. Non-invasive, toxin producers Bacillus anthracis (Bordetella parapertussis) Bordetella pertussis (Clostridium botulinum) Clostridium tetani Corynebacterium diphtheriae Invasive, protective responses to polysaccharides Haemophilus influenzae Neisseria meningitidis Streptococcus pneumoniae Intracellular (Francisella tularensis) Mycobacterium tuberculosis Mycobacterium bovis Enteric (Campylobacter jejuni) Salmonella typhi (Salmonella typhimurium) (Shigella dysenteriae) Parasite (Plasmodium spp) Other/emerging (Yersinia pestis) (Staphylococcus aureus) Allergenic products (Probiotics) DBPAP regulatory/research portfolio

  5. Non-invasive, toxin producers Bacillus anthracis (Bordetella parapertussis) Bordetella pertussis (Clostridium botulinum) Clostridium tetani Corynebacterium diphtheriae Invasive, protective responses to polysaccharides Haemophilus influenzae Neisseria meningitidis Streptococcus pneumoniae Intracellular (Francisella tularensis) Mycobacterium tuberculosis Mycobacterium bovis Enteric (Campylobacter jejuni) Salmonella typhi (Salmonella typhimurium) (Shigella dysenteriae) Parasite (Plasmodium spp) Other/emerging (Yersinia pestis) (Staphylococcus aureus) Allergenic products (Probiotics) DBPAP regulatory/research portfolioBacterial Polysaccharides (LBP)

  6. Akkoyunlu Regulation of humoral immune response against polysaccharide vaccines by bacterial products Bash To present protein targets as alternatives based on molecular epidemiology of the pathogen where polysaccharide vaccines have lacked success Cipollo Mass spectrometry of carbohydrates as a tool for characterization of bacterial vaccines and pathogens Freedberg Improvement of biological product quality by application of new technologies to characterize of vaccines and blood products: NMR spectroscopy and light scattering Vann To detemine the metabolic pathway for the synthesis of polysaccharides in gram negative pathogens and to use this knowledge to development methods for preparing glycoconjugate vaccines using metabolic engineering To improve and understand the manufacture of current conjugate vaccines through the investigation of conjugation chemistry Wang To investigate the genetics of pathogenesis of gram negative bacteria. M. catarrhalis is a model organism for these studies. To study the regulation of M. catarrhalis virulence gene expression and identify biomarkers for developing vaccine against M. catarrhalis. Bacterial polysaccharides (LBP)

  7. Non-invasive, toxin producers Bacillus anthracis (Bordetella parapertussis) Bordetella pertussis (Clostridium botulinum) Clostridium tetani Corynebacterium diphtheriae Invasive, protective responses to polysaccharides Haemophilus influenzae Neisseria meningitidis Streptococcus pneumoniae Intracellular (Francisella tularensis) Mycobacterium tuberculosis Mycobacterium bovis Enteric (Campylobacter jejuni) Salmonella typhi (Salmonella typhimurium) (Shigella dysenteriae) Parasite (Plasmodium spp) Other/emerging (Yersinia pestis) (Staphylococcus aureus) Allergenic products (Probiotics) DBPAP regulatory/research portfolioEnteric and Sexually Transmitted Diseases (LESTD)

  8. Enteric and Sexually Transmitted Diseases (LESTD) • Stibitz • Molecular genetics of virulence and virulence-gene regulation in bacterial respiratory pathogens • Kopecko • Evaluate safety and utility of Salmonella typhi Ty21a as an oral vaccine delivery platform for expression of foreign antigens and delivery of anti-cancer therapies • Analyze pathogenesis of and immune responses to Campylobacter jejuni infection in humans • Evaluate the vaccine potential of inactivated enteric bacteria

  9. Non-invasive, toxin producers Bacillus anthracis (Bordetella parapertussis) Bordetella pertussis (Clostridium botulinum) Clostridium tetani Corynebacterium diphtheriae Invasive, protective responses to polysaccharides Haemophilus influenzae Neisseria meningitidis Streptococcus pneumoniae Intracellular (Francisella tularensis) Mycobacterium tuberculosis Mycobacterium bovis Enteric (Campylobacter jejuni) Salmonella typhi (Salmonella typhimurium) (Shigella dysenteriae) Parasite (Plasmodium spp) Other/emerging (Yersinia pestis) (Staphylococcus aureus) Allergenic products (Probiotics) DBPAP regulatory/research portfolioImmunobiochemistry (LIB)

  10. Non-invasive, toxin producers Bacillus anthracis (Bordetella parapertussis) Bordetella pertussis (Clostridium botulinum) Clostridium tetani Corynebacterium diphtheriae Invasive, protective responses to polysaccharides Haemophilus influenzae Neisseria meningitidis Streptococcus pneumoniae Intracellular (Francisella tularensis) Mycobacterium tuberculosis Mycobacterium bovis Enteric (Campylobacter jejuni) Salmonella typhi (Salmonella typhimurium) (Shigella dysenteriae) Parasite (Plasmodium spp) Other/emerging (Yersinia pestis) (Staphylococcus aureus) Allergenic products (Probiotics) DBPAP regulatory/research portfolioMycobacterial Diseases and Cellular Immunology (LMDCI)

  11. Mycobacterial Diseases and Cellular Immunology (LMDCI) • Elkins • Understand innate immune responses to intracellular bacteria in general and LVS in particular, particularly facets with implications for safety and efficacy outcomes. • Define mechanisms by which vaccine-induced immune T cells provide protection against intracellular bacteria, and thus establish practical immune correlates • Morris • Characterization of novel vaccines and immunization strategies against TB • Development of assays to facilitate the assessment of TB vaccines • Cowley • Characterization of unique aspects of mucosal immune responses to intracellular pathogens. • Malaria program – collaboration with OBRR

  12. Non-invasive, toxin producers Bacillus anthracis (Bordetella parapertussis) Bordetella pertussis (Clostridium botulinum) Clostridium tetani Corynebacterium diphtheriae Invasive, protective responses to polysaccharides Haemophilus influenzae Neisseria meningitidis Streptococcus pneumoniae Intracellular (Francisella tularensis) Mycobacterium tuberculosis Mycobacterium bovis Enteric (Campylobacter jejuni) Salmonella typhi (Salmonella typhimurium) (Shigella dysenteriae) Parasite (Plasmodium spp) Other/emerging (Yersinia pestis) (Staphylococcus aureus) Allergenic products (Probiotics) DBPAP regulatory/research portfolioRespiratory and Special Pathogens (LRSP)

  13. Arciniega Development and refinement of potency and toxicity tests for bacterial vaccines Burns Bacterial toxin structure/function relationships Study of host response to immunization with anthrax and Staphylococcal aureus vaccines Keller Clostridial neurotoxin vaccine and antitoxin research Merkel Development of animal aerosol challenge models for pertussis, anthrax and disease caused by Staphylococcus aureus. Analysis of gene regulation in Bordetella pertussis Schmitt Characterization of iron transport systems of Corynebacterium diphtheriae Analysis of gene regulation in C. diphtheriae Respiratory and Special Pathogens (LRSP)

  14. Immediate Office of the Director Jay Slater, MD – Director Drusilla Burns, PhD – Deputy Director (Acting) Regulatory Staff Jennifer Bridgewater – Assoc. Dir. Regulatory Policy Tina Roecklein – Regulatory Coordinator 5 FTE Laboratory of Bacterial Polysaccharides Willie Vann, PhD – Chief Mustafa Akkoyunlu , PhD Margaret Bash, MD Wei Wang, PhD John Cipollo , PhD Daron Freedberg , PhD 16 FTE, 11 ORISE Laboratory of Respiratory and Special Pathogens Drusilla Burns, PhD - Chief Juan Arciniega, D Sci James Keller, PhD Tod Merkel, PhD Michael Schmitt, PhD 16 FTE, 7 ORISE Laboratory of Enteric and Sexually Transmitted Diseases Scott Stibitz, Ph.D. – Chief Dennis Kopecko, PhD 7 FTE, 13 ORISE Laboratory of Mycobacterial Diseases & Cellular Immunology Sheldon Morris, Ph.D. – Chief Siobhan Cowley, PhD Karen Elkins, PhD 10 FTE, 9 ORISE Laboratory of Immunobiochemisty Ron Rabin, M.D. – Chief 9 FTE, 7 ORISE Division of Bacterial, Parasitic and Allergenic Products (DBPAP As of 15 April 2011

  15. LIB presenters • Ronald Rabin, MD (2002) • Ashraf El Fiky, MD PhD (2009) • Jay E. Slater, MD (1998) • Taruna Khurana, PhD (2009)

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