Division of Bacterial, Parasitic and Allergenic Products OVRRCBERFDA

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Division of Bacterial, Parasitic and Allergenic
ProductsOVRR/CBER/FDA
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Division Mission and Functions
Assure safe and effective products for
immunological control of bacterial, parasitic,
and allergenic agents affecting human health
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Examples of Possible New or Improved Products
Scope of DBPAP Product Responsibilities

• Respiratory Pathogens
• Streptococcus pneumoniae
• Mycobacterium tuberculosis
• Pseudomonas aeruginosa
• Neisseria meningitidis A,B,C,Y,W125
• Group B Streptococci
• Bordetella pertussis
• Chlamydia pneumoniae
• Corynbacterium diphtheriae
• Non-typeable H. influenzae
• Moraxella catarrhalis
• Sexually Transmitted Pathogens
• Neisseria gonorrheae
• Chlamydia trachomatis

• Pathogens Encountered by Penetrating Inoculation
• Borrelia burgdorfi
• Plasmodium species
• Leishmania species
• Clostridium tetani
• Staphylococcus aureus
• Schistosoma species
• Trypanosoma cruzi
• Special Pathogens (BT)
• Bacillus anthracis
• Clostridium botulinum
• Franciscella tularensis
• Yersinia pestis

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Examples of Possible New or Improved Products
Scope of DBPAP Product Responsibilities

• Diarrhea-Causing Pathogens
• Enterotoxigenic E. coli
• Shigella species
• Vibrio cholerae
• Campylobacter jejuni
• Other Mucosally-Trafficking Pathogens
• Clostridium difficile
• Salmonella typhi
• Mycobacterium leprae
• Helicobacter pylori
• STEC and EPEC

• Allergenic Antigens
• Latex
• Cockroach
• Short ragweed
• Skin Test Antigens
• PPD
• Coccidioidin
• Leishmania
• Live Biotherapeutic Products
• Lactobacillus
• E. coli
• Clostridia

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Division of Bacterial, Parasitic and Allergenic
Products (DBPAP)
Laboratory of Mycobacterial Diseases and
Cellular Immunology Sheldon Morris, Ph.D.-Chief
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Division of Bacterial, Parasitic and Allergenic
Products (DBPAP)

• 6 Laboratories (82 people)
• 13 Tenured Principal Investigators
• 7 Tenure-track investigators
• 43 Full-time equivalent staff
• 19 Contract staff (e.g., post-doctoral fellows)

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Laboratory Mission and Functions Dependent on
Researcher/Reviewers
Responsibilities of Researcher/Reviewers

• Conduct regulatory review
• Conduct critical research programmatic and
  special task
• Serve outside organizations as recognized subject
  matter experts
• Find outside resources to support research

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Regulatory Review and Laboratory Work A
Synergistic Combination

• Provide reagents/standards
• Assay development
• Improved technology
• Trouble-shooting
• Gain expertise to
• Better anticipate issues/identify and fill
  knowledge gaps
• Provide expert input to vaccine community
• Provide guidance advice to industry

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DBPAP Research Priorities

• Develop methods and models to assess and predict
  vaccine and biologics safety and efficacy
• Development and evaluation of novel vaccination
  strategies and technologies
• Development of animal models to predict vaccine
  efficacy
• Development of in vitro assays to predict vaccine
  safety
• Facilitate the development and evaluation of
  vaccines for high priority diseases including
  agents of bioterrorism
• Development of improved conjugation technologies
• Development of genetic tools for allelic exchange
  in B. anthracis
• Evaluate novel approaches to improve vaccine
  quality
• Apply new NMR methods to analysis of carbohydrate
  conformation
• Development and evaluation of new methods and
  assays for product characterization

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Laboratory of Respiratory and Special Pathogens

• Areas of Research
• Studies of Bordetella pertussis, Bacillus
  anthracis, C. diptheriae and C. botulinum and
  Yersinia spp.
• Characterization of Virulence Factors and Studies
  on Mechanism of Action
• Studies on Regulation of Gene Expression
• Animal Models of Infection
• Identification and characterization of
  iron-regulated virulence factors
• Mechanism of toxin entry into nerve cells, toxin
  interaction with cellular components, and toxin
  persistence

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Laboratory of Methods Development and Quality
Control

• Research and Regulatory Activities
• Develop and evaluate
• Quality control methods for bacterial vaccines
• Assay methods for immune response measurement
• Animal models
• Bioassays for potency and toxicity
• Members are testing specialists
• Activities not restricted to single product area

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LABORATORY OF BACTERIAL POLYSACCHARIDES

• Areas of Research
• Characterization of polysaccharide conjugate
  vaccines
• Conformation of polysaccharide antigens
• Biosynthesis of capsular polysaccharides
• Role of Neisseria outer membrane proteins in
  disease
• Interaction of polysaccharides with the immune
  system

Neisseria
Oligosaccharide antigen
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The Laboratory of Mycobacterial Diseases and
Cellular Immunology

• Areas of Research
• Evaluation of protective innate and adaptive
  immune responses to intracellular bacteria
• Assessment of live attenuated TB vaccine strains
  and DNA vaccination strategies against
  tuberculosis
• Characterization of a unique family of
  tuberculosis proteins

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Laboratory of Immunobiochemistry
Allergen structure and function
Cockroach allergen standardization Microarray
method for potency determinations Determination
of optimal surrogate test Depletion analysis of
CR extracts
MDR proteins in T cell activation
Regulation of T cell responses by RSV
Extract potency determinations
Modifying allergic responses
Endotoxins and b-glucans in allergen extracts
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Laboratory of Enteric and Sexually Transmitted
Diseases

• Areas of Research
• Invasion mechanisms of enteric pathogens
• Genetic regulation of bacterial virulence genes
• Mucosal immunity, dosing and adjuvants
• Anthrax and Shigella - Genetic analysis and
  development of live attenuated Salmonella-vectored
  vaccines