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Biodefense

NIAID Sponsored Workshop:
Aerosol Challenge Technology and Applications in Biodefense

December 3-4, 2003
Bethesda Hyatt

Introduction

Aerosol challenge technology is crucial to animal models for development of new Biodefense vaccines, diagnostics and therapeutics, the ultimate goal of NIAID's Biodefense Research Agenda. Understanding of this highly specialized technology is vital for regulatory acceptance of animal model data under the Animal Efficacy Rule or accelerated approval mechanisms, expected to see wide use for Biodefense product labeling. Harmonization of methods is also critical for model validation from institution to institution. Expansion of research resources in NIAID’s Biodefense program will increase our capacity to test and evaluate new therapeutics and vaccines, and we have a unique opportunity to grow the field with this meeting, by contributing to technological harmonization. The purpose of this meeting is to bring together experts in the field of aerosol challenge biology with NIAID contractors and grantees, as well as other government agencies that have a vested interest in this technology and ultimately testing, evaluation and licensure of new vaccines and therapeutics. This meeting was by invitation only, though it is anticipated that it will grow in future years into an open meeting that will also focus on animal models.

Agenda and Slides

December 3, 2003SessionSpeaker Topic
7:00 - 8:00 Continental Breakfast and Registration 
8:00 - 8:15 OpeningErnie Takafuji, OBRA/DMID/NIAIDOpening Remarks
8:15 - 8:45

USAMRIID
Aerobiology 101

Louise Pitt, USAMRIIDOverview: Brief history, aerosol exposures; Equipment in use; Animals in use; Video of full procedure; Class III cabinets; Plethysmography equipment
(PDF 2,773 KB)
8:45 - 9:00  Chad Roy, USAMRIIDAerosol generation: Overview of generation technologies; Collison nebulizer; BANG vs. Collison; Viability
(PDF 1,318 KB)
9:00 - 9:15  Chad Roy/Justin Hartings, USAMRIIDSampling: Methods of sampling (impinger, filter, etc.); Particle sizing; 'spray factor' 
(PDF 1,711 KB)
9:15 - 9:45  Justin Hartings, USAMRIIDEmerging Technology: Genesis of the automated system; Potential applications; GLP aspects
(PDF 1,471 KB)
9:45 - 10:00  
Break
 

10:00 - 10:15

 Chad Roy/Justin Hartings, USAMRIIDDose: How is dose defined; Calculations
(PDF 337 KB)
10:15 - 10:45 Louise Pitt/Chad Roy USAMRIIDExamples: Y. pestis; B. anthracis; SEB
(PDF 337 KB)
10:45 - 11:30SafetyManuel BarbeitoBiosafety
(PDF 245 KB)
11:30 - 1:00  
Lunch
 
1:00 - 1:45 Primate Challenges Microbiological Aerosol Challenges at Dstl Porton Down
1:45 - 2:10   Aerosol Challenge of Primates
2:10 - 3:00  Roy Barnewall, BattelleInhalation Exposure System and Non-Human Primates
(PDF 1,304 KB)
3:00 - 3:15 
Break
 
3:15 - 3:45 Anthrax Aerosol Application Nina Marano, CDC

CDC Anthrax Vaccine Research Program (AVRP)
(PDF 175 KB)

3:45 - 4:15  Brian Plikaytis, CDCStatistical Issues Related to AVA Vaccine Evaluation: Correlates of Protection
(PDF 156 KB)
4:15 - 5:00  Pat Fellows, Southern Research InstituteSpore Lot Consistency, Points to Ponder
(PDF 2,344KB)
5:15 - 6:15  

Networking Reception
(Cash Bar)

 

 

December 3,
2003
SessionSpeaker Topic
7:00 - 8:00 
Continental Breakfast and Registration
 
8:00 - 8:45Small Animal TB ChallengesHardy Kornfeld, U Mass.Technical and Safety Considerations for TB Challenges in Mice
(PDF 1,649 KB)
8:45 - 9:30

 

David McMurray, Texas A&MPulmonary Delivery of Mycobacteria and Other Respiratory Pathogens to Small Animals in a Specially-Designed Aerosol Chamber
(PDF 2,831 KB)
9:30 - 10:15 Laura Via, TRS/DIR/NIAIDAerosol delivery of MTB and Chemotherapeutics: Pitfalls and Plans
(PDF 959 KB)
10:15 - 10:30 
Break
 
10:30 - 11:00 Regulatory Aspects Karen Goldenthal, CBER/FDAAnimal Rule / Biologics
(PDF 48 KB)
11:00 - 11:30 Lew Schrager, CDER/FDAAnimal Rule / Therapeutics
(PDF 157 KB)
11:30 - 1:00 
Lunch
 
1:00 - 1:45 Facility Facility Design, Reconciling the User Needs with the Regulatory Requirements
1:45 - 2:30  Performance and Safety Validation of Aerosol Infection Equipment
2:30 - 3:15Small Animal BioD ChallengesRick Lyons, UNMLung Biodefense
(PDF 1,532 KB)
3:15- 3:30 
Break
 
3:30 - 4:00 Pratim Biswas, Wash. UDesign of Exposure System Chambers and Bioagent Inactivation Devices: Aerosol Generation, Measurement and Characterization
(PDF 3,433KB)
4:00 - 4:30 Mark Buller, St. Louis URespiratory Challenge Models for Efficacy Testing of Therapeutics and Vaccines Against Smallpox
(PDF 693 KB)
4:30 - 5:15  Wangxue Chen, NRC CanadaMurine model of nose-only small particle aerosol infection with virulent Francisella tularensis: Technical aspects and considerations 
(PDF 2,583 KB)
5:15  
Closing
Closing Remarks
(PDF 656 KB)

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