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, 2003 | Session | Speaker | Topic |
---|
7:00 - 8:00 | | Continental Breakfast and Registration | |
8:00 - 8:15 | Opening | Ernie Takafuji, OBRA/DMID/NIAID | Opening Remarks |
8:15 - 8:45 | USAMRIID Aerobiology 101 | Louise Pitt, USAMRIID | Overview: 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, USAMRIID | Aerosol generation: Overview of generation technologies; Collison nebulizer; BANG vs. Collison; Viability (PDF 1,318 KB) |
9:00 - 9:15 | | Chad Roy/Justin Hartings, USAMRIID | Sampling: Methods of sampling (impinger, filter, etc.); Particle sizing; 'spray factor' (PDF 1,711 KB) |
9:15 - 9:45 | | Justin Hartings, USAMRIID | Emerging 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, USAMRIID | Dose: How is dose defined; Calculations (PDF 337 KB) |
10:15 - 10:45 | | Louise Pitt/Chad Roy USAMRIID | Examples: Y. pestis; B. anthracis; SEB (PDF 337 KB) |
10:45 - 11:30 | Safety | Manuel Barbeito | Biosafety (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, Battelle | Inhalation 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, CDC | Statistical Issues Related to AVA Vaccine Evaluation: Correlates of Protection (PDF 156 KB) |
4:15 - 5:00 | | Pat Fellows, Southern Research Institute | Spore Lot Consistency, Points to Ponder (PDF 2,344KB) |
5:15 - 6:15 | | Networking Reception (Cash Bar) | |
December 3, 2003 | Session | Speaker | Topic |
---|
7:00 - 8:00 | | Continental Breakfast and Registration | |
8:00 - 8:45 | Small Animal TB Challenges | Hardy Kornfeld, U Mass. | Technical and Safety Considerations for TB Challenges in Mice (PDF 1,649 KB) |
8:45 - 9:30 | | David McMurray, Texas A&M | Pulmonary 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/NIAID | Aerosol 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/FDA | Animal Rule / Biologics (PDF 48 KB) |
11:00 - 11:30 | | Lew Schrager, CDER/FDA | Animal 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 - 3:15 | Small Animal BioD Challenges | Rick Lyons, UNM | Lung Biodefense (PDF 1,532 KB) |
3:15- 3:30 | | Break | |
3:30 - 4:00 | | Pratim Biswas, Wash. U | Design of Exposure System Chambers and Bioagent Inactivation Devices: Aerosol Generation, Measurement and Characterization (PDF 3,433KB) |
4:00 - 4:30 | | Mark Buller, St. Louis U | Respiratory Challenge Models for Efficacy Testing of Therapeutics and Vaccines Against Smallpox (PDF 693 KB) |
4:30 - 5:15 | | Wangxue Chen, NRC Canada | Murine 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) |
back to top