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June 7, 2010 TB Public Workshop Slides, Video and Transcript


Advancing the Development of Diagnostic Tests 
and Biomarkers for Tuberculosis


Sponsored by FDA, CDC, and NIAID 

June 7-8, 2010, National Labor College, Silver Spring, Maryland 20903


For the workshop slides go to the docket at http://www.regulations.gov
Document Type: Select 'Other'. Keyword or ID: FDA-2010-N-0156 

Workshop Transcript

Workshop Videos are posted below:

June 7, 2010 Morning session

June 7, 2010 Afternoon Session

June 8, 2010 Morning Session 

June 8, 2010 Afternoon Session

June 8, 2010 Afternoon Summation

Please note that the slider control when starting the web cast video allows fast-forwarding to specific times within each presentation.  

The Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and National Institute of Allergy and Infectious Diseases (NIAID) jointly sponsored a workshop that addressed 2009 Federal Tuberculosis Task Force recommendations to develop strategies for expedited discovery, evaluation, and implementation of new rapid methods for laboratory confirmation of Tuberculosis (TB) and identification of drug resistant TB. 

These recommendations were made in response to the current need for validated diagnostic tests and biomarkers that address critical issues in TB research, clinical care, and control, including:

  • The detection of pulmonary TB in adults and presence of resistance mutations
  • The detection of extrapulmonary TB
  • Predicting possible relapse during or following treatment of TB
  • Predicting vaccine efficacy
  • The detection of latent TB infection


Discussion topics included: 

  • Background, Current Research, and Barriers: P. Della-Latta , R. Chaisson, J. Belisle, M. Giovanni
  • Regulatory Perspectives on the Development of New TB Diagnostics: S. Hojvat, M. Powell
  • Resources for Developing New TB Diagnostics: B. Mulach, J. Gheuens, B. Nikolic, S. Dorman, J. Ellner, A. Luetkemeyer
  • Components of/requirements for a TB Repository: A. Ramsay, M. Guillerm, D. Dixon
  • Perspective on the Development of TB Diagnostics and Biomarkers: V. Jonas, D. Persing, D. McNeely, M. Perkins, P. Small
  • Panel Discussion: M. Spigelman, P. Small, M. Perkins,  (partial list)  

Conveners: Leonard Sacks (FDA), Bonnie Plikaytis, (CDC), and Christine Sizemore (NIAID)