FDA-IDSA Public Workshop: Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory Tract Infections, November 12-13, 2009

FDA announces a Public Workshop co-sponsored by the Food and Drug Administration (FDA) and the Infectious Diseases Society of America (IDSA) regarding scientific issues in the development of molecular and other tests for the diagnosis of respiratory infections. This FDA-IDSA Public Workshop titled "Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory Tract Infections" will be held November 12 - 13, 2009 at the Hilton Washington DC North/Gaithersburg, 620 Perry Parkway, Gaithersburg, Maryland.

Topics to be discussed include:

• Clinical Background and Perspective: E. Wald, A. Pavia, S. Sethi, J. Bartlett
• Regulatory Background: S. Hojvat, K. Whitaker, E. Russek-Cohen
• Technical Background and Laboratory Perspective: C. Ginocchio, A. Caliendo, B. Beall
• Industry Perspective: R. Janeczko, F. Tenover
• Biomarker Development: D. Gilbert, S. Mandrekar, C. Fowler
• Influence of Rapid Molecular Diagnostics: L. Rice, S. Dorman, M. Kurilla
• Clinical Trial Design: R. Becker, K. Meier, T. Grewing
• Use of Molecular Diagnostics to Detect Pathogen Resistance: L. Peterson, R. Bonomo
• Group Discussion: E. Cox, W. Koch, M. Metersky, F. Nolte, J. Rex, D. Talan (partial list)
• Co-Chairs: John Bartlett, David Gilbert, Sally Hojvat
• Rapporteur: Brad Spellberg

For additional information, please email respdiagmtg@fda.hhs.gov or call 301-796-5711. Registration is free. To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax numbers) to respdiagmtg@fda.hhs.gov by November 8, 2009. Persons without access to the Internet can call 301-796-5711 to register. Interested parties are encouraged to register early because space is limited. Seating will be available on a first-come, first-served basis. Persons needing a sign language interpreter or other special accommodations should notify Christine Kellerman at 301-796-5711 at least 7 days in advance.