Medical Devices

Public Workshop - Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use, October 16, 2015

The Food and Drug Administration (FDA) announced a Public Workshop entitled “Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.” The purpose of this workshop was to receive input from stakeholders and discuss approaches to establish the performance of non-microbial biomarker assays for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis.


Date, Time and Location:

This meeting was held October 16, 2015 beginning at 8:00 a.m. to 5:00 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

FDA Campus Information (Airports, Directions, Lodging Accommodations, Public Transportation, etc.)

Webcast

Agenda

8:00 – 8:15 AMWelcome and Meeting GoalsAlberto Gutierrez, FDA
8:15 – 8:50 AMAcute Respiratory Illness from the Host PerspectiveEphraim Tsalik, Duke University
8:50 – 9:25 AMThe Immunology of Sepsis - the problem of sepsis and non-resolving inflammation/infectionSteven Opal, Brown University
9:25 – 10:05 AMFDA experience with clinical with trials for immune biomarkers for infection and sepsisSteven Gitterman, FDA
10:05 – 10:20 PMBreak 
10:20 – 10:40 AMPediatric Considerations for In Vitro Diagnostic Non-Microbial Biomarker TrialsBrittany Goldberg, FDA
10:40 – 11:05 AMOverview of Statistical ConsiderationsKevin Snyder, FDA
11:05 – 12:00 PMOpen Public Comment
(Registered speakers)
David Gilbert - Presentation
Eric Gluck - Presentation

Eliot Godofsky - Presentation
Luc Van Hove  - Presentation
Patrick Joseph - Presentation
Mark Miller
12:00 – 1:00 PMLunch break 
1:00 – 2:30 PMPanel Discussion: Issues regarding the study of non-microbial biomarkers for viral versus bacterial respiratory infection.
Moderator: Steven Gitterman, FDA
Paul G. Auwaerter, Johns Hopkins University
Sam Bozzette, BioMérieux
Angela Caliendo, Brown University
Greg Campbell, formerly FDA
Nathan Shapiro, Harvard University
Ephraim Tsalik, Duke University
Ronald Turner, University of Virginia
2:30 – 2:45 PMBreak 
2:45  – 4:15 PMPanel Discussion: Issues regarding the study of non-microbial biomarkers for sepsis. Moderator: Kristian Roth, FDAGreg Campbell, formerly FDA
Alan Cross, University of Maryland
Peter Eichacker, National Institutes of Health
Mary Catherine Harris, University of Pennsylvania
Henry Masur, National Institutes of Health
Richard L. Moore, Becton Dickinson
Steven Opal, Brown University
Hector Wong, University of Cincinnati
4:15 –  4:30 PMSummary and Wrap UpSteven Gitterman, FDA

Registration to Attend the Workshop:

As of October 6, 2015, electronic registration is now closed. On-site registration will be available the morning of the workshop.  For registration to view the webcast, please email Susan Monahan (susan.monahan@fda.hhs.gov) no later than October 15, 2015.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to make an oral presentation during the open comment session at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation. In order to keep the open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak. All requests to make oral presentations must be received by September 16, 2015. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by September 22, 2015.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

Contact

For questions regarding workshop content please contact:

Natasha Townsend, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66 Rm 5525, Silver Spring, MD 20993-0002, Tel. 301-796-5927, FAX: 301-847-2512, email: natasha.townsend@fda.hhs.gov.

Page Last Updated: 11/02/2015
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