The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers”.
The purpose of this workshop was to discuss the clinical and public health applications and performance validation of these devices, the quality criteria for establishing the accuracy of reference databases for regulatory use and ways to streamline clinical trials for microbial identification. This discussion was essential to establish the safety and effectiveness of high throughput sequencing devices when used to test human specimens or clinical isolates for the diagnosis of infectious diseases and detection of antimicrobial resistance markers.
- Date, Time and Location
- Federal Register Notice
- Discussion Paper
- Contact Us
This meeting was held April 1, 2014, beginning at 9:00 a.m. at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (the Great Room)
Silver Spring, MD, 20993
|Name of Speaker|
|9:00-9:05||Welcome||Uwe Scherf, PhD|
|9:05-9:15||OCET Welcoming Remarks||Rebecca S. Lipsitz, PhD|
|9:15-9:25||CDRH Welcoming Remarks||Alberto Gutierrez, PhD|
|9:25-9:45||Enabling Sequence-based Technologies for Diagnostics: FDAs Division of Microbiology Perspective.||John Hobson, PhD|
|10:00-10:25||Clinical Pathogen Genome Sequencing||Lynn Bry, MD, PhD|
|10:25-10:50||Current State of the Art for Reference Databases: Challenges and Feasibility Studies||Tom Slezak|
|11:00-11:25||NIAID Genomics and Bioinformatics Programs||Vivien Dugan, PhD|
|11:25-11:50||Pathogen Genomics at NCBI||David J Lipman, MD|
|11:50-12:00||Q&A (All Presentations)|
|13:00-14:15||Panel 1 – Clinical Applications:|
Lynn Bry MD PhD, Joseph Campos PhD, Lauren Cowan PhD, Eric Donaldson PhD, Brittany Goldberg MD, Duncan MacCannell PhD, Uwe Scherf PhD, Julie Segre PhD
|Steven Gitterman, MD|
|14:30-15:45||Panel 2 – Database/Informatics:|
Eric Brown PhD, Chris Detter PhD, Vivien Dugan PhD, John Hobson PhD, Arifa Khan PhD, David Lipman MD, Tom Slezak
|Tamara Feldblyum, PhD|
|15:45-16:30||Wrap-up/ Q&A||Uwe Scherf, PhD|
Registration is closed as of March 25, 2014. Onsite registration will be available the morning of April 1, 2014. 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 require special accommodations due to a disability, or need additional information regarding registration, please contact: Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, firstname.lastname@example.org.
For questions regarding workshop content please contact: Heike Sichtig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, Heike.Sichtig@fda.hhs.gov.