Medical Devices

Public Workshop – Proteomics in the Clinic, June 13, 2014

The Food and Drug Administration (FDA) announced a public Workshop entitled: “Proteomics in the Clinic”. The topic discussed was the state of the art and challenges surrounding validation of proteomic methodologies for in vitro diagnostic tests.


Date, Time and Location:

This meeting was held June 13, 2014, beginning at 8:30 a.m. (EDT) at the following location:

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

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Agenda

TimeSubjectName of Speaker
8:30-8:35WelcomeAlberto Gutierrez (FDA)
8:35-8:50IntroductionJulia Lathrop (FDA)
8:50-9:15Prioritizing our Validation EffortsAndy Hoofnagle (UWashington)
9:15-9:35Development of omics-based tests for clinical use:  the challenge of achieving statistical robustness and clinical utilityLisa McShane (NCI)
9:35-9:55BREAK 
9:55-10:15Validation of Assays for the Clinical Diagnostics LabRussell Grant (Labcorp)
10:15-10:45Questions for all speakers and BREAK 
10:45-12:30Community Initiatives Overview  
10:45-11:00NCI-Clinical Proteomic Tumor Analysis Consortium: Building A Standardized Proteogenomic Pipeline for Understanding Cancer BiologyEmily Boja (NCI)
11:00-11:15Translating Proteomics in Diabetes and Metabolic Diseases at the NIDDKSalvatore Sechi (NIDDK)
11:15-11:30Development and Usage of Reference Materials for Proteomics ResearchKaren Phinney (NIST)
11:30-11:45Human Proteome Organization InitiativesMaria Chan (FDA)
11:45-12:00Questions for all speakers 
12:00-12:45LUNCH 
12:45-13:10Working with FDA: Experiences in a Mock 510k Submission ProcessLeigh Anderson (SISPCAPA)
13:10-13:30Successful Validation and Clearance of MALDI-ToF MS for Microorganism identificationYvonne Shea (FDA)
13:30-15:00Clinical study design
Clinical and analytical issues related to assays producing a single score
Abraham Tzou (FDA) and Marina Kondratovich (FDA)
15:00-15:15BREAK 
15:15-16:45Points for Discussion for Proteomic TechnologiesJulia Lathrop
16:45-17:00Wrap upMaria Chan

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Transcript

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Webcast

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Contact Us

For questions regarding workshop content please contact:

Julia Tait Lathrop, Center for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66 Rm. 5534, Silver Spring, MD 20993, Tel: 240-402-5034, Email: julia.lathrop@fda.hhs.gov

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Page Last Updated: 07/29/2014
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