Medical Devices

Public Workshop - Next Generation Sequencing-Based Oncology Panels, February 25, 2016

The Food and Drug Administration (FDA) announced the following public workshop entitled “Next Generation Sequencing-Based Oncology Panels.” The purpose of this workshop was to obtain feedback on analytical and clinical validation approaches for next generation sequencing (NGS)-based oncology panels. Comments and suggestions generated through this workshop will help guide the development of appropriate regulatory standards for evaluation of NGS-based oncology panels in cancer patient management.


Date, Time and Location

This meeting was held February 25, 2016, beginning at 8:30 am - 5:00 pm at the following location:

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

Webcast Archive

Discussion Paper

Agenda

TimeSubjectSpeakerAffiliation
7:30–8:30Security Screening and Registration
8:30–8:40Welcome and IntroductionElizabeth Mansfield, Ph.D.Deputy Office Director, Personalized Medicine, FDA/CDRH/OIR
8:40–9:00Meeting Overview of Goals and BackgroundReena Philip, Ph.D.Division Director, CDRH/OIR/DMGP
9:00–10:30Panel Discussion: Pre-Analytical Challenges and Quality ControlModerators: Eunice Lee, Ph.D. and Aaron Schetter, Ph.D.CDRH/OIR/DMGP
PanelistsDara Aisner, M.D., Ph.D.University of Colorado
John Pfeifer, M.D., Ph.D.Washington University
Rajyalakshmi Luthra, Ph.D.MD Anderson
Michael Berger, Ph.D.Memorial Sloan Kettering
Michael Rossi, Ph.D.Emory University
10:30–11:00Break
11:00–12:30Panel Discussion: Analytical ChallengesModerators: Donna Roscoe, Ph.D. and Jennifer Dickey, Ph.D.CDRH/OIR/DMGP/MGB
PanelistsRobert Klees, Ph.D.New York State Department of Health
Eliezer M. Van Allen, M.D.Dana Farber Cancer Institute
Madhuri Hegde, Ph.D.Emory University
David Eberhard, M.D., Ph.D.University of North Carolina
Josh Deignan, Ph.D.University of California Los Angeles
12:30–1:30Lunch Break
1:30–3:00Panel Discussion: Clinical ClaimsModerators: Abraham Tzou, M.D. and Sharon Liang, M.D., Ph.D. 
PanelistsJeffrey Sklar, M.D., Ph.D.Yale University
Dane Dickson, M.D.Med-C
Shashi Kulkarni, Ph.D.Washington University
Greta KruezPatient Advocate
Gideon Blumenthal, M.D.FDA/CDER
Apostolia-Maria Tsimberidou, M.D., Ph.D.MD Anderson
3:00–3:30Break
3:30–4:30Open Public CommentModerators: Anand Pathak, M.D., Ph.D., You Li, Ph.D., and Soma Ghosh, Ph.D. 
4:30–5:00Summary and Wrap UpYun-Fu Hu, Ph.D. and Reena Philip Ph.D.CDRH/OIR/DMGP

Registration to Attend the Workshop

Additional seating has become available,  so on-site registration will be held the morning of the workshop.  

Contact Us

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.

For questions regarding workshop content please contact:

Jennifer Dickey, Ph.D., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66 rm. 5648, Silver Spring, MD 20993, 301-796-5028, email: Jennifer.Dickey@fda.hhs.gov.

 

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