Monday, February 29, 2016

FDA Posts Video, Slides: Regulating NGS Cancer Panels, Feb 20, 2016

On February 25, 2016, FDA held a workshop on "Next Generation Sequencing-Based Oncology Panels," agency web page for this meeting, here.  The FDA posted an 8 page discussion paper for the meeting, here.

FDA also compiled the slide decks presented as one 200 page, 8 mb file (here).  The video webcast is archived on line (here).  Update: Unofficial transcript in the cloud, here.

The agency accepted written public comment until March 28, 2016.  The agenda is posted below the break.

For those with subscription, detailed coverage from Genomeweb of the 2016 workshop, here.  FDA personalized medicine leader Elizabeth Mansfield is quoted as stating: "We think panels are a really great way to move forward in oncology where you can get all the information you need out of one test … FDA actually supports this idea."  For additional subscription coverage, at Gray Sheet, here.

The conference follows last year's February 2015 workshop on NGS diagnostic tests in general (webpage here, which includes archival decks and transcript.)

Note: On a related topic, see the open access Goldfeder et al. article the same week in Genome Medicine on interlaboratory standards and accuracy of NGS (here).

Note: The FDA also held a workshop a few days later on "Patient and Medical Professional Perspectives on the Return of Genetic Test Results," March 2, 2016, here.


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
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
3:30–4:30Open 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

 Webcast Archive

Discussion Paper