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.
Agenda
- Presentation Slides (PDF - 8.7MB)
| Time | Subject | Speaker | Affiliation |
|---|---|---|---|
| 7:30–8:30 | Security Screening and Registration | ||
| 8:30–8:40 | Welcome and Introduction | Elizabeth Mansfield, Ph.D. | Deputy Office Director, Personalized Medicine, FDA/CDRH/OIR |
| 8:40–9:00 | Meeting Overview of Goals and Background | Reena Philip, Ph.D. | Division Director, CDRH/OIR/DMGP |
| 9:00–10:30 | Panel Discussion: Pre-Analytical Challenges and Quality Control | Moderators: Eunice Lee, Ph.D. and Aaron Schetter, Ph.D. | CDRH/OIR/DMGP |
| Panelists | Dara 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 | ||
| 10:30–11:00 | Break | ||
| 11:00–12:30 | Panel Discussion: Analytical Challenges | Moderators: Donna Roscoe, Ph.D. and Jennifer Dickey, Ph.D. | CDRH/OIR/DMGP/MGB |
| Panelists | Robert 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 | ||
| 12:30–1:30 | Lunch Break | ||
| 1:30–3:00 | Panel Discussion: Clinical Claims | Moderators: Abraham Tzou, M.D. and Sharon Liang, M.D., Ph.D. | |
| Panelists | Jeffrey Sklar, M.D., Ph.D. | Yale University | |
| Dane Dickson, M.D. | Med-C | ||
| Shashi Kulkarni, Ph.D. | Washington University | ||
| Greta Kruez | Patient Advocate | ||
| Gideon Blumenthal, M.D. | FDA/CDER | ||
| Apostolia-Maria Tsimberidou, M.D., Ph.D. | MD Anderson | ||
| 3:00–3:30 | Break | ||
| 3:30–4:30 | Open Public Comment | Moderators: Anand Pathak, M.D., Ph.D., You Li, Ph.D., and Soma Ghosh, Ph.D. | |
| 4:30–5:00 | Summary and Wrap Up | Yun-Fu Hu, Ph.D. and Reena Philip Ph.D. | CDRH/OIR/DMGP |
Webcast Archive
Discussion Paper
- Discussion Paper for Workshop (PDF - 325KB)
