Public
Event Title
Public Workshop - Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology, January 29, 2018
January 29, 2018
- Date:
- January 29, 2018
- Time:
-
03:30 AM - 12:00 PM EST
The Food and Drug Administration (FDA) announced a public Workshop entitled, "Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology." The goal of precision oncology is to use a cancer patient's genetic data to help determine which therapeutic(s) might be most effective in treating their disease. Next generation sequencing (NGS) is increasingly employed in oncology because the technology can be used to screen for a large number of mutations simultaneously to optimize and personalize patient care. The increasing number of reported mutations may lead to uncertainty for clinicians in the interpretation and prioritization of the variants with respect to the clinical significance and optimal course of action, respectively.
FDA held this public workshop to engage stakeholders and solicit input from experts in precision oncology to discuss how genetic sequencing data is best implemented in patient management so that innovative regulatory strategies can be advanced to support the development of safe and effective precision-based drugs and devices for marketing.
Date, Time and Location:
This meeting was held January 29, 2018 beginning at 8:30 a.m.-5:00 p.m. at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
The meeting was be webcast.
To request 508 compliant industry presentations please contact:
Gideon Blumenthal, M.D.. or Reena Philip, Ph.D.
Agenda
| Time | Subject | Speaker | Affiliation |
|---|---|---|---|
| 8:30-8:45 | Welcome and Introduction | Gideon Blumenthal, M.D. | Deputy Director (acting), Office of Hematology and Oncology Products FDA/CDER/OHOP |
| Reena Philip, Ph.D. | Division Director, Division of Molecular Genetics and Pathology FDA/CDRH/OIR/DMGP | ||
| 7:30-8:30 | Security Screening and Registration | ||
| 8:45-10:15 | Topic 1: Overview of the state of science for sequence variant classification in oncology and its practical use in treating patients | Moderator: Julia Beaver, M.D. | FDA/CDER/OHOP/DOP1 |
| Speakers/Panelists | Michael Berger, Ph.D. | Memorial Sloan Kettering | |
| John Deeken, M.D. | Inova Translational Medicine Institute | ||
| Vincent Miller, M.D. | Foundation Medicine, Inc. | ||
| 10:15-10:25 | Break | ||
| 10:25-11:55 | Topic 2: Levels of evidence required for reporting variants and guiding patient treatment | Moderator: Anand Pathak, M.D., Ph.D. | FDA/CDRH/OIR/DMGP |
| Speakers/Panelists | Sashikant Kulkarni, M.S., Ph.D., FACMG | Baylor College of Medicine | |
| Howard McLeod, PharmD, FCCP | Moffitt Cancer Center | ||
| Apostolia-Maria Tsimberidou, M.D., Ph.D. | MD Anderson | ||
| Neal Lindeman, M.D. | Association for Molecular Pathology | ||
| 11:55-1:05 | Lunch Break | ||
| 1:05-2:50 | Topic 3: Best practices for use of public/private databases for variant classification and interpretation in oncology | Moderator: Hisani Madison, Ph.D., M.P.H. | FDA/CDRH/OIR/DMGP |
| Speakers/Panelists | Heidi Rehm, Ph.D., FACMG | Harvard University | |
| Kenna Shaw, Ph.D. | AACR Project GENIE | ||
| Ben Park, M.D., Ph.D. | Johns Hopkins Kimmel Cancer Center | ||
| Karla R. Bowles, Ph.D., FACMG | Myriad Genetic Laboratories | ||
| 2:50-3:00 | Break | ||
| 3:00-4:30 | Topic 4: Future Directions for data sharing, standardization and establishing consistency in precision oncology | E. David Litwack, Ph.D. | FDA/CDRH/OIR |
| Speakers/Panelists | Dane Dickson, M.D. | CureOne | |
| Dennis Dean, Ph.D. | Seven Bridges Genomics | ||
| Robert Grossman, Ph.D. | University of Chicago | ||
| J. Leonard Lichtenfeld, M.D., MACP | American Cancer Society | ||
| 4:30-5:00 | Summary and Closing Remarks | Robert Schuck, Ph.D., Pharm.D. | FDA/CDER/OCP |
Webcast
Transcript
Contact Us
For questions regarding workshop content please contact:
Hisani Madison, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Room 5547, Silver Spring, MD 20993, 240-402-6581, hisani.madison@fda.hhs.gov.