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  5. Public Workshop - Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology, January 29, 2018
  1. Workshops & Conferences (Medical Devices)


Event Title
Public Workshop - Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology, January 29, 2018
January 29, 2018

January 29, 2018
3:30 AM - 12:00 PM ET

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.


8:30-8:45Welcome and IntroductionGideon 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
7:30-8:30Security Screening and Registration
8:45-10:15Topic 1: Overview of the state of science for sequence variant classification in oncology and its practical use in treating patientsModerator: Julia Beaver, M.D.FDA/CDER/OHOP/DOP1
Speakers/PanelistsMichael Berger, Ph.D.Memorial Sloan Kettering
John Deeken, M.D.Inova Translational Medicine Institute
Vincent Miller, M.D.Foundation Medicine, Inc.
10:25-11:55Topic 2: Levels of evidence required for reporting variants and guiding patient treatmentModerator: Anand Pathak, M.D., Ph.D.FDA/CDRH/OIR/DMGP
Speakers/PanelistsSashikant Kulkarni, M.S., Ph.D., FACMGBaylor College of Medicine
Howard McLeod, PharmD, FCCPMoffitt Cancer Center
Apostolia-Maria Tsimberidou, M.D., Ph.D.MD Anderson
Neal Lindeman, M.D.Association for Molecular Pathology
11:55-1:05Lunch Break
1:05-2:50Topic 3: Best practices for use of public/private databases for variant classification and interpretation in oncologyModerator: Hisani Madison, Ph.D., M.P.H.FDA/CDRH/OIR/DMGP
Speakers/PanelistsHeidi Rehm, Ph.D., FACMGHarvard University
Kenna Shaw, Ph.D.AACR Project GENIE
Ben Park, M.D., Ph.D.Johns Hopkins Kimmel Cancer Center
Karla R. Bowles, Ph.D., FACMGMyriad Genetic Laboratories
3:00-4:30Topic 4: Future Directions for data sharing, standardization and establishing consistency in precision oncologyE. David Litwack, Ph.D.FDA/CDRH/OIR
Speakers/PanelistsDane Dickson, M.D.CureOne
Dennis Dean, Ph.D.Seven Bridges Genomics
Robert Grossman, Ph.D.University of Chicago
J. Leonard Lichtenfeld, M.D., MACPAmerican Cancer Society
4:30-5:00Summary and Closing RemarksRobert Schuck, Ph.D., Pharm.D.FDA/CDER/OCP



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.

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