FDA-AACR: Liquid Biopsies in Oncology Drug and Device Development
July 19, 2016 | 8:15 a.m. - 5 p.m.
Walter E. Washington Convention Center, Washington, D.C.
Co-sponsored by the FDA and the AACR
Slide/audio recordings and transcripts are now available.
The analysis of tumor-derived cell-free DNA (cfDNA) in plasma, a noninvasive method for detecting genetic alterations in tumors, holds considerable promise both for improving cancer diagnoses and monitoring and in drug development. This technology is advancing quickly, is being incorporated into numerous drug development programs, and is likely to be rapidly integrated into clinical care.
The purpose of this workshop was to provide a forum for the discussion of relevant scientific advances in the field of liquid biopsies and of the regulatory environment that will support the translation of this emerging technology into improved patient care. After reviewing the current state of science in the broader field, the meeting focused on the application of cfDNA technologies for lung cancer, as these areas are accelerating rapidly towards clinical use.
View/download presentation slides
Slide/audio recording - Session 1
Slide/audio recording - Session 2
Slide/audio recording - Session 2 Panel Discussion
Slide/audio recording - Case Study
Slide/audio recording - Session 3
Slide/audio recording - Session 3 Panel Discussion
Slide/audio recording - Session 4
Slide/audio recording - Session 4 Panel Discussion
Gideon Blumenthal, MD, clinical team leader, Thoracic and Head/Neck Oncology, Office of Hematology and Oncology, Center for Drug Evaluation and Research, FDA
Pasi Jänne, MD, PhD, director, Lowe Center for Thoracic Oncology; scientific director, Belfer Institute for Applied Cancer Science; senior physician, Dana Farber Cancer Institute, and
professor of medicine, Harvard Medical School
Reena Philip, PhD, director, Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, FDA
Session I – Cancer Liquid Biopsies: State of the Science
Session II – Liquid Biopsies in Lung Cancer Drug Development and Clinical Use
Session III – Liquid Biopsy Test Development
Session IV – Accelerating Liquid Biopsy Applications to Improve Patient Care
View speaker/panelist bios.
Anna Sadusky, PhD
Associate Director for Regulatory Science and Policy