​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​FDA-AACR Regulatory Science and Policy Workshop 

FDA-AACR: Liquid Biopsies in Oncology Drug and Device Development Part II

Date: Oct. 10, 2017.

Slides and other materials from this workshop will be posted here in a few weeks. Only slides from presenters who have given permission will be included. Some presenters have opted not to have their slides posted.

Transcripts: Session 1. Session 2. Session 3. Session 4.

Videos: Session 1. Session 2. Session 3. Session 4.

Slides: All sessions.

Purpose: As a noninvasive method to detect genetic alterations in tumors, analysis of tumor-derived cell-free DNA (cfDNA) in plasma holds much promise for improving cancer diagnosis and monitoring as well as drug development. This technology is advancing quickly, being incorporated into numerous drug development programs, and likely to be rapidly incorporated into clinical care.

Theme: Technology has evolved to enable the development of tests that can detect signs of cancer in blood and other bio-fluids. Although liquid biopsies are an exciting development, this technology presents with a set of unique regulatory concerns, particularly in establishing analytic and clinical validity. This session will build upon a July 2016 U.S. Food and Drug Administration-AACR co-sponsored workshop on liquid biopsies and will examine the regulatory challenges in adopting this technology for early detection, disease monitoring, and the potential use as surrogate end point markers for drug development.

SESSION I: Cancer Liquid Biopsies: State of the Science

SESSION II: Liquid Biopsies for Early Detection

SESSION III: Liquid Biopsies in Cancer Drug Development and Clinical Use

SESSION IV: Liquid Biopsy Test Development

See the agenda. Read the speaker bios.

Workshop Co-chairs:

  • AACR:
    • Carlos L. Arteaga, MD, AACR president, 2014-2015; director, Harold C. Simmons Comprehensive Cancer Ctr., UT Southwestern Medical Ctr.
    • Pasi A. Jänne, MD, PhD, AACR Regulatory Science and Policy Subcommittee member; 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
  • FDA:
    • Julia Beaver, MD, director (acting), Division of Oncology Products 1, Office of Hematology and Oncology (OHOP), Center for Drug Evaluation and Research (CDER), FDA
    • Gideon Blumenthal, MD, deputy director (acting), Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER), FDA
    • Reena Philip, PhD, director, Division of Molecular Genetics and Pathology (DMGP), Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices and Radiological Health (CDRH), FDA