Monday, April 11, 2016

FDA Announces July 19, 2016 Workshop on Liquid Biopsy Cancer Tests

Update (July 21, 2016)
A detailed subscription article on this conference is available at Genomeweb (here).

As a follow-on meeting to the FDA's February workshop on genome panel tests in tumors, the FDA has announced a workshop on liquid biopsies in oncology on Tuesday, July 19, 2016.

The FDA has posted the agenda here. ~~Registration is open.~~ The workshop will be held in Washington rather than on the FDA campus.

The FDA writes, "Lquid biopsy technologies are advancing quickly...are likely to be rapidly incorporated into clinical care."

The workshop is co-sponsored by the American Association for Cancer Research. Over the past year, the AACR has urged the FDA to regulate cancer LDT's as devices (here).

For a non official transcript of the February oncogene panel workshop, here.

Agenda clipped as of April 11, 2016:

Public Workshop – Liquid Biopsies in Oncology Drug and Device Development, an FDA-AACR public workshop, July 19, 2016

The Food and Drug Administration (FDA) and Co-sponsor American Association for Cancer Research (AACR) are announcing a public Workshop, Liquid Biopsies in Oncology Drug and Device Development. As a noninvasive method to detect genetic alterations in tumors, analysis of cell-free tumor DNA (cfDNA) in plasma holds much promise for improving cancer diagnosis and monitoring as well as drug development. Liquid biopsy technologies are advancing quickly. They are being incorporated into numerous drug development programs and are likely to be rapidly incorporated into clinical care.
The workshop will provide a forum to discuss relevant scientific advances in the field of liquid biopsies in oncology and a regulatory environment that will support rapid translation of this emerging technology into improved patient care. The workshop aims to: 1) provide a state of the science overview of liquid biopsies in oncology; 2) discuss the use of tumor-derived cfDNA in drug development and clinical use, focusing on the treatment of lung cancer as a case study; 3) discuss current approaches to validation of in vitro diagnostic devices (or tests); and 4) discuss with diverse stakeholders ways to accelerate development of these technologies to advance cancer care.

Date, Time and Location:

This meeting will be held July 19, 2016, beginning at 8:15 a.m. – 4:45 p.m. at the following location:
Walter E. Washington Convention Center
801 Mt. Vernon PL NW
Washington, DC. 20001

AGENDA

Time	Subject	Session Chair
8:15 AM	Welcome
8:30 – 9:50 AM	Cancer Liquid Biopsies: State of The Science	Julia Beaver, MD
10:20 AM – 12:00 PM	Liquid Biopsies in Lung Cancer Drug Development and Clinical Use	Pasi Jänne, MD, PhD
1:15 – 3:00 PM	Liquid Biopsy Test Development	Reena Philip, PhD
3:15 – 4:40 PM	Accelerating Liquid Biopsy Applications to Improve Patient Care	Gideon Blumenthal, MD
4:40 – 4:45 PM	Wrap up

Registration to Attend the Workshop:

If you wish to attend this Workshop, please visit AACR’s website using the website link below:
http://www.aacr.org/AdvocacyPolicy/GovernmentAffairs/Pages/FDA-AACR-liquid-biopsies-in-oncology-drug-and-device-development.aspx

Contact Us

For questions regarding workshop content please contact:
Pamela Bradley, Center for Devices and Radiological Health, Food and Drug Administration, [see original webpage for contact information].