Workshop

Event Title

Public Workshop - Detecting Circulating Tumor DNA for Cancer Screening

March 9, 2020

Date:: March 9, 2020
Time:: 9:00 AM - 5:00 PM ET
Location:: Event Location

White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States

Organized By:: Organizer

Center for Devices and Radiological Health

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Detecting Circulating Tumor DNA for Cancer Screening." The purpose of the workshop is to bring together experts from several disciplines and across multiple sectors to discuss the appropriate study designs needed to demonstrate the safety and effectiveness of cancer screening tests and to support claims of cancer screening. The goal is to discuss the clinical, scientific, and regulatory challenges associated with the development of Circulating Tumor DNA (ctDNA) based cancer screening tests.

INTRODUCTION

All cells have a finite lifetime. After cell death, many types of cells release their interior contents into the bloodstream for subsequent degradation, including their DNA. This process also applies to many types of cancer cells, which carry unique DNA variants not present in normal cells. Recent advances in the technology to isolate ctDNA from blood samples, coupled with advances in the ability to detect these unique cancer-specific variants, have fueled the development of cancer screening tests using ctDNA in asymptomatic subjects. At this time, FDA would like to discuss the optimal regulatory approach for this developing technology given that there are several clinical and scientific challenges associated with these screening tests. Such challenges include the ideal clinical study design to determine the requisite level of sensitivity and specificity for these tests and the data needed to assess whether the benefits of such tests outweigh the risks.

DATE, TIME and LOCATION

This public workshop will be held March 9, 2020, from 9:00 a.m. to 5:00 p.m. (EST) at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

FDA Campus Information, (e.g., local airports, directions, local hotels, etc.)

WEBCAST

Webcast Link

AGENDA

The following public meeting draft Agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

Time	Subject
8:00 – 9:00	Security Screening and Registration
9:00 – 9:15	Welcome and Introduction Timothy Stenzel, MD, PhD Director, Office of In Vitro Diagnostics and Radiological Health FDA/CDRH/OPEQ/OHT7 Reena Philip, PhD Division Director, Division of Molecular Genetics and Pathology FDA/CDRH/OPEQ/OHT7/DMGP
9:15 – 10:45	Session 1: State of the Science: Technical Considerations and Translation of Results into Clinical Actionability Moderators: Soma Ghosh, PhD Branch Chief, Division of Molecular Genetics and Pathology Abde Abukhdeir, PhD Scientific Reviewer, Division of Molecular Genetics and Pathology FDA/CDRH/OPEQ/OHT7/DMGP Panelists: Sudhir Srivastava, PhD, MPH National Cancer Institute Chyke Doubeni, MBBS, MPH Mayo Clinic Stephen Gruber, MD, MPH, PhD City of Hope Daniel Hayes, MD University of Michigan Chetan Bettegowda, MD, PhD Johns Hopkins University
10:45 – 10:55	Break
10:55 – 12:25	Session 2: Clinical Validation for Single Cancer Screening Tests vs. Multi-Cancer Tests Moderators: Jeffrey Seidman, MD Medical Officer, Division of Molecular Genetics and Pathology FDA/CDRH/OPEQ/OHT7/DMGP Anand Pathak, MD, PhD, MPH Medical Officer, Division of Molecular Genetics and Pathology FDA/CDRH/OPEQ/OHT7/DMGP Prakash Jha, MD Medical Officer, Division of Molecular Genetics and Pathology FDA/CDRH/OPEQ/OHT7/DMGP Panelists: Barry Kramer, PhD Scientific Consultant to the Division of Cancer Control and Population Sciences, NCI Barbara McAneny, MD New Mexico Oncology Hematology Consultants, Ltd. Geoffrey Oxnard, MD Dana-Farber Cancer Institute Julia Beaver, MD US Food and Drug Administration CDER/OND/OHOP/DOPI
12:25 – 1:35	Lunch Break
1:35 – 2:20	Session 3: Public Comment Moderator: Pam Gallagher, PhD Scientific Reviewer, Division of Molecular Genetics and Pathology FDA/CDRH/OPEQ/OHT7/DMGP
2:20 – 3:50	Session 4: Clinical Study Design Considerations Moderators: Wei Wang, PhD Mathematical Statistician, Biostatistics Team IV FDA/CDRH/OPEQ/OCEA/DCEAII Erik Bloomquist, PhD Team Lead, Division of Biometrics V FDA/CDER/OTS/OB/DBV Anand Pathak, MD, PhD, MPH Medical Officer, Division of Molecular Genetics and Pathology FDA/CDRH/OPEQ/OHT7/DMGP Panelists: Colin Begg, PhD Memorial Sloan Kettering Cancer Center Donald Berry, PhD Berry Consultants Steven Skates, PhD Massachusetts General Hospital Chyke Doubeni, MBBS, MPH Mayo Clinic Constantine Gatsonis, PhD Brown University Gene Pennello, PhD US Food and Drug Administration CDRH/OSEL/DIDSR
3:50 – 4:00	Closing Remarks Reena Philip, PhD Division Director, Division of Molecular Genetics and Pathology FDA/CDRH/OPEQ/OHT7/DMGP

REGISTRATION

Online registration is closed. Onsite registraton will be available beginning at 8:00 am the morning of the workshop.

There is no fee to register for the Workshop. Early registration is recommended because seating is limited. Registration will be on a first-come, first-served basis.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32 - Room 5255, Silver Spring, MD 20993, 301-796-5661, [email protected].

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov, Docket No. FDA-2020-N-0708 by April 6, 2020.

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.

The meeting transcript will be posted to the Docket as soon as it is available, and accessible at http://www.regulations.gov.

CONTACT

For questions regarding workshop content please contact:

Abdelrahmman (Abde) Abukhdeir
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, Rm. 3302
Silver Spring, MD 20993
240-402-6482
[email protected]

Event Materials

Title	File Type/Size
Instructions for Submitting Comments - DNA Cancer Screenings Workshop	pdf (25.88 KB)
Transcript for DNA CANCER SCREENING	pdf (831.89 KB)