The Food and Drug Administration (FDA) is announcing a public workshop to provide a forum to discuss whether currently available information support the use of the biomarker minimal residual disease (MRD) in Acute Myeloid Leukemia (AML) as a surrogate endpoint in evaluating new drugs for the treatment of the disease.
Date: March 4, 2013
Time: 8:00 a.m. to 4:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Avenue,
Bldg. 31, Room 1503
Silver Spring, Maryland 20993
- Federal Register Notice
- Agenda (PDF - 16KB)
- Meeting Roster (PDF - 29KB)
- Transcript: Monday, March 4, 2013 (PDF - 532KB)
Meeting Information on MRD in ALL held on April 18, 2012
- Public Workshop on Minimal Residual Disease (http://www.fda.gov/Drugs/NewsEvents/ucm294931.htm)
Webcast of the Meeting
For those unable to attend in person, the meeting will also be webcast. Watch the webcast on February 27, 2013 from 8:00 am to 4:00 pm. Requirements and instructions for accessing the webcast are below.
You may access the webcast via this link:
Adobe Connect Minimum Requirements:
- View meetings on Windows, Macs, Unix, and Linux platforms
- Lan or Broadband internet connection
- Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL
- Adobe Flash Player (no other downloads needed)
- VPN and Parachute compatible but not required
- Test my computer for Adobe Connect-Readiness
All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB) for directions and further details about transportation and lodging.
Here is a map of the campus Map of White Oak Visitor Parking (PDF - 105KB)
Lunch and Refreshments
Coffee, water, and light snacks will be available for a nominal fee starting at 7:15 a.m., again at 9:45, and for a final time at 2:20 p.m.
Salads and sandwiches will also be available for purchase during the lunch break at 12:05.
There is no registration fee for the public workshop. To register electronically, please use the following website:
For Further Information Contact
Christine Lincoln, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-796-4117, Christine.Lincoln@fda.hhs.gov
Clara Bloomfield, M.D. and Gregory Reaman, M.D.(PDF - 39KB) [ARCHIVED] Albert Deisseroth, OMPT(PDF - 96KB) [ARCHIVED] David Grimwade(PDF - 1.3MB) [ARCHIVED]
- David Grimwade (WT1) (PDF - 769KB) [ARCHIVED]
Michael Heuser(PDF - 455KB) [ARCHIVED] Peter Hokland(PDF - 1.1MB) [ARCHIVED] Peter Hokland (MRD)(PDF - 298KB) [ARCHIVED] Michael R. Loken and Children's Oncology Group(PDF - 6.4MB) [ARCHIVED] Elizabeth Mansfield, Ph.D.(PDF - 157KB) [ARCHIVED] Mark D. Rothmann(PDF - 129KB) [ARCHIVED] Adriano Venditti(PDF - 1MB) [ARCHIVED] Discussion Points, AML Workshop(PDF - 37KB) [ARCHIVED]