Drugs
Public Workshop on Minimal Residual Disease
The Food and Drug Administration (FDA) is announcing a public workshop to provide a forum for discussion of the use of minimal residual disease (MRD) as a biomarker for evaluating new drugs for the treatment of Acute Lymphoblastic Leukemia (ALL). The meeting is cosponsored with the American Society of Clinical Oncology and will be the first in a series of workshops intended to bring together scientific and advocacy communities and the pharmaceutical and in vitro diagnostic device industries to help develop processes and procedures to qualify MRD as a biomarker of efficacy and/or response to treatment in a group of hematological malignancies.
Date: April 18, 2012 Time: 8:00 am to 4:00pm Location: FDA White Oak Campus
10903 New Hampshire Avenue
Bldg 31, Room 1503
Silver Spring, Maryland 20993
- Federal Register Notice
- Agenda (PDF - 77KB)
- Briefing Document (PDF - 122KB)
- Meeting Roster (PDF - 41KB)
- Transcript: Wednesday, April 18, 2013 (PDF - 526KB)
Presentations
Minimal Residual Disease (MRD) in Acute Lymphoblastic Leukemia (ALL) (PDF - 162KB)Gregory Reaman, MD Clinical Benefit for New Drug Approvals (PDF - 360KB)Albert Deisseroth, MD, PhD In vitro Diagnostics- Role in Efficacy Biomarker Assessment (PDF - 199KB)Elizabeth Mansfield, PhD Biomarkers, Surrogates & Qualification (PDF - 182KB)Marc K Walton MD, PhD Presentation (PDF - 8KB)Nicola Gökbuget, MD Relapsed ALL: Does End-Induction MRD Predict 1 yr or 2 yr EFS ? (PDF - 276KB)Elizabeth A. Raetz, MD & William L. Carroll, MD MRD as a Surrogate Endpoint for Efficacy Evaluation of New Drugs in Very High Risk ALL: Lessons from Ph+ ALL (PDF - 194KB)Stephen P. Hunger, MD Surrogate Endpoints (PDF - 48KB)Mark Rothmann Minimal Residual Disease (MRD) as a Surrogate Enpoint in Acute Lymphoblastic Leukemia (ALL) Workshop (PDF - 91KB)Maria Grazia Valsecchi Minimal Residual Disease (MRD) as a Surrogate Endpoint in Acute Lymphoblastic Leukemia (ALL) Meenakshi Devidas (PDF - 84KB)Meenakshi Devidas Minimal residual disease in acute lymphoblastic leukemia (PDF - 920KB)J.J.M. van Dongen Flow Cytometric Assessment of MRD (PDF - 4.9MB)Brent Wood MD, PhD Comparison of flow cytometric and molecular monitoring of MRD in pediatric ALL (PDF - 1.8MB)G.Cazzaniga Questions for the Workshop Panelists (PDF - 37KB)FDA - EuroFlow Consortium and MRD strategies: Novel Concept in Diagnostic flow cytometry. Jacques J.M.van Dongen (PDF - 2.6MB)
Webcast of Meeting
For those unable to attend in person, the meeting will also be webcast. Watch the webcast on April 18 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:
https://collaboration.fda.gov/mrd/
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
Webcasts of the Meeting
- Minimal Residual Disease (MRD) in Acute Lymphoblastic Leukemia (ALL) Introductions
- Statistical Considerations for Surrogate Endpoints
- Questions for the Workshop Panelists
- Questions for Technical Discussion
Visitor Information
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 10:05, and for a final time at 2:30 p.m.
Salads and sandwiches will also be available for purchase during the lunch break at 12:25.
Registration Information:
There is no registration fee for the public workshop. To register electronically, please use the following website: http://www.zoomerang.com/Survey/WEB22EJ4HRZLW9
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.
