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FDA-NBTS Public Workshop: Product Development for Central Nervous System (CNS) Metastases

FDA-NBTS Public Workshop: Product Development for Central Nervous System (CNS) Metastases

Co-Sponsored by the:
U.S. Food & Drug Administration (FDA) and
the National Brain Tumor Society (NBTS)disclaimer icon

In collaboration with:
Accelerate Brain Cancer Cure (ABC2); American Brain Tumor Association (ABTA);
Friends of Cancer Research (Friends); Kidney Cancer Research Alliance (KCCure);
LUNGevity Foundation; Melanoma Research Alliance (MRA);
Metastatic Breast Cancer Alliance (MBC Alliance)
RANO (Response Assessment in Neuro-Oncology)
and Society for NeuroOncology (SNO)disclaimer icon

Twitter: #MetsCNS2019 #CNSMetsWorkshop2019

Date: March 22, 2019

Time: 8:00 am to 4:00 pm

Location: FDA White Oak Campus
Building 31, Room 1503 – Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993
FDA Campus Information, (e.g., local airports, directions, and local hotels)

Background:

There is a paucity of effective treatments for patients with central nervous system (CNS) metastases. Moreover, there are few clinical trials and a need for more attention to this high unmet medical need. One impediment to product development for CNS metastases is uncertainty on the optimal clinical trial endpoints and study designs for evaluating products. This unique workshop will bring key stakeholders together to evaluate what is needed to advance development of effective products and consider optimal endpoints and clinical trial designs related to this topic.

Workshop Goals and Objectives:

  • To provide a forum for open discussion among FDA, clinicians, researchers, patient advocates, and industry in neuro-oncology product development on clinical trials for patients with brain metastases
  • To discuss and work toward identifying endpoints for clinical trials for patients with brain metastases
  • To educate researchers and product developers about relevant regulatory science and policy issues important to CNS metastasis product development
  • To accelerate the development of products for the treatment of CNS metastases
  • Facilitate open discussions among major stakeholders in the field of CNS metastases

Webcast Information Replay:

Opening – Session II:  https://collaboration.fda.gov/p1s1r7ochw0u/

Session III - Lunch:  https://collaboration.fda.gov/p178xjsvyode/

Post-Lunch Session III:  https://collaboration.fda.gov/puj6tld22ylg/

Session IV - Adjourn:  https://collaboration.fda.gov/pddyrrv7zn5c/

Workshop Information:

NBTS Meeting Condensed Transcript with index (PDF - 5.44MB)

NBTS Meeting Full Transcript (PDF - 975KB)

Contact:

Joan Ferlo Todd, RN
Regulatory Health Project Manager
Office of Hematology and Oncology Products (OHOP)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration
Joan.Todd@fda.hhs.gov

Sarah O'Connor
Executive Assistant
National Brain Tumor Society
55 Chapel Street, Suite 200
Newton, MA 02458
soconnor@braintumor.org
Facebook: @braintumors; Twitter: #MetsCNS2019; #CNSMetsWorkshop2019; www.braintumor.org