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FDA-NBTS Public Workshop: Product Development for Central Nervous System (C...

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FDA Building 31

10903 New Hampshire Avenue

The Great Room

Silver Spring, MD 20993

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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)

In collaboration with: Accelerate Brain Cancer Cure (ABC2); American Brain Tumor Association (ABTA); Friends of Cancer Research (FOCR); 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)

Facebook: @braintumors

Twitter: #MetsCNS2019 and #CNSMetsWorkshop2019; www.braintumor.org

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)

Registration:

Persons interested in attending this public workshop must register online at https://www.eventbrite.com/e/product-development-for-central-nervous-system-cns-metastases-public-workshop-tickets-53818045222 by 5 p.m. on March 20, 2019.

If you need special accommodations due to a disability, please contact Joan Todd before 5:00 PM, EST, March 7, 2019.

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 metastase
  • 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:

FDA will provide a free-of-charge, live webcast of this workshop. Further information regarding the webcast, including the web link for the webcast, will be made available closer to the workshop date.

FDA plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Workshop Information: (documents will be added when available)

  • DRAFT Agenda
  • List of Speakers and Panelists
  • Planning Committee

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


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Location

FDA Building 31

10903 New Hampshire Avenue

The Great Room

Silver Spring, MD 20993

View Map

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