Drugs

FDA Public Workshop: FDA-AACR-SGO Workshop on Drug Development in Gynecologic Malignancies

      Twitter: #OCEGynCancers18disclaimer icon

Co-Sponsors: American Association for Cancer Research (AACR) and Society of Gynecologic Oncology (SGO)

Co-Chairs:

U.S. Food and Drug Administration:

  • Julia A. Beaver, MD
  • Sanjeeve Balasubramaniam, MD, MPH

American Association for Cancer Research:

  • Deborah K. Armstrong, MD - John Hopkins Kimmel Comprehensive Cancer Center
  • Gordon B. Mills, MD, PhD - UT MD Anderson Cancer Center

Society of Gynecologic Oncology:

  • Robert Coleman, MD, FACOG, FACS - UT MD Anderson Cancer Center
  • Thomas Herzog, MD - University of Cincinnati Cancer Institute
  • Rebecca Arend, MD - University of Alabama at Birmingham

Date:

June 14, 2018

Time:

8:00 am to 5:00 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:

http://www.aacr.org/AdvocacyPolicy/GovernmentAffairs/Pages/FDA-AACR-SGO-drug-development-in-gynecologic-malignancies-workshop.aspx#.WsfR3DiWymRdisclaimer icon

Background:

Gynecologic malignancies continue to be a major cause of morbidity and mortality in the United States, resulting in an unmet medical need. In 2015, FDA held a public workshop to facilitate drug development in gynecologic malignancies, with a focus on ovarian cancer, where we covered topics including immunotherapy, novel clinical trial designs, novel endpoints, and expanded eligibility criteria. The impact of this workshop reached patients and clinicians, as well as pharmaceutical industry stakeholders who were in attendance. At this point, we can take advantage of the impact of that first workshop and continue to support the development of these treatment options.

Workshop Objectives:

  • To provide a forum for open discussion between the FDA, clinicians, laboratory experts, and researchers on the way forward for diagnosis and treatment of gynecologic malignancies
  • Accelerate the development of immunotherapy in gynecologic malignancies
  • Facilitate open discussions in the area of gynecologic malignancies
  • Obtain input from multiple stakeholders on approaches to novel study designs to leverage rare subtypes in gynecologic malignancies
  • Discuss the impact of biomarkers in gynecologic malignancies

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.

Meeting Information:

  • Agenda and speakers list coming soon

Contact:

Sherwin Sapasap, MS, MBA, MHA
Center for Drug Evaluation and Research
Office of New Drugs
Office of Hematology and Oncology Products
Sherwin.Sapasap@fda.hhs.gov

 

Page Last Updated: 04/26/2018
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