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FDA, AACR, and SGO to Present Workshop on Gynecologic Malignancies

The U.S. Food and Drug Administration (FDA), the American Association for Cancer Research (AACR), and the Society of Gynecologic Oncology (SGO) present a workshop on drug development in gynecologic malignancies, a major cause of morbidity and mortality in the United States.

This workshop is designed to facilitate open discussion between the FDA, clinicians, laboratory experts, researchers, and patients on the way forward for diagnosis and treatment of gynecologic malignancies. Sessions will focus on immunotherapy, biomarkers, and novel study designs for rare subtypes.

WHEN:

Thursday, June 14
8 a.m.-5 p.m. ET
In-person or live stream attendance is free but advance registration is requested. RSVP to Julia Gunther at julia.gunther@aacr.org or 215-446-6896.

WHERE:

FDA White Oak Campus
Great Room A
10903 New Hampshire Avenue
Silver Spring, MD 20993

Transportation to FDA: Information about public meetings at White Oak, including directions and parking, can be found here. Please allow time to locate parking (parking map), use the shuttle to Building 1, go through routine security procedures, and sign in. All visitors should park in Northwest Surface Lot 1, 3, or 4.

SPEAKERS AND PROGRAM:

Interviews can be arranged per the availability of the speakers.

Workshop Co-chairs:

– FDA:

– Sanjeeve Bala, MD, MPH, Clinical Team Leader Gynecologic Malignancies Group, Division of Oncology Products 1 (DOP1), Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER), FDA

– Julia A. Beaver, MD, Director, Division of Oncology Products 1 (DOP1), Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER), FDA

– AACR:

– Deborah K. Armstrong, MD, Director, Breast and Ovarian Surveillance Service; Professor of Oncology, John Hopkins Kimmel Comprehensive Cancer Center

– Gordon B. Mills, MD, PhD, Member, AACR Board of Directors; Co-Director, Zayed Institute for Personalized Cancer Therapy, Department of Systems Biology 1, Division of Cancer Medicine, UT MD Anderson Cancer Center

– Society of Gynecologic Oncology (SGO):

– Rebecca Arend, MD, Assistant Professor of Obstetrics & Gynecology, University of Alabama at Birmingham

– Robert Coleman, MD, FACOG, FACS, Vice Chair, Clinical Research, Department of Gynecologic Oncology and Reproductive Medicine, UT MD Anderson Cancer Center

– Thomas Herzog, MD, Deputy Director and Professor of Obstetrics & Gynecology, University of Cincinnati Cancer Institute

Program:

8:20-9:55 a.m.: Development of Immunotherapy in Gynecological Malignancies – Part 1

10:10-11:55 a.m.: Development of Immunotherapy in Gynecological Malignancies – Part 2

1-2:35 p.m.: Biomarker Development and PARP Inhibitors

2:50-4:35 p.m.: Development of Drugs for Rare Gynecological Malignancies