FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop

The Food and Drug Administration (FDA), in co-sponsorship with the American Association for Cancer Research (AACR), American Society of Clinical Oncology (ASCO) and the Breast Cancer Research Foundation (BCRF), is announcing a public workshop that will provide a forum to explore means of accelerating the development of highly effective targeted agents for patients with metastatic breast cancer. The workshop will bring together an international group of breast cancer experts, FDA, industry representatives, and patient advocates to discuss the intricacies of developing an international genomically driven trial to test multiple agents in patients with metastatic breast cancer. Stakeholders will discuss potential biomarkers, testing platforms, study designs, statistical models, and implementation strategies to optimize the path to regulatory approval. The workshop will be critical to securing the path forward toward improved targeted drug development in breast cancer.


October 21, 2014


8:00 a.m. to 5:00 p.m


Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD 20814


There is no registration fee for the public workshop, but for planning purposes, please register at the following site: Registration for BreastWorkshop2014disclaimer icon. Confirmation of your registration will be sent from ASCO by Kaitlyn Antonelli (kaitlyn.antonelli@asco.org). Seats are limited and conference space will be filled in the order in which registrations are received.


Jura Viesulas, MS, EdD.
Oncology Program
Office of Hematology and Oncology Products (OHOP)
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration
Phone: (301)796–7538
E-mail: Jura.Viesulas@fda.hhs.gov

 Webcast Information

If you wish to pre-register, you may do so at any time prior to the meeting by providing your name and email address. By pre-registering, you receive an automated confirmation email and are provided the option of adding the event to your calendar. Login will open at 7:00am ET (one hour prior to 8:00am broadcast meeting start) on the day of the workshop.


Page Last Updated: 10/16/2014
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