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


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

Session 1
Improving Targeted Drug Development For “Small” Populations With Genomic Alterationsdisclaimer icon

Session  2
Combining Targeted Agentsdisclaimer icon

Session 3
Strategies to Implement a Global, Genomically-driven Metastatic Breast Cancer Studydisclaimer icon

Session 4
Optimizing Regulatory Requirements for a Global, Genomically-driven Metastatic Breast Cancer Studydisclaimer icon

Page Last Updated: 11/26/2014
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