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FDA-AACR-ASCO-BCRF Innovations in Breast Cancer Drug Development-Next Generation Oncology Trials Workshop

The AACR cosponsored this workshop to explore means of accelerating the development of highly effective targeted drugs agents for patients with metastatic breast cancer. The workshop examined how best to design a single genomically-driven trial to simultaneously test multiple agents by bringing together an international group of breast cancer experts, FDA, industry representatives, and patient advocates. Stakeholders discussed potential biomarkers, study designs, statistical models, testing platforms, study designs, statistical models, and implementation strategies to optimize the path to regulatory approval.

Webcast Information

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

Session 2
Combining Targeted Agents

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

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

Detailed event agenda