BCAN 2019: FDA Collaboration with the Bladder Cancer Community

Washington, DC (UroToday.com) The expert panel of providers and FDA discussed ongoing and future collaborations with the FDA and bladder cancer. The FDA Oncology Center of Excellence (OCE) leverages the combined skills of regulatory scientists and reviewers. The panel reviewed the structure of the OCE and how expedited programs within the FDA strive to accelerate drug development and approval.

Chana Weinstock from the FDA presented ongoing engagement between stakeholders as the next generation of clinical trials are designed. The Office of Hematology and Oncology is composed of >80 medical oncologists and a radiation oncologist with expertise in GU malignancies. They review investigational new drugs, new drug applications, and biological license applications. All providers maintain regular patient contact in addition to their FDA responsibilities. There are various stages of drug development which include fast-track, breakthrough therapy, priority review, and accelerated approval. 

Presented by: Chana Weinstock, MD, Genitourinary Oncology Team Leader, FDA, Silver Spring, MD 

Written by: Stephen B. Williams, MD, Medical Director for High Value Care; Chief of Urology, Associate Professor, Director of Urologic Oncology, Director Urologic Research, The University of Texas Medical Branch at Galveston, TX and Ashish M. Kamat, MD, Professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX at the 2019 Bladder  Cancer Advocacy Network  (BCAN) Think Tank August 8-10,  2019  - the Capital Hilton, Washington, DC, USA