Oncology Center of Excellence (NCRAF Spring Symposium_Opportunities and Challenges: Pilots and Projects in the Oncology Center of Excellence)

Speaker:  Linda Bowen, M.S, RAC, FRAPS,

Executive Director and Head of the Regulatory Centers of Excellence – Seagen

Description: 

FDA’s Oncology Center of Excellence (OCE) was created under the 21st Century Cures Act of 2016 and launched in 2017, with the goal of uniting “experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.” The Center, which sits in the Commissioner’s Office, is the first intra-center function at the agency.
Since its inception, OCE has been known for various initiatives, including projects and pilot programs, some that you might be familiar with including the Real Time Oncology Review, Project Orbis, Project Front Runner, Project Optimus and Project Equity. This presentation will highlight the opportunities and challenges presented by these initiatives and take a look at how they have changed the way we look at oncology drug development.

Networking and Drinks: 5:30 – 6:30 pm

Dinner: 6:30 – 7:30 pm

Presentation: 7:00 – 8:00 pm