NCRAF 2023 Spring Symposium

Opportunities and Challenges: Pilots and Projects in the Oncology Center of Excellence

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

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.

Linda Bowen has 40 years of experience in the BioPharma Industry, of which 30 years were spent in regulatory strategy, intelligence, and policy roles. She is the Executive Director and Head of the Regulatory Centers of Excellence at Seagen, Inc. Bowne has also been an assistant adjunct professor in the Temple RAQA Master's Program for the last 25 years. 

She attained regulatory affairs certification for the US, Canada, and Europe, and was an inductee into the 2011 Class of RAPS Fellows. Linda was honored with the Drug Information Association's 2012 Excellence in Volunteer Leadership, the 2019 Americas Inspire Awards, the 2022 Global Inspire Award - Community Engagement, and the RAPS 2020 Founder’s Award. 

She is a past two-term member of the RAPS Board of Directors and current Chair of the Affiliate Board. She helped start the NJ NY RAPS Chapter in April 2003 and has been a part of the chapter leadership team since then. Linda chairs the DIA Regulatory Affairs Community and created the DIA Regulatory Intelligence Working Group. She sat on the planning committee for the 2013-2017 DIA Annual Conference, the 2011-2017 RAPS Annual Convergence and was Program Chair for the 2018 & 2019 RAPS Annual Convergence. 

Linda is most proud of her role as an educator and mentor to those entering the regulatory profession.