返回 Agenda
Mid-Day Keynote
Session Chair(s)
Simone P. Pinheiro, MSc
Head, PharmacoEpidemiology Center of Excellence (PeCoE)
AbbVie, United States
The FDA is committed to facilitating rapid development, review and action on promising cancer treatments. This exciting DIAmond session will discuss recent progresses and novel approval pathways for oncology therapeutic products, including real world evidence. This session will also discuss the Oncology Center of Excellence, developed as part of the 21st Century CURES Act, and its role in the development of regulatory approaches to expedite drug development. This 45-min session will be composed of two presentations followed by Q&A.
Speaker(s)
Novel Approaches in Oncology Products
Sean Khozin, MD, MPH
CancerLinQ, LLC, United States
Executive Vice President of ASCO; Chief Executive Officer
Oncology Center of Excellence
Tamy Kim, PharmD
FDA, United States
Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence