Biopharmaceuticals (includes Biologics)

Intermediate

Novel Approaches in the Development and Review of Oncology Drugs

Session Leader(s)

• 

  Marissa Braff, PhD, RAC

  Executive Director, Regulatory Affairs
  Seattle Genetics, Inc.

Speaker(s)

• 

  Lauren Cutler, MBS, RAC

  Director, Regulatory Affairs
  Seattle Genetics, Inc.
• 

  Lisa Chao, PhD

  Director, Global Regulatory Affairs
  Merck & Co Inc.

Panelist(s)

• 

  Tamy Kim, PharmD

  Associate Director of Regulatory Affairs, OCE
  FDA

This session will highlight case studies, hands-on experience, and lessons learned from two recent oncology approvals incorporating novel trial design and accelerated pathways. The presentations will be followed by a panel discussion and Q&A on the benefits and future opportunities to engage FDA’s Oncology Center of Excellence in development of oncology products.

Learning Objectives:

• Understand the role of the Oncology Center of Excellence (OCE) in the review of oncology products
• Develop an understanding of the use of novel clinical trial design such as basket studies and tissue-agnostic approaches
• Describe FDA’s use of the Real Time Oncology Review (RTOR)