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FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?”
Session Chair(s)
Sabrina Girty, JD
Executive Director, Global Regulatory Affairs, Oncology, Merck & Co., Inc., United States
The FDA Oncology Center of Excellence "Projects" address gaps in oncology drug development and present opportunities as well as challenges for industry. Learn from FDA and industry experts the value of these initiatives and how and when to join in.
Learning Objective : Recognize high-value FDA OCE priorities and projects that impact industry; Identify how and when to engage with these FDA initiatives to produce optimal results for industry, patients, and other stakeholders; Describe how to advance opportunities for harmonization of these high-value OCE Projects with global Health Authorities.
Speaker(s)
FDA Overview and Perspective on OCE Projects
Tamy Kim, PharmD
Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States
Industry Case Study: Implementing OCE Projects in Drug Development
Vandana Pathak, MS, RAC
Director Global Regulatory Affairs, Amgen, United States
From Policy to Practice: Maximizing Collaboration to Support Oncology Innovation
Mark Stewart, PhD
Vice President, Science Policy, Friends of Cancer Research, United States
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