No Stone Unturned: Optimizing the Use of Expedited Pathways and Oncology Center of Excellence Programs to Optimize Drug Development in Oncology

It is a fundamental human instinct to do everything possible for the cancer patients in our lives. We leave no stone unturned in providing comfort and seeking out the best care. As drug development professionals, we have a unique opportunity to extend this approach beyond the personal level and into our work.

From a regulatory perspective, a key part of “leaving no stone unturned” is understanding the full scope of programs offered by the FDA to speed up the approval of cancer treatments.  This talk will provide a thorough review of these programs: how to apply for them, how to apply them to drug development challenges, and their consequences for the future of oncology approvals.

This MMS Experts Insights Webinar is a must-attend event for early development Sponsors considering effective and early Agency engagement as well as for late-stage Sponsors planning NDA/BLA submissions with aggressive timelines.

Watch This Webinar To:

• Gain knowledge on the constellation of programs available to sponsors supporting drug development in oncology
• Consider key decision points and potential outcomes that drive expedited programs in oncology
• Understand how these programs seek to address the inherent tension between rapid approval and robust demonstration of efficacy/safety

What You Will Learn:

• Gain detailed background on Expedited Programs for Serious Conditions as they relate to the development of oncology products
• Review programs specifically designed to speed up development of oncology products
• Hear steps that Sponsors can take at each stage of development to leverage these programs
• Understand the challenges and future directions in oncology drug development

Who Will Benefit From Attending?

• Regulatory Affairs and Submissions Professionals
• Medical & Regulatory Writing Professionals
• Clinical Operations and Compliance Professionals
• Oncologists, Researchers, and Advocacy Groups