March 12, 2024
Speaker: Marc Ellison
Educational Levels: Foundational, Practical

Since the FDA's adoption of the Standard for Exchange of Nonclinical Data (SEND) in 2016, it has continuously evolved, expanding beyond general toxicology to include disciplines such as Development and Reproductive Toxicology and genetic toxicology. Initially driven by FDA requirements for nonclinical safety assessment submission for Investigational New Drug Applications and New Drug Applications, SEND datasets are currently being utilized for innovative purposes, such as creating virtual control groups.

This session will explore the development of the SEND standard and the data currently within its scope. It will focus on the ongoing expansion of the standard, highlighting new data and study types that will soon be incorporated. The current submission requirements will be outlined, and upcoming changes will be discussed, addressing the challenges of remaining compliant with an ever-evolving standard. The webinar will also describe how the industry maximizes the value of SEND investments by collaboratively utilizing the standard to unlock and reuse legacy study data.

Enjoy exclusive access! If you’d like access to the additional Q&A from the live session, please contact [email protected].