Watch this webinar for an overview of BioCelerate’s SEND (Standard for Exchange of Nonclinical Data) Harmonization for Cross-Study Analysis initiative. Through a collaboration between BioCelerate and the US FDA (Food and Drug Administration) CDER (Center for Drug Evaluation and Research), the team is developing analytic approaches to enable the comparison of toxicological findings of two or more studies using SEND. An example analysis was conducted using studies from the BioCelerate TDS (Toxicology Data Sharing) database intended for the same pharmacological target. Cross-study comparison tools using SEND data are expected to improve the identification of unique findings related to the intended target, species, and duration of dosing.
Slides can be viewed here. Watch the webinar here.
Panelists:
- Mark Carfagna, Executive Director of Toxicology, Eli Lilly & Company
- William (Bill) Houser, Senior Principal Scientist, Bristol Myers Squibb
- Stephanie Leuenroth-Quinn, Associate Director for Pharmacology and Toxicology, FDA
Ideal Attendees:
- Site Managing Director
- Safety Assessment
- Study Director
- Study Monitor
- Data Analyst
- Scientist
- Senior Scientist
- Toxicologist
- Science Analytics
- Pathologist
- Clinical pathologist
- Toxicology scientist
- Toxicologist
- Nonclinical safety
- Head of toxicology
- Toxicology associate