BioCelerate Nonclinical Common Templates Initiative is presenting an ePoster highlighting the results of the phase 1 pilot and the SEND Harmonization for Cross Study Analysis Initiative along with their collaboration partners FDA and PHUSE will be hosting a workshop as well as presenting three ePosters.
Monday, November 15 – noon-3:30 PM EDT
Session – Collaboratively Cracking the SEND Code: Unlocking the Potential Value of Standardized Toxicology Study Data
Session Chairs: Kevin Snyder (US FDA, CDER), and Mark Carfagna (Eli Lilly)
Presenters: Kevin Snyder (US FDA, CDER), and Mark Carfagna, (Eli Lilly) William Houser (BMS) Md Yousuf Ali (US FDA CDER), and Philip Drew (PDS Consultants)
Monday, November 15 – Virtual Poster Session – 3:30 – 5:30 PM EDT
- Nonclinical Common Templates:
- Supporting Efficiencies in Nonclinical Toxicology Studies Through Protocol and Report Templates: Progress Towards Adoption
- SEND Harmonization for Cross-Study Analysis BioCelerate-FDA-PHUSE Collaboration:
- SEND Data Analyses to Enable the Comparison of Multiple Studies
- Harmonization of SEND Implementation to Enable Historical Control Data Analysis: Recommendations for Exchanging Vehicle Details Using SENDIG v3.1.
- Cross-study Analysis of SEND Datasets Using an R package: sendigR