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Industry Event

ACT 2021 Conference

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