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Module I Summary

This session will cover the functional readouts and reference ranges for key liver complex in vitro model parameters. We will introduce relevant COUs and highlight liver MPS model characterization and proof-of-concept data for DMPK and safety testing. Additionally, the value of liver MPS in replicating species-specific toxicity that was not reproducible using traditional in vitro systems (i.e., 2D plated hepatocytes) will be discussed.

Date & Time

Monday, December 4, 2023 at 1:00 pm ET

Duration

90 minutes

Agenda

Welcome and Introduction

Aaron Fullerton, Genentech


Lessons from Module I Sessions 1-3 (Introduction to CIVM/MPS and Technical Considerations for Experiemental Design)

Jason Ekert, UCB

Rhiannon David, Astrazeneca,

Tom Chan, BMS

James Gosset, Pfizer


Q&A / Discussion

Deidre Dalmas Wilk, GSK


Lessons from Module I Sessions 4-5 (Leveraging MPS Data for In Silico Modeling and CIVM/MPS Qualification Considerations)

Dave Stresser, AbbVie

Aaron Fullerton, Genentech


Q&A / Discussion

Deidre Dalmas Wilk, GSK


Module I Closing Remarks

Nakissa Sadrieh, FDA


Introduction to Module II: Established CIVM/MPS (Organ-Specific Sessions)

Deidre Dalmas Wilk, GSK

Moderators and Presenters

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