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GI (Part I)

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

Thursday, October 31, 2024, 10:30 AM ET - 12:00 PM ET

Duration

90 minutes

Agenda

Welcome and Introduction

John Gleeson (Merck)

Abhinav Sharma (AbbVie)


Overview of GI CIVM/MPS

Mike Beshiri (AstraZeneca)


GI CIVM/MPS: Model Features, Technical Considerations, Functional Readouts, and Relevant COUs

John Gleeson (Merck)


Case Study: Predicting diarrhea and model qualification

Julia Co (Genentech)

Mike Beshiri (AstraZeneca)


Case Study: Modeling IBD phenotype

Sarah Wilson (AbbVie)


Q&A / Discussion

John Gleeson (Merck)

Abhinav Sharma (AbbVie)

Moderators and Presenters

John Gleeson, PhD

Associate Principal Scientist – Exploratory Biopharmaceutics

Merck & Co.

<h2 class="font_2"><strong>John Gleeson, PhD</strong></h2>
<p class="font_8">Associate Principal Scientist – Exploratory Biopharmaceutics</p>
<p class="font_8">Merck &amp; Co.</p>

John Gleeson is an Associate Principal Scientist in Merck’s Pharmaceutical Science and Clinical Supply division. John joined Merck in 2020 after completing his PhD (UCD; Ireland) and Postdoctoral research (Cedars-Sinai Medical Center; CA and Carnegie Mellon University: PA). He supports the pre-clinical to clinical formulation development of oral programs and de-risks clinical bioperformance issues. John leads the development of clinically predictive intestinal absorption models using conventional and complex in vitro models.

<h2 class="font_2"><strong>John Gleeson, PhD</strong></h2>
<p class="font_8">Associate Principal Scientist – Exploratory Biopharmaceutics</p>
<p class="font_8">Merck &amp; Co.</p>

Mike Beshiri, PhD

Senior Scientist – Oncology Safety Science

AstraZeneca

Mike is a molecular/cellular biologist with a long-standing interest in cancer biology, particularly in the creation and application of preclinical models to address questions related to progression and resistance to therapy. At AstraZeneca, Mike has been working in Oncology Safety developing methods and models to evaluate and predict compound-induced intestinal toxicity.

<h2 class="font_2"><strong>John Gleeson, PhD</strong></h2>
<p class="font_8">Associate Principal Scientist – Exploratory Biopharmaceutics</p>
<p class="font_8">Merck &amp; Co.</p>

Julia Co, PhD

Senior Principal Scientist

Genentech

Julia is a Senior Principal Scientist at Genentech in the Complex in vitro Systems group in Safety Assessment. Her team focuses on developing, implementing, and democratizing GI in vitro models and assays for drug development applications. Prior to joining Genentech in 2020, she led a group at a startup using in vitro skin models to evaluate consumer products. Julia completed her postdoc at Stanford, where she developed GI organoid systems to investigate host-microbe interactions, and her PhD in Microbiology at MIT.

Sarah Wilson, PhD

Principal Scientist - Immunology Discovery, Gastroenterology Pharmacology and Pathology

AbbVie

Sarah Wilson is a Principal Research Scientist within Immunology Discovery at AbbVie. She joined AbbVie in 2016 after receiving her PhD in Microbiology from the University of Washington, where she developed intestinal organoid models of host-microbe interactions. In her current role, Sarah leads the development and deployment of complex in vitro models to advance projects at all stages of the gastroenterology immunology discovery pipeline, with a focus on small molecule and biologic modalities.

Abhinav Sharma, PhD

Senior Scientist - Translational Human Models Lead, Dermatology/Immunology Discovery

AbbVie

Abhinav joined AbbVie in 2020 after receiving a PhD in Chemical and Biological Engineering at University of Massachusetts Amherst where he developed in vitro models of human gut to study host-microbe interactions. In the current role he is leading efforts to establish MPS models of multiple organ systems for programs within AbbVie’s drug discovery and development pipeline.

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