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Lung

This session provides a comprehensive overview of the complex in vitro models (CIVMs) commonly employed by lung safety teams in the drug development process. Participants will gain a thorough understanding of the functional characterization of these models and how they are rigorously qualified for use through testing with tool compounds known to exhibit lung safety liabilities.
Through real-world case studies, we will explore different contexts of use, specifically focusing on the decision-making process for choosing between transwell, organoid and organ-chip models. This will include in-depth discussions on the critical role of cell sourcing and characterization in establishing trust and confidence in these models.

Date & Time

Tuesday, December 10, 2024, 10:30 AM ET - 12:00 PM ET

Duration

90 minutes

Agenda

Introduction and overview of lung complex in vitro models

Julie Harney (Pfizer)


Introduction to context of use and model validation expectations

Garrett Ainslie (AbbVie)


Case Study: Qualification of Human 3D Lung Models Through Predictive Correlation with Established In Vivo Outcomes

Muntasir Mamun Majumder (AstraZeneca)


Case Study: Characterization of Human Alveolus-Chip for Preclinical Safety Assessment of a Biotherapeutic Concept with Patient-Specific Risk

Luke Coyle (Boehringer Ingelheim Pharmaceuticals)


Case Study: Application of Human Lung Alveolus MPS Model in Mechanistic Understanding of ADC Induced Lung Toxicity

Rita Ciurlionis (AbbVie)


Case Study: Modeling lung pathobiology in a dish for pharmacological studies

Muriel Lize (Boehringer Ingelheim Pharmaceuticals)


Q&A / Discussion

Julie Harney (Pfizer)

Garrett Ainslie (AbbVie)

Moderators and Presenters

Garrett R. Ainslie, PhD

Principal Research Scientist, Quantitative, Translational and ADME Sciences

AbbVie

<h2 class="font_2"><strong>Garrett R. Ainslie, PhD</strong></h2>
<p class="font_8">Principal Research Scientist, Quantitative, Translational and ADME Sciences</p>
<p class="font_8">AbbVie</p>

Garrett Ainslie received his PhD in Toxicology from the University of North Carolina at Chapel Hill in 2014 and over 8 years of experience in the discovery and development of inhaled molecules. He currently leads inhalation discovery project teams and implements translational approaches at Abbvie.

<h2 class="font_2"><strong>Garrett R. Ainslie, PhD</strong></h2>
<p class="font_8">Principal Research Scientist, Quantitative, Translational and ADME Sciences</p>
<p class="font_8">AbbVie</p>

Julie Harney, MS

Senior Principal Scientist, Investigative Toxicology

Pfizer

Julie Harney is a Senior Principal Scientist in the Investigative Toxicology group within Drug Safety Research and Development at Pfizer. Her expertise in complex in vitro model development spans 15 years supporting nonclinical toxicological assessments across a wide variety of organ systems, therapeutic modalities and indications.

<h2 class="font_2"><strong>Garrett R. Ainslie, PhD</strong></h2>
<p class="font_8">Principal Research Scientist, Quantitative, Translational and ADME Sciences</p>
<p class="font_8">AbbVie</p>

Muntasir Mamun Majumder, PhD

Discovery Safety Scientist

AstraZeneca 

Mamun is a Discovery Safety Scientist at AstraZeneca with a PhD in Translational Medicine, specializing in the qualification and application of complex lung models for candidate prioritization. In his current role, he supports non-clinical safety assessments and leverages multi-omics technologies to discover safety biomarkers, enhancing the understanding and prediction of drug safety profiles.

Luke Coyle, MS

Scientist IV, Integrative Toxicology

Boehringer Ingelheim Pharmaceuticals

Luke Coyle is a scientist in the Integrative Toxicology group within Nonclinical Drug Safety at Boehringer Ingelheim. He specializes in the development and implementation of complex tissue models, which includes Transwell, organoid, and organ-chip for functional safety evaluation, derisking, and species qualification of biotherapeutics.

Rita Ciurlionis, MS DABT

Senior Scientist II

Investigative Toxicology & Pathology

Development Biological Sciences

Global Preclinical Safety

AbbVie

Rita received her MS in Biology at UC San Diego, La Jolla where she studied transcriptional regulation of Drosophila development. She is a board-certified Toxicologist and Senior Scientist in Investigative Toxicology and Pathology at AbbVie (Abbott Laboratories) with over 25 years of experience in investigation of molecular and cellular mechanisms of toxicity in drug development.

Muriel Lize, PhD

Boehringer Ingelheim Pharmaceuticals

Muriel Lizé, cell biologist, studies human disease mechanisms using complex primary cell derived models to enable disease mechanism understanding, drug discovery, profiling and development. In her current role as scientific expert in immunology and respiratory research she derives cellular models from omics to support new therapeutic concepts from exploratory until phase II. The linkage of functional endpoints in the preclinical models to clinically relevant biomarkers might enhance translatability of preclinical packages.

Ratnakar Potla, PhD 

Principal Scientist

Genentech-Roche

Ratnakar Potla is a physician scientist by training. He is currently a principal scientist in the Complex in vitro systems group within Genentech Research and early development (gRED) where he leads the lung team within Safety assessment. He supports the safety assessment of candidate molecules using complex in vitro systems like organ on chips and organoids using multiple commercially available and in house fabricated platforms.

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