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Module I
Introduction and Qualification of CIVM and MPS

Over the past decade, CIVM have become increasingly more diverse in design, capabilities, and sophistication, reaching a point where industry can now begin to apply these tools across drug discovery and development. While the rigor of qualification required to apply these models are largely dependent upon the specific context of use, there are fundamental technical and methodological considerations to be taken into account when designing CIVM experiments. This module will provide an overview of CIVM and how they are being used in drug discovery and development, and offer insights into how CIVM data may eventually be used in concert with in-silico modeling. This module will also outline key technical considerations, such as cell sources, statistical design, confounding device variables, and construction methodologies. The module will close with an overview of high-level qualifications considerations, such as recapitulation of known drug response and comparability to gold standards.

Aaron Fullerton leads the Investigative Toxicology laboratory within Safety Assessment at Genentech which is focused on the use of in-vitro models to support candidate selection and pre-clinical safety evaluation of a wide variety of therapeutic modalities in the Genentech portfolio.  CIVM and MPS approaches comprise a major component of these tools leveraged alongside traditional in-vitro models to provide comprehensive understanding of safety liabilities, mechanisms of drug toxicity and translatability of safety findings from in-vivo pre-clinical animal studies.

Introduction to CIVM and MPS

This session will provide an overview of the objectives and content of the IQ MPS Affiliate Training course followed by an overview of MPS platforms and how the pharmaceutical industry is currently using these and other Complex In Vitro Models.

Date / Time

Thursday, July 13, 2023 at 10:00 AM ET

IQ MPS 

IQ Microphysiological Systems Affiliate
Jason is responsible for the planning and directing of Complement biology and translational biology research, as well as seeking partnerships with research institutions and companies to remain on the leading edge of drug discovery. Before joining UCB he was Senior Director, GSK Fellow and Head of the Complex In Vitro Models (CIVM) group at GlaxoSmithKline. He was responsible for an integrated enterprise strategy for R&D applications of complex human-relevant and translatable complex in vitro models. He’s currently the past chair for the IQ-MPS affiliate and co-leads the regulatory sub-group for the IQ-MPS affiliate.

Technical Considerations for Experimental Design (Part I)

This session will cover the key components that should be considered when developing a MPS model, such as the context of use, and physical and biological inputs (including cells, matrices and media). Furthermore, the concept of good experimental design for MPS will be presented using a case study example.

Date / Time

Thursday, July 20, 2023 at 10:00 AM ET

IQ MPS 

IQ Microphysiological Systems Affiliate
Dr. Chan leads a group of scientists who focus on the use of in vitro tools to assess clinical drug-drug interaction risk in drug development. He also represents the DMPK department on selected projects in development.

Technical Considerations for Experimental Design (Part II)

Basic 2D monolayer cultures can fail to predict in vivo pharmaceutical candidate properties such as efficacy, ADME, or toxicity as they lack the necessary physical and biochemical cues found in vivo. MPS aim to fill this gap by exploiting advances in material sciences, microfabrication processes, and engineering to recreate the in vivo environment. In this session, technical design considerations of MPS are discussed with respect to:

- Material considerations
- Fluid dynamics in systems with flow
- Mechanical stimuli were applicable
- Device qualification and operation
- Body-on-a-chip configuration
- Immune cell incorporation

Date / Time

Thursday, August 24, 2023 at 1:00 PM ET

IQ MPS 

IQ Microphysiological Systems Affiliate
Diane Ramsden is a Director of Oncology DMPK leading the ADME and BA team within AstraZeneca’s Boston site.  Her team is evaluating MPS and CIVM models as tools for providing mechanistic ADME insights into small and large molecule disposition.

Leveraging MPS Data for in-Silico Modeling

With new approach methodologies (NAM) evolving in tandem and at a rapid pace, there is an opportunity to integrate them in ways previously thought impossible. This session aims to initiate discussion on how the diverse and complex datasets derived from CIVM and MPS models may be analyzed using quantitative systems biology (QSP), machine learning, and in silico modeling approaches. Examples will be provided through case studies, and a realistic view of the current gaps as well as future outlooks and opportunities will be discussed.

Date / Time

Thursday, September 21, 2023 at 10:00 AM ET

IQ MPS 

IQ Microphysiological Systems Affiliate
Aaron Fullerton leads the Investigative Toxicology laboratory within Safety Assessment at Genentech which is focused on the use of in-vitro models to support candidate selection and pre-clinical safety evaluation of a wide variety of therapeutic modalities in the Genentech portfolio.  CIVM and MPS approaches comprise a major component of these tools leveraged alongside traditional in-vitro models to provide comprehensive understanding of safety liabilities, mechanisms of drug toxicity and translatability of safety findings from in-vivo pre-clinical animal studies.

CIVM/MPS Qualification Considerations and Challenges

This session will provide an overview of qualification efforts for the use of CIVMs in various contexts of use and will include both a high-level overview of the current qualification landscape as well as examples of internal fit-for-purpose qualification efforts within Pharma companies for different contexts of use and discuss how these complex models present unique challenges to using traditional assay validation framework.

Date / Time

Thursday, September 28, 2023 at 10:00 AM ET

IQ MPS 

IQ Microphysiological Systems Affiliate

Module I Summary

Coming soon.

Date / Time

To Be Announced

IQ MPS 

IQ Microphysiological Systems Affiliate
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