Concurrent Session: Relevant Non-Human Models: Progress and Process
Sunday, September 10, 2023 09:15 AM - 10:15 AM
Grand Ballroom J-K
Chair
Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Baylor College of Medicine, USA
Speakers
Hang Lin, PhD, University of Pittsburgh, USA – Generation of multi-component organ-on-a-chip model to test treatments for knee joint diseases
Matthew Hewitt, PhD, Charles River Laboratories, USA – Can design beat evolution? Alternatives to in vivo models
Hajime Hiraragi, DVM, PhD, MBA, Lyell Immunopharma, USA – Relevant non-human models for GCT product development: Challenges & Opportunities
The use of animal models to initiate evaluation of product safety is a well-established component of drug and biological therapeutics development. However, their use in the development of cell and gene therapy products is problematic as relates to difficulty in finding optimal models. More globally, recent developments including difficulty sourcing non-human primates, development of non-animal models such as organoids and organs-on-a-chip, and changes in the regulatory requirement for animal studies prior to initiating studies in human subjects have further focused interest on different approaches to defining safety.
Session Objectives
Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Baylor College of Medicine, USA
Speakers
Hang Lin, PhD, University of Pittsburgh, USA – Generation of multi-component organ-on-a-chip model to test treatments for knee joint diseases
Matthew Hewitt, PhD, Charles River Laboratories, USA – Can design beat evolution? Alternatives to in vivo models
Hajime Hiraragi, DVM, PhD, MBA, Lyell Immunopharma, USA – Relevant non-human models for GCT product development: Challenges & Opportunities
The use of animal models to initiate evaluation of product safety is a well-established component of drug and biological therapeutics development. However, their use in the development of cell and gene therapy products is problematic as relates to difficulty in finding optimal models. More globally, recent developments including difficulty sourcing non-human primates, development of non-animal models such as organoids and organs-on-a-chip, and changes in the regulatory requirement for animal studies prior to initiating studies in human subjects have further focused interest on different approaches to defining safety.
Session Objectives
- To discuss progress in the development of organ on a chip/organoid models
- To summarize how animal models can be supplemented by organ on a chip/organoid models
- To interpret the current regulatory agency acceptance of the use of organ on a chip/organoid models in product development
Bambi Grilley RPh, RAC, CIP, CCRC, CCRP
Director, Clinical Research and Early Product Development
Baylor College of Medicine
Chair
Director, Clinical Research and Early Product Development
Baylor College of Medicine
Chair
Matthew Hewitt PhD
Vice President, Technical Officer CGT & Biologics
Charles River Laboratories
Speaker
Vice President, Technical Officer CGT & Biologics
Charles River Laboratories
Speaker
