Synopsis
The use of animal models to evaluate product safety is a well-established component of drug and biological therapeutics development. However, their use in the developing cell and gene therapy products is problematic in that it is difficult to find optimal models. More globally, recent developments—including difficulty sourcing non-human primates, the creation and improvement of non-animal models such as organoids and Organ-on-a-Chip technology, 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.
Key Objectives:
- Discuss the place for different types of models in the development of regulatory applications in relation to GM cell therapies
- Evaluate alternative approaches to animal models through presenting successful and innovative case studies
- Where, when, and how non-animal studies could substitute for, or supplement, animal studies in regulatory applications
- What the limitations to the use of non-animal studies are
- What the current status of the development of non-animal models is
