Session 05: Unlocking the Future of Safety: New Approach Methodologies (NAMs) and Microphysiological Systems (MPS)[Symposium Program （Session）]
New approach methodologies (NAMs) can provide the necessary information for chemical risk assessment without using animal tests. Significant advancements have been made in developing tools like computational models, microphysiological systems, and ‘omics’ technologies. However, there is often a lack of confidence in applying these methods within a regulatory setting. This symposium aims to raise awareness of NAMs and explore how their regulatory application can be accelerated by overcoming significant barriers. Key objectives include showcasing current uses of NAMs, identifying barriers and scientific gaps, and exploring ways to speed up validation and qualification. Many guidelines exist for developing and adopting new in vitro toxicological test methods, which are now routinely used to evaluate drug and chemical safety. Microphysiological systems (MPS) or tissue chips may address shortcomings in drug development by improving clinical efficacy and eliminating the need for animal-to-human extrapolation. Despite their promise, the complexity and cost of these models’ present adoption challenges. This symposium will bring together experts to discuss building confidence in using microphysiological systems as decision-informing tools in regulatory science.
NO.:1
Fit for purpose evaluation of a NAM-based systemic toxicity toolbox
NO.:2
The significance of mechanistic evidence in NGRA: is key characteristics-structuralized NAMs a reasonable approach?
NO.:3
A pharma perspective on the use and utility of MPS for drug safety assessment
NO.:4
Perspective on qualification of the microphysiological systems for regulatory use
Session 11: The Westward Movement of Botanicals[Symposium Program （Session）]
Humans have been looking after their health for thousands of years. From ensuring the balance of ‘humors’ to cold-water therapy, our understanding of health continues to evolve. While health and ill health were initially “dictated by the Gods”, the ancient Greeks were the first to look at human biology. Eastern medicine refers to various organically integrated practices encompassing spiritual, social, and temporal health determinants and underscores illness prevention. Standardized formulations of botanical mixtures and herbal extracts, informed by centuries of use, are adjusted to novel indications and to respond to specific patient characteristics and lifestyles. Here, the future may lie in the improved recapitulation of ancient Eastern approaches married to modern Western technology informed by ancient experience. This session aims to provide an overview of the westward movement and the scope of key botanicals being promoted for improved health. In addition, safety considerations and regulatory pathways that allow for premarket approval in the European Union and North America, including US FDA GRAS (generally recognized as safe) and NDI (new dietary ingredient) paradigms, will be discussed.
President:
NO.:1
The western movement
NO.:2
Generally recognized as safe/new dietary ingredients
NO.:3
Botanicals and herbal medicines
