drugtestingconference.com
Description: Safer Medicines is an independent patient safety organisation of scientists and doctors with extensive expertise in drug development. Our aim is to change the way medicines are tested, so they are safer for humans: moving from a system based mainly on tests on animals to one focused firmly on human biology.
New Approach Methodologies (NAMs) based on human biology have the potential to reduce, and ideally eliminate, toxicities that arise during drug discovery and development. Pharmaceutical companies are already using NAMs in early drug development, with considerable success. However, there are areas of unmet need where NAMs might deliver more predictive power, potentially improving and expediting drug development. At present there is no overarching consensus on how NAMs may be incorporated within regulatory gu
NAMs need to be included within a scientifically valid, integrated human-relevant pharmaceutical safety assessment strategy that will be acceptable to industry and regulators. With this in mind, we held a series of 5 workshops with 13 international experts (regulators, preclinical scientists and NAMs developers), to identify feasible NAMs and discuss how to use them in specific safety assessment contexts.
Participants generated four decision tree ‘maps’ showing how NAMs could be used to assess safety for the liver, respiratory, cardiovascular and central nervous systems. These organ system maps provide guidance on how specific human-relevant tests may be used in each context, as well as a template that could be applied to additional organ systems, or testing in other contexts. Maps like these have potential to guide stakeholders and generate confidence in using NAMs to complement and ultimately replace in vi
drugtestingconference.com