New approach methodologies for drug discovery - PubMed
6 hours ago
- #Drug Discovery
- #Human-Centered Research
- #New Approach Methodologies
- Traditional animal-based drug discovery has high failure rates, leading to the adoption of human-centered new approach methodologies (NAMs).
- Advances in stem cell-, organoid-, and in silico-based NAMs are supported by evolving NIH and FDA frameworks, covering disease modeling, drug design, and efficacy testing.
- Progress includes identifying therapeutic candidates, developing advanced models and technologies, and using NAMs as potential treatments in preclinical and clinical contexts.
- Key bottlenecks in biology, technology, and regulation must be addressed for robust translational adoption of NAMs.
- Translational and societal considerations are essential for responsible NAM adoption, with future human-centric pipelines set to redefine drug discovery.