New Approach Methodologies for Drug Discovery
Traditional animal‑based drug discovery suffers a 90 % failure rate, prompting regulators and scientists to adopt human‑centric new approach methodologies (NAMs). Recent policy shifts—including the FDA Modernization Act 2.0 that removes mandatory animal testing and the NIH’s 2025 Organoid Development Center—create a clear regulatory pathway for NAMs. Stem‑cell, organoid, organ‑on‑a‑chip and AI‑driven in silico platforms now span the entire discovery continuum, from disease modeling to efficacy testing. Early IND approvals using exclusively NAMs signal a transformative change in preclinical strategy.
Atomic Unification in Molecular AI
Artificial intelligence has rapidly advanced molecular science, yet progress has largely unfolded through specialized models tailored to specific tasks. In this issue of Cell, Peng et al. introduce PocketXMol, a unified 3D generative framework that reframes molecular design problems as conditional...
RNA Modifications in Gene Regulation: Functions and Pathways
RNA epigenetics has expanded to over 170 chemically modified nucleotides that shape gene expression at transcriptional and post‑transcriptional levels. The review highlights m6A as the most studied mark, detailing its writer‑METTL3/14 complex, erasers FTO/ALKBH5, and diverse readers that control RNA...