TY - JOUR
KW - 3Rs
KW - Animals
KW - Drug Evaluation, Preclinical
KW - Drug Industry
KW - Drug-Related Side Effects and Adverse Reactions
KW - Humans
KW - New Approach Methodologies (NAMs)
KW - Risk Assessment
KW - case examples
KW - Drug development
KW - industry consortium
KW - nonclinical safety
KW - nonhuman primate
KW - pharmaceuticals
KW - regulatory submission
KW - replacement of animals
AU - Jacintha Shenton
AU - Imein Bousnina
AU - Michael Oropallo
AU - Rhiannon David
AU - Lucinda Weir
AU - Thomas K. Baker
AU - Helen-Marie Dunmore
AU - Remi Villenave
AU - Mary McElroy
AU - Betty Pettersen
AU - Tushar Kokate
AU - Claudette L. Fuller
AU - Kimberly A. Homan
AU - Eloise Hudry
AU - Charles Wood
AU - Sam Gunter
AB - Sharing New Approach Methodology (NAM)-based regulatory experiences is crucial for improving human risk assessment and reducing animal use in drug safety testing. To foster broader adoption, the Biotechnology Innovation Organization surveyed companies about NAM usage and collected case studies showcasing NAM-based regulatory filings for biotherapeutics, where NAMs replaced large animal studies for safety assessment. These scientifically justified approaches were generally accepted by global health authorities, particularly in the context of species relevance limitations, prior target modulation experience, and/or when addressing severe disease. Despite successes with NAM-based global regulatory filings, there are concerns from companies about global regulatory harmonization and clinical translatability. NAMs have the potential for greater uptake with enhanced guidance and industry-regulatory agency collaboration being key to their adoption.
BT - Drug Discovery Today
DA - 2025-04
DO - 10.1016/j.drudis.2025.104328
IS - 4
LA - eng
N2 - Sharing New Approach Methodology (NAM)-based regulatory experiences is crucial for improving human risk assessment and reducing animal use in drug safety testing. To foster broader adoption, the Biotechnology Innovation Organization surveyed companies about NAM usage and collected case studies showcasing NAM-based regulatory filings for biotherapeutics, where NAMs replaced large animal studies for safety assessment. These scientifically justified approaches were generally accepted by global health authorities, particularly in the context of species relevance limitations, prior target modulation experience, and/or when addressing severe disease. Despite successes with NAM-based global regulatory filings, there are concerns from companies about global regulatory harmonization and clinical translatability. NAMs have the potential for greater uptake with enhanced guidance and industry-regulatory agency collaboration being key to their adoption.
PY - 2025
EP - 104328
T2 - Drug Discovery Today
TI - Opportunities and insights from pharmaceutical companies on the current use of new approach methodologies in nonclinical safety assessment
VL - 30
SN - 1878-5832
ER -