In an IQ Consortium working-group survey of 45 companies in Asia, the United States and Europe, NAM use was most prevalent in early discovery. Uncertainty about regulatory acceptance and human translatability was cited most often as a barrier.
The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium), a pharmaceutical and biotechnology R&D consortium, examined how companies identify, assess and implement new approach methodologies (NAMs). Its 3Rs Implementation of Replacement Working Group conducted the survey. Responses came from 45 organizations, predominantly large and midsize companies headquartered across Asia, the United States and Europe.
Respondents described governance, accountability, evaluation strategies and use across drug development. NAM use was most prevalent in early discovery. The working group saw scope for wider use at later decisions that involve regulatory submissions.
The most frequently cited barriers were uncertainty about health-authority acceptance and whether findings would translate to humans. Respondents pointed to a health-authority-accepted NAM database, real-world evidence of validity and shared knowledge infrastructure as useful enablers.
Among these respondents, the absence of harmonised frameworks, validated-method databases and clearly defined contexts of use helps explain why companies differ in how they evaluate and govern NAMs. The requested infrastructure reflects their reported needs for later-stage implementation.
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