title: What can nanosafety learn from drug development? The feasibility of "safety by design".
abstract: "Safety by design" (SbD) is an intuitively appealing concept that is on the rise within nanotoxicology and nanosafety research, as well as within nanotechnology research policy. It leans on principles established within drug discovery and development (DDD) and seeks to address safety early, as well as throughout product development. However, it remains unclear what the concept of SbD exactly entails for engineered nanomaterials (ENMs) or how it is envisioned to be implemented. Here, we review the concept as it is emerging in European research and compare its resemblance with the safety testing and assessment practices in DDD. From this comparison, it is clear that "safety" is not obtained through DDD, and that SbD should be considered a starting point rather than an end, meaning that products will still need to progress through thorough safety evaluations and regulation. We conclude that although risk reduction is clearly desirable, the way SbD is currently communicated tends to treat safety as an inherent material property and that this is fundamentally problematic as it represents a recasting and reduction of societal issues into technical problems. SbD therefore faces a multitude of challenges, from practical implementation to unrealistic stakeholder expectations.
authors.affiliation: a Department of Environmental Engineering , Technical University of Denmark , Kgs. Lyngby , Denmark.
authors.forename: Rune
authors.initials: R
authors.lastname: Hjorth
authors.affiliation: b Department of Society, Ecology and Ethics , GenØk Centre for Biosafety , Tromsø , Norway.
authors.forename: Lilian
authors.initials: L
authors.lastname: van Hove
authors.affiliation: b Department of Society, Ecology and Ethics , GenØk Centre for Biosafety , Tromsø , Norway.
authors.forename: Fern
authors.initials: F
authors.lastname: Wickson
mesh_terms: D055808:Drug Discovery; D006801:Humans; D049329:Nanostructures / Q000633:toxicity*; D036103:Nanotechnology; D012449:Safety; D014116:Toxicology
keywords: Safety by design; drug development; nanosafety; nanotoxicology