Abstract

The first two decades of the 21^st century has seen a rapid increase, from a near zero base, for European nanosafety and nanomedicine research. This has been achieved by dramatically increasing funding and establishing effective networks of experts in both disciplines to drive forward science and technology for both and inform EU Research and Innovation planning. Initially, both disciplines focused on their respective areas, but from 2010 onwards they increasingly co-operated to better drive forward their respective disciplines and achieve safe and ethical solutions for future industrial and clinical beneficiaries of their respective science areas. At the junction of the 2^nd and 3^rd decades and the transition from Horizon 2020 and Horizon Europe Programs, it is possible to describe general Safe-by-Design principles for nanoenabled pharmaceuticals and implanted medical devices that are heavily dependent on the new science created by nanosafety and nanomedicine science to meet the demanding clinical requirements of the 3^rd decade.

Keywords: Nanomedicine; Nanoenabled Medical Devices; Nanosafety; Hazard; Exposure; Nano-EHS; Safe-by-Design

References

1. Wilkins TA. Mid-term assessment”. FP6-TP3: Nanotechnology and Nanosciences, Knowledge-based Multifunctional Materials, New Production Processes and Devices Expert Advisory Group Sixth Framework Programme (2002-2006), Thematic Priority 3, European Commission (2005).
2. Nanosafety Cluster.
3. Ritz S., et al. “Protein Corona of Nanoparticles: Distinct Proteins Regulate the Cellular Uptake”. Biomacromolecules 4 (2015): 1311-1321.
4. FP7 NANoREG Project - framework for the safety assessment of nanomaterials.
5. H2020 PROSAFE Project – Actions for Best Practice.
6. Wilkins TA., et al. “QSAR ref (Q)SAR modelling of nanomaterial toxicity: A critical review”. Particuology 21 (2015): 1-19.
7. Wilkins TA., et al. “Nano (Q) SAR: Challenges, pitfalls and perspectives”. Nanotoxicology5 (): 636-642.
8. Oksel C., et al. “Literature Review of (Q)SAR Modelling of Nanomaterial Toxicity”. Modelling the Toxicity of Nanomaterials (2017):103-142.
9. Gousiadi C., et al. “Machine Learning Predictions of Concentration-Specific Aggregate Hazard Scores of Inorganic Nanomaterials in Embryonic Zebrafish (2020).
10. Wilkins TA, Newton-Dunn W (MEP): “Small SIZE: BIG Impact”, Nanotechnology in Society Explained, EU Parliament monograph (2012).
11. Biannual Comparative Survey of Industrial Technologies, European Chemical Industry Facts and Figures, CEFIC, Brussels (2014).
12. Nanomedicine European Technology Platform.
13. H2020 EU BIORIMA Project | Risk Management of Biomaterials (2017-2021).
14. Wilkins TA., et al. “Physicochemical Characterization and Biological Evaluation of Alpha, Beta and Amorphous Silicon Nitride Particles for Healthcare Applications”. Nanotoxicology (2020).
15. Wilkins TA., et al. “Calcination of Titanium Dioxide”. EP 0 767 222 B1; Assigned to Tioxide Group Services Ltd; Filed in (1996).
16. Afnan A (2004).
17. Kurtz S., et al. “Projections of primary and Revisions of Hip and Knee Arthroplasty in the United States from 2005 to 2030”. Journal of Bone and Joint Surgery4 (2007): 780-785.
18. FP7 LLJ – lifelongjoints Project - Silicon Nitride Coatings For Improved Implant Function.