Impact and effectiveness of risk mitigation strategies on the insurability of nanomaterial production: evidences from industrial case studies

Bergamaschi, Enrico; Murphy, Finbarr; Poland, Craig A.; Mullins, Martin; Costa, Anna Luisa; McAlea, Eamonn M.; Tran, Lang; Tofail, Syed A. M.

doi:10.1002/wnan.1340

Cited by 22 publications

(19 citation statements)

References 47 publications

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“…One of the major problems in reaching the market is the scaling up of the synthesis process [7,12,54,78]. Although controlled at the laboratory scale, in medium- and large-scale production, other factors affect the process, and batch-to-batch variations appear in nanomedicines’ characteristics that prevent clinical testing [10,38].…”

Section: Development Of Novel Nanomedicinesmentioning

confidence: 99%

“…There is an urgent need for effective communication between research labs, public initiatives, and all internal and external stakeholders (e.g., clinicians, investors, etc.) involved in each project, applying risk-mitigation strategies to demonstrate the cost-effectiveness (Figure 4) that makes nanomedicine different or relevant compared to current therapies, therefore seeing it as a cutting-edge technology for the treatment of human healthcare and the improvement of a country’s economy [7,19,54,78,79]. At this point, it is important to highlight the problem of risk aversion from industries and economic stakeholders, which prevents nanomedicines from even starting to be developed [34].…”

Section: Development Of Novel Nanomedicinesmentioning

confidence: 99%

“…Currently, the regulatory field is not yet mature: the development of nanomedicines has evolved faster than the regulations [34,78], and there is still no specific regulation regarding nanomedicine in the European Union [4,7,10,78]. Regulatory reform is required for nanomedicine to establish “nanoguidelines” in order to facilitate their translation into commercial products, since traditional regulations are not appropriate for nanoproducts [7,12].…”

Section: Pharmaceutical Industry Opportunitiesmentioning

confidence: 99%

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Personalized Nanomedicine: A Revolution at the Nanoscale

Fornaguera

García-Celma

2017

JPM

124

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Nanomedicine is an interdisciplinary research field that results from the application of nanotechnology to medicine and has the potential to significantly improve some current treatments. Specifically, in the field of personalized medicine, it is expected to have a great impact in the near future due to its multiple advantages, namely its versatility to adapt a drug to a cohort of patients. In the present review, the properties and requirements of pharmaceutical dosage forms at the nanoscale, so-called nanomedicines, are been highlighted. An overview of the main current nanomedicines in pre-clinical and clinical development is presented, detailing the challenges to the personalization of these therapies. Next, the process of development of novel nanomedicines is described, from their design in research labs to their arrival on the market, including considerations for the design of nanomedicines adapted to the requirements of the market to achieve safe, effective, and quality products. Finally, attention is given to the point of view of the pharmaceutical industry, including regulation issues applied to the specific case of personalized medicine. The authors expect this review to be a useful overview of the current state of the art of nanomedicine research and industrial production, and the future opportunities of personalized medicine in the upcoming years. The authors encourage the development and marketing of novel personalized nanomedicines.

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Section: Development Of Novel Nanomedicinesmentioning

confidence: 99%

Section: Development Of Novel Nanomedicinesmentioning

confidence: 99%

Section: Pharmaceutical Industry Opportunitiesmentioning

confidence: 99%

See 1 more Smart Citation

Personalized Nanomedicine: A Revolution at the Nanoscale

Fornaguera

García-Celma

2017

JPM

124

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“…12,[32][33][34] SWCNTs can be used in sensors, electronic devices, wastewater treatment, and many other applications. Exposure to SWCNTs could also be due to the use of CNTs in biomedical applications, such as drug delivery systems and cancer treatment.…”

Section: Discussionmentioning

confidence: 99%

Systemic distribution of single-walled carbon nanotubes in a novel model: alteration of biochemical parameters, metabolic functions, liver accumulation, and inflammation in vivo

Principi¹,

Girardello²,

Bruno³

et al. 2016

IJN

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The increasing use of carbon nanotubes (CNTs) in several industrial applications raises concerns on their potential toxicity due to factors such as tissue penetrance, small dimensions, and biopersistence. Using an in vivo model for CNT environmental exposure, mimicking CNT exposition at the workplace, we previously found that CNTs rapidly enter and disseminate in the organism, initially accumulating in the lungs and brain and later reaching the liver and kidneys via the bloodstream in CD1 mice. Here, we monitored and traced the accumulation of single-walled CNTs (SWCNTs), administered systemically in mice, in different organs and the subsequent biological responses. Using the novel in vivo model, MITO-Luc bioluminescence reporter mice, we found that SWCNTs induce systemic cell proliferation, indicating a dynamic response of cells of both bone marrow and the immune system. We then examined metabolic (water/food consumption and dejections), functional (serum enzymes), and morphological (organs and tissues) alterations in CD1 mice treated with SWCNTs, using metabolic cages, performing serum analyses, and applying histological, immunohistochemical, and ultrastructural (transmission electron microscopy) methods. We observed a transient accumulation of SWCNTs in the lungs, spleen, and kidneys of CD1 mice exposed to SWCNTs. A dose- and time-dependent accumulation was found in the liver, associated with increases in levels of aspartate aminotransferase, alanine aminotransferase and bilirubinemia, which are metabolic markers associated with liver damage. Our data suggest that hepatic accumulation of SWCNTs associated with liver damage results in an M1 macrophage-driven inflammation.

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“…This information can be used to facilitate risk assessment, where more detailed information is lacking. So called 'read across' methods are being developed for nanotechnology (Bergamaschi et al, 2015). Using information which is known (for example data from asbestos, showing the toxicity of fibres with a high aspect ratio; or evidence regarding the adverse impacts of insoluble ultrafine particles from pollution) can be used to predict the toxicity of other fibres or materials.…”

Section: Better Utilisation Of Knowledgementioning

confidence: 99%

Managing the unknown – Addressing the potential health risks of nanomaterials in the built environment

Jones

Gibb

Goodier

et al. 2016

Construction Management and Economics

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Nanomaterials offer significant potential for high performing new products in the built environment and elsewhere. However, there are uncertainties regarding their potential adverse health effects and the extent to which they are currently used. A desk study and interviews with those working across the construction, demolition and product manufacture sectors (n=59) identified the current state of knowledge regarding nanomaterial use within the built environment. Some nanomaterials are potentially toxic, particularly those based on fibres; others are much less problematic but the evidence base is incomplete. Very little is known regarding the potential for exposure for those working with nano-enabled construction materials. Identifying which construction products contain nanomaterials, and which nanomaterials these might be, is very difficult due to inadequate labelling by product manufacturers. Consequently, those working with nanoenabled products typically have very limited knowledge or awareness of this. Further research is required regarding the toxicology of nanomaterials and the potential for exposure during construction and demolition. Better sharing of the information which is already available is also required through the construction, demolition and manufacture / supply chains. This is likely to be important for other innovative products and processes in construction, not just those which use nanomaterials.

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Impact and effectiveness of risk mitigation strategies on the insurability of nanomaterial production: evidences from industrial case studies

Cited by 22 publications

References 47 publications

Personalized Nanomedicine: A Revolution at the Nanoscale

Personalized Nanomedicine: A Revolution at the Nanoscale

Systemic distribution of single-walled carbon nanotubes in a novel model: alteration of biochemical parameters, metabolic functions, liver accumulation, and inflammation in vivo

Managing the unknown – Addressing the potential health risks of nanomaterials in the built environment

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