Safe- and sustainable-by-design: The case of Smart Nanomaterials. A perspective based on a European workshop.

The European Commission's Green Deal is a major policy initiative aiming to achieve a climate-neutral, zero-pollution, sustainable, circular and inclusive economy, driving both the New Industrial Strategy for Europe and the Chemicals Strategy for Sustainability. Innovative materials can help to reach these policy goals, but they need to be safe and sustainable themselves. Thus, one aim is to shift the development of chemicals to Safe- and Sustainable-by-Design, and define a new systems approach and criteria for sustainability to achieve this. An online workshop was organised in September 2020 by the Joint Research Centre and the Directorate-General Research and Innovation of the European Commission, with participants from academia, non-governmental organisations, industry and regulatory bodies. The aims were to introduce the concept of Safe- and Sustainable-by-Design, to identify industrial and regulatory challenges in achieving safer and more sustainable Smart Nanomaterials as an example of innovative materials, and to deliver recommendations for directions and actions necessary to meet these challenges. The following needs were identified: (i) an agreed terminology, (ii) a common understanding of the principles of Safe- and Sustainable-by-Design, iii) criteria, assessment tools and incentives to achieve a transition from Safe-by-Design to Safe- and Sustainable-by-Design, and (iv) preparedness of regulators and legislation for innovative chemicals/nanomaterials. This paper presents the authors' view on the state of the art as well as the needs for future activities, based on discussions at the workshop and further considerations. The case of Smart Nanomaterials is used to illustrate the Safe- and Sustainable-by-Design concept and challenges for its implementation. Most of the considerations can be extended to other advanced materials and to chemicals and products in general.

The Sustainability Challenge of Food and Environmental Nanotechnology: Current Status and Imminent Perceptions.

Nanotechnology is a connection among various branches of science with potential applications that extend over a variety of scientific disciplines, particularly in the food science and technology fields. For nanomaterial applications in food processing, such as antimicrobials on food contact surfaces along with the improvement of biosensors, electrospun nanofibers are the most intensively studied ones. As in the case of every developing skill, an assessment from a sustainability point of view is necessary to address the balance between its benefits to civilization and the unwanted effects on human health and the environment. The current review aimed to provide an update regarding the sustainability of current nanotechnology applications in food science technology, environment, and public health together with a risk assessment and toxicity evaluation.

Biophotonics: the big picture.

The 5th International Conference on Biophotonics (ICOB) held April 30 to May 1, 2017, in Fremantle, Western Australia, brought together opinion leaders to discuss future directions for the field and opportunities to consider. The first session of the conference, "How to Set a Big Picture Biophotonics Agenda," was focused on setting the stage for developing a vision and strategies for translation and impact on society of biophotonic technologies. The invited speakers, panelists, and attendees engaged in discussions that focused on opportunities and promising applications for biophotonic techniques, challenges when working at the confluence of the physical and biological sciences, driving factors for advances of biophotonic technologies, and educational opportunities. We share a summary of the presentations and discussions. Three main themes from the conference are presented in this position paper that capture the current status, opportunities, challenges, and future directions of biophotonics research and key areas of applications: (1) biophotonics at the nano- to microscale level; (2) biophotonics at meso- to macroscale level; and (3) biophotonics and the clinical translation conundrum.

Assessing the protection of the nanomaterial workforce.

Responsible development of any technology, including nanotechnology, requires protecting workers, the first people to be exposed to the products of the technology. In the case of nanotechnology, this is difficult to achieve because in spite of early evidence raising health and safety concerns, there are uncertainties about hazards and risks. The global response to these concerns has been the issuance by authoritative agencies of precautionary guidance to strictly control exposures to engineered nanomaterials (ENMs). This commentary summarizes discussions at the "Symposium on the Health Protection of Nanomaterial Workers" held in Rome (25 and 26 February 2015). There scientists and practitioners from 11 countries took stock of what is known about hazards and risks resulting from exposure to ENMs, confirmed that uncertainties still exist, and deliberated on what it would take to conduct a global assessment of how well workers are being protected from potentially harmful exposures.

China and the United States--Global partners, competitors and collaborators in nanotechnology development.

USA and China are two leading countries engaged in nanotechnology research and development. They compete with each other for fruits in this innovative area in a parallel and compatible manner. Understanding the status and developmental prospects of nanotechnology in USA and China is important for policy-makers to decide nanotechnology priorities and funding, and to explore new ways for global cooperation on key issues. We here present the nanoscience and nanomedicine research and the related productivity measured by publications, and patent applications, governmental funding, policies and regulations, institutional translational research, industrial and enterprise growth in nanotechnology-related fields across China and USA. The comparison reveals some marked asymmetries of nanotechnology development in China and USA, which may be helpful for future directions to strengthen nanotechnology collaboration for both countries, and for the world as a whole.

Caring for nanotechnology? Being an integrated social scientist.

One of the most significant shifts in science policy of the past three decades is a concern with extending scientific practice to include a role for 'society'. Recently, this has led to legislative calls for the integration of the social sciences and humanities in publicly funded research and development initiatives. In nanotechnology--integration's primary field site--this policy has institutionalized the practice of hiring social scientists in technical facilities. Increasingly mainstream, the workings and results of this integration mechanism remain understudied. In this article, I build upon my three-year experience as the in-house social scientist at the Cornell NanoScale Facility and the United States' National Nanotechnology Infrastructure Network to engage empirically and conceptually with this mode of governance in nanotechnology. From the vantage point of the integrated social scientist, I argue that in its current enactment, integration emerges as a particular kind of care work, with social scientists being fashioned as the main caretakers. Examining integration as a type of care practice and as a 'matter of care' allows me to highlight the often invisible, existential, epistemic, and affective costs of care as governance. Illuminating a framework where social scientists are called upon to observe but not disturb, to reify boundaries rather than blur them, this article serves as a word of caution against integration as a novel mode of governance that seemingly privileges situatedness, care, and entanglement, moving us toward an analytically skeptical (but not dismissive) perspective on integration.

La gran revolución de lo pequeño: nanotecnologías y prevención de riesgos laborales / The great revolution of the small: nanotechnology and occupational risk prevention

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H2020 EU Research & Innovation Program Boost the Transfer of Technological Breakthroughs, Enable New Solutions for Personalised Health and Impact the Industry and Healthcare Systems.

Our Healthcare systems worldwide are facing grand challenges that can be addressed by intelligent, miniaturized and interconnected devices. Many of today's pharmaceutical drugs create bigger problems than solutions, as drugs help only 40% of the patients and kill, in the USA alone, over 100,000 people per year. The widespread use of antibiotics has led to new strands of bacteria that defy all known antibiotics and kill well over 100,000 people yearly in the world. Outbreaks of infections by new viruses and anti-resistant bacteria are expected with even more grave consequences. The quality of food around the world is steadily deteriorating, as the soils are becoming depleted of essential nutrients and contain increasing amounts of pesticides, herbicides and fungicides. Our environment is burdened with 2.5 billion tonnes of chemicals per year that accumulate in the soil, groundwater, rivers and seas, and eventually end up in our food and our drinking water. As a consequence, there is a strong increase in the incidence of diseases hardly known fifty years ago. In parallel, an increasing number of people are taking the responsibility for their health and well-being in their own hands and are looking for mobile and in-obtrusive ways to objectively monitor their health status. The development of intelligent, miniaturized systems, by the heterogeneous integration of technologies such as micro- and nano-electronics, photonics, biotechnology, materials and information & communication, addresses these issues and has received intensive public support in the EU over the past two decades in the FP6 and FP7 programs. Proven concepts and functional prototypes exist with the potential to create new opportunities to improve our healthcare systems, in particular personalized or precision medicine. These device concepts offer unique abilities to sense, detect, analyze, communicate, respond, and monitor phenomena from the macro (e.g. body, tissues) to the nano scale (e.g. molecules, genes) on the spot, with short response times. For the majority of the projects, the planning for the next phase of prototype validation, through product design, supply chain setup, user targeting, clinical validation and commercial roll-out is now taking full attention. However, significant hurdles exist in the successful translation of the new technology to new products. As these technologies are new-to-the-world the resulting products carry a high risk, often necessitating the creation of new companies. Therefore the EU has developed the Horizon 2020 program as a framework for technology development and new business creation. Horizon 2020 is focusing on support for technology transfer, and on building ecosystems and value chains to ensure shorter times-to-market, thus enabling a higher impact of knowledge-based technologies. This paper will argue the necessity of developing these new class of devices, discuss its state-of-the-art, and the challenges for the implementation of Horizon 2020 and the new opportunities in intelligent miniaturized systems for pHealth.

Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars.

Nanomedicines are highly complex products and are the result of difficult to control manufacturing processes. Nonbiological complex drugs and their biological counterparts can comprise nanoparticles and therefore show nanomedicine characteristics. They consist of not fully known nonhomomolecular structures, and can therefore not be characterized by physicochemical means only. Also, intended copies of nanomedicines (follow-on similars) may have clinically meaningful differences, creating the regulatory challenge of how to grant a high degree of assurance for patients' benefit and safety. As an example, the current regulatory approach for marketing authorization of intended copies of nonbiological complex drugs appears inappropriate; also, a valid strategy incorporating the complexity of such systems is undefined. To demonstrate sufficient similarity and comparability, a stepwise quality, nonclinical and clinical approach is necessary to obtain market authorization for follow-on products as therapeutic alternatives, substitution and/or interchangeable products. To fill the regulatory gap, harmonized and science-based standards are needed.

Nanotechnology and the diagnosis/treatment of leishmaniasis / La nanotecnología y el diagnóstico/tratamiento de la leishmaniasis

Aim: The review article updates the current state of the art in the engineering of nanoplatforms against leishmaniasis. Special attention is devoted to the development of drug nanocarriers to be given to patients through the parenteral, topical, and oral routes of administration. Challenges and opportunities coming from advanced formulation methods/strategies introduced in the design of these nanosystems are emphasized. Finally, particular attention is also given to the use of nanoparticulate systems for vaccine delivery and for the diagnosis of the disease. Materials and Methods: To that aim, the Web sites of PubMed, HCAplus, Thomson, and Registry were used as the main sources to perform the search for the most significant research articles published on the subject. The information was then carefully analyzed, highlighting the most important preclinical results in the development of nanomedicines against leishmaniasis, as well considering vaccine delivery systems and nanoparticulate-based diagnosis. Results and Conclusion: The introduction of nanotechnology into the leishmaniasis arena is intended to optimize both the diagnosis and treatment (drug/vaccine therapy) of the disease. The objective is always to improve the selectivity of the imaging molecules or drugs/vaccines toward the parasite, especially when it is located inside phagocytic cells and neutrophils, while keeping to a very minimum the toxic side effects. Of course, only the wise engineering of the nanoparticulate delivery system will assure the best diagnostic/therapeutic outcomes

Objetivos: Este trabajo pretende actualizar la situación actual en el diseño de nanoplataformas contra la leishmaniasis. En este sentido, especial atención merecen los nanotransportadores de fármacos diseñados para ser administrados al paciente a través de las vías de administración parenteral, tópica y oral. Asimismo, se discuten las posibilidades que ofrecen las técnicas o estrategias de formulación más avanzadas en el diseño de estas nanoplataformas biomédicas. Finalmente, también se dedica especial atención a la utilización de estos nanosistemas en la administración de vacunas y en el diagnóstico de la leishmaniasis. Material y Métodos: Con este fin, se utilizaron las páginas Web PubMed, HCAplus, Thomson y Registry como principales fuentes para la búsqueda de los trabajos de investigación más interesantes publicados sobre la materia. La información así obtenida fue cuidadosamente analizada, resaltando aquellos resultados preclínicos más relevantes en cuanto al desarrollo de nanomedicamentos contra la leishmaniasis, y considerando también los nanosistemas transportadores de vacunas y las nanoplataformas de utilidad en el diagnóstico de esta enfermedad. Resultados y conclusiones: La nanotecnología es utilizada para mejorar el diagnóstico y tratamiento de la leishmaniasis. El objetivo es, en todos los casos, la mejora de la selectividad por el parásito de los fármacos, vacunas y moléculas utilizadas como agentes de contraste en técnicas de imagen, especialmente cuando este microorganismo se encuentra localizado en el interior de macrófagos y neutrófilos. Con esta interesante nanoherramienta, se puede también obtener una significativa reducción en la aparición y severidad de la toxicidad asociada a las técnicas de diagnóstico y tratamiento de la leishmaniasis. Es evidente que sólo con un inteligente diseño de estos nanosistemas se logran los mejores resultados de diagnóstico y terapia de la enfermedad

Issues and concerns in nanotech product development and its commercialization.

The revolutionary and ubiquitous nature of nanotechnology has fetched it a considerable attention in the past few decades. Even though its enablement and application to various sectors including pharmaceutical drug development is increasing with the enormous government aided funding for nanotechnology-based products, however the parallel commercialization of these systems has not picked up a similar impetus. The technology however does address the unmet needs of pharmaceutical industry, including the reformulation of drugs to improve their solubility, bioavailability or toxicity profiles as observed from the wide array of high-quality research publications appearing in various scientific journals and magazines. Based on our decade-long experience in the field of nanotech-based drug delivery systems and extensive literature survey, we perceive that the major hiccups to the marketing of these nanotechnology products can be categorized as 1) inadequate regulatory framework; 2) lack of support and acceptance by the public, practicing physician, and industry; 3) developmental considerations like scalability, reproducibility, characterization, quality control, and suitable translation; 4) toxicological issues and safety profiles; 5) lack of available multidisciplinary platforms; and, 6) poor intellectual property protection. The present review dwells on these issues elaborating the trends followed by the industry, regulatory role of the USFDA and their implication, and the challenges set forth for a successful translation of these products from the lab and different clinical phases to the market.

Reflecting on public engagement and science policy.

This article presents a personal reflection on the evolution of thinking about public engagement with science in the UK, with a particular emphasis on the experience with nanotechnology.

Building the capacity for public engagement with science in the United States.

This paper reviews efforts of the Center for Nanotechnology in Society at Arizona State University (CNS-ASU) to begin to build capacity for public engagement with science in the United States. First, the paper sets a context in the US of the current challenges to democracy and for science. It then reviews the literature on the accomplishments of the National Citizens' Technology Forum (NCTF) on nanotechnology and human enhancement, held in 2008, as well as some caveats that emerged from that enterprise. It concludes with a brief discussion of two kinds of activities - participation in the World Wide Views process organized by the Danish Board of Technology, and methodological innovations that include more concrete and experiential modes of engagement - that have spun off from the NCTF.