SMEs are at the heart of innovation in EU. They play a vital role with their capacities to generate new ideas and quickly transform these into business assets. In this context NovaMechanics (R&D performing SME) express an interest for participation in the following projects :
Topic:NMBP-12-2017: Development of a reliable methodology for better risk management of engineered biomaterials in Advanced Therapy Medicinal Products and/or Medical Devices
Specific Challenge: The development of new biotechnology-based products needs to be complemented with a scientifically valid identification of the potential hazards from these biomaterials to human health and to the environment, together with the monitoring and reduction of the risk that these new technologies pose. Current knowledge is still incomplete and the established methods may be inappropriate for specific materials in view of their eventual deployment. The necessary integration of physical, chemical, biochemical and clinical methods is an open challenge. Hence, future production system engineering requires development of integrated and validated methodologies as basis for an appropriate integrated risk management.
Scope: The development of new biotechnology-based products needs to be complemented with a scientifically valid identification of the potential hazards from these biomaterials to human health and to the environment, together with the monitoring and reduction of the risk that these new technologies pose. Current knowledge is still incomplete and the established methods may be inappropriate for specific materials. Hence, future production system engineering requires validated methodologies as basis for an appropriate integrated risk management. As relevant, the proposed activities should address sex and gender specific aspects
Projects are expected to initiate and support standardisation of the proposed biomaterials and methods, including methods that will reflect their eventual deployment as part of Advanced Therapy Medicinal Products and/or Medical Devices. The expected projects should be related to validating, adapting and/or developing a reliable methodology for risk assessment and thorough overarching hazard identification for engineered biomaterials and should address the following areas:
Comparison and validation of current (and/or development including validation of new) test methods and test schemes, including in vitro and in silico methods, to detect adverse effects from biomaterials to:
human health including acute and chronic toxicity (oral, inhalation, dermal);
modelling toxicity behaviour of engineered Biomaterials, including development of ready-to-use predictive models (web services etc);
the environment; eco-toxicity tests, bioaccumulation, persistence, bioavailability and life cycle impacts onto all forms of biota.
Topic:NMP-28-2017: Framework and strategies for nanomaterial characterisation, classification, grouping and read-across for risk analysis
Specific Challenge: The number of available nanomaterials is growing rapidly and testing each material thoroughly is virtually impossible. For convincingly managing eventual risk, precise quantification of hazards and exposure would be necessary for all cases and engineering-out or reducing risk must follow in cases of non-acceptable risks. All engineered nanomaterials (ENMs) would need characterising along all value chains and all used media and physiological chemistries. It is therefore essential to set the basis for an appropriate and sustainable framework and define strategies towards ENMs classification, grouping (categorisation for further purposes) and read-across for risk analysis in a regulatory perspective.
Scope: The existing and rapidly progressing knowledge in this domain, in terms of characterisation of material properties and of possible adverse effects from their applications, is expected to allow for classification of ENMs based on morphology, composition, complexity/functionality, and by bio or eco-interactions. The classification approaches should aim to support grouping of ENMs for further risk analysis, to help in developing intelligent testing strategies and identifying "ENMs properties of concern" that need to be tested more thoroughly. Methods for grouping and for read-across within or between groups, should be defined to reduce unnecessary efforts in testing. Grouping can take into account quantification of possible adverse effects depending on the use on ENMs in specific applications. Results from these studies should be collected and combined in a consistent and progressive system enabling both the integration of newer data and the use of raw and aggregated data for regulatory purposes. Particular attention should be paid to supporting safer-by-design practices, so that novel products containing ENMs provide the benefits originally claimed by maintaining fullest possible intended functionality and at the same time pose the least possibly risks to humans, the environment and ecosystem services. The proposed projects should include appropriate data curation expertise, modelling (including development of theoretical models if appropriate) and input into the possible development of Q(n)SP/AR approaches in order to develop user friendly interfaces to enable data driven predictions from other ENMs with similar properties or behaviour, and predictive risk assessment tools.
The research approach should be innovative and represent a significant advance beyond the current state-of-the-art in the whole area of nanomaterials hazard and exposure assessment;
Sustainable solutions to the long-term challenge of nanosafety at a level that will allow both consistent integration of newer data and regulatory application of scientifically sound concepts;
Cutting-edge progress towards a framework and methods for groupings and read-across useable in a regulatory environment;
Demonstration of consistent, applicable and scientifically sound grouping and read-across strategies in specific value chains, ready for use by industry and regulators, enabling predictive hazard and exposure modelling for risk analysis, and including the input towards safer-by-design guidance;
Outputs should be tailored to address the needs of each of the stakeholder communities, including the modelling community. Delivered predictive models and tools should be disseminated through publically available, ready-to-use applications.
NovaMechanics contribution: modelling toxicity behaviour of engineered Biomaterials, including development of ready-to-use predictive models (web services etc), molelling and simulation, nano-QSAR, QNAR, data analysis, chemoinformatics (cheminformatics), QSAR, toxicity prediction, computational models of structure-property-activity relationships, identify the key physico-chemical parameters, predictive toxicology, computational chemistry, virtual screening, de novo design, , materials by rational design, computational screening, High Content Analysis (HCA), methods for groupings and read-across
Melagraki Georgia*; Afantitis Antreas* A Risk Assessment Tool for the Virtual Screening of Metal Oxide Nanoparticles through Enalos InSilicoNano Platform Current Topics in Medicinal Chemistry, Volume 15, Number 18, September 2015, pp. 1827-1836(10) 2015 (link)
Georgia Melagraki*, Antreas Afantitis*, Enalos InSilicoNano Platform: An online decision support tool for the design and virtual screening of nanoparticles RSC Advances 2014, 4, 50713-50725 2014 (link)
Book Chapter: Quantitative Nanostructure-Activity Relationship Models for the Risk Assessment of NanoMaterials Author(s)/Editor(s): Eleni Vrontaki ; Thomas Mavromoustakos ; Georgia Melagraki* ; Antreas Afantitis* ISBN13: 9781466681361; EISBN13: 9781466681378(link)