- WG Nanotherapeutics/Nano-enabled Medical Devices (G. TOSI, Università di Modena e Reggio Emilia, F. QUAGLIA, Università Federico II Napoli, G. PASUT, Università di Padova, G. CAVALLARO, Università di Palermo)
All the applications of nanotechnology in order to get innovative therapies for unmet medical needs. The WG covers well established concepts like nanoformulation of Active Pharmaceutical Ingredients (APIs) and Controlled Drug Delivery, but also more innovative frontier concepts like the interaction between nano enabled technologies and other therapeutic approaches like advanced therapies, active and passive targeting, nanotechnology for gene therapies, etc. Nanotechnology-enabled (nanoenabled) medical products consist of a broad and rapidly growing global catalog of human drug products, medical devices, and in vitro diagnostics (IVDs) that have been developed (or are in the process of being developed) for the main purpose of improving human health.
- WG Preclinical Evaluation (L. CALZA, Università di Bologna, M. VALENZA, Università di Milano)
WG on Preclinical Evaluation will be impacting on all the aspect on safety, efficacy, selection of nanomedicines for therapy or diagnosis with both in vitro and vivo experiments on cells, 3D models and diseased animal models, with a proper aim of creating clear efflux of data reliable, transferable and with the focus on producing proof for future clinical transfer up to TRL6, with GLP environments for testing. Major focus will be (i) appropriateness of the in vitro and in vivo models for efficacy studies, regarding the intended clinical use. Shared data repository for animal models characterization will be promoted, such as multicenter preclinical trials for efficacy studies; (ii) improvement of in vitro models of biological barriers (blood-brain, placental, intestinal, etc.) coupled to high content screening technologies; (iii) data reproducibility and replicability, starting from the appropriateness of the analytical methods; (iv) to provide the Italian platform with fast and reliable screening methods to accompanies the nanoenabled medical products along design and development until the prototype production, to progressively refine the nanoproduct; (v) to improve biodistribution studies, from in vivo to microscopy imaging.
- WG Clinical Interface & Regenerative Medicine (M. BEDONI, Fondazione Don Gnocchi)
WG Clinical Interface is aimed at bridging the gap between promising results from research and development activities and real application world represented by key clinical operators and healthcare providers at European level. Expert clinicians enter the process by bringing in their know-how in terms of unmet clinical needs and scientific sponsorship of clinical trials. Nanotechnologies and nanomaterials offer a wide range of new possibilities to optimize regenerative medicine, which is the process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function. Nanoparticles and nanofibers may notably act as carriers, targeting elements and/or scaffolds in combination with biomaterials, to trigger better and faster replacement of damaged tissues and organs by stimulating the body’s own repair mechanisms. This WG acts to promote and facilitate all these applications of nano-enabled regenerative medicines.
- WG Regulatory & Industrial Transfer (EMA, AIFA, Farmindustria)
The WG will be devoted to key aspect in Nanomedicine developments, namely the regulatory environments (namely rules for production, characterization, authorization, and so..) for novel and not novel products, as well as Industry driven approaches with highlights in scale-up and transfer into industrial development of nanomedicine, levering the TRL from 6 to 9.
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