In the pre-TNA phase focus has been on integrating scientific and regulatory input. However, their development progressed under the 2nd reporting period. For the TNA, correlation analysis of TNA results and modelling of the analytical decision process was performed and contributed to the rational and targeted improvements of the analytical assay cascade. The 1st reporting period was mostly dedicated to set up the infrastructure, its processes, its assays, its quality management system, and its management and operation. The first TNA campaign received 10 applications. However, during the hearings and discussions with the sponsors during the selection phase, the CET realised that some accompaniment of developer of nanomedicine was necessary to generate a wider impact on their development and finally, on the speed of delivery of these innovative nanomedicines to the market. These additional aspects were experimented in the second TNA campaign.
The major impact of EUNCL on the nanomed community during the third period is easily measured by the number of external applications received by EUNCL. 35 applications have been processed in three consecutive campaigns by the Core Expert Team with the input from the external peer reviewers. This exceeds by far our initial objective of 10-20 samples. 3 out of the 35 have even reached the ultimate stage of in vivo characterisation, which also exceed our initial objective. 35 SOPs have been produced and 3 protocols have been submitted to ASTM international for standardisation. This process has even further improved the collective assessment capacity of the Core Expert Team, resulting in a much stronger collective expertise in a wide range of nanomedicines. The Core Expert Team is a rare example of integration of EU knowledge coming from 8 different partners localised in 8 different Member States. A body of knowledge on the preclinical assessment of nanomedicines is now growing. This result is a more reliable support to applicants at an early stage of their development. The collective expertise put together by the Core Expert Team is not exceeding in quality and diversity what is available at US NCL, despite their longer history. It’s a good example of the beauty and effectiveness of EU cooperation. An indirect impact worth to mention is the submission and successful approval of a Research and Innovation Action – REFINE. REFINE project is dedicated to the refinement of the Science Regulation Framework for nanomedicines and nanobiomaterials and a way to further develop some analytical assays previously identified in the Joint Research Activities of EUNCL.
EUNCL has submitted a proposal for a new infrastructure dedicated to the characterisation of nanomaterials for medical use as an advanced community, called EUNCL2. EUNCL2 was looking at scaling up its analytical capacity to serve a larger basis of industrial users, mostly start-ups and SMEs, as well as reinforcing its services to users by providing tailored support before their application to increase their chances of success. After 4 years of operation of EUNCL we realised how diverse each nanomaterial for medical use was; this would require a tailored approach, case by case, in order to adapt the best analytical cascade to better fit the expectations from regulators at a later stage, when assessing the compound. Unfortunately, to our great despair, this EUNCL 2 proposal has not been retained by EC reviewers, leaving Europe without any centralised analytical infrastructure dedicated to nanomedicines.
