Project combines the expertise of nine partners in eight countries to foster innovation in nanomedicine and facilitate regulatory approval
CEA-Leti has announced the launch of the European Nano-Characterisation Laboratory (EU-NCL), which is funded by the European Union’s Horizon 2020 research and innovation programme.
Its main objective is to reach a level of international excellence in nanomedicine characterisation for medical indications such as cancer, diabetes, inflammatory diseases or infections, and make it accessible to any organisation developing candidate nanomedicines prior to their submission to regulatory agencies to get the approval for clinical trials and, later, marketing authorisation.
‘As reported in the ETPN White Paper, there is a lack of infrastructure to support nanotechnology based innovation in healthcare,’ said Patrick Boisseau, Head of Business Development in Nanomedicine at CEA-Leti and Chairman of the European Technology Platform Nanomedicine (ETPN).
‘Nanocharacterisation is the first bottleneck encountered by companies developing nanotherapeutics. The EU-NCL project is of great importance for the nanomedicine community as it will contribute to the competiveness of nanomedicine products and tools and facilitate regulation in Europe.’
EU-NCL is partnered with the sole international reference facility, the Nanotechnology Characterisation Lab of the National Cancer Institute in the US (US-NCL), to accelerate the international harmonisation of analytical protocols.
‘We are excited to be part of this co-operative arrangement between Europe and the US,’ said Scott E. McNeil, Director of US-NCL. ‘We hope this collaboration will help to standardise regulatory requirements for the clinical evaluation and marketing of nanomedicines internationally. This venture holds great promise for the use of nanotechnologies to overcome cancer and other major diseases around the world.’
EU-NCL is also closely connected to national medicine agencies and the European Medicines Agency to continuously adapt its analytical services to the requests of regulators. EU-NCL is designed, organised and operated according to the highest EU regulatory and quality standards.
This project is important for Europe, as it will be the first transnational infrastructure in nanomedicine. It aims to foster innovation by sharing knowledge and technologies between academia and industry.