attended the nTrack
consortium kick-off meeting in Barcelona on the 16-17th of October 2017 at Leitat Technological Center
in Barcelona. Leitat, the coordinator of the project and consortium, and a scientific and technological managing partner, organized the meeting which was attended by all 12 partners from 6 countries including representatives from nanotechnology, biotherapy, medicine and regulatory affairs fields.
Within nTrack, Asphalion will have a tight collaboration with Dutch National Institute for Public Health and the Environment
(RIVM), the leader of the regulatory work package of the project, but will also be in close collaboration with all the other partners involved. Asphalion will participate in several tasks including: the development of a regulatory strategy and roadmap that includes several consultations with the Competent Authorities through scientific advice procedures
. One of the key aims of the project will be the difficult task of qualifying novel methodologies and cutting edge technologies with the EMA.
Additionally, Asphalion will contribute to the preparation of regulatory documentation to support future clinical investigations and provide ongoing advice and recommendations regarding the regulatory steps of nanotechnology-enabled cell therapy. Asphalion is proud to participate in the consortium and looks forward to a challenging and fruitful collaboration with all partners.
The main goal of nTrack is to develop a safe and highly sensitive multimodal nano-imaging agent enabling non-invasive, quantitative and longitudinal stem cell tracking and whole body biodistribution, in concomitant with the detection of cell functionality and long-term viability using the combination of positron emission tomography-computed tomography (PET-CT) and positron emission tomography-magnetic resonance imaging (PET-MRI), which are both structural and functional imaging modalities that are clinically available. A second goal of nTrack is to establish a predictive model for early assessment of treatment effectiveness for muscle regeneration, based on short-term evaluation of the typical migration and biodistribution patterns of stem cells. This predictive model could substantially improve overall management of the treated disease and will transform cell therapy treatment from “one size fits all” concept towards personalised treatment.
ASPHALION is an International Scientific and Regulatory Affairs consultancy firm based in Barcelona, Madrid and Munich. We offer comprehensive services
for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices
Since 2000, we have consistently grown and now have over 70 professional consultants with backgrounds in Life Sciences (Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Medicine and Veterinary Medicine). Our consultants are experts in their field and are in direct contact with EU agencies (EMA and NCAs) for the development and implementation of new regulatory standards.
Asphalion provides a global range of services, for global clients. Our services range from early development, throughout the registration, until marketing and post-commercialization phases of your product.
Through our network of regulatory consultants, Asphalion is in a position to support your worldwide scientific & regulatory activities. We make use of a dedicated US agent in the fields of Pharma/Biotech, Medical Devices and In Vitro Diagnostics.
Asphalion is actively participating in Horizon 2020 programmes as a partner of several consortiums funded under this European Commission initiative to translate research ideas into the market.
Cristina Ustrell – Asphalion
nTrack: This research project has received funding from the EU’s H2020 framework programme for research and innovation under grant agreement no. 761031.