Last week, after participating in the 12 month meeting of the H20H20 project nTRACK, we attended to the meeting with the EMA’s Innovation Task Force (ITF) to discuss the regulatory pathway and other topics of this product.
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 companies.
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