Invitation for ATMP-developers to help improve product development and its regulation
Advanced Therapy Medicinal Products (ATMPs) are medicinal products including gene therapies, somatic cell therapies and tissue engineered products. They are characterised by their innovative character, frequently addressing disease with high unmet medical need. Despite considerable development activity in this dynamic field, a limited number of ATMPs have received Market Authorisation in the European Union. There is a growing urgency to understand which factors are associated with the advancement of ATMPs through the medicines life-cycle.
ATMP developers – past and present – are invited to participate in a survey investigating these factors, impacting the development ATMPs within the EU. Amongst others, the following factors will be explored: scientific challenges, manufacturing issues, clinical considerations and regulatory requirements. The survey will be executed by the Escher platform of Lygature together with Utrecht University.
The survey will be conducted on-line and take approximately 30 minutes to complete. Data collection will start end of March and results are expected late 2017.
Interested ATMP developers can contact Lygature to participate: firstname.lastname@example.org
In order to optimise the confidentiality of the participating developers Lygature will act as intermediate (as honest broker) between the ATMP developers and the Utrecht University research team. The name and contact details of the developer will be separated from the answers. Results will only be published using aggregate data, making it impossible to trace back information to individual developers. The intent is to publish the results in a scientific journal.
The research is carried out with an unrestricted research grant from European Federation of Pharmaceutical Industries and Associations (EFPIA) and European Biopharmaceutical Enterprises (EBE).