Response deadline: 30 June 2017
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. Despite considerable development activity in this dynamic field, a limited number of ATMPs have received Marketing 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.
End of March 2017 Lygature, a Dutch public-private collaboration catalysing new medical solutions, the European Biopharmaceutical Enterprises (EBE), together with EFPIA (European Federation of Pharmacetical Industries and Associations (EFPIA) and Utrecht University (UU) launched an open inivitation to European ATMP-developers to help product development, regulation and commercialization.
ATMP developers – past and present – were invited to participate in a survey investigating factors, impacting the development ATMPs within the EU. Amongst others, scientific challenges, manufacturing issues, clinical considerations and regulatory requirements are explored. This is the first of its kind research investigating the developer challenges in a systematic way.
The response to the survey continues to increase, with new participation requests still coming in. This shows the commitment of developers, and their willingness to improve ATMP product development and its regulation. Recognizing the need for comprehensive information and acknowledging the willingness to contribute, the survey remains open until the end of June.
Interested ATMP developers can still contact Lygature to participate at firstname.lastname@example.org.
The deadline for declarations of interest is 15 June 2017 and the deadline for submission of responses to the survey is set for 30 June 2017.
The survey is conducted on-line and takes approximately 30 minutes to complete.
Results are expected late 2017 and will be shared with survey respondents.
Optimising confidentiality of participating developers Lygature acts as intermediate (as honest broker) between the ATMP developers and the Utrecht University research team, ensuring data security and anonymizing responses. 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 EFPIA and EBE.