EuroGCT D4-1: Landscape mapping, report on mapping of European cell and gene therapy landscape at multiple levels

Résumé 0

Deliverable 4.1 is a report on the mapping of the European gene-based and cell therapieslandscape. This deliverable provides an update to the earlier deliverable, D.4.8 InitialLandscape Mapping, which was submitted in the first reporting period. D4.8 reported themapping, performed by EuroGCT, of the European landscapes associated with gene and celltherapy related product development pathways including ethical, legal, regulatory and societalissues (ELSI). Related, D4.7 Information collation, also submitted in the first reportingperiod, detailed our methodology for information collection and curation. The work reportedin D4.7 and D4.8 resulted in creation of a development framework for a practical tool entitled“Development pathways for bringing gene and cell therapies from the lab to patients” with the short website name of “Research Pathways” (see D4.8). This tool was organised as a Webtree, into which general information on the development pathways for bringing gene and celltherapies from the lab to patients (hereafter the “Research Pathways Tree”) was organised.The Research Pathways Tree also included the organised information (mapping/inventory ofinformation) of the practical steps required for cell and gene therapy development in Europeas well as links on relevant and existing information and guidance.The present report, D4.1, therefore moves beyond the initial mapping to focus onimplementation of these processes. This has required a combination of actions: Identificationof the detailed information required to populate the Research Pathways Tree was describedin D4.8; in this reporting period, we have: 1) created original EuroGCT resources arounddevelopment pathways for bringing gene and cell therapies from the lab to patients, theResearch Pathways Tree (see D4.8 Annex 1 for details), 2) co-developed resources throughcollaboration, 3) selected and signposted to existing high quality resources (based on themethodology detailed in D4.7), and 4) launched an updated ‘Research Pathways’ databasefeaturing improved navigability and information organisation. In the following sections, weprovide the details of each action we have taken, our thought processes and some challengeswe have come across.The outputs are published on the EuroGCT website in the Research Pathways section(www.eurogct.org/research-pathways) as a searchable and filterable database and willcontinually be updated throughout the course of the project. (See also: D4.2).