The MW-ATTC have established a project management office framework to monitor and deliver the objectives of the MW-ATTC. This framework has been shared with new Innovate UK projects such as PROmics. A PPI working group has developed a comprehensive PPI strategy including focus groups, involvement in clinical studies and public engagement events. The MW-ATTC have generated generic standard of care clinical patient process maps for autologous and allogeneic ATMPs as well as matrices for estates, technical, clinical and operations requirements. The Trials Acceleration Programme for Cellular Therapy (TAP-CT) framework with a dedicated Trials Team Leader across the MW-ATTC has been set up.
TrakCel have developed a data structure and accompanying user interface which will support allogeneic therapies. This has opened up many new potential customers for TrakCel, with the software now capable of managing different allogeneic therapies. Evaluation of Asymptote’s prototype shipper has been completed at all clinical sites. The manufacturing team have created a Process Development Template; a checklist for ATMP manufacturers to evaluate needs for adoption of new advanced therapies.
A new economic model has been agreed with Rexgenero and Health Technology Wales (HTW); this will inform data required from Secure Anonymised Information Linkage Database (SAIL) and will deliver the economic evaluation of an exemplar. The outcome of this work will support determining a new way of assessing and costing ATMPs. UHB NHSFT and NWIS have engaged with relevant partners to generate a process map that captures data flow from “needle to needle” so that IT interfaces and relevant data points can be identified and recorded between these partners. UHB and NWIS have designed and built an informatics prototype IT system with an interface ready to interact with TrakCel and the other NHS organisations.
Throughout the first year, external engagement with new industrial partners (GSK, Pfizer, Autolus) about use of MW-ATTC for delivery of further ATMPs has been carried out. Additionally, the MW-ATTC raised funding for new ATMP projects in its local region.