PES-RIA: Clinical trials of combined Advanced Therapy Medicinal Products (ATMPs)

Our aim is to go into Phase 2 clinical trials and above of combined ATMPs focussing on: - technologies ready to undergo interventional clinical trials in patients/end users assessing the usability and clinical performance, and/or - technologies that have demonstrable safety/performance profiles and should undergo clinical validation in view of their inclusion into guidelines for specific clinical pathways. - Delivery of safe and clinically validated combined ATMPs that are compliant with current European regulatory requirements. The related regulatory work should be considered as an essential component and the proposed work should involve consultation/interaction with competent regulatory agencies such as the European Medicines Agency (EMA) or national regulatory agency. Applicants are encouraged to seek regulatory and/or Health Technology Assessment (HTA) advice as appropriate. We will include innovative treatments for any medical condition that are ready to be assessed for clinical efficacy (performance and clinical benefit) in a specific indication on a big number of patient cohorts; already existing market solutions are not in the scope of this topic.