D1.1 – Implementation of working groups addressing the main tasks of the Strategic Research & Innovation Agenda
D1.2 – Draft of Governance (structure and processes) of the candidate LSRI RESTORE
D1.3 – List of governing bodies (names)
D1.4 – Map of European´s ecosystem and non-European network activities for Advanced Therapies
D1.5 – Defining Key Performance Parameters for the candidate LSRI RESTORE
D2.1 – Roadmap of WP2
D2.2 – Strategy paper on iPSC as source
D2.3 – Strategy paper on GMP-conform cell sorting approaches
D2.4 – Strategy paper on various issues of manufacturing (including automation) of advanced therapy medicinal products (ATMPs)
D2.5 – Strategy paper on viral/non-viral vector development for in vivo/ex vivo gene therapy
D2.6 – Strategy paper on biomaterial developments and composite products
D2.7 – Completion of selection and description of regulatory acceptable “contexts of use” for advanced animal vs human-on-chip model developments
D2.8 – Strategy paper on new clinical indications
D3.1 – Roadmap of WP3
D3.2 – Strategy Paper on Regulatory Science for Advanced Therapies
D3.3 Strategy paper on early Health-Technology Assessment tools for Advanced Therapies & D4.4 Strategy paper on Health Economics & Reimbursement
D3.4 – Strategy paper on innovative early and late clinical trial design and regulatory rules for Advanced Therapies
D3.5 – Strategy paper on benefit and requirements of mechanistic side studies
D4.1 – Roadmap of WP4
D4.3 – Proposal to establish best practice for patient follow-up and data capture
D5.4 – Publication of the strategy and position papers as well as the White Paper
D5.6 – Publications and material for communication first report
D5.7 – Publications and material for communication second report
D6.1 – Report to EC