Annex 1 to the Decision of the Governing Board of the Innovative Medicines Initiative 2 Joint Undertaking no. IMI2-GB-DEC-2019-11 approved on 21.06.2019 1 Contents Factsheet – IMI at a glance ..................................................................................................................... 4 Foreword.................................................................................................................................................. 6 Executive summary ................................................................................................................................. 8 1 Implementation of the Annual Work Plan 2018 .............................................................................. 13 1.1 Key objectives in 2018 ........................................................................................................... 13 1.2 Research & innovation activities............................................................................................ 15 IMI projects are delivering results in disease areas with high unmet medical and social needs 16 IMI projects have an impact on the regulatory framework ................................................ 19 IMI projects are delivering tools and resources that are accessible to the wider scientific community ...................................................................................................................................... 20 Collaboration among consortia and with external bodies and other sectors ..................... 22 1.3 Stakeholder engagement ...................................................................................................... 23 SME involvement ............................................................................................................... 23 Patient involvement ........................................................................................................... 23 Interactions and involvement with regulatory authorities .................................................. 24 1.4 Calls for proposals and grant information .............................................................................. 25 Launch and management of Calls in 2018 ........................................................................ 25 Interim reviews for IMI projects .......................................................................................... 44 Progress against key performance indicators (KPIs) and statistics .................................. 48 1.5 Dissemination and information about project results ............................................................ 50 1.6 Operational budget execution................................................................................................ 55 1.7 EFPIA and IMI2 Associated Partner contributions ................................................................ 60 2 Support to operations ..................................................................................................................... 71 2.1 Communication activities ....................................................................................................... 72 2.2 Legal and financial framework ............................................................................................... 79 2.3 Budgetary and financial management ................................................................................... 80 2018 budget approval ........................................................................................................ 80 Budget transfers ................................................................................................................ 82 Budget execution ............................................................................................................... 83 Overview of the carry over appropriations to 2019 ............................................................ 85 2.4 Procurement and contracts ................................................................................................... 86 2.5 IT and logistics ....................................................................................................................... 87 2.6 Human resources .................................................................................................................. 89 2.7 Data protection ...................................................................................................................... 91 2.8 Access to documents ............................................................................................................ 91 3 Governance .................................................................................................................................... 92 3.1 Governing Board ................................................................................................................... 92 2 3.2 Executive Director ................................................................................................................. 92 3.3 States Representatives Group .............................................................................................. 92 3.4 Scientific Committee .............................................................................................................. 93 3.5 Stakeholder Forum ................................................................................................................ 93 3.6 Strategic Governing Groups (SGGs) ..................................................................................... 93 3.7 Associated Partners .............................................................................................................. 94 4 Internal control framework .............................................................................................................. 96 4.1 Financial procedures ............................................................................................................. 96 4.2 Ex ante controls on operational expenditure ......................................................................... 96 4.3 Ex-post control of operational expenditure and error rates identified.................................. 105 4.4 Audit of the European Court of Auditors .............................................................................. 110 4.5 Internal audit ........................................................................................................................ 112 4.6 Risk management and conflict of interest ........................................................................... 113 4.7 Fraud prevention and detection ........................................................................................... 115 4.8 Compliance and effectiveness of internal control ................................................................ 116 5 Management assurance ............................................................................................................... 118 5.1 Elements supporting assurance .......................................................................................... 118 5.2 Reservations ........................................................................................................................ 119 5.3 Overall conclusion ............................................................................................................... 119 6 Statement of the manager in charge of risk management and internal control ........................... 120 7 Declaration of assurance ............................................................................................................. 121 Annexes ............................................................................................................................................... 122 Annex 1 - Organisational chart ........................................................................................................ 123 Annex 2 - Establishment plan .......................................................................................................... 124 Annex 3 – Project outputs ................................................................................................................ 127 IMI1 project outputs ...................................................................................................................... 128 IMI2 project outputs ...................................................................................................................... 145 Annex 4 - Publications from projects ............................................................................................... 154 Annex 5 - Patents from IMI2 projects .............................................................................................. 161 Annex 6 - Scoreboard of Horizon 2020 common KPIs .................................................................... 162 Annex 7 - Indicators for monitoring cross-cutting issues ................................................................. 167 Annex 8 - Scoreboard of KPIs specific to IMI .................................................................................. 177 Annex 9 – Final annual accounts ..................................................................................................... 182 Annex 10 - Materiality criteria .......................................................................................................... 184 Annex 11 – Media highlights ...........................................................................................................