A 003887 24.06.2020 Ref. Ares(2020)3284159 - 24/06/2020 Mr David Maria Sassoli President of the European Parliament Rue Wiertz 60 1047 Brussels Belgium IMI reference: Save number: imi.admin(2020)3760186 Brussels, 23 June 2020 Subject: Transmission of the IMI2 JU Annual Activity Report 2019 Dear Mr Sassoli, I am pleased to send you, in accordance with the Art 23 paragraph 3 of the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU) Financial Rules, the following documents: . IMI2 JU Annual Activity Report for the year 2019; . copy of the IMI2 JU Governing Board Decision approving this report; . copy of the IMI2 JU Governing Board Analysis and Assessment on the IMI2 JU Annual Activity Report 2019. This report has been published on the IMI2 JU website here: https://www.imi.europa.eu/about-imi/reference- documents. Sincerely yours, [e-signed] Pierre Meulien CC Elise Oukka, Iris Ontavilla Matschilles, Hugh Laverty, Auste Damaseviciute, Catherine Brett (IMI2 JU) Enclosures Pierre Meulien Tel +32 (0)2 221 8181 • Fax +32 (0)2 221 81 74 • www.imi.europa.eu Executive Director Postal address: IMI JU • TO56 • 1049 Brussels • Belgium ElectronicallyInnovative signed onMedicines 23/06/2020 Initiative 17:02 (UTC+02) (IMI) in accordance Visiting with article address: 4.2 (Validity Ave de of laelectronic Toison documents) d’Or 56-60 of Commission• 1060 Brussels Decision • 2004/563Belgium Ref. Ares(2020)3209112 - 19/06/2020 Annual Activity Report 2019 Copyright © 2020 Innovative Medicines Initiative In accordance with Article 17 of the Statutes of IMI2 JU annexed to Council Regulation (EU) No 557/2014 of 6.05.2014 and with Article 23 of the Financial Rules of IMI2 JU adopted by the IMI2 JU Governing Board on 27.05. 2020. The Annual Activity Report is made publicly available following approval by the IMI Governing Board. Annex 1 to the Decision of the IMI2 Governing Board no. IMI2 GB-DEC-2020-19 approved by the Governing Board of the Innovative Medicines Initiative 2 Joint Undertaking on 19.06.2020 1 Contents Factsheet – IMI2 JU at a glance .......................................................................................................................... 4 Foreword .............................................................................................................................................................. 6 Executive summary ............................................................................................................................................. 8 1 Implementation of the Annual Work Plan 2019 .......................................................................................... 12 1.1 Key objectives in 2019 ....................................................................................................................... 12 1.2 Research & innovation activities ........................................................................................................ 15 1.2.1 Infectious diseases ........................................................................................................................ 15 1.2.2 Alzheimer’s disease and other neurological disorders .................................................................. 18 1.2.3 Diabetes ......................................................................................................................................... 20 1.2.4 Cancer ........................................................................................................................................... 20 1.2.5 Other challenges in health research and drug development ......................................................... 21 1.2.6 Collaboration among consortia and with external bodies and other sectors ................................. 24 1.3 Stakeholder engagement ................................................................................................................... 26 1.3.1 SME involvement ........................................................................................................................... 26 1.3.2 Patient involvement ....................................................................................................................... 26 1.3.3 Interactions and involvement with regulatory authorities ............................................................... 28 1.4 Calls for proposals and grant information .......................................................................................... 29 1.4.1 Launch and management of IMI2 JU Calls in 2019....................................................................... 29 1.4.2 Interim reviews for IMI projects ...................................................................................................... 46 1.4.3 Progress against key performance indicators (KPIs) and statistics .............................................. 53 1.5 Dissemination and information about projects results ....................................................................... 55 1.6 Operational budget execution ............................................................................................................ 59 1.7 EFPIA and IMI2 Associated Partner contributions ............................................................................ 64 2 Support to operations ................................................................................................................................. 74 2.1 Communication activities ................................................................................................................... 74 2.2 Legal and financial framework ........................................................................................................... 82 2.3 Budgetary and financial management ............................................................................................... 83 2.3.1 2019 budget approval .................................................................................................................... 83 2.3.2 Budget transfers............................................................................................................................. 85 2.3.3 Budget execution ........................................................................................................................... 86 2.3.4 Overview of the carry over appropriations to 2020 ........................................................................ 88 2.4 Procurement and contracts................................................................................................................ 90 2.5 IT and logistics ................................................................................................................................... 91 2.6 Human resources .............................................................................................................................. 93 2.7 Data protection .................................................................................................................................. 95 2.8 Access to documents ......................................................................................................................... 95 3 Governance ................................................................................................................................................ 96 3.1 Governing Board ................................................................................................................................ 96 2 3.2 Executive Director .............................................................................................................................. 96 3.3 States Representatives Group........................................................................................................... 96 3.4 Scientific Committee .......................................................................................................................... 96 3.5 Stakeholder Forum ............................................................................................................................ 97 3.6 Strategic Governing Groups (SGGs) ................................................................................................. 97 3.7 Associated Partners ........................................................................................................................... 98 4 Internal control framework ........................................................................................................................ 101 4.1 Financial procedures ....................................................................................................................... 101 4.2 Ex ante control on operational expenditure ..................................................................................... 102 4.3 Ex-post control of operational expenditure and error rates identified .............................................. 112 4.4 Audit of the European Court of Auditors .......................................................................................... 117 4.5 Internal audit .................................................................................................................................... 119 4.6 Risk management and conflict of interest ........................................................................................ 120 4.7 Fraud prevention and detection ....................................................................................................... 122 4.8 Compliance and effectiveness