Ref. Ares(2020)3206340 - 19/06/2020 In accordance with Article 16 of the Statutes of the IMI2 JU annexed to Council Regulation (EU) No 557/2014 of 6 May 2014 and with Article 33 of the Financial Rules of the IMI2 JU. The third amended Annual Work Plan will be made publicly available after its adoption by the Governing Board. Sole annex to the Decision of the Governing Board of the Innovative Medicines Initiative 2 Joint Undertaking no. IMI2-GB-DEC-2020-20 adopted on 19.06.2020 Page 1 of 238 Table of Contents 1 Introduction ................................................................................................................................................... 5 2 Annual Work Plan Year 2020 ....................................................................................................................... 6 2.1 Executive Summary ....................................................................................................................................... 6 2.2 Operations ..................................................................................................................................................... 6 2.2.1 Objectives & indicators - risks & mitigations ....................................................................................... 6 2.2.2 Scientific priorities for 2020 ............................................................................................................... 14 A. Neurodegeneration and other neuroscience priorities .................................................................. 15 B. Infection control including vaccines ............................................................................................... 16 C. Big data, digital health, clinical trials and regulatory research ....................................................... 18 D. Oncology ........................................................................................................................................ 19 E. Immunology ................................................................................................................................... 21 F. Facilitating Rare Disease therapies (including Advanced Therapy Medical Products) reaching patients in Europe....................................................................................................................................... 22 G. Other enablers of research topics.................................................................................................. 23 H. Restricted Call to maximise the impact of IMI2 JU objectives and scientific priorities .................. 24 Calls for Proposals ..................................................................................................................................... 25 Budget ....................................................................................................................................................... 29 2.2.3 Call management (planning, evaluation, selection, …) ..................................................................... 30 2.2.4 Activities to support and monitor ongoing projects ........................................................................... 30 2.2.5 Monitoring and analysis of projects’ results ...................................................................................... 32 2.2.6 Stakeholders’ engagement and external collaborations ................................................................... 32 2.2.7 Dissemination and information about projects results ...................................................................... 34 2.2.8 Socio-economic impact assessment ................................................................................................. 34 2.3 Call management rules ................................................................................................................................ 35 2.4 Support to Operations.................................................................................................................................. 42 2.4.1 Communication and events ............................................................................................................... 42 2.4.2 Procurement and contracts ............................................................................................................... 43 2.4.3 IT and logistics................................................................................................................................... 44 2.4.4 Human Resources ............................................................................................................................. 45 2.4.5 Administrative budget and finance .................................................................................................... 46 2.4.6 Data protection .................................................................................................................................. 48 2.4.7 Access to documents ........................................................................................................................ 48 2.5 Governance ................................................................................................................................................. 49 2.6 Internal Control framework .......................................................................................................................... 51 2.6.1 Ex-ante and ex-post controls ............................................................................................................. 51 2.6.2 Internal and External audits ............................................................................................................... 52 3 Budget 2020 ............................................................................................................................................... 53 3.1 Staff Establishment Plan 2020 .................................................................................................................... 65 Annex I - IMI2 JU Call 20 topics text ................................................................................................................. 67 Annex II - IMI2 JU Call 21 topic text ................................................................................................................ 141 Annex III - IMI2 JU Call 22 topic text ............................................................................................................... 150 Annex IV - IMI2 JU Call 23 topics text ............................................................................................................. 160 List of acronyms ............................................................................................................................................... 232 Page 2 of 238 NOTICE For UK applicants: Please be aware that following the entry into force of the EU-UK Withdrawal Agreement* on 1 February 2020 and in particular Articles 127(6), 137 and 138, the references to natural or legal persons residing or established in a Member State of the European Union are to be understood as including natural or legal persons residing or established in the United Kingdom. UK residents and entities are therefore eligible to participate in calls in this work plan. * Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community Page 3 of 238 Chronology and list of reviews Version Date of the Items adoption by the Governing Board Version 1.0 13.12.2019 Annual Work Plan and Budget for 2020 Version 2.0 28.02.2020 Update of the following sections: . Notice . 2.1 Executive Summary . 2.2.1 Objectives & indicators - risks & mitigations . 2.2.2 Scientific priorities for 2020 . 2.2.3 Call management (planning, evaluation, selection, …) . 2.2.4 Activities to support and monitor ongoing projects . 2.3 Call management rules . 3 Budget . List of acronyms Insertion of Annex II - IMI2 JU Call 21 topic text Version 3.0 08.05.2020 Update of the following sections: . 2.2.2 Scientific priorities for 2020 . 2.2.3 Call Management . 2.2.4 Activities to support and monitor ongoing projects . 3 Budget . Annex I IMI2 JU Call 20 topics text . Annex II IMI2 JU Call 21 topic text . List of acronyms Version 4.0 19.06.2020 Update of the following sections: . 2.2.2 Scientific priorities for 2020 . 2.2.4 Activities to support and monitor ongoing projects . 2.2.5 Monitoring and analysis of projects’ results . 2.2.7 Dissemination and information about projects results . 2.4.2 Procurement and contracts . 2.5 Governance . 3 Budget . 3.1 Staff Establishment Plan 2020 . List of acronyms Insertion of Annexes III and IV - IMI2 JU Call 22 and 23 topics texts Page 4 of 238 1 Introduction In 2020, IMI2 JU will continue to focus on its core activity of launching Calls for proposals for projects that address key challenges highlighted in the IMI2 JU Strategic Research Agenda in areas such as diabetes/metabolic disorders, neurodegeneration, immunology, infection control (including vaccines), translational safety, digital health, and oncology. This will be in principle the last year of allocation of funding for IMI2 JU and as such will be a pivotal year in terms of budget commitment for the Programme Office. In addition, the Programme Office will continue implementing the recommendations of the experts’ panel on the interim evaluation of IMI2 JU. This will include continuing with the strategy to attract more small and