Horizon 2020 Review of Work Programme Focus on topics including Clinical Trials/Studies

Transcription

1 Horizon 2020 Review of Work Programme Focus on topics including Clinical Trials/Studies ECRIN European Correspondent Meeting Dr Sabine Klager - 08/11/2017

2 Health, demographic change and wellbeing Call 1 Better Health and Care, economic growth and sustainable health systems 5 main priorities with a total of 32 topics 21 topics open in November Call 2 Digital transformation in Health and Care 1 main priority with a total of 13 topics 7 topics open in November Call 3 Trusted digital solutions in Health and Care 2 main priorities with a total of 3 topics 2 topics open in November 1

3 General comments First calls open Nov deadline 18 April 2018 Mostly single stage applications Many topics are now open for US participants (because US NIH opened programmes to EU researchers) Several topics require participants from specified countries: i.e. Canada, disease-endemic countries, China, Russian Federation, CELAC* Clinical Trials/Studies are only possible in topics of Call 1 * Community of Latin American and Caribbean States 2

4 Call 1- Better health and care, economic growth and sustainable health systems Five main priorities: Personalised medicine (8/6/1)* Innovative health and care industry (4/2/2) Infectious diseases and improving global health (12/9/2) Innovative health and care systems Integration of care (5/3/1) Decoding the role of the environment, including climate change, health and well-being (3/1/1) > Out of 48 topics, only 7 topics with possible inclusion of a clinical trial/study or prospective cohort *total topics/ open Nov17/CT-CS included 3

5 1- Exploiting research outcomes and application potential of the human microbiome for personalised prediction, prevention, and treatment of disease Personalised Medicine (SC1-BHC ) Deadline 18 April 2018 / one stage Reuse of existing data > but could involve production of new data - new study/trial/cohort Focus on the future European Open Science Cloud to enable sharing and re-use of data Total budget 50 million / million per project Research and Innovation action (RIA) 4

6 2- Regenerative medicine: from new insight to new applications Innovative health and care industry (SC1-BHC ) Call opens only 26 July 2017/deadline 16 April 2019 New therapies/ new approaches for therapy for large population groups- genome editing; gene therapy; cell therapyreprogramming- trans-differntiation; 3D bio-printing; organoids; Project can include proof of concept or clinical trial Total budget 50 million / 6-8 million per project Research and Innovation action 5

7 3- Innovation platforms for advanced therapies of the future Innovative health and care industry (SC1-BHC ) Deadline 18 April 2018 / one stage Project should create knowledge, testing and exploitation platforms around innovative concepts Improve perspective for use of advanced therapy in large patient population not just individuals First-in-man, proof of concept, safety can be included Total budget of 54 million / million per project Research and Innovation action (RIA) 6

8 4- Stratified host-directed approaches to improve prevention, treatment and/or cure of infectious diseases Infectious diseases and improving global health (SC1-BHC ) 2 stages: first 2 Oct 2018 / second 16 Apr 2019 Novel, emerging concepts in drug/vaccine development Identification/use of host-factors/ host-pathogen interaction for stratification Selection/clinical validation of relevant biomarkers Late pre-clinical and early clinical research / proof of concept Total budget of 95 million / 6-10 million per project Research and Innovation action (RIA) 7

9 5- New anti-infective agents for prevention and/or treatment of neglected infectious diseases (NID) Infectious diseases and improving global health (SC1-BHC ) 2 stages: First 6 Feb 2018 / second 4 Sep 2019 Neglected infectious diseases (viral diseases excluded) Bridging gap between pre-clinical and clinical Focus on late pre-clinical, GMP, early clinical up to Phase I; drug or vaccine; Multidisciplinary, academic and industry teams Total budget 52 million / 5-10 million per project Research and Innovation action (RIA) 8

10 6- Novel patient-centred approaches for survivorship, palliation, and/or end-of-life care Innovative health and care system Integration of Care (SC1-BHC ) Deadline 18 April 2018 / one stage Focus on palliative, end-of-life care; pain management Effectiveness and cost-effectiveness of new pharmacological or non-pharmacological interventions Randomised clinical trials or observational studies Adults and children Total budget of 44 million / 3-4 million pre project Research and intervention action (RIA) 9

11 7- The Human Exposome: a toolbox for assessing and addressing the impact of environment on health Decoding the role of the environment, including climate change, for health and well-being (SC1-BHC ) Opens 26 Jul 2018; deadline 16 April 2019, one stage Included could be well designed retrospective epidemiological studies Creation of prospective Europe-wide expasomics cohort and biobank; integrating behavioural, socio-economic factors, and clinical records Total budget of 50 million / 8-12 million per project Research and Innovation action (RIA) 10

12 Conclusion: Horizon 2020 work programme for provides only two clear options for inclusion of classic randomised controlled trials Project mostly for pre-clinical and early clinical phase: First-in-man; Phase I, proof of concept, safety Opportunity for large (retrospective) and prospective multinational cohorts 11