Opportunities for Vaccine Research in Horizon 2020

Transcription

1 Opportunities for Vaccine Research in Horizon 2020 Workshop on the joint procurement of medical countermeasures 29 April 2015 Luxemburg Cornelius Schmaltz, MD European Commission DG Research and Innovation 'Fighting infectious diseases and global epidemics' Research & Innovation

2 Introduction H2020 Overview Examples of major ongoing vaccine projects in H2020: I-MOVE+, TBVAC2020, EMI-TB Opportunities: 'Collaborative Research' SME instrument IMI2 EDCTP2 Financial Instruments Policy Research and Innovation

3 HORIZON 2020 ( ) European Research Council Future and Emerging Technologies Marie Skłodowska-Curie actions Research infrastructures Excellent science Leadership in enabling and industrial technologies Access to risk finance Innovation in SMEs Industrial leadership Societal challenges SC1- Health, demographic changes and wellbeing ( 7.4 b) The new EU programme for research and innovation 79 billion ( ) Research & Innovation

4 Health in H2020 Excellent science 24bn Future and Emerging Technologies Marie Skłodowska Curie European Research Council Industrial leadership 17bn Research Infrastructures SME instrument Fast Track to Innovation IMI-2 Eureka Eurostars-2 SC1 Health 7.5bn (of 31bn) Collaborative projects LEIT Biotech AAL-2 Financial instruments EDCTP-2 Research & Innovation

5 EU support in vaccine R&I: strategy Discovery Preclinical Phase I Phase II/ III Regulatory Capacity building vaccine Inplementation modalities IMI - precompetitive technology, bottlenecks, few vaccine projects Translational research Research & Innovation Small/Large collaborative projects SME instrument EDCTP clinical trials program BioVacSafe Clinical capacity Advance

6 Vaccine research in H2020 legal base 'Specific Programme' 1 Societal Challenge 1 'Health, Demographic Change and Wellbeing': Intro: 'Promotion of health, active ageing, well-being and disease prevention also depend [ ] on effective preventive tools, such as vaccines [ ].' ' Developing better preventive and therapeutic vaccines' ' Treating disease, including developing regenerative medicine': There is a need to support the improvement of cross-cutting support technologies for drugs, biotherapies, vaccines and other therapeutic approaches [ ], to increase success in the drug and vaccine development process (including alternative methods to replace classical safety and effectiveness testing, e.g. the development of new methods); [ ] to develop new biopharmaceuticals, including therapeutic vaccines; [ ] ' Improving scientific tools and methods to support policy making and regulatory needs': There is a need to support research, development, integration and use of scientific tools, methods and statistics for rapid, accurate and predictive assessment of the safety, efficacy and quality of health interventions and technologies including new drugs, biologics, advanced therapies and medical devices. This is particularly relevant for new developments in domains concerning biopharmaceuticals, vaccines, [ ] 1

7 Why EU support for vaccine R&I Policy objectives High social and economic impact disease eradication, avoid pandemics Cost-effective for health systems and society Reduce the risk of AMR Mantain European leadership in vaccine R&D and manufacturing boost economy Scientific challenges such as Increase effectiveness Easy to use in developing countries Serious gaps: protective vaccines available only for some diseases; therapeutic vaccines only at beginning Elderly population Research & Innovation

8 I-MOVE+, a scientific public health platform to Identify, pilot test, use and disseminate the best study designs to measure the effectivenes (direct effect) and the impact (indirect and overall effect) of influenza and pneumococcal vaccines against clinical and laboratory confirmed outcomes in the elderly population 8

9 Study settings in EU / EEA countries Influenza 17 GP (2000) sentinel networks in 13 countries EU network of 24 hospitals in 12 countries Pooling of 6 electronic data bases in 5 countries Deliverables: generic protocols, VE and impact results (reports, articles, scientific conferences) Pneumococcal diseases A hospital / laboratory network in 6 countries Registry based studies Deliverables: generic protocols, VE and impact results (reports, articles, scientific conferences) Cost benefit analyses Group of experts from 5 countries using data from all countries Deliverables: generic protocols, VE and impact results (reports, articles, scientific conferences) 9

10 I MOVE + partners Participant No Short name Participant organisation name Country 1 EPICONCEPT EPICONCEPT France 2 ISCIII Instituto De Salud Carlos III Spain 3 HSE Health Service Executive Ireland 4 NHSNSS NHS National Services Scotland United Kingdom 5 INCDMIC National Institute of Research-Development for Microbiology and Immunology "Cantacuzino" Romania 6 NIZP-PZH National Institute of Public Health - National Poland Institute of Hygiene 7 Instituto Nacional de Saúde Dr. Ricardo Jorge Instituto Nacional de Saúde Dr. Ricardo Jorge Portugal 8 Organismo Autonomo Instituto De Salud Insituto de Salud Pública y Laboral de Navarra Spain Publica y Laboral de Navarra 9 RCGP Royal College of General Practitioners United Kingdom 10 NLNA National Institute for Public Health and the The Netherlands Environment (RIVM) 11 Centre Hospitalier Universitaire CIC St Eloi - Centre Hospitalier Universitaire de France Montpellier 12 Assistance Publique - Hopitaux de Paris Centre Cochin-Pasteur de Vaccinologie, France Assistance Publique-Hôpitaux de Paris 13 DH Public Health England United Kingdom 14 CNIPH Croatian National Institute of Public Health Croatia 15 NIVEL Stichting Nederlands Instituut voor Onderzoek The Netherlands van de Gezondheidszorg 16 UEDIN The University of Edinburgh United Kingdom 17 THL National Institute for Health and Welfare Finland 18 Statens Serum Institut Statens Serum Institut Denmark 19 Robert Koch Institut Robert Koch Institut Germany 20 OCMO Office of the Chief Medical Officer Hungary 21 Istituto Superiore di Sanità Istituto Superiore di Sanità Italy 22 InVS Institut de veille sanitaire France 23 UPMC Université Pierre et Marie Curie France 24 NIPH Norwegian Institute of Public Health Norway 10

11 Horizon 2020: TB vaccine research projects TBVAC2020 Advancing novel an promising TB vaccine candidates from discovery to preclinical and early clinical development 40 partners; Coordinator Tuberculosis Vaccine Initiative(TBVI) Total EU Budget: 18.2 million Other countries: 5.2 million Project start: January 2015 Duration: 4 years EMI-TB Eliciting mucosal immunity in tuberculosis 14 partners; Coordinator St George's University of London Total EU Budget: 8.0 million Project start: January 2015 Duration: 4 years 11

12 'COLLABORATIVE RESEARCH' Biannual workprogrammes (with updates) published by EC Aims to foster collaboration between Countries Sectors Diciplines Open for the participation of the world but Minimum: 3 legal entities from 3 different EU Member States or FP-associated countries Priorities addressed in : Vaccine development for poverty related and neglected infectious diseases 2014 Tuberculosis 25 million 2015 HIV/AIDS 21 million Research & Innovation

13 Understanding the call topics: example 'PHC ' 'Specific challenge' 'Scope' 'Expected impact' 'Type of action'

14 New SME instrument H2020:~ 3 billion SC1 Health: ~ 500m Inspired by the US Small Business Innovation Research (SBIR) Single company support possible Target group: Innovative SMEs Only EU SMEs allowed to apply for funding Competitive, market-oriented, EU dimension Health topic for 2014/15: PHC-12: Clinical validation of biomarkers and/or diagnostic medical devices Next cut-off dates: 17 June, 17 September, 25 November (phase 1 and 2)

15 SME instrument Idea Phase 1 Phase 2 Phase 3 Concept & Feasibility Assessment Innovation / R&D activities Commercialisation Market Feasibility of concept Risk assessment IP regime Partner search Design study 50,000 6 months Clinical trials Prototyping Piloting, scaling-up Miniaturisation, design Demonstration Market replication 1 to 5 million 36 months 100% funding rate in SC1 Facilitate access to private finance Support via networking, training, coaching, knowledge sharing, dissemination No direct funding

16 IMI Europe s partnership for health Partnership bn

17 IMI 2 research strategic agenda European Health Priorities to be addressed by IMI2 1.osteoarthritis 2.cardiovascular diseases 3.diabetes 4.neurodegenerative diseases 5.psychiatric diseases 6.respiratory diseases 7.immune-mediated diseases 8.ageing-associated diseases 9.cancer 10.rare/orphan diseases 11.vaccines

18 How to get involved Organisations bringing own resources to the project Become an EFPIA partner in research Involved in topic incubation Become an IMI2 Associated Partner Join a pre-established topic prior to Call launch Organisations not bringing own resources to the project Submit a topic idea Form / join a consortium and submit a proposal

19 Future IMI Calls - Timelines & info Find out more: Call launch: Summer 2015 Disclaimer - All information regarding future IMI Call topics is indicative and subject to change. Final information about future IMI Calls will be communicated after approval by the IMI Governing Board.

20 Stay in touch Visit our website Sign up to our newsletter bit.ly/iminewsletter Follow us on Join our LinkedIn group bit.ly/linkedinimi us

21 EDCTP2 ( ) 1. extended scope to include neglected infectious diseases, all clinical phases, diagnostics and delivery optimization 2. increased budget: 2 bn, with ~ 1.3 bn from European participating states + nearly 700 million from the EU 3. Extended duration 10 Years ( ) 4. Implemented by the EDCTP Association which has 13 European and 13 African countries as members with equal voting rights in the EDCTP General Assembly 5. EU provides co-funding of 683 million from Horizon 2020 ( ) matching contributions from the European participating states Research & Innovation

22 How EDCTP operates Capacity for Clinical Trials in Africa Synergy Clinical Trials in Africa on PRDs 22 Research & Innovation

23 What EDCTP funds Diseases: HIV/AIDS, TB, Malaria, NIDs, emerging infectious diseases of particular relevance for Africa, including Ebola New tools and interventions: Diagnostics, drugs, vaccines and microbicides Capacity Development: Fellowships, Networks, Ethics, Regulatory General rules for participation: At least 2 legal entities in EU Member States or in countries associated to Horizon 2020 and one legal entity in Sub Saharan Africa 23 Research & Innovation

24 Financial instruments H2020 budget: ~ 2.8 billion InnovFin Large Projects Loans from 7.5 m to 300 m; delivered directly by EIB InnovFin MidCap Growth Finance Loans from 7.5 m to 25 m; delivered directly by EIB InnovFin MidCap Guarantee Guarantees to financial intermediaries (banks, etc.) Loans from 7.5 m to 25 m; implemented by EIB InnovFin SME Guarantee Guarantees / counter-guarantees to financial intermediaries Loans from 25,000 to 7.5 m; implemented by EIF InnovFin Advisory Improve 'bankability' of large projects

25 Financial instruments: indirect support

26 Fast Track to Innovation (FTI) FTI ( ): 200 million Pilot call: 100 million in 2015 ; 100 million in 2016 Expected impact: Fast development, commercial take-up and/or wide deployment of sustainable innovative solutions Time to initial market take-up no later than 3 years after the start of the project. Fully bottom-up, close-to-market activities, 70% funding rate Restricted to MS and AC, minimum 3, maximum 5 partners, maximum 3 m EU contribution per project Eligibility: 60% of the overall project budget allocated to industry participants in the consortium or majority of industry participants Next deadline: 29 April 2015

27 All H2020 information, including call documentation published on the Participant Portal Research & Innovation

28 We need experts! Appropriately qualified individuals may apply to work as experts in H2020 evaluations Application via Participant Portal experts/index.html Research & Innovation

29 HORIZON 2020 Thank you for your attention! Find out more: