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Symposium at AIDS2016: Every mother, every child: closing the gaps in HIV management Durban, 20 July 2016 The EU Framework Programme for Research and Innovation HORIZON 2020 EC strategy and opportunities for research on HIV research for maternal and child health Alessandra Martini, PhD European Commission Directorate-General "Research and Innovation" 'Fighting infectious diseases and advancing public health' EU response to HIV/AIDS a coordinated approach.. Research Health Develop and validate effective tools to prevent, treat and cure HIV/AIDS. Training and education. Optimise treatment & care Public health policy and programes (priority regions, key populations), registration of drugs, joint-procurements, surveillance (ECDC) AIDS-free world Development Equitable access to health systems in developing countries, GFATM Trade TRIPS Provisions to allow procurement of affordable medicines Justice Protect human rights, fight stigma, discrimination. Monitoring Drugs and Drug Addiction (EMCDDA) Role of EC on Research Develop and implement European research and innovation policy agreed by the EP and European Council Provides financial support to research through multi-annual framework programmes (since 1984) FP7 portfolio on HIV/AIDS collaborative research highlights of outcomes Drugs Treatment -Pre-clinical development of drug candidates tackling 4 novel targets - Large network of cohorts >350.000 HIV+ individuals. Standardised methods & protocols for data collection and sharing. - New mechanism of drug resistance - European cohorts for HIV-comorbidities and identification of new biomarkers in adults - PK, PD studies (incl. 5 clinical trials) for new drugs formulations for paediatric use - clinical trials, cohort studies collaborations with studies for children and pregnant women, training/ educational programmes Cure Vaccines Microbicides - In-vitro and in-vivo models of HIV latency and persistence -Development of several new vaccine candidate, of which 11 into phase I/IIa clinical trial Development of novel candidates microbicides; 1 combination proved safety in phase I CT -Development of a platform for microbicides optimisation and formulations -Development of a new point-of-care diagnostic tool for testing HIV-Syphilis in newborn and pregnant women. Diagnostics -Validation of a low-cost viral-load test (now under H2020 InnoFin ID) H2020 funding programme structure and funding instruments Excellent science €24bn Future and Emerging Technologies European Research Council Research Infrastructures Industrial leadership €17bn Fast Track to Innovation SME instrument Marie Skłodowska Curie Eureka Eurostars-2 LEIT Biotech Societal challenge 1 Health €7.5bn IMI-2 Collaborative projects EDCTP-2 AAL-2 Financial instruments H2020 portfolio (first 2 years 2014-15) HIV/AIDS research € 74 million* Relevant topics in SC1 WP 2016-17 2016 (call for proposal closed. Evaluation on-going) SC1-PM-04–2016 Networking and optimising the use of population and patient cohorts • at EU level (€ 30m) • SC1-PM-09–2016: New therapies for chronic diseases (€ 60m) • SC1-PM21-2016: Implementation research for scaling-up of evidence based interventions and good practice in Europe and LMIC (€ 40m) 2017 (call for proposal open 29 July. First deadline: 6 October 2016. 2-stages evaluation) • SC1-PM-07–2017: Promoting mental health and wellbeing in the young (20m€) • SC1-OA2*: InnovFin Infectious Diseases - Loans • Birth Day Prize**: Prize on reducing maternal and newborn morbidity and mortality ** deadline 6 September 2017 A New Financial Instrument for Infectious Diseases R&D • Jointly developed by the European Commission and European Investment Bank. • Provides loans between EUR 7.5m and EUR 75m to innovative players active in developing vaccines, drugs, medical and diagnostic devices, and research infrastructures for combatting infectious diseases • Applications must be in pre-commercial phase with pre-clinical phase (PoC) completed and clinical validation required for further development, and must have proven public health impact • 1st InnovFin loan (June 2015) to CAVIDI to develop an automated, high- throughput version of a low-cost HIV viral load testing device (validated under FP7 EU project) EIB: [email protected] CONTACTS: European Commission: Patricia Paukovits [email protected] #HorizonPrize Horizon Birth Day Prize • The Birth Day Prize joint initiative between the European Commission, Mothers. Bill & Melinda Gates Foundation and MSD for • Main Prize : €1 million from the European Commission. Additional prizes from Bill & Melinda Gates Foundation (€1 million) and MSD for Mothers (€0.5million) • Deadline: 6 September 2017 - award decision: end 2017 http://ec.europa.eu/research/horizonprize/index.cfm?prize=birthday Research and Innovation #HorizonPrize • Challenge: Approximately 300 000 women still died from preventable causes related to pregnancy and childbirth in 2013. Maternal and perinatal conditions are the seventh contributors to the global burden of disease • Scope: A novel solution to improve the outcome of facility-based deliveries ( of a clinical, technological or managerial nature, or a combination of these). It must take into account relevant social factors and have the potential of scaling up rapidly • Expected Impact: Demonstrated reduction in maternal and/or new-born morbidity and mortality and/or stillbirth during facility-based deliveries. • Who can participate The contest is open to all legal entities (i.e. natural persons or legal entities, including International organisations) or groups of legal entities regardless of place of establishment Research and Innovation what's next? Identification of research gaps that can be addressed by the SC1 work programme 2018-2020 • 2016/2017 Consultation with the research community through conferences and workshops • On-going: Stakeholders consultation of the Health Advisory Group Report for Health, Wellbeing and Demographic changes WP20182020 https://ec.europa.eu/research/health/index.cfm • 2016/2017 Meetings with Member States representatives for SC1 • end 2017 Adoption on the WP 2018-2020 Thank you! H2020 Participant Portal all information including call documentation, guidelines http://ec.europa.eu/research/participants/po rtal/page/home Twitter @Moedas from Commissioner for Research, Science and Innovation @innovationunion from RTD on H2020 activities @EU_H2020 Background slides HISTORY and MISSION Paediatric European Network for Treatment of AIDS (PENTA) (www.penta-id.org) Established in 1991 as collaboration between paediatric HIV centres in Europe. Aim: to undertake independent clinical trials to address questions about antiretroviral therapy (ART) in HIV infected children where answers cannot be extrapolated from trials in adults Activities: not just clinical trials, but cohort studies collaboration, pregnancy studies and training/ educational programmes. Funding from: - European Commission: 8 projects coordinated by PENTA since 1993 from Biomed 1 to H2020), involvement in more than 20 EU funded projects - Other major funding: MRC, INSERM/ANRS, US-NIH (project-based), UNICEF, Industries From the initial focus on HIV to the broader area of Paediatric Infectious Diseases 15 large Clinical trials in HIV infected children globally with more than 2500 children enrolled 22 observational pediatric HIV cohorts (> 6000 pediatric patients) and 7 large HCV cohorts (> 6000 HCV infected children) 42 international training courses in 32 countries worldwide (more than 2000 people trained) 2011 onwards: from PENTA and PENTi to PENTAid European funding: - NeoMero (neonates) - NeoVanc (neonates) - GRiP (“medicine for children”) - PREPARE (prevention of epidemics) - EMIF (creation of a European epidemiology/ICT platform) - COMBACTE-MAGNET (molecules against Gram Negative infections) - GAPP (clinical trials on “off-patent” drugs) - ZIKAction Specific contracts and agreements with major International Paediatric Hospitals 2011: PENTAid recognised by the EnprEMA as a level 1 Paediatric Clinical Trial Network in Europe to conduct clinical trials in pediatric HIV, antimicrobials and vaccinology.