Hacia el Programa de Trabajo del SC1 y convocatorias IMI2

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1 Hacia el Programa de Trabajo del SC1 y convocatorias IMI Juan E. Riese PhD MBA Punto Nacional de Contacto Reto Social 1 H2020 & IMI2 Oficina de Proyectos Europeos Subdirección General de Programas Internacionales de Investigación y Relaciones Institucionales

2 Hablaremos de Hacia el Programa de Trabajo del SC1 Presente y futuro de las convocatorias de la Iniciativa de Medicamentos Innovadores - IMI2

3 Hablaremos de Hacia el Programa de Trabajo del SC1 Presente y futuro de las convocatorias de la Iniciativa de Medicamentos Innovadores - IMI2

4 Hacia las convocatorias de SC Tendencias al alza en: Medicina personalizada Enfermedades raras Enfermedades infecciosas Enfermedades crónicas Enfermedades de la infancia Salud Pública y Prevención& Prevention (incl. inmigración) Envejecimiento Activo y Saludable Big Data, IoT (Internet of Things), e-health Silver Economy, Esquemas PCP y PPI (compra pública), Investigación Responsable (RRI)

5 Hacia las convocatorias de SC AREA 1.1 UNDERSTANDING HEALTH, WELL-BEING & DISEASE 1. Understanding causative mechanisms in co-morbidities RIA RTD 2. Endocrine disruptors (EDs) testing for better regulation and improved understanding of health effects RIA RTD 3. Regenerative medicine 3.0 RIA RTD 4. Systems approaches for discovery of combinatorial therapies for multifactorial diseases - RIA RTD AREA 1.2 PREVENTING DISEASE 1. Exploiting research results and potential of the Human Microbiome for health and prediction and prevention of disease RIA - RTD 2. Climate change and the early detection of emerging infectious diseases INCO [GlopID-R, Canada & HIRO] FA COP 21 RIA RTD 3. Mental health in the workplace RIA RTD 4. Novel risk-adapted screening strategies RIA RTD 5. The Human Exposome Project: a toolbox for assessing and addressing the impact of environment and climate change on health FA COP 21 RTD

6 Hacia las convocatorias de SC AREA 1.3 TREATING AND MANAGING DISEASE 1. Rare Disease Joint Programme Co-Fund RTD 2. Personalised approaches to overcome treatment failure and/or improve prevention of infectious diseases RIA RTD 3. New anti-infective agents for prevention or treatment of neglected infectious diseases (NID) - RIA RTD 4. Novel patient-centred approaches for survivorship, palliation and end-of-life care RIA RTD 5. Global Alliance for Chronic Diseases (GACD) 1 RIA RTD 6. Global Alliance for Chronic Diseases (GACD) 2 RIA RTD 7. New therapies for NCDs RIA RTD 8. Innovation for the advanced therapies of the future RIA RTD 9. Big data for monitoring health status and quality of life after the cancer treatment (RIA) - CNECT

7 Hacia las convocatorias de SC AREA 1.4 ACTIVE AGEING & SELF-MANAGEMENT OF HEALTH 1. Health care interventions for the management of the elderly multi-morbid patient - RIA - RTD 2. Personalised early risk prediction, prevention and intervention RIA CNECT 3. Adaptive smart environments in support of working and independent living in an ageing society - RIA CNECT 4. International cooperation in digital solutions and robotics for independent living - RIA CNECT 5. Large scale implementation of digital innovation for health and care in an ageing society - PPI CNECT 6. Trusted big data solutions for prevention and personalised health and care services - IA, large scale pilots FA Digitisation - CNECT

8 Hacia las convocatorias de SC AREA 1.5 METHODS AND TOOLS 1. International flagship collaboration with Canada for human data storage, integration and sharing for developing personalised medicine approaches INCO [Canada] RIA - RTD 2. Digital diagnostics developing tools for clinical decisions integrating in vitro and in vivo diagnostics RIA RTD 3. Next generation sequencing (NGS) for routine diagnosis PCP RTD 4. EU safety testing 2030 RIA RTD 5. Accelerating the uptake of in-silico methods for testing medicines with dermatological use and cosmetic products - IA CNECT 6. Exploiting the full potential of in-silico medicine research for personalised diagnostics and therapies in cloud-based environments (RIA) - CNECT 7. Prototyping a cloud-based standardised EHR for Europe RIA - CNECT 8. Scaling up the univocal Identification of Medicinal Products - IA- CNECT 9. ehealth and care delivery services PCP/PPI - CNECT 10. Toolkit for assessing and reducing cyber risks in hospitals and care centres to protect data/infrastructures (RIA, IA) FA Security CNECT

9 Hacia las convocatorias de SC AREA 1.6 HEALTH CARE PROVISION & INTEGRATED CARE 1. Demonstration pilots for implementation of Personalised Medicine in health care RIA RTD 2. HTA (Health Technology Assessment) research to support evidence-based healthcare RIA RTD 3. Implementation research for maternal and child health RIA RTD 4. Innovation in health care - Using pre-commercial procurement and public procurement of innovative solutions in health care systems PPI - RTD 5. Large-scale pilots of personalised & outcome based integrated care - IA CNECT AREA 1.7 SPECIFIC IMPLEMENTATION ASPECTS COORDINATION +1. EU - CELAC collaboration for research on non-communicable diseases INCO [CELAC] RIA - RTD +2. Bringing results of Framework Programme projects closer to market or clinical practice RIA and/or IA RTD

10 Hacia las convocatorias de SC PRIZES TWO LARGE PRIZES (> 10 mio ): 1. Novel antimicrobials and alternatives for infections that have developed or are at risk of developing anti-microbial resistance Inducement-RTD 2. Surgery-based therapies in resource-poor settings -Inducement RTD 4 PRIZES ~1 mio 1. Personalised medicine in health care - Recognition RTD 2. Solutions for neglected infectious diseases - Inducement- RTD 3. Smart medical devices for establishing neuronal function - Inducement RTD 4. Novel tools that replace test animals in biomedical sciences or safety testing Inducement RTD

11 Hablaremos de Hacia el Programa de Trabajo del SC1 Presente y futuro de las convocatorias de la Iniciativa de Medicamentos Innovadores - IMI2

12 La Iniciativa de Medicamentos Innovadores 2 Fuente: IMI

13 Topics propuestos para la 10ª convocatoria Estado del Programa de Trabajo e IMI2 1. Understanding hypoglycaemia: the underlying mechanisms and addressing clinical determinants as well as consequences for people with diabetes by combining databases from clinical trials 2. How big data could support better diagnosis and treatment outcomes for prostate cancer (Note: topic forms part of the IMI Big Data for Better Outcomes (BD4BO) programme) 3. Improving the care of patients suffering from acute or chronic pain - this topic consists of three subtopics: 1. A : Using patient reported outcome measures to improve the management of acute and chronic pain (PROMs) 2. B : Improving the translatability of pharmacodynamic biomarkers in pain pathways of healthy subjects and preclinical species (BIOM) 3. C: Improving translation in chronic pelvic pain (PCC) 4. Creation of a pan-european paediatric clinical trials network 5. Biomanufacturing 2020: Development of innovative high throughput analytical tools and methods to characterize cell culture fluid during development and commercial cell culture processes 6. Unlocking the solute carrier gene-family for effective new therapies 7. Enhanced patient voice in medicines lifecycle 8. Precision medicines approaches in autism spectrum disorders Apertura: 21 diciembre 2016 Cierre: 28 marzo 2017 (1ª fase; 17:00:00 CET)

14 Financiación Topic Financiación IMI2 JU (Euros) Duración (meses) A, 3B, 3C A: ; B: C:

15 La 8ª convocatoria de IMI Ebola and other filoviral haemorrhagic fevers (Ebola+) programme: future outbreaks

16 La 11ª Convocatoria de IMI2. Exploitation of IMI Project Results Fuente: IMI

17 Quo Vadis IMI ? Creación de Strategic Governing Groups (SGGs) en: Diabetes / metabolic disorders Neurodegeneration Translational safety Data and knowledge management Infections control Oncology

18 El SGG de Oncología Visión del Oncology SGG. Objetivo: duplicar en 2025 La supervivencia libre de progresión / supervivencia global Nº de pacientes con acceso a medicinas personalizadas innovadoras Rapidez del desarrollo farmacéutico Tolerancia al tratamiento Coste-eficacia en el desarrollo de fármacos antitumorales Objetivos en cuidados personalizados del cáncer Estratificación de pacientes Especificidad del contexto MutOmics Inmunoncología Biopsia líquida La era de Big Data

19 Composición el SGG en Oncología Lead: Novartis Co-leads: Bayer, GSK Supporting IMI Scientific Officer: Oussama Karroum Supporting IMI Operations WG contact person: Stephan Korte SGG Operations manager: Jacquelyn White EFPIA Companies: AbbVie, AstraZeneca, Bayer, Biogen, BMS, Boehringer Ingelheim, Eli Lilly, GSK, Ipsen, Janssen, Merck, MSD, Novartis, Orion Pharma, Pfizer, Servier, Takeda, UCB, Varian Medical Systems Representatives from the European Commission: Dominika Trzaska and Jan-Willem Van De Loo (DG RTD) Representatives from the Scientific Committee: to be confirmed

20 Otras prioridades para IMI2 a debate (Stakeholders Forum sept. 2016) Respuesta a brotes epidémicos ( Biopreparedness ) En ATMP (Advanced Therapy Medicinal Products) Precision Genome Editing (PGE) Clinical development Patient Access Manufacturing Immunogenicity

21 Información sobre convocatorias en: Estado del Programa de Trabajo e IMI2