Convocatorias 7ª y 8ª. Innovative Medicines Initiative (IMI2)

Transcription

1 The Strategical Conference of EU Taiwan ICT Technical Cooperation Reunión Puntos de Contacto en CCAA Madrid, 25 de Enero de 2016 Convocatorias 7ª y 8ª. Innovative Medicines Initiative (IMI2) Juan E. Riese H2020 SC1 NCP Oficina de Proyectos Europeos Subdirección General de Programas Internacionales de Investigación y Relaciones Institucionales

2 Base conceptual de IMI2 2

3 El espíritu de IMI2 Deciphering the complexity of human diseases and finding safe, costeffective solutions that help people live healthier lives requires collaboration across scientific and medical communities throughout the health care ecosystem. Indeed, we must acknowledge that no single institution, company, university, country, or government has a monopoly on innovation. Fuente: 3

4 La Iniciativa de Medicamentos Innovadores 2 4

5 Empresas EFPIA, los coartífices de IMI 5

6 Prioridades establecidas 6

7 La 7ª convocatoria de IMI2 2 call Validation of translational imaging methods in drug safety assessment (TRISTAN) 2. Identification of druggable targets modulating misfolded proteins in Alzheimer s and Parkinson s Diseases 3. Pathological neuron glia interactions in neuropathic pain 4. Dry age related macular degeneration: development of novel clinical endpoints for clinical trials with a regulatory and patient access intention 5. A comprehensive paediatric preclinical POC platform to enable clinical molecule development for children with cancer Topics under the Big Data for Better Outcomes programme 6. Coordination and support action (CSA) for the big data for better outcomes programme 7. Increase access and use of high quality data to improve clinical outcomes in heart failure (HF), atrial fibrillation (AF), and acute coronary syndrome (ACS) patients 7

8 Condiciones de la convocatoria 2 call 7 0 8

9 Presupuestos por topic de la 7ª convocatoria (I) 9

10 Presupuestos por topic de la 7ª convocatoria (II) 10

11 Primer paso: diseño del consorcio público Consortia consisting of: IMI fundable legal entities carrying out activities relevant for achieving the project objectives Additional legal entities carrying out activities relevant for achieving the project objectives. 11

12 2º paso: diseño del consorcio público privado Consortia consisting of: Partners of the 1st ranked proposal Industry consortium (contributing with in kind / cash contributions) 12

13 The IMI2 proposal life cycle (for a 2 stages evaluation procedure) 13

14 Herramienta de búsqueda de socios search 14

15 Consorcios industriales en cada topic Topic Composición consorcio industrial 1 Bayer (coordinator), Abbvie (co coordinator), Sanofi, GSK, Novo Nordisk, Pfizer, PMB Alcen, General Electrics, Bruker 2 Lundbeck (lead company), J&J, Abbvie, Novartis, Lili & Lilly 3 Esteve, (coordinator), Grünenthal 4 Bayer Pharma AG (Leader), Novartis (Novartis Pharma as Deputy leader, Alcon, NIBR), Janssen CilagLtd,Roche,Zeiss 5 Eli & Lilly (Project Leader), Roche (co Project Leader), Bayer, PharmaMar,Pfizer 6 (CSA) Novartis (lead), Bayer + Janssen (co leads), 22 empresas, EFPIA y Farmaindustria 7 Bayer (lead), Vifor Pharma (co lead), Novartis, Servier, Somalogic 15

16 Criterios de Evaluación RIA Fase 1 Fase 2 Criterio 1 Exc. S&T Criterio 2 Impacto Criterio 3* 1. Clarity and pertinence of the objectives; 2. Credibility of the proposed approach; 3. Soundness of the concept, including trans disciplinary considerations, where relevant; 4. Extent that proposed work is ambitious, has innovation potential, and is beyond the state of the art; 5. Mobilization of the necessary expertise to achieve the objectives of the topic and to ensure engagement of all relevant key stakeholders. 1. The expected impacts of the proposed approach listed in the IMI2 annual work plan under the relevant topic; 2. Enhancing innovation capacity and integration of new knowledge; 3. Strengthening the competitive ness and industrial leadership and/or addressing specific societal challenges; 4. improving European citizens' health and wellbeing and contribute to the IMI2 objectives; 5. Any other environmental and socially important impacts; 6. Effectiveness of the proposed measures to exploit and disseminate the project results (including management of IPR), to communicate the project, and to manage research data where relevant. 1. The following aspects will be taken into account: 2. Coherence and effectiveness of the project work plan, including appropriateness of the allocation of tasks and resources; 3. Complementarity of the participants within the consortium (where relevant); 4. clearly defined contribution to the project plan of the industrial partners (where relevant); 5. Appropriateness of the management structures and procedures, including risk and innovation manage ment and sustainability plan. *: Quality and efficiency of the implementation 16

17 Criterios de Evaluación CSA Fase 1 Fase 2 Criterio 1 Exc. S&T Criterio 2 Impacto Criterio 3* 1. Clarity and pertinence of the objectives; 2. Credibility of the proposed approach; 3. Soundness of the concept, including trans disciplinary considerations, where relevant; 4. Quality of the proposed coordination and/or support measures; 5. Mobilization of the necessary expertise to achieve the objectives of the topic and to ensure engagement of all relevant key stakeholders. 1. The expected impacts of the proposed approach listed in the IMI2 annual work plan under the relevant topic; 2. Contribute to the IMI2 objectives; 3. Effectiveness of the proposed measures to exploit and disseminate the project results (including management of IPR), to communicate the project, and to manage research data where relevant. *: Quality and efficiency of the implementation 1. Coherence and effectiveness of the project work plan, including appropriateness of the allocation of tasks and resources; 2. Complementarity of the participants within the consortium (where relevant); 3. Clearly defined contribution to the project plan of the industrial partners (where relevant); 4. Appropriateness of the management structures and procedures, including risk and innovation management (and sustainability plan where relevant). 17

18 Criterios de Participación Pueden participar únicamente: a) legal entities established in a Member State or an associated country, or created under Union law; and b) which fall within one of the following categories: i. micro, small and medium sized enterprises and other companies with an annual turnover of EUR 500 million or less, the latter not being affiliated entities of companies with an annual turnover of more than 500 million; the definition of affiliated entities within the meaning of Article 2(1)(2) of Regulation (EU) No 1290/2013 shall apply mutatis mutandis; ii. secondary and higher education establishments; iii. non profit organisations, including those carrying out research or technological development as one of their main objectives or those that are patient organisations. c) the Joint Research Centre; d) international European interest organisations; In accordance with Article 10(2) point (a) of the Regulation (EU) No 1290/2013, in case of participating legal entity established in a third country, that is not eligible for funding according to point (a) above, funding from the IMI2 JU may be granted provided the participation is deemed essential for carrying out the action by the IMI2 JU. 18

19 Posibles topics para 2016 (1ª conv.) Diabetes/metabolic disorder Non alcoholic fatty liver disease Immunology Immune Tolerance therapies Other enablers of innovation Sustainable pan EU pediatric CT network (EUPCTN) Patient stakeholders engagement in product lifecycle Data and Knowledge Management Generation and exploitation of real world evidence Infection control including vaccines Innovation in vaccines Translational safety Models & platforms to improve the prediction & toxicity & safety CNS including neurodegeneration Autism spectrum disorders Presupuesto aprox. 200 Mio. 19

20 Posibles topics para 2016 (2ª conv.) Diabetes/metabolic disorders Diabetes CNS including neurodegeneration Alzheimer s Disease Pain Immunology Multiple Sclerosis Epigenetics Infection control including vaccines Antibiotics and antimicrobial resistance Human challenge trials Translational safety Models & platforms to improve the prediction & toxicity & safety Biomarkers Data and Knowledge Management Generation and exploitation of real world evidence Access standards and interoperability Support new research paradigms Other enablers of innovation Stakeholders engagement in product life cycle Unlocking the Solute Carrier Gene Superfamily for Effective New Therapies 20

21 La 8ª convocatoria de IMI2 2 call 8 1. Ebola and other filoviral haemorrhagic fevers (Ebola+) programme: future outbreaks 21

22 Entregables esperados en los proyectos Key deliverables might include (but are not limited to) the following: the progression of a novel vaccine candidate, diagnostic or treatment up to a stage ready for testing in an outbreak setting; the development of toolstohelpwithpre clinical and clinical development of vaccine candidates and treatments (incl. Proof of Concept testing of existing platforms for screening compounds for Ebola and other filoviruses); the development and/or validation of a novel diagnostic test that is sufficiently sensitive, rapid, user friendly, cheap, and usable in resource limited settings; the development of novel strategies to improve the stability of vaccines against Ebola and other filoviral infections during transport and storage, e.g. which would allow storage at 8 C or ambient temperatures for prolonged durations; the development of novel manufacturing and delivery strategies; the development of learning and strategies for optimal deployment and adherence to vaccination programmes; the facilitation of the exploitation of recent advances in our understanding of Ebola and other filoviral infections and the acceleration of their development into health care interventions. 22

23 Otros aspectos a tener en cuenta en el topic conv. 8 Every proposal should plan for a clearly defined strategy on how to ensure translation of the relevant project outputs into regulatory, clinical and healthcare practices, and ultimately into value for people in countries at risk of future outbreaks of filoviral haemorrhagic fevers. Activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem should take into account the country level pharmacovigilance systems. In that respect, a plan for interactions with regulatory agencies/health technology assessment bodies including relevant milestones and allocated resources should be proposed (e.g. qualification advice on the proposed methods for novel methodologies for drug development, qualification opinion). A plan for aspects related to sustainability, facilitating continuation beyond the duration of the project, should also be proposed. 23

24 La colaboración con pacientes en un proyecto IMI2 Applicant consortia are encouraged to consider whether their proposal could benefit from patient involvement. While preparing their proposals, applicant consortia should ensure that needs of patients are adequately addressed and, where appropriate, patient involvement is encouraged. There are a number of ways for patients to get involved in IMI projects as full project partners or as members of advisory committees (such as ethics boards), for example. It might be interesting to set up a Patient Advisory Platform / Group, which would be relevant all the way through the project and through to the sustainability elements post IMI funding. Patient organisations are your gateway to real life implementation. This is an excellent opportunity to involve them in the sustainability of the project when thinking of uptake of the research 24

25 La colaboración con pacientes en un proyecto IMI2. Qué pueden hacer los pacientes? input into operationalisation and monitoring of patient recruitment for clinical trials co designing the value proposition for patients taking part in the study/ trial development of materials to encourage patient recruitment input into the wording of informed consents input into Patient Reported Outcomes tools input into benefit risk discussions community outreach and dissemination, especially from the patient perspective. 25

26 La Propiedad Industrial en IMI2 26

27 Juan E. Riese isciii.es 27