IMI2 - Oficina de Proyectos Europeos

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
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Base conceptual de IMI2
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El espíritu de IMI2
“Deciphering the complexity of human diseases and finding safe, cost‐
effective solutions that help people live healthier lives requires
collaboration across scientific and medical communities throughout the
health care ecosystem.
Fuente:
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Indeed, we must acknowledge that no single institution, company,
university, country, or government has a monopoly on innovation.”
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La Iniciativa de Medicamentos Innovadores 2
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Empresas EFPIA, los coartífices de IMI
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Prioridades establecidas
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La 7ª convocatoria de IMI2
http://www.imi.europa.eu/content/imi‐2‐call‐7‐0
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
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1. 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
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Condiciones de la convocatoria
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http://www.imi.europa.eu/content/imi‐2‐call‐7‐0
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Presupuestos por topic de la 7ª convocatoria (I) 9
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Presupuestos por topic de la 7ª convocatoria (II) 10
Primer paso: diseño del consorcio público
Consortia consisting of:
 IMI fundable legal entities carrying out activities relevant for
achieving the project objectives
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 Additional legal entities carrying out activities relevant for achieving
the project objectives.
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2º paso: diseño del consorcio público‐privado
Consortia consisting of:
 Partners of the 1st ranked proposal
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 Industry consortium (contributing with in‐kind / cash contributions)
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The IMI2 proposal life cycle
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(for a 2‐stages evaluation procedure)
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www.imi.europa.eu/content/partner‐search
http://www.fitforhealth.eu/
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Herramienta de búsqueda de socios
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Topic
Composición consorcio industrial
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Bayer (coordinator), Abbvie (co‐coordinator), Sanofi, GSK, Novo Nordisk, Pfizer, PMB Alcen, General Electrics, Bruker
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Lundbeck (lead company), J&J, Abbvie, Novartis, Lili & Lilly
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Esteve, (coordinator), Grünenthal
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Bayer Pharma AG (Leader), Novartis (Novartis Pharma as Deputy
leader, Alcon, NIBR), Janssen‐Cilag Ltd, Roche, Zeiss
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Eli & Lilly (Project Leader), Roche (co‐Project Leader), Bayer,
PharmaMar, Pfizer
6 (CSA) Novartis (lead), Bayer + Janssen (co‐leads), 22 empresas, EFPIA y Farmaindustria
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Bayer (lead), Vifor Pharma (co‐lead), Novartis, Servier, Somalogic
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Consorcios industriales en cada topic
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Criterios de Evaluación ‐ RIA
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. IMI2 – 7ª y 8ª convocatorias
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Fase 2
Fase 1
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*: Quality and efficiency of the implementation
Criterios de Evaluación ‐ CSA
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. 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). *: Quality and efficiency of the implementation
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Fase 2
Fase 1
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Criterios de Participación
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.
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Pueden participar únicamente:
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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. €
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Posibles topics para 2016 (1ª conv.)
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Posibles topics para 2016 (2ª conv.)
Diabetes/metabolic disorders
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CNS including neurodegeneration
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Models & platforms to improve the prediction & toxicity & safety
Biomarkers
Data and Knowledge Management
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Antibiotics and antimicrobial resistance
Human challenge trials
Translational safety
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Multiple Sclerosis
Epigenetics
Infection control including vaccines
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Alzheimer’s Disease
Pain
Immunology
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Diabetes
Generation and exploitation of real world evidence
Access standards and interoperability
Support new research paradigms
Other enablers of innovation
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Stakeholders’ engagement in product life cycle
Unlocking the Solute Carrier Gene‐Superfamily for Effective New Therapies
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La 8ª convocatoria de IMI2
http://www.imi.europa.eu/content/imi‐2‐call‐8
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1. Ebola and other filoviral haemorrhagic fevers (Ebola+) programme: future
outbreaks
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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 tools to help with pre‐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.
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Entregables esperados en los proyectos
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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.
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Otros aspectos a tener en cuenta en el topic conv. 8
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La colaboración con pacientes en un proyecto IMI2
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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
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Applicant consortia are encouraged to consider whether their proposal could benefit from patient involvement.
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La colaboración con pacientes en un proyecto IMI2. ¿Qué pueden hacer los pacientes?
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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.
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La Propiedad Industrial en IMI2
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Juan E. Riese
jriese@eu‐isciii.es
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