Madrid, 25/11/2010 Marta Gómez Quintanilla IMI Representative Health Delegate Dpto. Programa Marco I+D

Transcription

1 Madrid, 25/11/2010 Marta Gómez Quintanilla IMI Representative Health Delegate Dpto. Programa Marco I+D 1 (18/02/2011)

2 Índice Spanish participation 1st call & 2nd call statistics 3rd call Rules for submision How to find partners Useful links Get support 2 (18/02/2011)

3 Índice Spanish participation 1st call & 2nd call statistics 3rd call Rules for submision How to find partners Useful links Get support 3 (18/02/2011)

4 1 st & 2 nd Call IMI funding + EFPIA contribution (estimation) Call topics Expressions of Interest EoIs/topic Participants Funded Projects ES in Funded Projects (no EFPIA) ES participations (no EFPIA) ES entities (no EFPIA) 1st Call million million = 246 million , (3 SMEs) 2nd Call (under negociation) 80 million + 80 million = 160 million , * (0 SMEs) 4 (18/02/2011)

5 Budget possible scenario: IMI-JU + EFPIA M ~ 700M IMI JU for next calls EFPIA IMI JU * 2010* 2011** 2012** TOTAL Call * estimated budget, tbd 5 (18/02/2011) ** remaining budget divided between two years, tbd

6 IMI 1 st call Projects IS (1) NL (12) BE (11) UK (34) IE (2) NO (1) SE (10) FI (6) DK (8) LU (1) FR (25) PL (1) HU (2) PT (1) ES (17 partners) CH (14) IT (14) AT (6) RS (2) DE (30) 6 (18/02/2011)

7 Chemotargets SL NST S.L. LMD S.L. CNIO AEMPS CEIFE U. Murcia ES (17 partners) IMI 1 st call Projects ESTEVE ALMIRALL IMIM ICCC FICF (HUVH-UAB) UAB) UA. Barcelona U. Barcelona U.Pompeu Fabra IDIBAPS CSIC-IIBB IIBB 7 (18/02/2011)

8 IMI 1 st call Projects Integrating bioinformatics and chemoinformatics approaches for the development of expert systems allowing the in silico prediction of toxicities The etox project partners will develop innovative strategies and novel software tools to better predict the safety and the side-effects of new candidate medicines for patients. Reliable prediction of side-effects in the initial phases of drug development lowers the failure rate in later phases, significantly reduces the number of animal tests needed and accelerates the development of new drugs. Acronym: etox Coordinator: Novartis Pharma (CH) Partner (ES): - Laboratorios Esteve, S.A. - Fundació IMIM -CNIO - Chemotargerts - Lead Molecular Design (SMEs) Financing: - IMI funding: 4,7 M - Other contribution: 1,2 M - EFPIA in kind contribution: 7,0 M - Total Project Cost: 12,9 M 8 (18/02/2011) Website:

9 IMI 1 st call Projects Safer and faster evidence-based translation The scientists of the SAFE-T project are developing improved tools for prediction, detection, and monitoring of drug-induced injuries to the kidney, the liver, and the vascular system, using markers in patients blood and/or urine. The consortium will focus on measuring sets of safety biomarkers across a variety of patient populations in order to define background variability, response to specific organ injury, and biomarker profiles under different disease conditions. The ultimate goal is to identify for each of the three organ toxicities a set of biomarkers Acronym: SAFE-T Coordinator: Novartis Pharma (CH) Partner (ES):- Laboratorios Almirall, S.A - Consorci Institut Català de Ciències Cardiovasculars Financing: - IMI funding: 13,9 M -Other contribution: 4,1 M - EFPIA in kind contribution: 17,8 M - Total Project Cost: 35,9 M Website: 9 (18/02/2011)

10 IMI 1 st call Projects Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium The PROTECT project will enhance the monitoring of the safety of medicinal products. It will also contribute to better evaluate and communicate their benefit-risk profile throughout their lifecycle. To this end, innovative tools and methodological standards will be developed. Acronym: PROTECT Coordinator: GlaxoSmithKline R&D LTD (UK) Partner (ES): - Agencia ES de Medicamentos y Productos Sanitarios - Fundacion Institut Català de Farmacologia - Centro ES de Investigación Farmacoepidemiológica Financing: - IMI funding: 11,0 M -Other contribution: 8,8 M - EFPIA in kind contribution: 9,9 M - Total Project Cost: 29,8 M Website: 10 (18/02/2011)

11 IMI 1 st call Projects Understanding Chronic Pain and Improving its Treatment The scientists will search for changes in the nervous system that contribute to pain, in order to fill the gaps in the current knowledge of chronic pain. They will elucidate the mechanisms of pain, using novel experimental models, human volunteers and clinical data of pain patients. They will search objective methods to measure pain in patients and they will examine the mechanisms that are activated by placebo ( fake ) pain. By identifying the mechanisms involved in chronic pain, the EUROPAIN consortium will open possibilities for better treatments for patients. As new pain medication may hold a risk of abuse, the scientists will scan the effect of new pain drugs on the brain. Acronym: EUROPAIN Coordinator: AstaZeneca AB (SE) Partner (ES):- Laboratorios Esteve, S.A. - Neuroscience Technologies, S.L. (SME) Financing: - IMI funding: 6,0 M -Other contribution: 0,7 M - EFPIA in kind contribution: 11,5 M - Total Project Cost: 18,2 M Website: N/D 11 (18/02/2011)

12 IMI 1 st call Projects Novel Methods leading to New Medications in Depression and Schizophrenia The NEWMEDS consortium will develop three important missing tools that will facilitate the translation of scientific findings into benefits for patients: - They will search for detectable signs of disease (biomarkers) in the DNA and the proteins of patients / - the scientists will develop new techniques for the interpretation of brain scan images / - they will develop improved experimental models that mimic schizophrenia or depression in humans. Acronym: NEWMEDS Coordinator: H. LundbeckA/S (DK) Partner (ES): - CSIC IIBB (Inst. Inv. Biomédicas de Barcelona) Financing: - IMI funding: 8,2 M -Other contribution: 2,6 M - EFPIA in kind contribution: 13,2 M - Total Project Cost: 24,0 M Website: 12 (18/02/2011)

13 Prediction of Cognitive Properties of new Drug Candidates for Neurodegerative Diseases in Early Clinical Development The Pharma-Cog project aims to develop and validate new tools to test candidate drugs for the treatment of symptoms and disease in a faster and more sensitive way. By bringing together databases of previously conducted clinical trials and combining the results from blood tests, brain scans and behavioural tests, the scientists will develop a 'signature' that gives more accurate information on the progression of the disease & the effect of candidate drugs than current methods do Acronym: PHARMA-COG Coordinator: GlaxoSmithKline R&D LTD (UK) Partner (ES): - IDIBAPS (Inst D Inv Biomediques August Pi-Sunyer) - Universidad de Murcia Financing: - IMI funding: 9,6 M - Other contribution: 7,8 M - EFPIA in kind contribution: 10,2 M - Total Project Cost: 27,7 M Website: IMI 1 st call Projects 13 (18/02/2011)

14 Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes The U-BIOPRED project aims to speed up the development of better treatments for patients with severe asthma. The researchers will create and validate innovative testing methods to classify patients into distinct severe asthma types. Using a sophisticated systems biology approach, they will bring together genetic data from patients, results from tissue samples, blood tests and breathing tests, as well as clinical findings and patient reported symptoms. This will be linked to results of preclinical models, in order to facilitate future drug development. Acronym: U-BIOPRED Coordinator: Academic Medical Center (NL) Partner (ES): - Laboratorios Almirall, S.A. Financing: - IMI funding: 9,0 M -Other contribution: 1,3 M - EFPIA in kind contribution: 10,4 M - Total Project Cost: 20,7 M Website: IMI 1 st call Projects 14 (18/02/2011)

15 IMI 1 st call Projects Physical Activity as a Crucial Patient Reported Outcome in COPD The aim of PROactive is to develop new tools that will enable patients, their doctors and clinical researchers to accurately assess the improvement or deterioration of Chronic Obstructive Pulmonary Disease (COPD). The PROactive consortium will develop Patient Reported Outcome-tools that detect small, but clinically relevant changes in physical activity and its related symptoms and as such, it will offer results more relevant to patients and doctors. Acronym: PROACTIVE Coordinator: Chiesi Famaceutici S.p.A. (IT) Partner (ES):- Laboratorios Almirall, S.A. - Fundación IMIM Financing: - IMI funding: 6,7 M -Other contribution: 1,7 M - EFPIA in kind contribution: 8,2 M - Total Project Cost: 16,7 M Website: 15 (18/02/2011)

16 IMI 1 st call Projects European Modular Education and Training Programme in Safety Sciences for Medicines SafeSciMET is a new and unique pan-european network, which will develop and establish a comprehensive modular education and training programme in safety sciences for medicines. The network will encompass the safety, ethical, regulatory and societal aspects of drug discovery and development. The training will lead to a new generation of safety specialists with strong competences in the application of novel technologies in risk assessment. Acronym: SAFESCIMET Coordinator: F. Hoffmann-La Roche AG (CH) Partner (ES):- Laboratorios Almirall, S.A. Financing: - IMI funding: 2,2 M -Other contribution: 0,8 M - EFPIA in kind contribution: 3,4 M - Total Project Cost: 6,6 M Website: 16 (18/02/2011)

17 IMI 1 st call Projects 3 Pharmaceutical Medicine Training Programme The main objective of the PharmaTrain project is to build and implement a new modular Master level programme for advanced studies in Pharmaceutical Medicine and Drug Development Sciences. The programme is based on the Bologna credit and title system and builds on the new PharmaTrain Syllabus 2010 of the European Federation of Courses in Pharmaceutical Medicine (EFCPM). Acronym: PharmaTrain Coordinator: EU Fed Of courses in Pharmaceutical Medicine (CH) Partner (ES): - Laboratorios Almirall, S.A. - Laboratorios Esteve, S.A. -U. Barcelona -U.A. Barcelona - U. Pompeu Fabra Financing: - IMI funding: 3,5 M - Other contribution: - EFPIA in kind contribution: 3,1 M - Total Project Cost: 6,6 M 17 (18/02/2011) Website:

18 IMI 1 st call Projects 1 EU Programme in Pharmacovigilance and Pharmacoepidemiology Eu2P aims to improve the understanding of the risks and benefits of medicines in large groups of people, by developing a European training and education platform in ph.covigilance and ph.coepidemiology. The Eu2P programme will offer courses in pharmacovigilance and pharmacoepidemiology with specialties in benefit assessment, regulatory aspects, risk quantification, public health and risk communication, Acronym: EU2P Coordinator: F. Hoffmann-La Roche AG (CH) Partner (ES): - Laboratorios Almirall, S.A. - Fundacio Institut Català de Farmacologia Financing: - IMI funding: 3,5 M - Other contribution: - EFPIA in kind contribution: 3,8 M - Total Project Cost: 7,3 M Website: 18 (18/02/2011)

19 IMI 1 st call Projects European Medicines Research Training Network EMTRAIN will establish a pan-european platform for education and training, covering the entire life-cycle of medicines, from basic research, clinical tests and market authorisation to follow-up research of drugs already on the market. The consortium will provide a mechanism to ensure that industry and academia cooperate on courses that can be rapidly designed and implemented, in order to enable a faster implementation of new scientific & technological developments in academic teaching. Acronym: EMTRAIN Coordinator: AstaZeneca AB (SE) Partner (ES):- Laboratorios Almirall, S.A. - Laboratorios Esteve, S.A. Financing: - IMI funding: 4,0 M - Other contribution: - EFPIA in kind contribution: 3,7 M - Total Project Cost: 7,7 M Website: 19 (18/02/2011)

20 IMI 1 st call Projects MARCAR - BioMARkers and Molecular Tumour Classification for Non-Genotoxic CARcinogenesis (Total Project Cost 13,3 M ; Coordinator: Novartis Pharma) IMIDIA - Improving Beta-cell function and identification of Diagnostic Biomarkers for Treatment monitoring in Diabetes (Total Project Cost: 25,9 M ; Coordinator: Sanofi-Aventis) SUMMIT Surrogate Markers for Micro- and Macro Vascular hard endpoints for Innovative Diabetes Tools (Total Project Cost: 28,5 M ; Coord.: Boehringer Ingelheim Int.) 20 (18/02/2011)

21 Índice Spanish participation 1st call & 2nd call statistics 3rd call Rules for submision How to find partners Useful links Get support 21 (18/02/2011)

22 To start with... Who? Any legal entity carrying out activities in European Member States or Countries Associated with the 7th Framework Programme* Funding for SMEs, non profit public bodies, intergovermental organisations, non-profit organisations which carry out research or technological development as one of their main objectives, secondary and higher education establishments & non-profit qualified patients organisations How? Submiting a proposal (Guidelines) When? Deadline 18 January 2011 Why? Participate in public-private consortia, contribute to the drug development process. Access to EU funding: Grants 22 (18/02/2011)

23 Elegibility Receipt of the expressions of interest before the deadline date and time established in the Call. Respect of the "minimum conditions", as referred to in the IMI Rules for Participation. 1st stage: 2 independent entities elegible to receive funding 2nd stage: 2 independent entities elegible to receive fundinig + 2 EFPIA companies Completeness of the expressions of interest: Part A + Part B Scope: the content of the expression of interest must relate to the scope of one specific topic in the Call 23 (18/02/2011)

24 Funding Up to 75% Up to 100% 24 (18/02/2011)

25 Process 11 months 25 (18/02/2011)

26 1st stage 26 (18/02/2011)

27 PART A: ADM. Submision of Expresion of Interest 1. Form A1 for the Coordinator of the Applicant Consortium 2. One form A2 for each organisation PART B: TECHNICAL Section 1. Scientific/technological case (max six pages) 1.1. Innovative approaches and strategy you intend to use, 1.2. Level of novelty, of practical applicability, of scientific and/or technological impact of your project. Section 2. Partnership case 2.1. Composition of the Applicant Consortium (max half page per participant) Complementarities within the Applicant Consortium (max one page): Section 3. Summary work-plan (max three pages) - Work plan general outline -Workpackagelist - List of the main deliverables and indicative timelines - Indicative budget plan 27 (18/02/2011) Section 4. Ethical Issues (max half page)

28 Submision of Expresion of Interest Deadline: 18 January, 17:00:00 Brussels time Electronic submision Practical issues: Read ALL the documents Font type: Times New Roman 12 Respect page limits Deadline is fix Late proposals are not elegible! 28 (18/02/2011)

29 1st stage 29 (18/02/2011)

30 1st peer review Evaluation: Independent experts + EFPIA coordinator and deputy coordinators Observers Panel ranking: Independent experts Observers 30 (18/02/2011)

31 1st stage 31 (18/02/2011)

32 2nd stage No EFPIA 32 (18/02/2011)

33 Negotiation & Signature 33 (18/02/2011)

34 Two types of Partner Search Coordinator Partner 34 (18/02/2011)

35 A winning consortium # Partners # Countries Complementarily Multidisciplinary Multi-sector Work distribution Financial distribution Budget Collaborators Publications Friends / Known people FP project coordinators / partners Partner Search Tools Technology Platforms Info-days (national international) NCPs (national international) Enterprise Europe Network Scientific congresses National and international networks 35 (18/02/2011)

36 Partner Search Tools & Data bases (II) (18/02/2011)

37 Partner Search Tools & Data bases FIT FOR HEALTH: PS tool + data base LIFE COMPETENCE: FP6 projects database HEALTH COMPETENCE: FP7 projects database 37 (18/02/2011)

38 Partner Search Tools & Data bases (II) 38 (18/02/2011)

39 Partner Search Tools & Data bases (III) (18/02/2011)

40 CORDIS Partners service: Partners profile database (searchable) Partner search CORDIS Database: Cordis Service 6PM- 7PM - Health library with compiled projects: Search: Choice: Simple, Advanced, Professional, Map-based & Conceptual 40 (18/02/2011)

41 CORDIS Service (II) (18/02/2011)

42 Partner Search NCPshttp://cordis.europa.eu/fp7/health/ncp_en.html ICPCs CPs Enterprise Europe Network: Technology Platforms: International events / CE Indodays: (new Health web) Publications: e.g (18/02/2011)

43 GET SUPPORT IMI Scientific + Legal Officers 3rd call topics Maria Teresa De Magistris Safety Elisabetta Vaudano Efficacy Ann Marie Martin Knowledge Management Fatiha Sadallah Education and training Sophie Dogny Administrative Management Topic 1. DILI Topic 2. Immunogenicity Topic 3. Immunosafety Topic 6. Diabetes Topic 7. Patient awareness Topic 4. Tuberculosis Topic 5. Autism Magali Poinot Legal Manager Contact details: María Teresa de Magistris: mariateresa.demagistris[at]imi.europa.eu Elisabetta Vaudano: elisabetta.vaudano[at]imi.europa.eu Ann Marie Martin: ann.martin[at]imi.europa.eu 43 Fatiha Sadallah: fatiha.sadallah[at]imi.europa.eu (18/02/2011) Magali Poinot: magali.poinot[at]imi.europa.eu

44 LINKS Mailing List Agenda Info FP7 & IMI 44 (18/02/2011)

45 Conclusiones EC money easy money Only the best proposal Stablish a very competitive consortium & a very competitive proposal Strategy & suport (NCP, IMI JU, support offices, UII (Plat. Med. Inn., Asebio, Nanomed, etc.) Good luck! 45 (18/02/2011)

46 Tlf: / (18/02/2011)