Addressing the needs of the rare diseases research community: The E-Rare perspective
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1 Addressing the needs of the rare diseases research community: The E-Rare perspective Daria Julkowska 7 th European Conference on Rare Diseases & Orphan Products 8-10 May 2014 Berlin, Germany
2 E-Rare Consortium ( ) ERA-Net for Research Programmes on Rare Diseases 15 European (or Associated) Member States 19 Research (funding) Agencies/Ministries + Affiliated members: Canada, Switzerland Member of the International Rare Diseases Research Consortium (IRDiRC)
3 Why need for ERA-Net on rare diseases? Rare Diseases Facts: Rare diseases represent major health impact and burden 7000 rare diseases (80% of genetic origin) Mio people affected in Europe Chronic and/or life threatening Lack of information, knowledge on natural history Absence of early diagnosis and appropriate medical care RD Research Weaknesses: Large number of diseases Small number of patients per disease Scattering of patients all over geographical zones Clinical heterogeneity Difficulties in collecting clinical information and biological samples «Low of interest» of pharmaceutical companies
4 Rare diseases research: NEEDS NATURAL HISTORY FUNDING ACHIEVING OF CRITICAL MASS COOPERATION TRAINING BIOBANKS TRANSLATION REGISTRIES INVOLVEMENT OF PATIENTS BIOMARKERS THERAPY SUSTAINABILITY
5 E-Rare-2 E-Rare-1 E-Rare Joint Transnational Calls: FUNDING JTC 2007 X X X X X X JTC 2009 X X X X X X X X X X JTC 2011 X/X X X X X X X X X JTC 2012 (YI) X X X X X X X X X X JTC 2013 X/X X X X X X X X X X X/X X X/X X JTC 2014 X X X X X X X X X X X X/X X X X X JTC 2007: 6 call partners from 6 countries JTC 2014: 17 call partners from 16 countries Non Funded Funded Since January 2008 (JTC 2007, 2009, 2011, 2012 & 2013): 45.7 Mio. to support 287 research groups in 65 research consortia 2600 applications, 640 consortia. The global success rate of E-RARE proposals is 10% Consortia Teams
6 E-Rare Joint Transnational Calls: SCOPE Clinical studies Natural history of diseases, Registries, Databases, Genotype/Phenotype Correlation studies, Diagnosis/Prognosis markers Pre-clinical Therapeutic Research Development of new therapeutic tools, Proof-of-concept, Innovative biotechnology research, Drug toxico/pharmacol. Physiopathology Gene identification, Epigenetics, Molecular mechanisms, New animal models, Omics, Biomarkers Human & Social Sciences Focused calls: Young Investigator Novel therapeutic approaches
7 E-Rare Joint Transnational Calls: MEDICAL DOMAINS JTC Applying consortia Funded consortia
8 E-Rare funded projects: PREVALENCE JTC
9 E-Rare funded projects: CRITICAL MASS Assessment of JTC 2007 & 2009 funded projects ALL funded consortia achieve critical mass necessary for the development of the scientific project Infrastructures initiated by consortia: 6 5 New setup Combination of previously existing Nature of the samples in biobanks % 19% 38% DNA Cells Tissues Fluids 0 Registry Database Biobank 19%
10 E-Rare funded projects: COLLABORATION & TRAINING Assessment of JTC 2007 & 2009 funded projects 77% NEW COLLABORATIONS 54% SUCCESSFUL APPLICATION FOR NEW FUNDING 58 Master students 33 Post-docs 76 PhD 14 PUBLIC WEBSITES & 21 DOCUMENTS 13 DEDICATED CONFERENCES
11 E-Rare Achievements E-Rare achievements and future activities A major contributor to transnational research (funding) on rare diseases JTC 2007: 6 call partners from 6 countries JTC 2014: 17 call partners from 16 countries Since January 2008 (JTC 2007, JTC 2009, JTC 2011 & JTC 2013): 45.7 Mio. to support 287 research groups in 65 research consortia Foreseen funding for current call: Mio. Recognized catalyser of research collaboration & exchange Achievement of critical mass in funded projects Training Successful application to subsequent funding Publications & communication: 319 publications, 2942 citations; mean IF 9.66
12 Future Activities: E-Rare-3
13 E-Rare-3: E-Rare beyond achievements Europe and future activities More partners: From 17 full partners in 13 countries to 27 partners in 17 countries: NCBR, Poland; LAS, Latvia DGF, Germany; FFG, Austria; ASSR, Italy SNSF, Switzerland CIHR, FRQS, Genome Canada, Canada New capacities & knowledge: 1 st joint call: co-funding by European Commission Funding of clinical trials Private public partnerships Collaboration with voluntary health organizations Strengthened collaboration with IRDiRC Promotion of transnational funding Strategic research agenda
14 E-Rare-3: E-Rare collaborations achievements and future activities PATIENTS ORGANIZATIONS Involvement of patients organizations in collaborative research funding Building upon experience (CIHR, Canada; ZonMw, Netherlands) EURORDIS: key role in brokering conversation with patients organizations and brining their input Establishment of funding model Connecting patients & researchers
15 E-Rare-3: E-Rare collaborations achievements and future activities EUROPEAN RESEARCH INFRASTRUCTURES: BIOBANKS, CLINICAL TRIALS, TRANSLATIONAL MEDICINE, MOLECULE SCREENING, MOUSE MODELS Facilitated access Exchange of best practices Models for sustainability Communication & training
16 E-Rare-3: E-Rare collaborations achievements and future activities EUROPEAN MEDICINES AGENCY Assistance for rare diseases researchers Promotion of scientific advice for orphan medicines Communication & learning (dedicated pages & workshops)
17 E-Rare-3: E-Rare collaborations achievements and future activities RE(ACT) COMMUNITY & CONGRESS Facilitated collaboration between researchers Information gathering Identification of new funding mechanisms (incl. through crowd funding), Optimizing of synergies between rare diseases stakeholders such as patient organizations, academic institutions, centers of expertise, health industry, regulators and policy makers Common congress
18 THANK YOU 7 th European Conference on Rare Diseases & Orphan Products 8-10 May 2014 Berlin, Germany
19 Work Package 5: Preliminary results E-Rare funded projects: INFRASTRUCTURE/SUSTAINABILITY Assessment of JTC 2007 & 2009 funded projects Registries Databases Biobanks Nb % Registries 4 31* Nb % Database 9 69* Nb % Biobank 7 54* New 2 50 New 5 56 New 3 43 Existing 2 50 Existing 4 44 Existing 4 57 Harmonisation Harmonisation Critical mass Critical mass Critical mass Sustainability** 5 71 Sustainability** Sustainability** 7 78 * Expresses the proportion of all JTC2007 consortia able to establish the concerned facility ** At least one option/scenario of sustainability is envisaged
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