RARE-Bestpractices Conference
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1 RARE-Bestpractices Conference 24 November 2016, Istituto Superiore di Sanità, Rome, Italy Funding relevant rare diseases research: experience from E-Rare
2 Funding relevant rare diseases research: experience from E-Rare ERA-NET for research programmes on rare diseases Sonja van Weely, E-Rare NSC co chair/wp8 leader In collaboration with Daria JULKOWSKA, E-Rare Coordinator RARE-Bestpractices Conference Rome, Italy November 24, 2016
3 E-Rare Introduction About E-Rare How to fund relevant rare disease research
4 E-Rare What is E-Rare? ERA-Net = European Research Area Network INSTRUMENT created by European Commission that shall contribute to the development of European Research Area by improving coherence and coordination of research programmes across Europe and to ENABLE TO TACKLE COLLECTIVELY tasks that would be much less efficient or not possible when done independently ERA-Net consortium brings together funding bodies/ministries
5 E-Rare Why E-Rare? Rare disease facts ± 7000 rare diseases (80% of genetic origin) About 30 Mio people affected in Europe Represent major health impact and burden and are chronic and/or life threatening Lack of information and knowledge on natural history Often absence of early diagnosis and appropriate medical care Rare disease research weaknesses Large number of diseases BUT small number of patients per disease Scattering of patients all over geographical zones Clinical heterogeneity and difficulties in collecting clinical information and biological samples Fragmentation of research on rare diseases Few public funding programmes specific for rare disease research
6 E-Rare Major facts about E-Rare Created in 2006 (E-Rare-1) renewed in 2010 (E-Rare-2) at present funded under Horizon 2020 ERA-Net Co-fund E-Rare- 3 ( ) Main objective: coordinate and promote European and international efforts for funding research on rare diseases and increase collaboration, collection of patient samples, etc. E-Rare is mentioned in more than half of the National Plans for Rare Diseases 26 partners from 18 European, Associated and non-european countries (AT, BE, CA, CH, ES, FR, GR, HU, IT, JP, IL, LV, NL, PO, PL, RO, TR)
7 E-Rare-3: beyond Europe E-Rare achievements and future activities 26 partners in 18 countries FBRI CIHR FRQS GC
8 E-Rare activities Coordination & support activities Harmonization of national research programmes Development of strategic agenda & contribution to IRDiRC Development of common funding mechanisms Monitoring and assessment of funded research projects Collaboration with relevant stakeholders Communication & dissemination Joint Transnational Calls No cross-border funding Virtual common pot = each agency funds its own national research teams (except co-fund of EC) Launched with regular periodicity (yearly) Topic to be defined: open vs focus E-Rare is member of IRDiRC and follows IRDiRC priorities, recommendations and guidelines
9 E-Rare International Rare Diseases Research Consortium International Rare Diseases Research Consortium (IRDiRC) teams up researchers, funding agencies, companies and umbrella patient organisations in order to achieve two main objectives by 2020: deliver 200 new therapies for rare diseases diagnostic tools for most rare diseases Members of IRDiRC engage to spend at least 10 M $/5 years for research on rare diseases 3 rd IRDiRC Conference in Paris, 8-9 February 2017, see
10 E-Rare International Rare Diseases Research Consortium Governance structure of IRDiRC Funding agencies (including EC and E-Rare), companies, patient umbrella organisations, Chairs of Scientific Committees Mainly scientists
11 E-Rare-3 Joint Transnational Calls: Theme of the Calls Quality of the proposals Monitoring of the granted projects
12 Joint Transnational Calls: PREPARATION Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Definition of topic Recruitment of call partners: ERA-Net E-Rare members New funding bodies (National agencies/ministries/private companies/private foundations or patients associations) VIRTUAL COMMON POT Each agency funds only ITS national research teams Preparation of call documents Funding commitment MoU signature Call pre-announcement Call launch
13 E-Rare Choice of topic E-Rare JTC Topic Selection Working group (task 6.1) (several E-Rare partners and the E- Rare partner with Joint Call Secretariat responsibility) List of potential topics taken into account e.g.: IRDiRC Scientific Committee (SC) recommendations Results of Strategic Workshop E-Rare March 2016 Topics of earlier E-Rare Calls and their results Analysis of on going calls (especially Horizon 2020) 1 page summary of the proposed topics for consultation E-Rare partners External Advisory Board of E-Rare (15 members including chairs of IRDiRC SC) Decision of the topic by E-Rare partners joining the Call: result of what is needed in rare disease research and what is feasible for the funding agencies
14 E-Rare-3 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 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 2015 X/X X/X X X X/X X X X X/X X X X X/X/X X X X X JTC 2016 X X/X X 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 2015: 23 call partners from 17 countries applications per call (2015 call 230 applications) The global success rate of E-RARE proposals is 10% (PP vs FF) or 25% (FP vs FF) Average budget per call: 14 Mio Average budget per project: 800 K Since January 2008 we implemented 7 joint calls: 78 Mio. to support 449 research groups in 98 research consortia JTC 2015 with co-funding from European Commission of about 3 M
15 E-Rare Joint Transnational Calls: scope OPEN CALLS FOCUSED CALLS 2007, 2009, 2011, 2013, 2015: Clinical studies Physiopathology Pre-clinical therapeutic research Epidemiology & natural history studies Animal models, biomarkers 2012: Young investigator driven projects (recommendation of EAB & SEC) 2014: New therapeutic approaches for RDs (recommendation of IRDiRC and EAB) 2016: Clinical research on repurposing of molecules (recommendation of IRDiRC & POs) 2017: Innovative therapeutic approaches for RDs Rare cancers/rare infectious diseases/rare adverse drug events are excluded from the scope
16 TIME SCHEDULE Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Call launch Pre-Proposals submission Eligibility check Evaluation by SEC 1 st SEC meeting Full Proposals submitted 2 nd SEC meeting +CSC Meeting (funding bodies) - Ranking of proposals based on evaluation criteria - Set up of the list of proposals recommended for funding - Selection and final decision for funding Each pre-proposal is allocated to 2 SEC members Negotiation Each full proposal is allocated to : 2-3 external peer reviewers 1 member of the SEC as rapporteur 2 members of the SEC as readers Evaluation by external experts 2-4 Rebuttal Evaluation by SEC FUNDING
17 E-Rare CALL: Evaluation Criteria M EVALUATION CRITERIA general calls: Excellence Impact Quality and the efficiency of the implementation Flexibility on: Additional evaluation criteria in focused calls Sub-criteria Scores (full; half-points; etc.)(0-5) Eligibility: Consortium: min 3 partners from 3 different countries 3 year projects National rules for institutions, budget limitations, etc.
18 E-Rare JTC: Evaluation process M in general Evaluation External independent experts Rebuttal by project coordinator Scientific evaluation panel Ranking list Step 1: Preproposal Step 2: Full proposal X X X X X Representatives of the funding agencies that join the call are observers
19 Monitoring at the end of the funded projects Indicators Goal 1. Indicators to assess Call inputs Launch transnational calls that responds to the RD research need Pool national resources for researchers in collaborative research projects Indicators: examples No of partners/countries Partners funding commitment 2. Indicators to assess Call outputs Funding transnational research projects Contribution to IRDiRC major goals Reduce fragmentation of resources Fund RD research with a public health impact Networking and knowledge exchange Sustainable/successful collaborations No of funded projects No new therapies/diagnostics/biomarkers No of new/existing registries, biobanks No of cohorts created/purpose of cohorts No of meetings/workshops No of consortia successful in subsequent JTCs or EC calls 3. Socioeconomic indicators Increase in level of education Job creation New products Gender balance No of masters/phd theses No of contracts No of licenced patents Ratio Male/Female
20 More than 100 STUDENTS TRAINED 40 PUBLICATIONS PER YEAR REGISTRIES SAMPLES DATABASES BIOBANKS 100% achieve critical mass 54% successful application E-Rare JTCs achievements PROTOCOLS 18 NEW genes Discovered (in 29 projects) 77% New sustainable collaboration 98 M 78 RESEARCH PROJECTS 449 TEAMS
21 E-Rare-3: E-Rare Some achievements of the next and steps future activities 2 additional joint calls (JTC 2017 & 2018) Analysis of pilot funding action with Patient Organisations in collaboration with EURORDIS Accelerate integration of results of E-Rare funded projects (databases, registries, biobanks, sequencing) into existing or emerging infrastructures/tools (RD-Connect, Orphanet, JRC registries platform, Matchmaker, etc.) Continue inclusion of new partners/new countries Prepare the future of E-Rare towards higher integration of MS efforts
22 Collaboration in rare disease research is necessary Thank you
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