ERA-Net COFUND Research Programmes on Rare Diseases (E-RARE)



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Bologna 15 Dicembre 2014 ERA-Net COFUND Research Programmes on Rare Diseases (E-RARE) The Role of RER-ASSR Antonio Addis Research Governance Area Agenzia Sanitaria e Sociale Regionale

How do Regions might have a role in the ERANet COFUND Research Programmes on Rare Diseases (E-RARE)?

ERA-NET Cofund: Eligibility conditions Who can participate? national and regional programmes (Joint call) research funders owning or managing public research and innovation programmes. Programme Owners Programme Managers Minimum conditions for participation: three independent legal entities from three different Member States or associated countries.

Emilia Romagna Research Facilities and Activities for Rare Diseases (RD) Network of Reference Centres for Rare Diseases (Reg.Act n. 160/2004): local health centres/specialized units (medical services, genetic and clinic laboratories): Certification and treatment of individual RD (Hub and Spoke model). Theoretical Research and application in clinical practice Training of professionals Epidemiological activities Regional Coordination Board Regional Technical Group Regional Registry: diagnoses and data of RD patients (June 2007)

Emilia Romagna Region Capacity to Fund and Manage Research Programmes

Agenzia Sanitaria e Sociale Regionale Programma di ricerca Regione-Universit Università Regional Law 29, 2004 R&D as the core duty of the Regional Health Service Close collaboration with the Regional University system key to make R&D effort successful and to improve its quality and sustainability 3 editions 2007-2009: 30 mil = 71 projects 2010-2012: 30 mil = 51 projects 2013: 5 mil = 22 projects Programme peculiarities 144 projects 3 Areas: Innovative research; Clinical governance; Training Two-step assessment process: Maieutic Approach Research Prioritarization: selecting research themes and research questions Programme for Young Investigators

Agenzia Sanitaria e Sociale Regionale Programma di ricerca Regione-Universit Università Aims: To enhance the research role of University hospitals within the regional healthcare service; To develop excellence in centers; To recognize the existence of professional networks; To promote scientific innovation; To foster new management methods and organizational changes; To increase training opportunities

The Assessment process Agenzia Sanitaria e Sociale Regionale Input Letter of Intent FULL PROPOSAL Principal Investigator Institution of research Pre-selection Selection Panel of Experts Individual Evaluation WORKSHOP Individual Evaluation STUDY SESSION Scientific committee Ranking approval Output Focus on strenght and weakness / suggestions for the Full Prpposal preparation Final Comments List of eligible and not-eligible proposals

Emilia Romagna Funding Programme on RD Next-Generation Sequencing and Gene Therapy to Diagnose and Cure Rare Diseases (Strategic Programme) Azienda ospedaliero-universitaria Policlinico di Modena 1.985.000 EURO Specific objectives 1. To improve diagnosis and management of patients with RD by generating 8 clinical databases for specific IMD populated with homogeneous and comprehensive genetic and clinical data. 2. To improve diagnostic accuracy measures of genetic test and provide patients referred for IMD with an accurate comprehensive and cost-effective genetic diagnosis by developing and implementing 3 disease-customized gene arrays. 3. To offer patients with IRD a cure in Italy by developing a protocol and implementing a gene therapy trial for a RD. 4. To identify new pathogenic genes for selected RDs where the pathogenic gene is unknown.

Emilia Romagna Funding Programme on RD Recognition, Diagnosis and Therapy of Mitochondrial Disorders in Neurological Services of the Emilia-Romagna Region (Strategic Project) Dr. Valerio Carelli, MD, PhD IRCCS Istituto delle Scienze Neurologiche di Bologna 1.323.300 EURO Specific objectives Primary: 1. To recognize the minimal prevalence and/or incidence of four frequent clinical phenotypes of MitD; 2. To create and harmonize a regional network of specialists using defined diagnostic pathways, shared among neurological/neuropsychiatric and pediatric services, 3. To recognize the four MitD phenotypes; 4. To provide the regional services with guidelines for clinical follow up of MitD patients and some feasible therapeutic options. Secondary: to discover new molecular defects causing MitD; to search for pathology biomarkers.

Emilia Romagna Funding Project on RD Bando Giovani ricercatori Alessandro Liberati 2013 Diagnostic accuracy and cost-effectiveness of Next Generation Sequencing (NGS) strategies in the genetic testing of Rare Orthopaedic Diseases IRCCS ISTITUTO ORTOPEDICO RIZZOLI BUDGET: 246.950

Trends Mol Med. 2010 Nov 11. Output of The Research N Engl J Med. 2010 Jul 8;363(2):147-55 Blood. 2012 Sep 20;120(12):2365-75. Epub 2012 Jul 11.

E-RARE Main Objectives Harmonize and develop synergies among national research programmes on rare diseases Set up cooperation between E-Rare partners Develop a common research policy Coordinate national actions to overcome the fragmentation of research and promote interdisciplinary approaches while intaining competitiveness Specific Goals and Activities Create a knowledge base for the development of joint and transnational activities Define strategic priorities, to develop and influence research policy on rare diseases and to shape national, transnational and European programmes Implement transnational cooperation (transnational calls)

E.RARE-3: The Role of RER-ASSR The Consortium: 23 partners from 17 EU, Associated and non- European Countries Opportunities: Internationalization of Research (EU/non EU) Shared Funding for International Research Projects Contribute to define Policies and Strategies (National, EU) for research on Rare Diseases

E.RARE-3: The Role of RER-ASSR General Identification of research priorities, preparation, launch and evaluation of transnational research calls (co-funded and non co-funded) Monitoring and evaluation of financed projects Communication, exploitation and dissemination of results of transnational funded projects Regional Information, Communication, Secretariat Technical support to Regional/Local entities and Institutions on the transnational research calls (co-funded and non co-funded)

E.RARE-3: The Role of RER-ASSR (1) Specific Technical Support WP8- Strategic Research Funding Policy: implementing IRDiRC Objectives and collaborating with other initiatives on Rare Diseases 8.1 Development of the Strategic Research Agenda 8.1.1 Gathering research needs from National Agencies, International Networks and EU projects 8.1.2 Organize strategic workshops for the identification of research topics (non co-funded calls) 8.2 Collaboration with EU Research Infrastructures (EATRIS, BBMRI, ECRIN) and other EU initiatives (EU- OPENSCREEN, INTRAFRONTIER) RER ASSR Task Leader 8.3 Involvement of Patient's Association in research funding

E.RARE-3: The Role of RER-ASSR (2) Specific Technical Support WP9- Strengthening Research Collaboration and enhancing knowledge translation 9.1 Development of the collaboration Platform for rare diseases researchers (RER-ASSR co-leader) 9.2 Connection with other Rare Diseases research initiatives and instruments (EU research infrastructures, regulatory bodies, expert groups, others) RER-ASSR task Leader 9.3 Dissemination of E.Rare Results and achievements (IT: ISS-MOH) 9.3.2 Final strategic meeting (IT: ISS-MOH)

Agenzia Sanitaria e Sociale Regionale Regions might have a role in the ERA-Net COFUND Research Programmes on Rare Diseases (E-RARE) Call definitions Priority setting Project monitoring Proposal' evaluations Research Pay back Regional Health Services