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The Project’s 2nd GA was held in Berlin, Germany, on the 23rd and 24th of October 2017 where the most advanced technology in data sharing was presented to contribute to a better understanding of hematologic cancers. Public and private organizations will contribute data on most hematologic cancers. The use of a common data model will allow to conduct analysis at an unprecedented scale.

Synapse is member of the HARMONY’s Project Management Office, and supports the Executive and Steering Committees in facilitating collaboration and ensuring the effective contribution from all partners in this ambitious project.

Read more at: press release

More info at: www.harmony-alliance.eu

Company Statement
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Synapse has kicked-off its Social Programme as part of Synapse’s corporate social responsibility to support initiatives related with the citizen’s health care.

Synapse’s Social Programme has started funding two local initiatives:

  • ASIMAGA, a Spanish non-profit association created from the concern of families of children affected with the Cri du chat syndrome, which is considered a rare genetic disorder.
  • The Enriqueta Villavecchia Private Foundation for Child Oncology, a non-profit organization from Barcelona (Spain), which provides integral care for children and youngsters suffering from cancer and gives support to their families.

More info at: www.synapse/social-programme

Carlos Diaz, CEO of Synapse, and Dr. Montserrat Cases, Project Manager at Synapse, are co-authors of a Comment published in the prestigious scientific magazine Nature Reviews Drug Discovery that summarises the relevance of data sharing for improving the in silico prediction of organ toxicities in the drug development pipeline, the challenges faced and lessons learned during eTOX project. The eTOX project – Integrating bioinformatics and chemoinformatics approaches for the development of expert systems allowing the in silico prediction of toxicities- is an IMI project which run from January 2010 to December 2016.

Article: “Legacy data sharing to improve drug safety assessment: the eTOX project” Ferran Sanz, François Pognan, Thomas Steger-Hartmann, Carlos Díaz, eTOX, Montserrat Cases, et al. Nature Reviews Drug Discovery, 2017. doi:10.1038/nrd.2017.177

More info:at: Nature Reviews|Drug Discovery

More about eTOX:  www.etoxproject.eu

Synapse publications: synapse-managers.com/publications

The APM Project Management Awards 2017, sponsored by RPC UK Ltd, recognises the achievements of the Project Management profession and rewards the work of young project managers and experienced professionals working in complex projects.

The EPAD project, in which Synapse is the Project Manager, is finalist in the Category of Social Project of the year. This category is for projects with the specific aim of developing solutions that deliver benefits to society- locally, regionally, nationally and globally.

The ceremony will be held on Monday 20th November 2017 at the Old Billingsgate in London. Sandra Pla will be attending on behalf of Synapse.

More info about IMI2 EPAD in: www.ep-ad.org

More info about APM Project Management: www.apm.org.uk

Synapse is the project manager for the IMI 2 five-year project, Enhancing Translational Safety Assessment through Integrative Knowledge Management (eTRANSAFE). The project officially started on September 1st 2017 while the official kick of will be in Barcelona (Spain) on the 26-27 of the same month. The project aims to develop an advanced data integration infrastructure together with innovative computational methods to improve the security in drug development process.

The eTRANSAFE project aims at improving the safety assessment across the drug discovery and development process by applying bioinformatics approaches to shared preclinical and clinical data to systematically analyse the translatability of effects. Thus, enabling the optimisation of resources and the development of safer medicines.
The main specific objectives of the eTRANSAFE project are:

  • The development of a state-of-the-art, powerful and flexible strategy and technological architecture for data sharing (diverse sources of nonclinical and clinical data), data integration and data exploitation.
  • The implementation of the following key elements for this architecture: a specialised SEND (“standards for the exchange of non-clinical data”) data management system, a database of shared proprietary data managed by an honest broker, a Knowledge Hub providing seamless access to all the databases and data sources, and an ecosystem of data exploitation modules.
  • The establishment of overarching policies and guidelines for safeguarded data sharing, secondary use of human safety data and use of pooled data and models in drug safety assessment.
  • Optimising how preclinical studies are run and how the industry designs these studies.

Based on the experience gained in the previous eTOX project, in which Synapse was also the Project Manager, the eTRANSAFE project will carry out key efforts in the field of data standardisation and quality control, promoting the development and implementation of relevant data sharing policies and procedures that will have a great global impact in the community.

The eTRANSAFE consortium is formed by a private and public partnership of 8 academic institutions, 6 SMEs and 12 pharmaceutical companies which is coordinated by Ferran Sanz from the Fundació Institut Mar d’Investigacions Mèdiques (IMIM) and lead by François Pognan from Novartis Pharma AG. The project is co-coordinated by Carlos Diaz from Synapse, and Thomas Steger-Hartmann from Bayer AG., is the deputy leader.
The eTRANSAFE project is mainly sponsored by the European Union’s Horizon 2020 research and innovation programme and the European pharmaceutical industry (via EFPIA) under the auspices of the Innovative Medicines Initiative 2 Joint Undertaking (www.imi.europa.eu).
For more information contact info@etransafe.eu, check out http://www.etransafe.eu/

Synapse participates in the IMI 2 DRIVE project (Development of Robust and Innovative Vaccines Effectiveness) carrying out specific tasks mainly at the project management level. The 5 years project kicked off on the 17th to the 19th July 2017 in the city of Valencia (Spain) and counted with the attendance of the members of the consortium.

Along with Synapse, the DRIVE project is formed by a consortium coordinated by Fundación Fisabio (Spain), while other members are the Institut de Recherche pour le Développement (France), P95 CVBA (Belgium), the Università degli Studi di Firenze (Italy), the National Institute for Health and Welfare (Finland), Istituto Superiore di Sanità (Italy), University of Surrey (United Kingdom), Confederation of Meningitis Organisations Ltd. (United Kngdom), Université Claude Bernard Lyon (France), Association Internationale de Standardisation Biologique pour L’Europe (France), Sanofi Pasteur (France), Abbott Biologicals B.V. (The Netherlands), Seqirus UK Limited (United Kngdom) and Glaxosmithkline Biologicals (Belgium).

Influenza is a major public health problem which can infect annually 60 of the 500 million inhabitants of the European Union. Vaccines are the cornerstone for preventing influenza and its consequences. Current influenza vaccines have a moderate variable effect, given the mismatch between vaccine and circulating strains, waning immunity and interference from previous vaccination, among others.

The single most important challenge in achieving Vaccine Effectiveness studies is the ability of the different stakeholders to work in collaboration. Indeed, to enable a sustainable network of influenza Vaccine Effectiveness studies, the Development of Robust and Innovative Vaccines Effectiveness (DRIVE) main goal will be the development of a governance model between public and private entities.

A second challenge will be to reach the capacity to perform vaccine brand- specific effectiveness studies, which is agile enough to deliver the needed outputs in timely manner, and robust enough to provide results by different age and risk groups and flexible enough to utilize novel tools while at the same time aims to be sustainable.

Combining these outputs, DRIVE will establish a sustainable platform for joint influenza vaccine effectiveness evaluation which will have a positive impact on European citizens public health.

DRIVE project is mainly sponsored by the European Union’s Horizon 2020 research and innovation programme and the European pharmaceutical industry (via EFPIA) under the auspices of the Innovative Medicines Initiative 2 Joint Undertaking (www.imi.europa.eu).

Synapse is the project manager for the RESCEU project (Respiratory Syncytial Virus Consortium in Europe), kicked-off on January 12-13, 2016 in Sitges (Barcelona, Spain), which will investigate serious lung infections caused by respiratory syncytial virus (RSV) that particularly affect babies and older people, and those with weakened immune systems, including cancer patients and people with chronic lung diseases such as emphysema.

Diseases caused by respiratory syncytial virus (RSV) are estimated to affect more than 30 million children under five each year throughout the world. There are no specific treatments for RSV and there is no vaccine. Current therapies are focused on alleviating the symptoms of the infection.

The consortium, composed by a pull of international experts from 18 universities, public health institutes and pharmaceutical companies, will work to assess the full scale of the problem in Europe (through gathering robust statistics on the number of RSV each year), which is currently unknown, assessing the economic impact of the disease and the burden it places on healthcare systems. Armed with this information, RESCEU will put together best practice guidelines to improve the way RSV-associated disease is monitored across Europe and to advise future vaccination programmes, ensuring that future decisions on RSV prevention and treatment policies can be based on good evidence and made without undue delay.

The consortium also aims to set up a framework to conduct Europe-wide trials of new medicines and vaccines to improve treatment – and even prevention – of the disease.

The project, led by Professor Harish Nair at the University of Edinburgh, was born out of an existing research collaboration called the Respiratory Syncytial Virus Network (ReSViNET) which aims to improve understanding of this virus, and to develop safe and effective preventive treatment and prevention strategies. 43 research and public health institutions, patient societies and clinical societies from Europe and rest of the world are also affiliated to the project.

Synapse leads the work package focused on Project Management and the design and implementation of a communication and outreach strategy to key stakeholders. With RESCEU, Synapse is involved already in the management of 10 IMI projects, thus reinforcing the expertise of the company in public private partnerships.

RESCEU is mainly sponsored by the European Union’s Horizon 2020 research and innovation programme and the European pharmaceutical industry (via EFPIA) under the auspices of the Innovative Medicines Initiative 2 Joint Undertaking (www.imi.europa.eu).

For more information, contact info@resc-eu.org, check out www.resc-eu.org or follow @RESCEUproject on Twitter.

Synapse is part of the Project Management team of the TransQST project (Translational Quantitative Systems Toxicology), kicked-off on 23-24 January 2017 in Barcelona (Spain), and which aims to develop novel computational approaches using the best available data from the public and private domains to improve the understanding of adverse drug reactions (i.e. unwanted side effects of medication) in order to reduce significantly patient morbidity, mortality and hospitalisation costs.

TransQST will provide innovative methodologies and software tools to leverage the best available data and expertise from both public and private domains to generate and validate novel computational models that will help addressing the problems of safe drug development. Specifically, the project will:

  • provide fit-for-purpose QST models addressing key toxicity outcomes for liver, kidney, heart and GI-tract.
  • provide quantitative risk assessment for off-target toxicities in man based on in vitro and in vivo models.
  • provide a quantitative mechanistic read-across from species (in vitro and in vivo) currently used for the toxicological evaluation of a new drug.
  • provide definition and applicability of the human physiological and pharmacological relevance of preclinical test systems.
  • provide a battery of translational biomarkers that can be used for quantitative read-across from in vitro systems to man, and which relate to intracellular pathways (and systems) relevant to drug toxicity.

The project brings together world-leading experts from 21 partner organisations, including 8 pharmaceutical companies, 3 Small and Medium-sized enterprises (SMEs) and 10 academic institutions.

The 5-year project is coordinated by the University of Liverpool and led by the pharmaceutical company AbbVie.

SYNAPSE, in collaboration with the University of Liverpool, supports the Executive and the Steering Committees in steering efforts from partners, following-up activities and monitoring compliance with the work plan, planned resources and time schedule, including also quality control and risk management. SYNAPSE is also leader of the Communication WP, promoting the dissemination of information and knowledge generated by the project to relevant stakeholders through adequate tools and dynamics.

TransQST is mainly sponsored by the European Union’s Horizon 2020 research and innovation programme and the European pharmaceutical industry (via EFPIA) under the auspices of the Innovative Medicines Initiative 2 Joint Undertaking (www.imi.europa.eu).

Synapse is part of the Project Management Office of the HARMONY project (Healthcare Alliance for Resourceful Medicines Offensive against Neoplasms in HematologY), which will be kicked-off on 16-17 January 2017 in Salamanca (Spain), and will capture, integrate, analyze and harmonize anonymous patient data from high-quality multidisciplinary sources to unlock valuable knowledge on multiple myeloma (MM), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), non-Hodgkins lymphoma (NHL), myelodysplastic syndromes (MDS) and pediatric HMs.

Building on pre-existing, long-lasting collaborations between Academic institutes and the pharmaceutical industry, HARMONY shall further advance HM management through a more efficient process of treatment development and rapid decision-making. The expected outcome will be better prognosis and quicker life-saving decisions, important for patients suffering from these hematological diseases. Specifically, the project will:

  • Develop a data sharing platform that empowers clinicians and policy stakeholders to improve decision-making
  • Establish a network reflecting the European HMs landscape
  • Define clinical endpoints and standard outcomes in ALL (paediatric & adult), NHL, MM, AML, CLL, MDS
  • Align key stakeholders on relevance of these outcomes (policy makers, payers, patients)
  • Provide means for analysing complex data sets comprising different layers of information
  • Identify specific markers for early registration of innovative and effective therapies for HMs

HARMONY’s final deliverable is a big data platform which integrates outcome measures and endpoint definitions for HMs. The project brings together world-leading experts from 51 partner organisations from 11 EU Member States, including 7 pharmaceutical companies, and involving key stakeholders and opinion leaders in the clinical, academic, patient, HTA (health technology assessment), regulatory, economical, and ethical fields.

The 5-year project is coordinated by Prof. Dr. Jesús Marïa Hernández (Instituto de Investigación Biomédica de Salamanca) and Dr. Guillermo Sanz (Instituto de Investigación Sanitaria del Hospital La Fe de Valencia), and led by two EFPIA companies, Tayyab Salimullah (Novartis Oncology) and Pam Bacon (Celgene International).

Synapse, as member of HARMONY’s PMO, will support the Executive and Steering Committee in steering efforts from partners, following-up activities and monitoring compliance with the work plan, planned resources and time schedule, including also quality control and risk management. SYNAPSE will also support the development of synergies with other IMI initiatives and stakeholders, within WP6 activities.

HARMONY is mainly sponsored by the European Union’s Horizon 2020 research and innovation programme and the European pharmaceutical industry (via EFPIA) under the auspices of the Innovative Medicines Initiative 2 Joint Undertaking (www.imi.europa.eu).

For more information, contact Harmonyoffice@ibsal.es.

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