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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.

harmony_infographic

The company’s annual retreat took place this year in December in Espacio Mood in Barcelona. A few internal training pills were provided by some members of SYNAPSE centred on IMI-2, the transition to the new IMI portal, and the key aspects affecting new IMI projects and proposals next year.

The meeting followed with specific corporate strategy-focused sessions addressing internal operating procedures and the new challenges for 2017. Aspects such as quality, proficiency and commitment were brought to the table by all members of the team through open and lively discussions. The new year will come with new projects and exciting challenges and we are all ready to face them.

Let’s go!

synapse_retreat-2016

Synapse is the project manager for the ROADMAP project (Real world Outcomes across the Alzheimer’s Disease (AD) spectrum for better care: Multi-modal data Access Platform), kicked-off on November 16-17, 2016 in Barcelona, which will deliver a series of scalable, transferable data integration methods and tools for patient outcomes, developed and tested through pilot projects, which will provide the foundation for a Europe-wide Real World Evidence (RWE) platform on AD.

Successfully delivering therapies to people with AD will also depend on building a sustainable global payer strategy to address challenges around drug access to markets. This will be dependent on the integration of RWE in health care systems to support approval as well as HTA/payer evidence. The development of a sustainable global payers strategy is one of ROADMAP’s objectives.

As the result of an ageing population, rising costs and more specialised treatments, Europe is now facing an acute healthcare challenge. In no area is this more apparent than in AD and dementia. The European Union, with the world’s most diverse and sophisticated health care systems, is uniquely placed to develop and exploit technologies to support RWE; addressing operational issues of data access, integration and security, alongside hypothesis testing, ELSI, health economic and budget impact, at a level of detail and complexity not possible elsewhere.

ROADMAP will identify RWE to better inform regulators on matters of efficacy and safety, providers on cost effectiveness, industry on pricing and manufacturing and scientists on mechanisms and pathways, to accelerate decision-making on re-purposing current treatments and developing new treatments.

ROADMAP brings together world-leading experts from 22 partner organisations to apply cutting-edge technology to a body of data of unprecedented depth and breadth, drawn from 6 EU Member States (Denmark, France, Netherlands, Spain, Sweden, UK), involving 75 national databases and clinical registries, more than 40 cohorts, several studies and 5 dementia-relevant trials, providing a unique opportunity for RWE in general, as well as in the dementia context.

The 2-year project is led by Novartis and coordinated by the University of Oxford. Synapse leads the Project Management work package and is involved in the design and implementation of the communication and patient/healthcare provider engagement strategy within WP7.

ROADMAP 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, check out http://www.roadmap-alzheimer.org/.

Synapse is the amypad_logoproject manager for the AMYPAD project (Amyloid imaging to prevent Alzheimer’s disease), kicked-off on October 5-6, 2016 in London, which will investigate the value of β-amyloid using positron emission tomography (PET) imaging as a diagnostic and therapeutic marker for Alzheimer’s dementia.

Beta-amyloid (β-amyloid) deposition in the brain is one of the neuropathological hallmarks on the path towards development of Alzheimer’s disease (AD). The recent advent of commercially available β-amyloid PET tracers has opened up new potential for the visualisation of brain β-amyloid in vivo. It may improve an early diagnosis of AD, and, when recognised in a pre-symptomatic population, even provide an opportunity for secondary prevention of AD. However, the full value of this relatively novel technology and its optimal position in the diagnostic workup of patients is not yet fully understood.

AMYPAD will determine in a real-life clinical setting for whom diagnostic β-amyloid imaging is appropriate, when this is best performed and how the resulting information is influencing diagnostic certainty, patient management and ultimately decision trees and cost-effectiveness of dementia care.

The AMYPAD consortium (15 public and private organisations formed by academic institutions, pharmaceutical companies, SMEs and patient organisations) will address the above goals in close collaboration with IMI-JU project EPAD (European prevention of Alzheimer’s dementia | www.ep-ad.org), a major global initiative, also managed by Synapse, to create a novel environment for testing new treatments for the prevention of Alzheimer’s dementia.

The project is led by GE Healthcare Life Sciences and coordinated by VU University Medical Center, Amsterdam. Synapse is member of the Executive Committee, leads the Project Management work package, and is involved in the design and implementation of dissemination plans and communication strategy within WP6 (Ethics, communication and dissemination) activities.

AMYPAD 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@amypad.eu, check out www.amypad.eu or follow @IMI_AMYPAD on Twitter.

The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS, University of Oxford) launched the 1st edition of Real World Data Epidemiology Summer School, sponsored by Synapse Research Management Partners and IMI-EMIF. The course was focused on the review of the existing sources and the basic introductory concepts of pharmacoepidemiology and medical device epidemiology using observational, routinely collected or registry-based data. The Summer School took place on 11th-15th of July in Oxford.

The course gathered a large number of participants, pharmacists, clinicians, registry staff, statisticians, epidemiologists, and related MSc/PhD students from the UK, Spain, Sweden, Italy, Hong Kong and other countries.

Renowned experts from academy and industry shared with the students their knowledge, views and potential solutions applied to the use of big health data.

During the course, the students were actively encouraged to participate in the interactive sessions as part of the training. These sessions allowed to address skills of study designs for the use of routinely collected healthcare data and understand the relevant issues using electronic health records: misclassification and potential bias, data management and interaction with industry and regulators.

The EPAD project, one of the major studies in Europe to find interventions that prevent the onset of Alzheimer’s dementia, has recruited its first participant. Julie Duffus, from Edinburgh (Scotland), is the first person to take part in the project.

Participants will have regular health checks including blood tests and brain scans. Researchers will also track their thinking skills over time using tests of mental agility. Afterwards, they will be invited to take part in clinical trials aimed at testing interventions that could delay, or even prevent, the onset of dementia.

According to Carlos Diaz, project manager of EPAD and CEO of SYNAPSE Research Management Partners: “The first patient in is one of the key and most exciting milestones in EPAD, the first step towards building the Longitudinal Cohort Study that will help us better understand early signs of Alzheimer’s disease. We are proud at SYNAPSE of our role as Algorithm Running Committee, which plays a critical part in the selection of all 6,000 volunteers to be involved in the EPAD project from across Europe.”

The 5-year, 36-partner, 64-million euro, Europe-wide initiative aims to improve understanding of the early stages of Alzheimer’s disease and how it leads to dementia. EPAD is mainly sponsored by the European Commission and the European pharmaceutical industry (via EFPIA) under the auspices of the Innovative Medicines Initiative Joint Undertaking (IMI JU). For more information: www.ep-ad.org.

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