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The first European OHDSI Symposium called “Bridging Europe” was held in Rotterdam on the 23rd and 24th of March. The Observational Health Data Sciences and Informatics (OHDSI) program is a multi-stakeholder, interdisciplinary collaborative initiative to leverage the value of health data through large-scale analytics, and it has established a global network of researchers and observational open-source health databases. OHDSI Europe is led by the Erasmus University Medical Center in Rotterdam. Peter Rijnbeek (Erasmus MC), welcomed over 200 international participants that were engaged in different sessions and tutorials.

During the Symposium, several posters were presented, some of them stemming from the EMIF (European Medical Information Framework) project. Noteworthy was the poster of the EMIF Data Catalogue, which is now available outside of EMIF to bona fide researchers. Synapse has been managing EMIF, an IMI funded project that has created an IT platform allowing access to multiple, diverse data sources. Nigel Hughes (Janssen), EMIF coordinator, has introduced the European Health Data Network, and OMOP Common Data Model and its adoption in future initiatives has centred the interest.

“On the overall scope, the most relevant outcome of the symposium would be “building bridges” between countries, specialists (engineers, physicians, informatics), pharma industry, public institutions, patients organizations and governmental authorities, that created a rich and multidisciplinary environment for discussion”, explained Gloria Garcia (Synapse), who attended the event.

More about OHDSI Symposium here.

More about EMIF at http://www.emif.eu/ 

The Computational Sciences Symposium (CSS) celebrated its 7th annual event in Silver Spring, Maryland (US). The event brings together Academia, Regulators, Industry, and technology providers to address computational science needs in support of regulatory review in order to bring safe and effective products. CSS has established itself as the premier collaboration within the clinical trial environment, including the engagement of regulatory agencies FDA, EMA and PMDA.

eTRANSAFE, a New Player in Translational Safety Assessment” poster, written by William Drewe (Lhasa Limited), Thomas Steger-Hartmann (Bayer AG), and Montserrat Cases (Synapse) was presented at the meeting by Wiliam Drewe on behalf of the project consortium. A separate meeting between eTRANSAFE and FDA representatives was organized with the aim to disseminate the project and to open a dialogue with the regulatory agency.

The eTRANSAFE project, managed by Synapse, develops an integrative data infrastructure and innovative computational tools that aim to improve predictivity and reliability of translational safety assessment during the drug development process.

More about eTRANSAFE at http://etransafe.eu/

 

The Brain Awareness Campaign is officially celebrated during this week, and we would like to use it as an opportunity to bring attention to brain science and advocate for science funding.

Synapse is greatly involved in some of the most ambitious European brain research initiatives, especially those conducting research on Alzheimer’s disease. Currently, Synapse is a part of four European initiatives for Alzheimer’s disease: EPAD, AMYPAD, ROADMAP and EMIF, all funded under the auspices of the IMI-JU.

EPAD (The European Prevention of Alzheimer’s Dementia) aims to create a novel environment for testing numerous interventions targeted at the prevention of Alzheimer’s dementia, while its sister project AMYAPAD (Amyloid imaging to prevent Alzheimer’s Disease) focuses on studying the value of β-amyloid imaging as a diagnostic and therapeutic marker for AD.

ROADMAP (Real world Outcomes across the Alzheimer’s Disease spectrum for better care: Multi-modal data Access Platform) and EMIF projects are focused on data integration tools for dataset characterisation and interpretation of Real World Evidence data, and re-use and exploitation of available patient-level data to support novel research.

The Brain Awareness Week is celebrated worldwide. In Barcelona, the Brain Film Fest 2018, supported by Pasqual Maragall Foundation, our partner in EPAD and AMYPAD, broadcasts featured and short films, and offers lectures and workshops.

To check Brain Awareness Week events near you, go to BAW Calendar.

More about our projects here: EPAD, AMYPAD, ROADMAP, EMIF.

 

 

On the 5th and 6th of March, Barcelona hosted XI Annual Conference of Biomedical Research Technology Platforms. Different advances in Innovative Medicines, Nanomedicine, Health Technology and Biotechnology Markets were presented. The focus was on the use of these advances and their necessary coexistence with the legal framework of clinical research and data protection.

Synapse CEO, Carlos Díaz participated in a debate on how to share data in biomedical research. The session was focused on the experience acquired in the IMI Big Data for Better Outcomes (BD4BO) initiative including representatives from the ROADMAP and HARMONY (both managed by Synapse), BigData@Heart and DO-IT projects.

Carlos Díaz presented the ROADMAP project, that provides the foundation for an integrated data environment and framework for real-world evidence (RWE) in Alzheimer’s disease, highlighting its main pillars and challenges. It was a great pleasure to present ROADMAP at the event alongside most other projects in the BD4BO programme – who all counted on Spanish representation. Good and interesting session allowing us to build bridges with our BD4BO colleagues, and understand better the new legal framework in Europe in terms of data protection.

To watch the presentation click here.

More about ROADMAP at https://roadmap-alzheimer.org/.

More about HARMONY at https://www.harmony-alliance.eu/.

More about BD4BO at http://bd4bo.eu/.

In the frame of its Social Programme, Synapse has sponsored the AFASAF, a non-profit association of families affected by Fetal Alcohol Spectrum Disorders (FASD). Last Thursday members of AFASAF have visited Synapse’s premises to explain more about the FASD and the association’s activities. FASD is a lifelong condition relating to permanent brain damage caused by fetal alcohol exposure. The syndrome often goes undetected or misdiagnosed, or even blamed on poor parenting. Most children with FASD have significant cognitive, behavioural, and learning difficulties, including problems with attention, cause and effect reasoning, impulsivity and adaptive functioning difficulties. FASD has a great impact, not only on the life of the person suffering from it, but also on their families.

The main objectives of the association are to improve the quality of life of the affected people and their families and obtain the official and social recognition of the Syndrome. AFASAF intends to raise awareness, sensitize society and promote the need for early detection and correct diagnosis.

The association also aims at promoting research and investigation in the field, and professional training of the medical practitioners. More info on their activities and initiatives at http://www.afasaf.org/.

More on the Synapse Social Programme here.

On February 28th Synapse hosted the 1st EU-ADR Alliance Methodological Workshop in its offices in Barcelona. The workshop aimed at discussing recent methodological issues and applications in pharmacoepidemiological studies within the EU-ADR Alliance framework. The entire day was devoted to exploring the methods dealing with confounding and discuss on missing data, quality control and validation amongst others. The team had insightful and interesting discussions and shared experiences and learnt lessons, while deriving recommendations for future work. Researchers from IDIAP Jordi Gol (Spain), Erasmus Medical Center (the Netherlands), PEDIANET (Italy), the Italian Society of General Practitioners (Italy), the University of Oxford (UK), Aarhus University (Denmark) and Synapse (Spain) participated in the meeting.

The EU-ADR Alliance is a collaboration framework for running observational studies (drug safety, the burden of diseases, prescription patterns, etc.) in a federated manner, using extracted data from multiple European EHR and healthcare databases.

More about EU-ADR Alliance at http://eu-adr-alliance.com/

Contact info at info@eu-adr-alliance.com

In 2017 the European Prevention of Alzheimer’s Dementia (EPAD) project launched EPAD Academy that is aiming to efficiently leverage EPAD resources to foster and develop academic research capacity and output in AD across Europe for maximum global impact. One of the main actions of the EPAD Academy is to help create the next generation of AD researchers by creating and facilitating opportunities for junior researchers’ career advancement. The EPAD Academy has established a register for the EPAD Academy Fellows, all of whom are eligible for Academy activities.

“The Academy originated from a realisation that EPAD was an ideal framework for young researchers (EPAD Fellows) to grow professionally, expand their views, enhance multidisciplinary perspectives and multiply the impact on their future careers – effectively helping to build the next generation of thought leaders in Alzheimer’s research”, explains Carlos Díaz, Synapse CEO.

With the beginning of the year, the EPAD Academy launched its first activity – EPAD Academy Webinars, online masterclasses on current topics in AD research, held by world-class senior researchers for EPAD Fellows. Fourteen webinars have been scheduled for 2018, including the introductory talk on the dementia concept after 2020, held by EPAD co-coordinator, Prof Craig Ritchie.

Synapse has been strongly involved in the creation of the EPAD Academy, in its foundation and establishment. Synapse is organising and hosting the webinars, as being responsible for the proper deployment of planned activities.

The webinars are exclusively held for the EPAD Fellows. Yet, the recordings of the webinars will be available on the EPAD YouTube channel. “The Dementia Concept after 2020: Research to change Practice, Public Perception and Politicians’ Perspectives” webinar is already available on the YouTube channel.

More about the EPAD project at http://ep-ad.org/.

More about the EPAD Academy here.

 

From 25th to 29th of June 2018, the Oxford Summer School on Real World Epidemiology will be held at the Lady Margaret Hall college in Oxford. The Director of the course is Prof Dr Prieto-Alhambra, Associate Professor and Co-Chair of the Big Health Data User Group, NDORMS, University of Oxford. This four-day training targets pharmacists, clinicians, and academics interested in the use of routinely collected data for research. The course will handle the topics such are: Data discovery and Characterization, Epidemiological study designs, Prediction modelling, Big data methods. Eva Molero, Synapse CEO, will speak on Project Management in Real World Epidemiology and the EU-ADR Alliance experience.

Synapse is supporting the Oxford Summer School on Real World Epidemiology from its first edition, and we are very proud to continue this sponsorship for the third consecutive year. Both, University of Oxford and Synapse are consortium partners in the IMI-JU funded EMIF project, that aims to develop common technical and governance solutions and improve access and use of health data and collaborate in multiple observational studies.

More about the Oxford Summer School on Real World Epidemiology here.

To book your place go here.

More about EMIF at http://www.emif.eu/.

On the 6th and 7th of February, the eTRANSAFE Consortium partners met in Basel to discuss the progress of the first six months of the project. Key topics such as data collection, interoperability, and integration were discussed. One of the project aims is to develop predictive services, contributing to the safety assessment of chemical compounds. Integrative analysis of preclinical and clinical data for generation of candidate translational biomarkers is another important goal of the project. Overall the Consortium was impressed by the progress made in almost all activities and the good team collaboration established in the different WPs. The need to get data as soon as possible was highlighted as one of the main challenges in this initial phase of the Project.

Carlos Díaz presented the Project management principles and the creation of a task force aimed at addressing the collection of data (both preclinical and clinical) by the EFPIA companies from a common perspective. Since eTRANSAFE is expected to build upon the success of eTOX, the access to eTOX assets (eTOXsys, OntoBrowser, etc.) is a pressing matter, for which important steps have been taken.  Eva Molero insisted on the need to consider the sustainability implications of any decision made in the project from the very start, and the importance of promoting and disseminating the information and the knowledge generated by the project.

More about eTRANSAFE at http://etransafe.eu/

 

On January 25th, the eTOX Executive Committee members François Pognan (Novartis Pharma), Ferran Sanz (FIMIM), Thomas Steger-Hartmann (BHC) and Carlos Díaz (SYNAPSE) held the close out meeting of the eTOX project at the IMI´s offices in Brussels. IMI´s Executive Director Dr Pierre Meulien also attended the meeting. The main points addressed during the meeting were project’s objectives and outcomes, impact, sustainability and lessons learned.

The eTOX project stems from the very first IMI Call (it started in 2010) and was the very first IMI project that Synapse has managed. The project successfully ended in December 2016. With a budget of over 18.5 million €, the project was undertaken by a consortium of 30 organisations led by Novartis, among which 13 EFPIA companies, 11 academic partners, and 6 SMEs. The eTOX project aimed to build a toxicology database and novel software tools to better predict in-vivo toxicology of new chemical entities in early stages of the drug development pipeline.

The eTOX project leaves behind as main assets: eTOXsys – a tool to facilitate the safety assessment of new drug candidates; OntoBrowser – a tool to support community-based ontology development; eTOXlab – a platform for the development and maintenance of the models. These tools are an important legacy that will be further used within eTRANSAFE, an IMI-2 project recently started, that is expected to build upon the success of eTOX.

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