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Synapse is the lead project manager for the EPAD project (European Prevention of Alzheimer’s Dementia Consortium), kicked-off on Jan 14-15, 2015 in Paris, which will work with 1.500 volunteers around Europe to participate in clinical trials towards the prevention of Alzheimer.
The EPAD project (www.ep-ad.org) is aimed at creating a platform for faster and better assessment of drugs for the prevention of Alzheimer’s dementia in people at risk of developing the disease, but with no or mild symptoms
A consortium of 35 academic institutions, pharmaceutical companies, SMEs and patient organisations have joined forces to develop this ambitious project, funded under the auspices of the Innovative Medicines Initiative (www.imi.europa.eu) programme.

Three Spanish organisations participation in the EPAD consortium:
– Synapse Research Management Partners SL (SYNAPSE)
– Barcelonabeta Brain Research Center (BBRC)
– Araclon Biotech S.L. (ARACLON)

The project is co-led by Janssen Pharmaceutica and the University of Edinburgh. Synapse co-leads the Project Management and Sustainability work packages.

For more information, please visit www.ep-ad.org or email us at info@ep-ad.org.

ACCIÓ, the Catalan Agency for Business Competitiveness, has published a Guide for managing Horizon 2020 projects,  written by SYNAPSE. The publication, authored by Ángel Honrado, Carlos Díaz and Eva Molero, is focused on the funding opportunities available in Horizon 2020 (and other European programmes) for the SMEs at the different stages of the research and innovation process.

Guia Acció

The PDF version of the guide, available only in Catalan, can be downloaded free here 

This guide gives an overview of the current European funding available, focusing on the Horizon 2020 programme and highlights the benefits of creating an international consortium to carry out R&D. The document goes through the different phases of a project, going from the preparation of the proposal until its execution.

It emphasises the importance of several components of EU research projects, such as the business plan, the communication, and the use and dissemination of results.

SYNAPSE has already developed previous editions of this guide in 2009 and 2010, focused on projects funded by the 7th Framework Programme.

 

Nature Reviews Drug Discovery has published an article addressing the link between the ongoing IMI projects and regulatory science. The article entitled The Innovative Medicines Initiative: an engine for regulatory science highlights key outcomes of several IMI projects, together with lessons learned, now that IMI is moving to its second phase.

The article refers to several projects funded within IMI 1 –eTOX, ADVANCE and EPAD- in which Synapse participates with responsibilities in project management, sustainability and dissemination.

The importance to translate scientific results into the regulatory framework are highlighted in this article, together with a call to projects to start contacts with the regulatory bodies as early as possible in order to align regulatory requirements as much as possible.

Synapse brings together 56 academic, pharmaceutical and SME partners, including 120 European scientists from the European Medical Information Framework (EMIF) project, in Barcelona during the week of the 8th-12th December.

 

IMI Logo2014-HorizPos

As the overall Project Manager of the EMIF project, Synapse will welcome the EMIF project partners to Barcelona for a week of events that will take place. The EMIF project gathers 57 partner organizations from across Europe for five years (2013-2017) with a budget of 56 million Euro to develop a common information framework of patient-level data that will link and facilitate access to diverse medical and research data sources, opening up new avenues of research for scientists. To provide a focus and guidance for the development of the framework (the EMIF Platform), the project is focusing on questions relating to obesity and Alzheimer’s disease.

Each of the three EMIF topics, Alzheimer’s, Metabolic and Platform, will hold their General Assembly meetings during the week of 8th-12th of December 2014. As all partners will be in the same location, EMIF week also offers an important opportunity for cross-topic meetings and scientific debates to take place. The meetings will allow for partners to share project progress and to examine solutions to scientific challenges identified in EMIF to date.

In addition, an EMIF Colloquium has been organized which will allow EMIF partners to explain the importance of real world data and the potential of EMIF unlocking this information, to a broader audience. The Colloquium attendees will consist of local stakeholders, pharmaceutical companies, the research community and media.
All project meetings will take place in Hotel H10 Marina in Barcelona, and the Colloquium will take place at the nearby Barcelona Biomedical Research Park (PRBB).

An overview of the agenda is as follows:
• Dec 8-9: General Assembly for EMIF-AD
• Dec 10: General Assembly for EMIF-Metabolic
• Dec 10: EMIF Colloquium (Open to external audience)
• Dec 11-12: Consortium Meeting for EMIF-Platform

For more information about the EMIF project visit: http://www.emif.eu/

 

IMI Logo2014-HorizPos

SYNAPSE has presented his IMI experience on the 26th of November. Vall d’Hebron Research Institute (VHIR) in collaboration with the Innovative Medicines Initiative (IMI2) and the Centre for Industrial Technological Development (CDTI) organized a conference to present the opportunities IMI2 represents for biomedical research.

 

IMI Logo2014-HorizPos

 

The event was aimed for researchers and research managers, as well as for small and median enterprises of the biomedical field. The conference focused on issues related to future topics of the IMI2 call for proposals, its rules of participation, and the experiences of ongoing projects.

The agenda of the event is available here 

Listed second in the ranking of the Spanish institutions participating in IMI projects, SYNAPSE has given an overview of its experience based on its current participation in three IMI projects. In 2015, two more IMI projects will be starting in which SYNAPSE also plays an important role.

The iHIVARNA strategy proposes using an mRNA-based therapeutic vaccine encoding HIV antigens as a novel and promising approach in HIV immunotherapy.

The four-year 6M€ European project iHIVARNA, funded by the European Commission, aims to successfully immunize antiretroviral-treated HIV-infected patients with 3 injections of the candidate universal HIV-TriMix-mRNA as an mRNA-based therapeutic vaccine with the final aim of improving the efficacy of therapeutic vaccination against HIV infection.

iHIVARNA is addressing the topic “Safety and efficacy of therapeutic vaccines” of the European Commission 7th Framework Programme Health 2013. The project brings together the expertise of a number of European groups (Spain, Belgium, and Netherlands) in dendritic cell targeting, rational design of immunogens, mRNA manufacturing and immuno-virological monitoring. This proposal continues the work in therapeutic vaccines performed in the last few years in the AIDS Research Unit of Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) leaded by Dr. Josep M Gatell and IrsiCaixa.

 

Our novel therapeutic vaccine candidate is going to be tested for the first time in two phase I and phase IIa clinical trials to assess if it is a valid alternative to lifelong cART treatment.

Dr. Felipe García, IDIBAPS

Dr. Josep M Gatell said: “Nowadays, over 30 million people worldwide are infected with HIV, most of them living in developing countries. Although combined antiretroviral therapy (cART) has proven to be highly effective to prevent clinical progression and death, by itself it is unable to eradicate the infection and other alternative approaches are urgently needed”. The consortium coordinator Dr. Felipe García, from IDIBAPS said: “Therapeutic vaccinations – vaccines targeting HIV infected patients with the ultimate aim of achieving a functional cure – have emerged as one of the most promising strategies that could restore HIV-specific T-cell responses in HIV infected patients and help them control viral replication without cART. Our novel therapeutic vaccine candidate is going to be tested for the first time in two phase I and phase IIa clinical trials to assess if it is a valid alternative to lifelong cART treatment.”

iHIVARNA-vaccine-candidate

 

The iHIVARNA vaccine candidate is the result of a long lasting scientific track record of the Consortium. The candidate is based on an innovative approach that uses naked mRNA, so far has only been recently applied in the cancer research field.  The HIV-TriMix-mRNA has two parts: HIV that has been rationally designed by IrsiCaixa based on data from large international cohorts; and TriMix designed by Vrije Universiteit Brussel to activate and target dendritic cells to improve the HIV antigen presentation. The combination of mRNA, rationally designed HIV antigen and TriMix is a very innovative approach for a therapeutic vaccine and is expected to improve the results of other more traditional strategies already tested.

Studies included in iHIVARNA comprise 1) the manufacturing of the HIV-TriMix-mRNA in GMP conditions, 2) a phase I dose escalation clinical trial and a phase IIa-proof-of-concept clinical trial to test safety, efficacy and immunogenicity of the vaccine candidate, and 3) ascertaining immune and viral predictors and correlates of protection.

For more information visit www.ihivarna.org

 

The General Assembly meetings take place twice per year and include senior representatives from each full partner of the ADVANCE project. The 2nd General Assembly meeting took place in Sitges, Spain between 27th-28th March 2014.

During the meeting, the Partners and Associate Partners shared updates on project progress to date and discussed how to move forward both at Work Package and Consortium levels. The two-day assembly was attended by over 65 people, including representatives from 25 of the full Partners, and 10 Associate Partners.

The meeting also allowed for several workshops to take place in relation to the ADVANCE Work Packages and thus contributed to good communication and working relations within and between the Work Packages.

In order to take further advantage of the gathering of Partners and Associate Partners; film-makers from the EU initiative CommHERE were also present at the meeting, where they had the opportunity to interview some of the key members of the ADVANCE Project. The footage will be used to develop a short video which will be used for communication on the outcome of the ADVANCE project to the media, the general public and other target groups including the EC in all of Europe and beyond.

For more information visit www.advance-vaccines.eu

 

EU grants a Project to build a platform to better recruit patients for clinical trials, especially those suffering from rare diseases

Barcelona hosts the kick-off meeting of the SEMCARE Project, which addresses the ever growing need to exploit medical data from clinical trials and for monitoring and improving healthcare delivery.

The two-year 1.5M€ European Project SEMCARE, funded by the European Commission, aims to build a semantic data platform able to identify patient cohorts based on clinical criteria (e.g. age, gender, diagnosis, indication, symptoms, lab results) scattered in heterogeneous clinical resources.

Currently, almost 80% of clinical trials fail to meet their patient enrolment quotas on time, causing delays in bringing new drugs to market. Exploiting patient-level data can optimize clinical studies in several ways, including better access to patients to new drugs and treatments and allowing pharmaceutical companies to earlier complete clinical trials, thus allowing drugs to reach the market in a shorter time frame.

SEMCARE is addressing the challenge “Technologies for Digital Content and Languages” of the European Commission 7th Framework Programme Information and Communication Technologies (ICT) 2013. The Project brings together the expertise of several EU players, including hospitals from three different European countries (Netherlands, UK and Austria) serving as pilot sites and with a particular interest in applying SEMCARE in their clinical research activities.

The Project addresses the “SME initiative on analytics” objective, which is oriented to help European Small and Medium Enterprises (SMEs) acquire the competences and resources they need to develop innovative content and data analytics services.

 

A better use of patient’s data will make a difference in addressing complex research and clinical challenges. We are proud to be part of a project that focuses on helping patients with rare diseases to ultimately have better diagnosis and treatment

Carlos Díaz - CEO of SYNAPSE

 

According to Mr. Carlos Díaz CEO of SYNAPSE, the Spanish project management partner of SEMCARE: “A better use of patient’s data will make a difference in addressing complex research and clinical challenges. We are proud to be part of a project that focuses on helping patients with rare diseases to ultimately have better diagnosis and treatment”. The Project Coordinator, Dr. Philipp Daumke, CEO of AVERBIS, a German SME specialized on text analytics, search technologies and data semantics applied to the healthcare sector, said: “Our long-term objective is to build a pan-European supported platform that hospitals all over Europe can use for patient identification in clinical trials and for diagnosis support, especially in the case of rare diseases.”

SEMCARE will integrate state-of-the-art text mining technologies and multilingual semantic resources (domain vocabularies, terminologies, nomenclatures, classifications, ontologies; in the following referred to as terminologies) to address specific idiosyncrasies of medical language like ambiguous terms, acronyms, compounds, derivations, spelling variants, uncorrected spelling errors, jargon, telegram style, etc.

SYNAPSE’s role in the project is focused on providing a management structure that both helps and monitors the project development and integration, which is a crucial tool for its success. Additionally, SYNAPSE will contribute to the development of the market analysis and play an important role in defining SEMCARE’s commercial exploitation and business planning.

By the end of 2016, the Project will produce a prototype that can provide diagnostic support and allows patient identification for device therapies or clinical trials (e.g., drugs, diagnostics, devices, therapy protocols) based on patient-level records.

 

ADVANCE_currentProjectsLeading organisations have joined forces to launch a unique project that will pave the way for a pan-European framework for rapidly assessing and communicating the benefits and risks of vaccines. Such a framework would make it easier for regulators and public health authorities to make fast, more informed decisions regarding vaccination strategies, and help to maintain public confidence in immunisation, particularly when questions are raised about the safety of specific vaccines.

The five-year, €10.7 million ADVANCE (‘Accelerated development of vaccine benefit-risk collaboration in Europe’) project is supported by the Innovative Medicines Initiative (IMI) and brings together the European Centre for Disease Prevention and Control (ECDC), the European Medicines Agency (EMA), as well as vaccine manufacturers, national public health and regulatory bodies, academic experts, and small and medium-sized enterprises (SMEs). ADVANCE is co-coordinated by the Erasmus University Medical Center in the Netherlands, the University of Basel / University Children’s Hospital Basel in Switzerland, GSK Vaccines (coordinating the vaccine manufacturers in the project) in Belgium, and Synapse Research Management Partners (Project Management) in Spain.


ADVANCE project (IMI website)

ADVANCE Press Release

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