The Safer and Faster Evidence-based Translation (SAFE-T)

At a Glance
  • Status: Active Consortium
  • Year Launched: 2009
  • Initiating Organization: Innovative Medicines Initiative
  • Initiator Type: Government
  • No disease focus
  • Location: International

Abstract

The Safer and Faster Evidence-based Translation (SAFE-T) consortium is an effort of the European Innovative Medicines Initiative to develop improved tools for the prediction, detection, and monitoring of drug-induced injuries to the kidney, the liver, and the vascular system, using markers in patients’ blood and/or urine.

Mission

The goal of the SAFE-T consortium is to qualify new specific and sensitive safety biomarkers for drug-induced kidney, liver, and vascular injury to improve safety assessment during drug development. In particular, the purpose of SAFE-T work is to:

2009 – Project start date
2011 – Kidney ‘SAFE-T’ studies get underway (July)
2012 – SAFE-T strategy spots drug-induced live injury
2013 - SAFE-T project enters formal collaboration with C-PATH safety project (May)

Structure & Governance

Communication manager/Managing entity for IMI beneficiaries
Nicole Schneiderhan-Marra

Project Coordinator
Michael Merz

Scientific Coordinator
Ina Schuppe-Koistinen

SAFE-T seeks collaboration with similar initiatives to establish strong links and networks in the field of biomarkers research and thus improve further the quality of research results. Currently, collaboration agreements are in the process of negotiation or signed with:

Financing

This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), resources of which are composed of financial contribution from the EU Seventh Framework Programme and EFPIA companies’ in-kind contribution. Large pharmaceutical companies participating in IMI projects do not receive IMI funding.

IMI aims to boost biopharmaceutical innovation in Europe and to speed up the development of better and safer medicines for patients. Through its unique and innovative funding scheme, IMI supports research projects in the areas of safety and efficacy, knowledge management, and education and training.

In addition to the large biopharmaceutical companies, the participating research consortia include small- and medium-sized enterprises, patient organizations, academia, and other research organizations, hospitals, and public authorities.

The European Commission's Seventh Framework Programme will contribute €1 billion to the IMI budget. That amount will be matched by in-kind contributions worth at least another €1 billion from the pharmaceutical companies that are members of EFPIA.

The IMI Intellectual Property (IP) Policy governs the IP regime of all projects funded by the IMI JU.  To assist with specific IP queries, IMI has set up a dedicated IP Helpdesk that can be contacted by e-mailing IMI-IP-Helpdesk@imi.europa.eu. The IMI IP policy can be accessed at the following address: http://www.imi.europa.eu/sites/default/files/uploads/documents/imi-ipr-policy01august2007_en.pdf

Data Sharing

According to IMI’s intellectual property policy, the participants undertake to disseminate the data as soon as reasonably practicable but not later than one year after the termination or expiry of the project. The Project Agreement shall include a description of the material which must be disseminated in accordance with the IP Policy and referenced in the Grant Agreement. If the participants do not disseminate within such time periods without good reason, the Executive Office has the right to disseminate such results in a manner consistent with the Grant Agreement.

Expected outcomes:

Homepage

http://www.imi-safe-t.eu/

Other website

http://www.imi.europa.eu/content/safe-t

Points of Contact

Michael Merz
Translational Sciences
Novartis Institutes for Biomedical Research
Basel, Switzerland

Nicole Schneiderhan-Marra
NMI Natural and Medical Sciences Institute,
Reutlingen, Germany
Tel: +49-7121-51530815
Email: schneiderhan@nmi.de

For press inquiries:
Joan Pitt
Novartis Institutes for BioMedical Research
Novartis Pharma AG
Tel: +41 61 6962632
Email: joan.pitt@novartis.com

Sponsors & Partners

Novartis Pharma AG, Basel, Switzerland

Laboratorios Almirall S.A., Barcelona, Spain

Amgen, Brussels, Belgium

AstraZeneca AB, Södertälje, Sweden

Bayer Schering Pharma AG, Berlin, Germany

Boehringer Ingelheim International GmbH, Ingelheim, Germany

Eli Lilly And Company Limited, Basingstoke, UK

GlaxoSmithKline Research and Development LTD, Brentford, UK

Pfizer Limited, Sandwich, UK

F. Hoffmann-La Roche AG, Basel, Switzerland

Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France

Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen, Reutlingen, Germany

Charite - Universitaetsmedizin Berlin, Berlin, Germany

Assistance Publique - Hopitaux De Paris, Paris, France

Consorci Institut Català de Ciències Cardiovasculars, Barcelona, Spain

The Foundation For Medical Research Infrastructural Development And Health Services, Tel Aviv, Israel

Firalis S.A.S., Huningue, France

Argutus Medical LTD, Dublin, Ireland

EDI Experimentelle und Diagnostische Immunologie GmbH, Reutlingen, Germany

Interface Europe, Brussels, Belgium

European Medicines Agency

Food and Drug Administration

Critical Path Institute


Last Updated: 04/08/2016

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