Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

SAFE-T Consortium under the EU Innovative Medicines Initiative (IMI) – First Year of Active Collaboration

16.06.2010
Faster Development of Safer Medicines through Translational Safety Biomarkers

The SAFE-T Consortium has been working together for a year now. The project addresses the current lack of sensitive and specific clinical tests to diagnose and monitor drug-induced injury of the kidney, liver and vascular system, which is a major hurdle in drug development.

The SAFE-T objective of qualifying new translational safety biomarkers is expected to enable potential new medicines to be evaluated more quickly and safely in patients. Daily care in clinical units should also benefit from this project, as these safety biomarkers are expected to support the patient’s treatment in order to prevent organ injuries on drug therapy.

The first year of this unique 5-year partnership of the European Pharmaceutical Industry, Academics and Small and Medium Enterprises was characterised by fruitful cooperation. At first, a generic scientific strategy was developed to define the qualification process of new translational safety biomarkers that will allow early identification, assessment, and management of drug-induced injuries throughout drug research and development. Common approaches and standard operating procedures were created which serve as a solid basis for next steps in assay development and biomarker qualification, and will ensure high common quality levels throughout all partner sites.

Furthermore, potential biomarker candidates for drug-induced injury of the kidney, liver and vascular system were evaluated and prioritized for clinical qualification. The chosen biomarkers require a variety of different assays for analysis. Thus, the initial step was to assess assay and reagent availability for the selected candidate biomarkers; assay development for the biomarker candidates (proteins, metabolites and RNA molecules) for translation studies has now been initiated.

As SAFE-T aims at providing statistically-based evaluations and evidence via integrative data analysis of each study for biomarkers qualification and linking the database with SAFE-T biobank sample repository, detailed requirements have been established for a project database and biobank in the first year. Standard operating procedures for sample handling and storage and all necessary documents for patient codification and correct sample tracking have been prepared.

Briefing documents for obtaining scientific advice from health authorities, such as European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), were prepared and submitted. The SAFE-T exploratory-phase plans of qualifying novel biomarkers for kidney and liver injuries were reviewed by, and discussed with EMA and FDA. The exploratory-phase plan for qualification of vascular injury biomarkers will be presented to the health authorities in October this year. EMA also contributes to the project as an external advisor. After the final stage of the project, the data will be submitted to the EMA, FDA and the Japanese PMDA agency who will be asked to issue a regulatory opinion regarding the qualification of the novel biomarkers for use in defined clinical contexts.

In summary, SAFE-T is working according to plan and has made considerable progress during the last 12 months. The main achievement during this year is the development of a productive collaboration between the partners from EFPIA, academia and SMEs that resulted in the planned project deliverables, such as lists of prioritised biomarkers for DIKI, DILI and DIVI, biomarker assays and defined biomarker qualification strategies.

SAFE-T has recently launched its website that gives more detailed information on the project http://imi-safe-t.eu
SAFE-T consortium members are:
- Almirall
- Amgen
- Argutus Medical Limited (formerly Biotrin)
- AstraZeneca
- Barcelona Cardiovascular Research Center
- Bayer Schering Pharma
- Boehringer Ingelheim
- Charité Hospital
- EDI GmbH
- Eli Lilly
- Firalis SAS
- GlaxoSmithKline
- Groupe Hospitalier Pitié Salpêtrière
- Hoffmann La Roche
- Interface Europe
- NMI Natural and Medical Sciences Institute at the University of Tuebingen
- Novartis Pharma
- Pfizer
- Sanofi-Aventis Research and Development
- Tel-Aviv (Souraski) Medical Center
For more information about SAFE-T, please contact:
Michael Merz, Coordinator of SAFE-T, (michael.merz@novartis.com)
Ina Schuppe Koistinen, Scientific Coordinator of SAFE-T (ina.schuppe-koistinen@astrazeneca.com)

Dr. Nadja Gugeler | idw
Further information:
http://imi-safe-t.eu

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Can we see monkeys from space? Emerging technologies to map biodiversity

An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.

Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...

Im Focus: Climate satellite: Tracking methane with robust laser technology

Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.

Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...

Im Focus: How protons move through a fuel cell

Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.

As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...

Im Focus: A unique data centre for cosmological simulations

Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.

With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...

Im Focus: Scientists develop molecular thermometer for contactless measurement using infrared light

Temperature measurements possible even on the smallest scale / Molecular ruby for use in material sciences, biology, and medicine

Chemists at Johannes Gutenberg University Mainz (JGU) in cooperation with researchers of the German Federal Institute for Materials Research and Testing (BAM)...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Plants are networkers

19.06.2017 | Event News

Digital Survival Training for Executives

13.06.2017 | Event News

Global Learning Council Summit 2017

13.06.2017 | Event News

 
Latest News

Supersensitive through quantum entanglement

28.06.2017 | Physics and Astronomy

X-ray photoelectron spectroscopy under real ambient pressure conditions

28.06.2017 | Physics and Astronomy

Mice provide insight into genetics of autism spectrum disorders

28.06.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>