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

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
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, (
Ina Schuppe Koistinen, Scientific Coordinator of SAFE-T (

Dr. Nadja Gugeler | idw
Further information:

More articles from Life Sciences:

nachricht Novel mechanisms of action discovered for the skin cancer medication Imiquimod
21.10.2016 | Technische Universität München

nachricht Second research flight into zero gravity
21.10.2016 | Universität Zürich

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

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

Im Focus: New 3-D wiring technique brings scalable quantum computers closer to reality

Researchers from the Institute for Quantum Computing (IQC) at the University of Waterloo led the development of a new extensible wiring technique capable of controlling superconducting quantum bits, representing a significant step towards to the realization of a scalable quantum computer.

"The quantum socket is a wiring method that uses three-dimensional wires based on spring-loaded pins to address individual qubits," said Jeremy Béjanin, a PhD...

Im Focus: Scientists develop a semiconductor nanocomposite material that moves in response to light

In a paper in Scientific Reports, a research team at Worcester Polytechnic Institute describes a novel light-activated phenomenon that could become the basis for applications as diverse as microscopic robotic grippers and more efficient solar cells.

A research team at Worcester Polytechnic Institute (WPI) has developed a revolutionary, light-activated semiconductor nanocomposite material that can be used...

Im Focus: Diamonds aren't forever: Sandia, Harvard team create first quantum computer bridge

By forcefully embedding two silicon atoms in a diamond matrix, Sandia researchers have demonstrated for the first time on a single chip all the components needed to create a quantum bridge to link quantum computers together.

"People have already built small quantum computers," says Sandia researcher Ryan Camacho. "Maybe the first useful one won't be a single giant quantum computer...

Im Focus: New Products - Highlights of COMPAMED 2016

COMPAMED has become the leading international marketplace for suppliers of medical manufacturing. The trade fair, which takes place every November and is co-located to MEDICA in Dusseldorf, has been steadily growing over the past years and shows that medical technology remains a rapidly growing market.

In 2016, the joint pavilion by the IVAM Microtechnology Network, the Product Market “High-tech for Medical Devices”, will be located in Hall 8a again and will...

Im Focus: Ultra-thin ferroelectric material for next-generation electronics

'Ferroelectric' materials can switch between different states of electrical polarization in response to an external electric field. This flexibility means they show promise for many applications, for example in electronic devices and computer memory. Current ferroelectric materials are highly valued for their thermal and chemical stability and rapid electro-mechanical responses, but creating a material that is scalable down to the tiny sizes needed for technologies like silicon-based semiconductors (Si-based CMOS) has proven challenging.

Now, Hiroshi Funakubo and co-workers at the Tokyo Institute of Technology, in collaboration with researchers across Japan, have conducted experiments to...

All Focus news of the innovation-report >>>



Event News

#IC2S2: When Social Science meets Computer Science - GESIS will host the IC2S2 conference 2017

14.10.2016 | Event News

Agricultural Trade Developments and Potentials in Central Asia and the South Caucasus

14.10.2016 | Event News

World Health Summit – Day Three: A Call to Action

12.10.2016 | Event News

Latest News

Resolving the mystery of preeclampsia

21.10.2016 | Health and Medicine

Stanford researchers create new special-purpose computer that may someday save us billions

21.10.2016 | Information Technology

From ancient fossils to future cars

21.10.2016 | Materials Sciences

More VideoLinks >>>