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

More articles from Life Sciences:

nachricht A novel synthetic antibody enables conditional “protein knockdown” in vertebrates
20.08.2018 | Technische Universität Dresden

nachricht Climate Impact Research in Hannover: Small Plants against Large Waves
17.08.2018 | Leibniz Universität Hannover

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

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

Im Focus: It’s All in the Mix: Jülich Researchers are Developing Fast-Charging Solid-State Batteries

There are currently great hopes for solid-state batteries. They contain no liquid parts that could leak or catch fire. For this reason, they do not require cooling and are considered to be much safer, more reliable, and longer lasting than traditional lithium-ion batteries. Jülich scientists have now introduced a new concept that allows currents up to ten times greater during charging and discharging than previously described in the literature. The improvement was achieved by a “clever” choice of materials with a focus on consistently good compatibility. All components were made from phosphate compounds, which are well matched both chemically and mechanically.

The low current is considered one of the biggest hurdles in the development of solid-state batteries. It is the reason why the batteries take a relatively long...

Im Focus: Color effects from transparent 3D-printed nanostructures

New design tool automatically creates nanostructure 3D-print templates for user-given colors
Scientists present work at prestigious SIGGRAPH conference

Most of the objects we see are colored by pigments, but using pigments has disadvantages: such colors can fade, industrial pigments are often toxic, and...

Im Focus: Unraveling the nature of 'whistlers' from space in the lab

A new study sheds light on how ultralow frequency radio waves and plasmas interact

Scientists at the University of California, Los Angeles present new research on a curious cosmic phenomenon known as "whistlers" -- very low frequency packets...

Im Focus: New interactive machine learning tool makes car designs more aerodynamic

Scientists develop first tool to use machine learning methods to compute flow around interactively designable 3D objects. Tool will be presented at this year’s prestigious SIGGRAPH conference.

When engineers or designers want to test the aerodynamic properties of the newly designed shape of a car, airplane, or other object, they would normally model...

Im Focus: Robots as 'pump attendants': TU Graz develops robot-controlled rapid charging system for e-vehicles

Researchers from TU Graz and their industry partners have unveiled a world first: the prototype of a robot-controlled, high-speed combined charging system (CCS) for electric vehicles that enables series charging of cars in various parking positions.

Global demand for electric vehicles is forecast to rise sharply: by 2025, the number of new vehicle registrations is expected to reach 25 million per year....

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

LaserForum 2018 deals with 3D production of components

17.08.2018 | Event News

Within reach of the Universe

08.08.2018 | Event News

A journey through the history of microscopy – new exhibition opens at the MDC

27.07.2018 | Event News

 
Latest News

Quantum bugs, meet your new swatter

20.08.2018 | Information Technology

A novel synthetic antibody enables conditional “protein knockdown” in vertebrates

20.08.2018 | Life Sciences

Metamolds: Molding a mold

20.08.2018 | Information Technology

VideoLinks
Science & Research
Overview of more VideoLinks >>>