Xceleron has announced that it has been asked to lead the European Union Microdose AMS Partnership Programme (EUMAPP).
The award of EUR2.1m is confirmation that the EU recognizes the value of microdosing in drug development and that Europe is to play a leading role in the further development of this technology.
The 30-month EUMAPP project gathers together 10 organisations from 5 different countries (United Kingdom, Sweden, Netherlands, France and Poland).
The programme aims to certify high and low voltage Accelerator Mass Spectrometry (AMS) technologies as accurate, reproducible and appropriate methodologies for all measurements required by microdosing studies.
The microdosing approach conducted with AMS offers ways of developing drugs by bridging the gap between the laboratory and the clinic.
The EUMAPP project will contribute to putting Europe at the forefront of microdosing by:
- Demonstrating the reliability of the microdosing approach for predicting drugs' pharmacokinetics (PK) when used at pharmacological doses (from 7 different biopharmaceuticals).
- Certifying AMS as the accurate and appropriate technology for reproducible measurements required by microdosing studies.
- Developing in silico modelling application to predict PK parameters from data derived from microdosing studies.
Professor Colin Garner, Xceleron's CEO commented, "we are delighted to be leading this European consortium which aims to further demonstrate to the pharmaceutical industry the merits of human microdosing as a science driven approach to drug development."
"This programme follows on from the successful CREAM trial and will add 7 more drugs to the growing portfolio of compounds tested by Xceleron."
Fergal Donnelly, MD, Scientific Officer for Biotechnology and Applied Genomics in the European Commission in Brussels, said, "the EUMAPP provides a tremendous opportunity for Europe to maintain its leading role in the field of microdosing."
"Companies of this nature, such as Xceleron, having pioneered human phase 0 microdose studies, will play a vital role in successful exploitation of EU-funded research."