A new EU-funded project kicked off this month which aims to bridge the gap between the laboratory and the clinic. The EU Microdose AMS Partnership Programme (EUMAPP) aims to boost Europe’s expertise in micodosing and its application of AMS, or accelerator mass spectrometry, to developing new candidate drugs for treating diseases the world over.
By using ‘micro’ amounts of a compound intended as a new drug, researchers can determine the likely dose needed in subsequent trials. The promise of ‘microdosing’ tools that improve predictability and efficiency along the drug development process is huge.
It comes as good news then that the EU Microdose AMS Partnership Programme (EUMAPP) has been awarded €2.1 million, under the Sixth Framework Programme’s (FP6) life sciences-related priority, to live up to this potential. This announcement confirms Europe’s desire to play a leading role in this technology and that it sees the merits of faster, more effective drug development.
The 30-month EUMAPP project gathers together ten organisations from five different countries: the United Kingdom, Sweden, The Netherlands, France and Poland. The programme aims to certify high- and low-voltage AMS technologies as the most accurate, reproducible and appropriate methods for all measurements required by microdosing studies.
As many as one in three drugs fail in Phase I clinical trials (i.e. testing them on healthy subjects) despite extensive pre-clinical screening of potential candidates and various in silico, in vitro, ex vivo and animal models. Less than ideal Pharmacokinetics – how drugs behave (are absorbed, distributed and metabolised) in the body – is blamed for many of these failures, and their poor performance raises concern about how safe or effective they would be in humans.
The microdosing approach conducted with AMS offers new ways of developing drugs by bringing the lab closer to the clinic. EUMAPP will put Europe in a strong position in drug microdosing by proving the method’s reliability in predicting how the drug will react in trials, and certifying AMS as the most accurate, appropriate and powerful technology in this field. It will also develop in silico modelling application to predict pharmacokinetic parameters from data derived from microdosing studies
EUMAPP is being led by Xceleron, a major biomedical AMS company co-located in the UK and the USA. The company has expressed its delight at taking part in the new EU project. Its CEO, Professor Colin Garner, says this European consortium aims to further demonstrate to the pharmaceutical industry the merits of human microdosing as a science-driven approach to drug development. In a statement, the Commission said it is equally happy to be funding such a leading-edge technology project.
The pharmaceutical industry acknowledges that more clinical information needs to be gathered earlier than currently practiced. Microdosing (or Phase 0 test on humans) could cut back on animal testing, improve human metabolism profiling and help with ‘candidate’ selection. This should fast track the testing and cut back on the failure rate of new drug compounds – bringing the lab closer to the clinic and improving the efficiency of drug development.
In addition, AMS technology can be used in combining Phase I/mass balance studies which investigate the rates and routes of excretion of novel drugs, saving time and possibly expense. EUMAPP will not only help improve Europeans’ health and welfare but will also make human clinical studies safer, and contribute to the animal testing 3Rs – i.e. reduce, refine and replace.