Xceleron and Servier sign microdosing drug development agreement

UK-based bioanalytical CRO Xceleron and French pharma company Servier have signed a 12-month rolling collaborative agreement covering the provision by Xceleron of accelerator mass spectrometry (AMS) services to assist Servier in taking candidate drugs into humans much earlier than conventional Phase 1 studies.

This agreement is believed to be the first of its kind whereby a pharma company is altering its traditional discovery/development processes to accommodate early human studies as part of the drug candidate selection processes.

Xceleron is a leading commercial biomedical AMS company, and has pioneered human Phase 0 microdose studies. The AMS technology permits Phase I mass balance studies to be combined; absolute bioavailability studies to be conducted with less animal safety testing; early human metabolite profiling; and human microdosing (Phase 0 studies) as an aid in candidate selection.

There is general recognition by the pharma industry that more clinical information needs to be gathered earlier than currently practised. All these approaches allow earlier entry into humans of new drug compounds and hence assist in reducing attrition rates later down the clinical development path.

This collaborative agreement is the result of Servier and Xceleron working together for a number of years to use the AMS technology to accelerate drug development,' said.Professor Colin Garner, Xceleron's ceo. 'It shows the far-sightedness of Servier in introducing novel enabling technologies to change their paradigm of drug development.'