GSK signs supplier agreement with Xceleron
three-year deal that provides support for GSK's bioanalytical AMS
programme for human metabolite profiling and obtaining mass balance
data.
The award of this contract to Xceleron signifies pharma's increasing drive to outsource much of the processes incorporated during the drug discovery cycle and demonstrates GSK's confidence in AMS - a technique that has rapidly gained prominence with big pharma.
As many as one in three drugs fail in Phase I (healthy volunteer) clinical testing despite extensive pre-clinical screening of potential clinical candidates with a wide variety of in silico, in vitro, ex-vivo and animal models.
A high proportion of these failures can be attributed to sub-optimal pharmacokinetics (PK) leading to potential efficacy or safety issues in humans.
In a validation of the use of AMS technology for accelerating drug development, GSK recently became the first pharmaceutical company to invest directly in this technique by buying two of its own AMS devices.
"This is a tremendous vote of confidence in Xceleron's expertise in this area. We have valued our relationship with GSK as co-founders of this company and strong supporters of AMS in drug development," commented Xceleron's CEO Professor Colin Garner.
Other applications of AMS zeptotechnology include absolute bioavailability and microdosing studies - all of which provide human clinical data much earlier.
There is general recognition by the pharma industry and the regulatory authorities that more clinical information needs to be gathered earlier than currently practiced.
The AMS technology permits Phase I / mass balance studies to be combined, absolute bioavailability studies to be conducted, early human metabolite profiling and human microdosing (Phase 0 studies) as an aid in candidate selection.
All these approaches allow earlier entry into humans of new drug compounds, reduce the use of animals in preclinical testing and hence assist in reducing attrition rates later down the clinical development path.
AMS has also been used in the study of metabolism of xenobiotics in animals and humans, pathways of biomarkers, metabolism of endogenous molecules including DNA and protein binding studies.
AMS is a process, which physically separates elemental isotopes on the basis of mass, charge and potential energy differences.
The technique itself centres on the separation of elemental isotopes at the single atom level. AMS was first used in the early 90's for the analysis of biological samples containing enriched 14C for toxicology and cancer research.
The nanotechnology of accelerator mass spectrometry (AMS) in drug development has been proven to speed drug development and reduce attrition rates, greatly enhancing its versatility and functions.
It is up to 100,000 times more sensitive than liquid chromatography-mass spectrometry (LC-MS) and 1,000,000 times more sensitive than liquid scintillation counting (LSC).
