Partnership aims to accelerate drug development through testing minute quantities in the human body through the ultra-sensitive analytical technique of accelerator mass spectrometry
Good news for the pharmaceutical industry in a climate of spiralling costs for developing new drugs.
By delivering sub-pharmacological (microdose) quantities of new drug candidates to human subjects, vital information can be gained at an early stage as to the potential for that candidate to become a drug. Pharmaceutical Profiles and Xceleron have announced a strategic business partnership to offer a commercial human microdosing service, where early testing is carried out using minute quantities of the new drug in the human body enabled by the use of the ultra-sensitive analytical technique of accelerator mass spectrometry (AMS).
AMS is the most sensitive measuring device ever invented - it can count individual atoms - so providing the sensitivity needed to analyse samples from microdose studies. Only 20g of candidate drug are needed to perform a microdose study and microlitre samples required for valid measurement. Human microdosing essentially enables 'First in Man' studies to be performed within six months of the new drug candidate being produced in the laboratory.
In a joint statement, Professor Colin Garner, CEO of Xceleron and Professor Ian Wilding, executive chairman of Pharmaceutical Profiles explained, "With so many drug candidates exiting discovery and entering development, the task of choosing and then advancing the right molecules into the clinic has become more and more difficult and the current system of producing potential new drugs is simply not working.
"Around 30% of drugs actually fail during healthy volunteer studies, and it will have cost the pharma company literally millions of dollars to get it to that stage in the first place.
"Microdosing offers a genuine way to highlight those new medicines most likely to be successful for the pharma company at a much earlier stage."
