The York University spinout has been growing rapidly since its formation in 2003. The company has pioneered the use of microdosing as a means of conducting 'exploratory investigational new drug' studies in humans in order to limit animal testing and simplifying toxicology requirements for pre-Phase I human trials. Since the company received its first £2m (€3m) investment the company has more than doubled its number of staff and revenues, and has now hired Ian Hallett, formerly of Covance and Quintiles, to help the company build upon its current success. "Ian joins us at a very exciting time in the company's development. Our novel approaches to enhancing exploratory clinical development are moving into mainstream use with over 100 clients including 15 of the world's top 20 pharmaceutical companies," said Professor Colin Garner, CEO of Xceleron. Human microdosing studies make so much sense for studying drugs in the body because "the best model for humans is humans," he said. "The major reason we are seeing an increase in our business is that biotechs and pharmaceutical companies keep trying to increase the efficiency of the drug discovery process," said Prof. Garner. The company has estimated that the microdosing market could be as big as $1bn and predict that all first in human studies will soon start with a microdosing experiment. According to Prof. Garner, a study carried out by an independent group across the while pharmaceutical industry showed that 40 per cent plan to adopt microdosing by 2008 and 90 per cent by 2010. He believes that one of the reasons for this is that one in three drugs fail when taken from animals into humans. Microdosing experiments could also help pharmaceutical companies choose which drug candidates are taken into Phase I experiments. "For smaller biotechs the key step is getting the drugs into humans so that investors release funds for further development," he said. The company has a few competitors in Japan and the US, but no competitors as yet in the EU due to the high cost of equipment. The technique uses accelerator mass spectrometry (AMS) to separate carbon14 (C14) isotopically labelled drugs from human samples. After an initial liquid chromatography step the samples are ionised and accelerated to high kinetic energies. This acceleration allows the concentration of the isotopically labelled drug to be calculated in various samples and enables the pharmacokinetic measurement of absorption, distribution, metabolism and excretion (ADME) of drugs administered to humans at very low levels.