Quintiles Transnational Corp has boosted its ability to carry out microdosing studies for its clients via an agreement with US firm Accium BioSciences that gives it access to a powerful range of bioanalytical testing tools.
Microdosing – also known as Phase 0 clinical testing - is a relatively new phemomenon in clinical testing, and is designed to make first-in-man studies easier and cheaper to carry out and safer for the volunteers who are exposed to much lower doses of experimental drugs.
The approach relies on the use of tiny doses of the investigational agent under investigation – typically one hundredth of the dose required to give a pharmacological effect – with sensitive bioanalyses used to determine measures such as pharmacokinetics, bioavailability and metabolite profiling that would ordinarily require a much more expensive, full Phase I trial.
But testing drugs at these tiny doses demands ultra-sensitive analytical apparatus, and that’s where Accium comes in. The company operates the only fully-commercial facility in North America offering accelerator mass spectrometry (AMS), a tool that uses carbon 14 labelling to focus in on the minute quantities under test in microdosing.
The equipment is expensive, costing $1.5 million to buy and 18 months to construct, so access to AMS is hard to come by. In Europe, for example, currently the only company offering this service is Xceleron, which operates a similar business model to Accium with the help of an AMS facility in York, UK.
Michael Chansler, vice president of business development at Accium, told PharmaTimes: “by working together [with Quintiles], we can now provide biopharmaceutical sponsors with a one-stop-shop solution for critical early phase drug trials.”
Quintiles will handle the dosing patients, while Accium takes responsibility for analysis and reporting functions, he said, But as far as clients are concerned, there is one vendor organisation at work, and no need to contract with multiple groups to carry out the same study.
And while Phase 0 studies are tiny for a company the size of Quintiles, the expansion into microdosing gives it an opportunity to get involved in the drug development process earlier, and once on board take projects into larger studies involving more patients.
While microdosing has been in use for some years in Europe – with the European Medicines Agency approving its use in drug development in 2003 – it has only recently started up in the USA, according to Chansler.
The catalyst, he said, was the US Food and Drug Administration’s publication of a final rule on Exploratory Investigational New Drugs, which came into effect January 13 this year and laid out specific guidance on the use of microdosing to examine the mechanism of action of drugs, select the most promising lead from a group of candidates and explore the biodistribution of a compound using imaging technologies.
But the reduction in cost with microdosing studies is also compelling, particularly for smaller companies aiming to take projects into the clinic and so attract venture capital funding and licensing partners, according to Chansler.
“Industry estimates for traditional approaches of obtaining first-in-human data are between $1.5 million to $3.0 million and require upwards of 18 months of time. In most cases, a microdosing study can be conducted for less than $500,000 [and] in less than six months,” he noted.