BIO profile: Q-Pharm expands service range

Q-Pharm is one of the few full service Phase 1 clinical trial units in Australia, providing comprehensive Phase 1 and Phase 2 clinical trial services to the biotechnology and pharmaceutical sectors in Australia and internationally.

The company has recently forged two important collaborations with international companies which will enable it to extend its services in very significant ways.

The most recent collaborative agreement was signed with Vitalea Science of Woodland, California, in February, and enables Q-Pharm to offer two new types of service to clients in Australia and Asia.

"These are microdosing ('Phase Zero') clinical trials, which are being strongly encouraged by the FDA as a major cost-saving efficiency in early drug development, and 'light-label' ADME studies, which greatly enhance the information derived from conventional Phase 1 trials," Q-Pharm managing director Wayne Hooper says.

"In microdosing studies only about one one-hundredth of the standard Phase 1 dose is administered, which makes it possible to commence studies in humans with abbreviated preclinical studies.

"The 'light-label' studies involve the use of 14C-labelled doses where the dose of radioactivity is below the levels requiring special approvals and precautions. Both types of studies depend on the exquisitely sensitive analytical technique of accelerator mass spectrometry (AMS) which can detect 14C at the level of 10-18 to 10-20 of a gram."

Hooper says Vitalea has pioneered the development of a new generation of AMS instruments which brings the technique into the realm of being both practical and affordable.

Under the collaborative agreement, Vitalea will provide AMS analytical services for trials conducted in Q-Pharm's clinics. The two companies are also embarking on a marketing program to bring these services to clients in the Asia-Pacific region.

Last year Q-Pharm finalised a collaboration with the Brain Gut Research Group (BGRG) in Bern, Switzerland, under which BGRG has agreed to provide to Q-Pharm specialised expertise in the areas of studies in gastroenterology and pain.

"The BGRG is a highly experienced niche provider of services in these two areas, and is keen to extend its activities into Australia," he says. "BGRG will provide training, specialised skills and support personnel as required to Q-Pharm to undertake sophisticated trials in these areas in Brisbane, again servicing the Asia-Pacific region."

These new initiatives as well as the continuing strong growth in Q-Pharm's business will be greatly assisted by two other recent initiatives taken by the company, he says.

In January Q-Pharm completed the renovation and commissioning of a new 500 m2 area which houses the expanded recruitment team and the busy outpatient activities conducted by the company. These facilities are in the same building as the company's Mervyn Eadie clinic which provides 36 "standard" beds for the conduct of bioequivalence, bioavailability and pharmacokinetic studies.

Telemetry facilities to enable the continuous monitoring of ambulant subjects within the specialised Phase 1 clinic (12-bed capacity) are currently being installed. These facilities will complement the fixed ICU style monitors currently in that ward.

Hooper says he is very confident that this set of recent initiatives will find broad market acceptance among Q-Pharm's client base, and will also enable to company to continue acquiring new clients.

Q-Pharm is exhibiting on stand 1607 as part of the Queensland Clinical Trials Network at BIO 2007.