Contract research organisation TetraQ has formed a strategic alliance with Ground Zero Pharmaceuticals Inc (GZP) to help new Australian pharmaceuticals get to market.
While only established in May , The University of Queensland (UQ) based TetraQ is quickly becoming a key provider of services for Australian drug development companies.
US regulatory approval is a critical issue for Australian companies and the Food and Drug Administration (FDA) is unforgiving of mistakes in the preclinical development stage TetraQ Business Development Manager Dr Stuart Behncken said.
"Australian drug development companies targeting the US market are often unaware of the issues they can encounter with the FDA, and they find that they also need help preparing the complex documentation," Dr Behncken said.
"The Californian-based GZP is perfect for assisting our clients because they provide advice on the drug development process and prepare regulatory submissions to the FDA."
In five months of operations, the organisation has conducted 36 pre-clinical studies for 15 Australian clients, including four ASX listed companies.
Formed by four leading UQ researchers and operating through UQ's main commercialisation company UniQuest Pty Ltd, TetraQ was designed to provide a "one-stop-shop" for pre-clinical drug development in Australia.
Australia's pre-clinical drug development capability is limited or fragmented, so most Australian companies contract the bulk of their pre-clinical drug development work overseas, according to Dr Behncken.
"It's TetraQ's mission to retain as much of this work in Australia as possible, as well as to give the extra advice and interpretation that is often lacking with the larger providers," he said.
"As we roll out additional TetraQ's services in all four areas of pre-clinical research, we expect to become a stronger alternative to the overseas organisations, but in the meantime will continue to provide value-added services to clients."
In the next six months, an $8.1 million grant from the Queensland State Government will be used to expand TetraQ's capability with the refurbishment of laboratory facilities fitted with state-of-the-art equipment.
In 2006, TetraQ will seek Good Lab Practice (GLP) accreditation, making it one of the few Australian groups qualified to perform toxicology services for clients that meet the requirements of regulators in the USA and Europe.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
Published on PsychCentral.com. All rights reserved.
Two roads diverged in a wood, and I--
I took the one less traveled by,
And that has made all the difference.
-- Robert Frost