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.
Media inquiries: Dr Stuart Behncken at TetraQ 61-733-469-933,About TetraQ
Based at The University of Queensland in Brisbane, TetraQ is the first contract research organisation in Australia to provide integrated pre-clinical services to the global pharmaceutical and biotechnology industries. TetraQ provides specialist services and advice to companies who are in the early stages of drug development and can assist in bridging the gap between drug discovery early stage clinical trials. Services include efficacy assessment, ADME (absorption, distribution, metabolism and elimination) profiling, toxicology assessment and pharmaceutics profiling, including preclinical drug formulation.
About Ground Zero Pharmaceuticals
Based in Irvine, a major centre of pharmaceutical and biotechnology innovation in Southern California, Ground Zero Pharmaceuticals Inc is a regulatory affairs and product development consulting firm providing strategic and tactical support to the pharmaceutical, biologics, biotechnology and medical device industries. Its service portfolio includes regulatory representation and submissions, strategic medical strategy, preclinical planning and data assessment, medical writing, manufacturing controls compliance, clinical assessment, data management, clinical monitoring, biostatics, and project management.