Jason Valentine, CEO
As the clinical trials sector heads towards a $60 billion market in the next five years, quality bioanalytical services that deliver progress and results analysis for a drug therapy are in high demand. Sponsors and CROs rely on a handful of world-class labs that offer bespoke analysis for study results. In Australia, the government’s mission to reduce the time and cost for clinical trials along with attractive R&D incentives and tax rebates of up to 43.5 percent has enabled the country to emerge as a clinical powerhouse for global pharmaceutical and biotech research. Australia is now a leading destination for international clinical trials and a regional hub for Asian clinical research support and management.
Agilex Biolabs, a state-of-the-art lab based in Adelaide, South Australia is one such facility that is making a name for itself as a leader in analysis for studies in Asia, Australia, New Zealand, EU and the USA. “As the largest and most experienced bio-analytical facility in Australia, Agilex is currently the go-to for bioanalytical testing for Asia region early phase clinical trials, and is the only lab of its type in Australia that has been inspected by the Food and Drug Administration (FDA),” says Jason Valentine, CEO of Agilex.
Recognized as a front runner in bioanalytics, with a track-record of 300 early phase clinical trials, the company’s facility boasts the latest technology including the Sciex 4000 LC-MS/MS, Sciex QTRAP 5500 LC-MS/MS, SpectraMax Plate Reader, Mesoscale Discovery System (MSD) and GyrolabxPlore that deliver the most accurate data for clinical trials. But clients say it is really about the excellence of Agilex Biolabs scientific team.
With over ten years of experience, our scientists are capable of developing and validating the most complex assays or preclinical and clinical programs
“With over ten years of experience, our scientists are capable of developing and validating a wide range of assays for preclinical and clinical programs,” says Valentine. The Agilex team also has a growing suite of biomarker assays, which enables detailed understanding of the changes taking place in the body in response to the drug being dosed. According to Valentine, Agilex Biolabs can de-risk early phase clinical trials by “delivering the quality assurance compliance required in the industry”.
Agilex uses a collaborative approach with its clients. Their team collects as much information as possible from the client about the compound, stability, and preclinical information. Then the project moves into the assay development phase to develop the bespoke assay required meeting the client’s clinical needs. Once developed, Agilex validates the method as per current FDA and EMA regulatory guidelines. When the validation phase is complete, samples are analyzed, and quality assurance checks take place. Data is then sent to the agreed group as the per data management plan and a fully compliant bio-analytical report is produced and sent to the client.
What distinguishes Agilex from competitors is its nimble and flexible team that is capable of meeting tight deadlines. “Our ability to scale staffing for speed with a 65 person experienced scientific team, coupled with advanced equipment, allows us to consistently deliver,” says Valentine.
Over the years, Agilex has helped many drug developers successfully register their product with the FDA. “More than 60 percent of our client base is from the U.S, while 30 percent is from the Asia region,” says Valentine. Anticipating a strong growth trajectory of 40 percent year on year, the company now aims to have additional assays developed by their strategic R&D team in order to serve the industry more widely.