Client Demand Pushes Early Phase Australian CRO to Expand to Large Molecules

09-Apr-2013 - Last updated on 12-Apr-2013 at 08:48 GMT

Early phase clinical trial provider CPR Pharma Services has expanded its bioanalytical offerings with a ligand-binding assay service for its clients developing large molecules such as biologics, monoclonal antibodies and biosimilars.

The new large-molecule laboratory in Adelaide, Australia was created after the company’s existing client base – consisting of mostly small US pharmaceutical and biotech companies – requested the large molecule immunochemistry analytical service, Jason Valentine, CEO of CPR Pharma, told Outsoucing-Pharma.com.

CPR is the only CRO in Australia with a certified GLP-compliant bioanalytical lab and “our client base has been asking, when are you extending to large molecules? And this when we decided to expand,” Valentine said.

“Australia is a good place to conduct” first-in-human clinical trials because of its expedited regulatory process, Valentine added. The quicker approval times can allow companies to obtain preliminary human data and go back to investors with results at a faster clip, he added. Companies can see between a 40% and 50% decrease in the length of time it takes them to finish these types of trials by working in Australia, Valentine noted.

In addition to the Adelaide lab, CPR also launched Singapore’s first bio-analytical laboratory last year and Valentine said the company is looking to expand its large molecule capabilities there as well. “Our client base in the US is looking at this region as an area of growth,” Valentine said.

John Chappell -- who worked for more than 20 years with CROs such as Covance, ClinTrials BioResearch, BAS Analytics, Veeda and ICON – will run the new lab in Adelaide with his experience in ligand binding-assay development, validation and implementation for clinical trials.

Scaling Back Preclinical Work?

Despite the expansion from CPR, a number of CROs have seen recent reductions or stunted growth in their preclinical businesses, according to industry insiders.

But Valentine maintained that small- and medium-sized pharma and biotech companies “are picking up the slack and likely to license their products to the larger pharma companies.” He added that CPR has not seen a slowdown in development from these smaller companies, despite the larger companies scaling back their R&D.