Holmes Biopharma gaining Phase I momentum
earlier this year in the US through its new clinical research
division, Qualia Clinical Service, Holmes Biopharma is starting to
see the business gain momentum.
The Canadian-owned company is very pleased with itself after recently bagging a Phase I clinical contract from a top five pharmaceutical company - its biggest so far.
The company will conduct the three-month study, which will focus on drug interaction and begin in the fourth quarter 2006, from its new facility in Omaha, Nebraska, as well as provide data capture, analysis and reporting services.
The firm hinted that similar new contracts were also now imminent, after its research clinic was inspected last week by a top three US pharmaceutical company, as well as a large Japanese pharma firm.
"The visit by the two pharma companies involved a thorough site qualification inspection of the facility. Representatives from the pharma companies met with the staff and reviewed all systems and processes in place," said John Metcalfe, president of Holmes Biopharma.
"The facility inspection process is an industry standard requirement completed in advance of contract awards."
Holmes Biopharma is one of a number of North American companies who are making moves to expand in the under-represented area of Phase I clinical research services and pinning their hopes on the continuing trend of biopharma firms seeking to have these tasks undertaken by external providers.
Canada's Allied Research International (ARI) recently expanded its Phase I testing capabilities after buying key assets of South Florida Bioavailability Clinic International's (SFBC) Miami, Florida operations, including a clinical laboratory, as well as equipment and a 46-station cardiac monitoring suite.
The expanded facilities add to ARI's existing Phase I clinic in Miami, as well as its 80-bed Phase I unit in Toronto, Canada, bringing its total capacity to over 230 Phase I beds.
A new Phase I clinical services company, Roanoke Clinical Research (RCR), was also formed in June in order to take advantage of this gap in the market.
In addition, CRO giant, Covance has also been making major expansions in its US Phase I/IIa drug development capabilities of late, buying eight early-phase clinical development sites from Radiant Research in May.
