Canada’s Biovail Contract Research says its stand-alone biostatistics unit will help sponsors “anticipate roadblocks ahead of time and create a sound statistical analysis plan for optimal results.”
With pharmaceutical firms cutting-in house expertise at a time when clinical trial programmes are becoming increasingly complex, demand for specialist serices across all aspects of drug R&D, including biostatistics, is expected to grow considerably.
Biovail’s new biostatistics contract service, showcased at the American Association of Pharmaceutical Scientist’s (AAPS) conference in Los Angeles, US, was set up to meet this need, as company biostatistician Navdeep Coelho told Outsourcing-pharma.
“We think the market for clinical biostatistics as pharmaceutical firms seek to reduce costs and shorten analysis timelines,” adding that with demand down across the research sector “it is important to think outside the box to increase market share.”
Coelho explained that the Biovail biostatistics team had grown out of the contract research organisation’s (CRO) wider range of services and will begin by carrying out between four and five projects a year.
The unit will offer pharma and biotechnology sponsors biostatistics consultation, programming and analysis for everything from pharmacokinetics and pharmakodynamics through to late Phase trials.
Business development plans, but Q3 hit by charges
The business development also ran through the Biovail group’s Q3 results presentation late last week.
Speaking on November 5 Biovail’s CEO, Bill Wells, reported that the three months to September had seen the firm “completed [its] fifth business development transaction since launching our new strategy only 18 months ago.”
“We remain active on the business development front and are currently evaluating a number of opportunities within our target therapeutic area of specialty central nervous system disorders,” adding that “we’re well positioned to execute on one or more of these to further build a long-term growth engine.”
Despite Biovail’s confidence in growing its business in the medium term through acquisitions, deals and setting up specialist units like the biostatistics group, charges associated these activities did have an impact on third quarterly profits.
Earnings for the period were $40m, down from $48.4m in the year earlier period, with the firm attributing the decline to an $8m charge for acquired in process R&D for JP-1730/fipamezole from Santhera Pharmaceuticals and $2m in restructuring costs linked to the closure of several facilities.