US and French medical imaging firms join
it strives to broaden its clinical trial medical imaging service
offerings.
The primary appeal of Theralys was its experience in the field of central nervous system (CNS) and neurovascular imaging, which US-based Bio-Imaging has been wanting to add to its current areas of oncology, musculoskeletal and cardiovascular imaging, Mark Weinstein, president and CEO of Bio-Imaging told Outsourcing-Pharma.com.
Specifically, Theralys, based in Lyon, France, operates an imaging core lab that enables the automated quantitation of various imaging parameters such as brain, white matter lesion and hippocampal volumes, MRI diffusion and perfusion.
"In addition, Theralys not only provides us with access to a new geographic area, but is a regional player, and we are on the look out for regional imaging firms that are complimentary to our business that we can turn into global players," said Weinstein.
The two firms, which have already worked together in the past, are in the business of facilitating the use of medical imaging techniques on various part of the body, such as medical resonance imaging (MRI), X-ray, ultrasound etc, at a sponsor company's clinical trial site, as well as organising centralised blinded image reading and analysis services on a contract basis.
Since 2000 the use of such imaging in phase II-IV trials across a range of therapeutic areas for the evaluation of response to therapy and/or indicators of disease progression over time has been actively encouraged by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is also moving in this direction.
10-15 per cent of studies in the US currently require such imagaing, according to Weinstein.
At the same time however, the regulatory authorities are insisting on the images for each trial being reviewed centrally by an independent third party radiographer in order to minimise variability of result interpretation.
As a result, biopharma companies are increasingly relying on the relatively few contract organisations that supply such services - there are currently three to four global players.
"This area of clinical research is a young industry and is growing well. Currently the overall clinical research organisation (CRO) industry is growing at about 12 per cent however the contract imaging market is growing at between 15 and 20 per cent," said Weinstein.
"In addition, this particular sector has a high barrier to entry and there have been no new entrants of late because pharmaceutical firms want to deal with companies that have experience. This is good news for those of us already well established."
