A shift among drugmakers to prefer existing patients, rather than healthy volunteers, for early stage trials, is forcing Parexel, one of the largest contract research organizations, to close offices and eliminate jobs. Specifically, the CRO is cutting up to 30 per cent of Phase I capacity and around 300 jobs, or about 3 per cent of its 10,350 workforce, according to afiling with the Securities and Exchange Commission.
Other factors are at work, though. The CRO acknowledged that some clients delayed the start of large projects, underscoring the weakness of the pharmaceutical pipeline. Meanwhile, as Outsourcing Pharma points out, Parexel execs believe the shift away from trials in healthy volunteers is permanent, or at least demand will be lower for the foreseeable future.
"We believe that the market for healthy volunteers is not going to be growing much, whereas the market for patient studies is growing more”, Parexel ceo Joseph von Rickenbach told investors on an earnings conference call. “I think historically some of the studies that were done…were probably premature. Clients are streamlining there development plans and conducting studies as needed to get to the next stage.”
To compensate, von Rickenbach hopes that later stage development work will grow as the CRO continues to pursue strategic alliances with drugmakers that extend beyond the usual consulting work. According to Lazard Capital Markets analyst Stephen Unger, Parexel plans to add about 150 staffers, after accounting for the layoffs, to handles projects that are backlogged.
5 Comments
Hmmm - speaking of the "weakness of the pharmaceutical pipeline" - has Dilbert switched industries? A familiar ring ...
Consider today's: http://dilbert.com/2011-05-04
This should probably put to rest any idea of a national Phase I subject registry.
My concern with many of the CRO industry's "healthy volunteers" is that some of them are professional guinea pigs -- it wouldn't surprise me if the "shift to real patients" is a way to get around that population.
Wow another lay-off I hope not, if so this will be the second for the company this year and the third in the last 2-3 years.
Let's be real there is no real "healthy volunteer" unless this is the person's first study. It's hard to trust any data that comes out of these clinical trials when most of the participants bounce from site to site study to study and do not observe "wash-out" periods before they enroll in another study. So they still possibly have other residual test drugs in their system that can sku the results of each study. Of course this is common knowledge but no one cares as long as the individual meets the inclusion requirements and don't disclose that information.
Parexel should have been decertified in the EU after the TGN 1412 disaster.
http://www.i-sis.org.uk/PMOTTD.php