cont.3 Jul 2010 13:25
Recently, there are some preliminary signs that pharma and biotech may be revisiting the biomarker space. Last year, contract research organization Covance established a Biomarker Center of Excellence and entered into a biomarker deal with Rules Based Medicine in response to an increase in demand for the company’s biomarker services, Tom Turi, vice president of the BCOE, told ProteoMonitor [See PM 12/11/09].
During the most recent quarterly earnings releases, some mass spec vendors reported better, but still-soft, pharma/biotech business, as those customers started to once again buy capital instruments such as mass specs.
Whether this means pharma/biotech will bring back their protein biomarker work in house is unclear, but Pisano said that drug companies and biotechs no longer have an appetite to do biomarker work and assay development themselves.
"If they can get someone [who] can help them from discovery through clinical trials, that’s one vendor versus multiple vendors doing multiple things along the way," he said. "They’re moving toward single source, if you will, for everything. Evidence of that is all of these pharma companies are putting together outsourcing groups. That’s their sole job — to manage the outsourcing that goes on in the company."
For the future, NextGen is eyeing areas such as biologics that have yet to impact the biomarker space.
"If you look at cancer drugs, the majority of the new cancer drugs are antibodies … and those will have to be monitored and the regulatory agencies will put more and more stringent requirements on them," he said.
Indeed, during the summer, trying to capitalize on biopharma’s outsourcing business, Sigma-Aldrich launched a new protein service business. The services offered include protein identification from gel bands, sequence analysis, and glycan analysis. Classic biomarker services, such as discovery, verification, and validation, are not on the menu, however [SeePM 06/11/09].
In traditional small-molecule work, increased biomarker research is being directed at predicting and monitoring drug efficacy and patient-drug reactions, which may eventually become another revenue source for NextGen, Pisano said.
For the immediate future, though, the company has its attention on traditional CRO work.
"We’ve got the discovery side going, we’ve got the assay-development side going. Now it’s time to get the testing side going," Pisano said. "That’s what we’re really focused on for this year, to get that part up and running."