By Deborah Borfitz
August 25, 2008 | Since its inception 18 months ago, Reporting and Analysis Services (RAS) has turned out to be one of the more active business divisions of the Mountain View, CA-based Pharsight Corp. Revenues have nearly tripled, the main operating center recently relocated to a roomier facility in Montreal, and a satellite RAS facility will be going up in Cary, NC, sometime this fiscal year.
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| John Murphy |
RAS reports to John E. Murphy, DrPH, senior vice president of consulting services. Moving forward, he says, growth will have two new, potentially significant drivers: preclinical reporting and biostatistical trial modeling. FDA documentation requirements for animal studies are no less stringent than for clinical trials. Pharsight can apply existing datasets, tools, and scientific expertise to make a decisive move into the pre-clinical arena. As it is, 20 percent of RAS business includes a pre-clinical component.
“In addition to analyzing and modeling the PK/PD [pharmacokinetic/pharmacodynamic] relationships, human trials require a rigorous statistical plan, analysis, and report of results,” says Murphy. “Safety issues are paramount in Phase I, while both safety and efficacy become important in later phase work. The RAS biostatistics group will handle those chores as well.”
Meanwhile, FDA’s Critical Path Initiative is actively encouraging study sponsors to do pharmaco-statistical modeling (“model-based drug development”) as a means to improve protocol design and predict the likely range of outcomes, limiting unnecessary human or animal experimentation while making drug development a more efficient process in terms of time and money, says Murphy. Modeling can guide decisions to eliminate trial arms, skip a study phase, or drop a molecule off the development agenda.
For the expansion, two new faces join Pharsight’s management team. One is Mark L.J. Reimer, PhD, filling the newly created position of senior director, operations and clinical development. He brings the added ability to consult on the transfer of compounds from preclinical to Phase I in the “most efficient manner possible,” says Murphy.
Jean-Sébastian Brunet, MS, will be debuting as senior associate, statistics and data management. “Our legacy is talented, world class modelers involved in consulting services to help [study sponsors] design trials,” says Murphy. “Now, we’re bringing in biostatistical expertise to plan, analyze, report, and model trials in greater depth…shortening the time it takes to do clinical trials by many more months, even years, and significantly increasing the confidence and quantitative basis for making good drug development program decisions.”
Pharsight’s RAS division has modeling proficiency in all therapeutic categories, making it an increasingly attractive place for large and mid-sized sponsor companies to outsource the work, says Murphy. The consulting customer base is well diversified with several dozen clients in both regulatory and strategic consultancy.
Pharsight, founded in 1996, offers PK/PD modeling and simulation tools, together with a data repository system for managing the data and models. Pharsight’s system also supports third-party tools, such as SAS and S-Plus, Murphy says. The company has the expertise to aid in the technically tricky business of PK/PD analysis, which was a “highly manual effort” in the recent past. “What used to take weeks or months, we can do in days.”
About 30 percent of the approximately $2 billion market for data management and statistical planning, analysis, and reporting is now outsourced to either Pharsight, contract research organizations (CROs), or a few smaller organizations. For CROs, statistical analysis and reporting is low-margin business, says Murphy. “We can take the burden off their back, provide a better service, and report in a better formatted way that the FDA can accept and do it faster and cheaper.”
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