Service Firms See a Fledgling Efficiency Revolution

Contract research organizations (CROs) have firsthand knowledge of how large pharmaceutical companies manage late-stage development and clinical trials. Lately, they have observed how their big pharma customers manage change in these areas, and they see room for improvement.

G. Stephen DeCherney, president of Clinical Development Services Americas at Quintiles Transnational would compare big pharma to the British army during the Revolutionary War.

Set in their monolithic ways, DeCherney says, the major drug companies are unable to make efficient use of clinical research contractors, whom he would liken to Minutemen.

"It seems to be difficult for the big companies to dismantle their clinical operations hierarchies," he says. Thus, rather than bringing in specialized expertise, the big drug companies often create redundancies in their use of CROs.

Not that they aren't trying to improve. DeCherney and other CRO executives say there is a distinct push to make late-stage development more efficient, characterized by cost cutting as well as a small revolution in clinical science. "They're on target in principle," DeCherney says, "But they are very far away from making clinical trials efficient."

Part of the problem is an overemphasis on cost cutting. "At the big Anglo- American corporations--AstraZeneca, Pfizer, Glaxo--procurement officers are being ordered by financial officers to cut costs, and they don't care how they do it," DeCherney says. "They open up bidding wars [for CRO services] with reverse auctions and other techniques to simply lower the price."

Lawrence A. Meinert, senior vice president of clinical operations at Covance, agrees. The advent of genomics and the push for personalized medicine call for an increase in systems biology techniques, he says, yet large drug companies remain wedded to the traditional sledgehammer approach of pushing small-molecule candidates as far as they will go--as quickly as possible and at the lowest cost.

"The effect is a massive increase in the number of units early on in the human testing phase," Meinert says. "Studies are bigger and more complicated in early discovery, with more of the compounds coming through not being sorted out preclinically. In essence, there is no increase in the net output of novel agents to the market."

But change is under way. "There are a few of what I call early innovators that are embracing the systems biology paradigm," Meinert says. "Their approach is to more efficiently manage the portfolio and elegantly get at the heterogeneity of the population in an efficient way rather than just barreling through and trying to squeeze the per-unit cost down."

Meinert and DeCherney agree that taking the time to optimize patient populations, dosing levels, and the size and location of trials has the potential to reduce cost and wasted effort further down the pipeline. It can also equip drug companies with better information on safety risks. "Under the systems biology paradigm, the complex, holistic picture is most important," Meinert says. "On the other hand, if everyone is focused on their narrow widget and making things move as fast as possible, it is more likely things will sit undetected. Nobody will be in a position to readily connect the dots."

DeCherney suggests that more detailed knowledge of safety characteristics may also have a marketing upside. "If you [can show] your drug is safer, you might get some brand mileage," he says. "People may be less likely to switch to the generic."