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A new, faster recipe for drug development: Chat up regulators. Outsource where you can. And know when to let go.
Greater collaboration with regulatory agencies, a heavier reliance on outsourcing--and knowing when to call it quits on a project--can speed drug development and increase revenues, particularly in oncology and anti-infectives.
A study released this month from the Tufts Center for Drug Development found that the five fastest drug developers bring products to market 17 months faster than average, gaining $1.1 billion in incremental prescription drug revenue.
These so-called "speed demons"--AstraZeneca, Allergan, Boehringer Ingelheim, and Merck--run the gamut in terms of size and therapeutic expertise. But they all follow a combination of strategic and operational tactics that contribute to their faster development times, the study found.
These companies put greater emphasis on working with regulatory agencies here and abroad, outsource more functions, and have a "commitment to implementing a particular strategy across the board, enterprise-wide, rather than on a project-by-project basis," said Ken Getz, senior research fellow at Tufts.
They also kill unsuccessful projects sooner: The "speed demons" terminated 56 percent of their unsuccessful projects in Phase I, while slower companies terminated just 36 percent in that stage.
"Speed demons" developed drugs within a median of 28.5 months, and received regulatory approval 7.1 months faster than average.
"Our study confirms that speed cannot be attributed to chance," Getz said. "There are many, many places along the complex drug development continuum where inefficiencies can occur."
There are a number of improvements that all companies can make across the board, noted Michael Rosenberg, MD, president and CEO of Health Decisions, a contract research organization.
Most companies still do not use electronic data collection systems--and even if they do, they're not interpreting those figures to find inefficiencies, he noted.
"Experience suggests that many of these 'speed demons' may actually be fast turtles," Rosenberg said. "Very few companies can answer simple questions about progress: which enrollment strategies are working best, which sites are performing well, where should monitoring resources be focused."
The study analyzed 332 drugs approved by FDA between 1994 and 2005; company-specific information was compiled on 29 firms with at least two product approvals between 2000 and 2005.
In some therapeutic categories, the contrast between the fastest and slowest developer was even starker. For instance, the slowest developers might need more than 400 months to bring an anti-infective or cancer drug to market, while "speed demons" need only 40 months.
Even as companies work to develop drugs more quickly, product managers need to research the competitive environment--specifically, how it relates to the price of the drug and its side-effect profile, according to Nancy Dreyer, chief of scientific affairs for Outcome, a consulting firm on post-approval strategies.
"Nowadays, buying decisions are influenced by both clinical effectiveness as well as efficacy," she said, referring to how a drug works in the "real world" as opposed to the ideal conditions of a clinical trial. "The companies that are most successful don't see [efficacy, cost, and safety] as three isolated areas."