January 20, 2010

Drug Development Still Under Stress

Pharmaceutical companies have increased efficiency, but still face pressures as more medicine patents expire

Although drug companies are improving their efficiency in research and development, in part by terminating work on unpromising drugs earlier, their success will depend on how well they partner with other firms, according to a new report by the Tufts Center for the Study of Drug Development (CSDD).

“Developers have made important progress in reducing R&D times,” says Kenneth I Kaitin, the CSDD director, in connection with the release of the center’s Outlook 2010 report on pharmaceutical and biopharmaceutical trends. “But because only three in 10 new drugs, on average, generate sufficient revenue to sustain R&D, pharmaceutical and biotech firms are under great and growing pressure to generate revenue to bring more products to market. The simple fact is that product launches are not keeping pace with patent expirations.”

According to CSDD, worldwide sales for all drugs coming off patent from 2009 through 2012 will exceed $88 billion. Currently, it costs on average more than $1 billion and takes more than seven years from the start of clinical trials to win approval to market a new drug in the United States.

Kaitin notes that while new technologies and improved protocol designs are helping to improve R&D efficiency, “future success for many will depend on their ability to collaborate with other drug companies, and on how well they engage and partner with outside service providers.”

The report notes that the total average clinical time in drug development “dropped 10 percent from 1992 through 2007, even as trials became more complex, while average approval time declined nearly 60 percent.”

Among the near-term trends cited in the Outlook 2010 report are:

  • More pharmaceutical firms will focus on improving clinical protocol design, such as helping reduce trial costs and speeding development cycles, to mitigate a trend toward increased protocol complexity.

  • A more activist Food and Drug Administration will focus on a regulatory pathway for approvals of follow-on biologics, drugs that have similar properties to ones with expired patents; over-the-counter product and drug safety; foreign facility inspections; preventable deaths from chronic diseases; and vaccine manufacturing capacity.

  • Clinical development time for novel protein products, which now averages seven years, is likely to stay the same, due to disease complexity, growth of protocols that lengthen studies and difficulty recruiting and retaining volunteers.

  • Off-label prescribing of biopharmaceuticals—uses of drugs for purposes other than those approved by the FDA—in the U.S. will be subject to increased scrutiny.

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