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Feb 26, 2013

Jump-Starting Phase I Clinical Investigations

  • Xceleron partnered with Kinetigen to assist drug developers in their early clinical investigations.

    Kinetigen specializes in pharmacokinetic analyses and in devising an overall clinical pharmacology strategy. Xceleron uses accelerator mass spectrometry to provide analytical insights into small molecule and biological therapeutics.

    “Together, Xceleron and Kinetigen leverage a conventional Phase I approach to expand the knowledge base and value of intellectual property before the onset of expensive late-phase clinical investigations,” explained Michael Butler, Ph.D., CEO of Xceleron.

    Nonoptimized or incomplete pharmacokinetic analyses commonly result in additional expenses and lost time over the course of a development program; such problems frequently become evident during expensive proof-of-concept investigations. Thoroughly understanding the pharmacokinetics of a drug or biologic in clinical Phase I studies allows investigators to make decisions earlier, according to Geoffrey Banks, Ph.D., Kinetigen’s CEO.

    The critical importance of making science-based decisions as early as possible in new drug development is illustrated in a recent study by the Tufts Center for the Study of Drug Development (CSDD). One out of every five procedures performed during later stage clinical trials collects extraneous data and costs drug developers more than $1 million per trial, notes the Tufts team, which added that 18% of a typical clinical trial budget ($1.1 million) is spent on direct costs to administer procedures for supplementary secondary, tertiary, and exploratory endpoints.

    Based on the total number of active Phase II and III clinical trials regulated by the FDA, Tufts CSDD conservatively estimates that the pharmaceutical industry spends between $4 billion and $6 billion each year on procedures that generate extraneous clinical trial data.

    “The impetus to collect these data is strong, and until now there has been no systematic assessment of this practice,” said Ken Getz, assistant professor at Tufts CSDD. “We believe our findings offer a framework that pharmaceutical and biotechnology companies can use to streamline protocol designs, improve clinical research performance, and reduce development costs.”

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