Fixing the Broken Model: Look Inside Your Company

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did not appropriately forecast expenses in a clinical trial. So the firm ran out of money mid-trial. The problem, says Dombal, was that the company had planned on paying for clinical trials the same way one pays for a construction project, i.e., upon completion of major phases. But that’s not usually the case. If a clinical site delivers data on two patients, it wants payment for those two, Dombal says. “So you do not have the ability to accrue costs for the long term,” and this particular company’s plan did not reflect that, he says. People inside the company overseeing the trial understood how these payments worked, but they apparently were never asked for their input, he says. The company ran out of cash and liquidated all of its assets. It is sad to see, says Dombal, how the inability to ask the right questions inside a company can have such detrimental results—all the money and effort that went into developing this drug candidate is gone.

Another shocking example is that of a company that was finishing a large Phase III clinical trial and was getting ready to submit it for approval to the FDA. The company approached Halloran seeking help with putting together the FDA dossier. That’s when Halloran discovered that two of the company’s vendors—one in the clinical space and one in the manufacturing space—had severe issues. “One didn’t even have a quality system at all, no documentation,” Dombal says. The realization came after Halloran visited the vendors—something the company had not done. If the FDA visited the facilities, they would never pass muster, so Halloran had to break the bad news to the company: in its view, the NDA should not be filed. Essentially, the company has to start all over again. It has to manufacture the drug at a different facility and repeat big portions of its clinical program. “We’re talking tens of millions of dollars that are now lost,” Dombal says. “These are things that you would think could possibly never happen in our industry, and yet they do.”

One last example Dombal gave me was of a company with a combination product—a combo of a drug and a device—that failed to request designation from the FDA as to whether its product should be approved primarily as a drug or a device. The process is straightforward, says Dombal, consisting of an 8- to 10-page summary in which the company asks the agency to review its product through either the office that regulates devices or drugs, with supporting input from the remaining office. Because the company skipped that step, the product ended up in a division that wasn’t the best fit, Dombal says. Questions from the agency came up, and the product is now on clinical hold. “Does the product warrant clinical hold? Absolutely not,” says Dombal. “Did they make a tactical mistake? Yes. They assumed that FDA would understand the technology and did not ensure the right people were involved in the review.” The company is now working to set up a meeting with FDA to resolve the issue, and that effort has cost them nearly 3 months and $65,000.

All these anecdotes make me wonder: what would the $1.3 billion figure look like if one eliminated all failures due to human error, or incompetence, and only counted the unfortunate cases of failures from drugs that just weren’t efficacious enough, no matter how hard the company tried? Maybe that’s the number everyone should strive for.


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Sylvia Pagán Westphal is Xconomy's life sciences columnist. You can reach her at swestphal@xconomy.com or you can follow her on Twitter at http://twitter.com/sylviawestphal. Visit http://www.xconomy.com/author/swestphal/ for Sylvia's full bio and disclosures. Follow @

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