You know that ominous figure people always talk about, that one staggering number—$1.3 billion these days—that represents the cost to develop and market a drug? It is, to be sure, way too high and unsustainably so.

The billions of dollars that have been invested to discover the next generation of blockbusters have, for the most part, failed to bear fruit. In 2009, the industry spent some $65 billion in R&D. That same year 34 new drugs and biologics were approved. Even if one considers that the 2009 drugs were developed in the 10 years prior, the numbers are telling since the industry was spending some $26 billion a year in R&D in 2000. Divide that by 34 and the very crude, very unscientific allocation per drug is some $765 million.

Math games aside, the point is that everyone in the industry recognizes things just can’t go on this way. I’ve lost count of the number of times I have heard a very senior biotech and pharmaceutical executive admit that “the model is broken.” There is a lot of blame to go around: executives bemoan investors’ reluctance to fund their companies while companies, and investors, complain the FDA has become too unpredictable and is not approving drugs at the rate it used to. The growing sense of futility is having a chilling effect on the whole ecosystem of drug discovery.

Often, the $1.3 billion figure is used to illustrate how hard the business is and to help justify the large investment incurred to make drugs. That’s because the figure takes into account not just the one success but all the failures. For each FDA approval there is, on average, one Phase III failure and many more drugs in preclinical and early human tests that don’t make it. All that money spent and lost is clumped together with the money that was invested in the one success.

But a failure is a failure is a failure. The scenario often portrayed to the public is that there are hundreds of drug candidates whose promise dwindles as studies progress, simply because it is discovered that, sadly, they just don’t work as initially thought. This is certainly true of many drug candidates, but not all. A lot of drugs that might actually have made it die because of decisions poorly made, or human error.

Inexperience can play a major role when it comes to these failures, and the biotechnology industry, by virtue of being comprised of so many small, new companies, is especially vulnerable to that. One 2008 analysis published in Nature Reviews Drug Discovery found that 95% of the industry’s Phase III failures in 2006 and 2007 were products originating from biotechnology companies. During the period analyzed in the article, 65 drugs seeking approval experienced regulatory setbacks and 16 of those had 3-month delays. The vast majority of products with delays came from biotech companies. The authors ventured that “many of these delays may have resulted from poor quality NDA submissions, rather than from flaws in the drugs themselves.”

Sounds like a harsh assessment, but it appears as though it’s fairly accurate, at least based on a conversation I recently had with Greg Dombal, managing partner at Halloran Consulting Group, which helps life sciences companies with regulatory and quality assurance issues. I met Dombal last week, at the dinner to kick-off Xconomy’s XSITE summit, and some of the things he said were truly surprising. He says, for example, that about three quarters of the life sciences companies his group sees “have some fundamental gaps in competence.” In a “solid” 30-40 percent, he says, some of the issues can be found at the “C level”—meaning the chief executive, chief operating officer, and other top executives.

Dombal, who’s had extensive experience in regulatory affairs at various companies, later gave me more examples during a phone conversation. One was of a company that … Next Page »

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 @

Trending on Xconomy