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So Tell Me Again, Why Are We Doing This?

By Ernie Bush

January 20, 2010 | The Bush Doctrine | The previous installment of The Bush Doctrine ended with an assertion that current preclinical safety evaluation practices are not poor, but rather good all things considered. More importantly, improving the clinical predictivity of preclinical safety tests is not going to significantly improve portfolio attrition rates. I closed by asking the question: “Why then are we spending so much time, energy and money on improving preclinical safety testing methods?”

There are many good reasons to improve safety evaluation practices:

• Even a reduction of only 5% in the number of compounds dropped due to clinical safety issues will have significant financial benefit and has the added bonus of improved clinical outcomes

• Every professional should be constantly striving to improve the economics, effectiveness and efficiencies of their profession

• The advent of evaluation systems that reduce or eliminate testing on animals will fulfill many regulatory and ethical objectives of major constituencies in the U.S. and especially in Europe.

Although these are all valid reasons, I still find myself wondering: Is that it? I constantly hear someone harping on the immediate need to improve our preclinical testing methods, and the above rationalizations just do not seem to warrant that kind of attention or urgency.

It is particularly interesting to ask this question in light of the continuing mega-mergers between large pharma companies—Merck/Schering-Plough and Pfizer/Wyeth both just finalized within the past few months. Clearly profit, or lack thereof, is the obvious motivation behind these mergers; but I think it is well established that the deeper motive is the pharma industry’s low R&D productivity. The current big pharma R&D paradigm is simply not productive enough to be self-sustaining.

The really scary part is that after each merger thousands of jobs (including hundreds of R&D staff) are downsized, resulting in an amazing loss of intellectual capital as well as untold lost opportunities. The outcome is, inevitably, less new drug candidates and less new marketed products. Looking at large pharma over the past 20 years, one could easily be forgiven for reaching the conclusion that the whole industry is in one big downward spiral. Sooner or later, there will be no more mega-merger opportunities and then what?

Follow the Money

One could also be forgiven for asking, what do mega-mergers have to do with improving preclinical safety testing? The answer to all these questions is simple: it’s about the money, the cost of doing business. It amazes me that it costs several million dollars to go from a promising molecule to an approved IND (even for small two-person virtual companies), and at least half of that cost is for the preclinical safety package (i.e. GLP safety studies). Equally astounding is the fact that over half the molecules that start the IND-enabling program never make it into humans. Therefore, although current safety evaluation practices are pretty good at picking appropriate compounds for administration to humans, the reality is that they are too expensive and too time consuming for an industry that is up against the wall in terms of its productivity.

Ultimately then, the primary incentive behind creating new safety evaluation practices becomes not improving clinical predictivity but improving the economics of the investment. The industry can no longer afford to spend many million of dollars and several years just to reach the point of starting human clinical trials. However, we are adamant that we will not compromise on the safety of drugs entering into human subjects. So any new pre-clinical safety process must be of equal or better predictivity, but much much more cost effective.

And thus the simple answer to the question, “Why then are we spending so much time, energy and money on improving preclinical safety testing methods?” is no less than we are trying to save an industry. Or perhaps even more relevant, I am trying to save my job.

Ernie Bush is vice president and scientific director of Cambridge Health Associates, the leading organizer and facilitator of biopharmaceutical collaborations in the safety evaluation space. CHA administers the Drug Safety Executive Council, an online community of industry leaders in safety assessment. Ernie can be reached at

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