Thursday, February 21, 2008



by Daniel A. Silverstein

“You are what your numbers say you are” - Bill Parcels

Very large (5,000 to 10,000+ employee) PRIs are not reliable engines of discovery for new drugs. They are, in fact, extraordinarily productive at other things – particularly repeatable processes associated with aNDAs, sNDAs and the on-going maintenance of established drugs and their franchises. For activities like these, where there is a generally accepted way of doing things – one that is repeatable, and can be optimized – the management techniques and expertise of these kinds or organizations can get the job done quickly and reliably.

It is in the other arena – of breakthrough insights, creativity and originality, that the PRI fails to deliver reliable results; as if such can be “reliably” delivered by any entity known to man. In point of fact, scientific accomplishments such as these tend to be widely and randomly distributed throughout the scientific community. However, while no one knows exactly where the next really meaningful discovery may come from, chances are it will more likely emanate from an academic institution or a development stage Bio/Pharma company lab, than that of Big Pharma.

I commented generally in an earlier post that the absolute size, the extent of management controls and costs of doing business in these very large PRIs was in some measure responsible for this lack of creative output. More specifically however, I observe that never in the history of man have organizations of such size and monolithic character been put to the task of “discovering things.” Rather, discovery as a process, has taken place in more companionable, propitious surroundings populated mostly by newly minted Ph.D.s and Post Docs working in small groups.

Further, I ask you to recall that most great discoveries are made by scientists around the age of 30, who, interestingly enough, go on to careers based on never discovering anything else again. Moreover, there is support for the idea that the state of knowledge in all scientific fields changes so quickly that scientists 3 years past their Ph.D. are drifting out of touch with leading edge thinking, and those 10 years out from the academic training are suited only for work as doorstops, or in reality, as Managers of Discovery in Big Pharma.

This situation is exacerbated by the failure of Big Pharma to effectively establish equal pay, glory and stature for those who want to, or ought to, be kept on the scientific track. The result of this failure is evidenced by the endless desire of all those youngsters, profoundly trained in science, who can’t wait to rise to the position of Group Leader or Section Manager, stop discovering things and start managing people. They abandon their scientific heritage more quickly and more foolishly than a 40-year-old virgin in a house of ill repute.

So if Big Pharma Labs are best at process optimization and smaller labs excel at the kinds of thinking that leads to breakthrough discoveries, what to do?

One school of thought suggests that the PRI model ought to be changed and that the “R” needs to be conducted in a different setting from the “D”. Specifically, it should be both recognized and acknowledged that massive organizations are best for work characterized by processes that can be optimized; and that establishing numerous smaller, semi-autonomous labs, constantly refreshed by streams of new Post Docs on temporary assignment and nurtured by a revolving cast of academic thought leaders might be more likely places where something might actually get discovered, providing that the right incentives are put in place.

In support of the notion of getting the incentives right, I point out that except for the prospect of continuing employment, there are no appropriate rewards offered for the discovery of an important new drug. If you have a really great idea and work for a Big Pharma, you sign the patent over for a buck. If you do your work independently, get if financed on your own and make it a reality, the next 10 generations of your family will live with complete financial independence. No real basis of comparison, is there?

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