Sunday, March 7, 2010

“Just say no” vs. “The Champion”

In the pharmaceutical industry, it is always (almost) less costly to say no.  It is also more costly to continue a program that is almost certain to fail.  These competing tensions are constant in the industry and I thought I would take this opportunity to explore this dynamic a little today. 

Starting with the naysayers – they take almost no risk in saying no.  A program that is halted is one where we are very unlikely to know whether it would have ultimately been successful or not.  The only time that occurs is when another company wants to license the program or compound that the naysayer has killed.  If the other company is successful and makes it to the market with a good selling product, then the naysayer at the original company might be in trouble.  But the way things work in the industry, that naysayer has most likely gone on to bigger and better things by the time the product he/she killed hits the market for the competing company.  Look at daptomycin.  It was discovered at Eli Lilly in the early 1980s, killed by them in the mid 1990s and marketed by Cubist in 2003.  Where is the naysayer at Lilly?  I have no idea.

I have personal experience with this.  Back in the 1990s, we at Wyeth wanted to license a penem B-lactamase inhibitor from Glaxo-Smith-Kline.  They seemed very surprised that we would be interested.  They claimed that the compound was unstable and difficult to make.  We, at Wyeth, at least wanted to see for ourselves, but also we thought we could use their knowledge of the chemistry to improve on the compound. Then GSK started to waffle.  They said that maybe they would develop the compound themselves.  I suspected some internal strife for the naysayer there.  After working with them for over 6 months, we gave up and started our own program.  GSK never progressed the compound or the series further and they never outlicensed the program.  Meanwhile, we at Wyeth were able to weave our way through the GSK patents to make compounds that were active, stable and could be manufactured (with some difficulty).  (Rumor has it that this program has now been killed at Pfizer . . .another naysayer at work?).

This experience is typical.  The naysayers assume that everyone would agree with their reasoning in killing the program including outsiders.  Of course, that is not always the case and when such a prospect arises, the naysayer gets nervous.

On the other side of the naysayer is the scientist who cannot understand why his/her favorite project is being killed by the company. This inability or unwillingness to understand or agree with the corporate decision frequently leads to subterranean efforts by the scientist and their buddies to continue the project.  Their hope is that they will discover something new that will change the corporate mind.  I don’t know how often this actually happens – I suspect it does rarely.  But I never saw it.  In my experience, the naysayers usually win and the scientists end up like Quixote until they reach a dead end or finally realize the futility of their pursuit.  Of course, sometimes it is these very scientists who are the program champions that we so desperately need to move programs forward in spite of the naysayers.

For program champions, on the other hand, the risk rises exponentially as the compound advances later and later into development.  Why?  Because that’s when things start getting really expensive.  At least $30 million per phase 3 trial (for an antibiotic anyway).   Program champions (sometimes the champion is more than one person) have to continue to point out every reason why the compound or program should go forward.  They have to speak about the medical need, the market prospects, how the trial strategy is well informed, etc, etc.  They have to continually keep the positive aspects of the program in front of the eyes of top management.  If the program champion is “wrong,” and there is a late stage failure – they are the most visible image of that failure in the company.

But without these brave souls, program champions, I am convinced that few or no drugs would ever be developed in large pharmaceutical companies.   Why?  Because there is little or no risk in saying no.

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