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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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August 15, 2005

Out the Door and Over the Edge

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Posted by Derek

Handing a compound over to the clinical development group is usually a reason to celebrate, but there can be times when you don't feel like getting out the party hats. Just as a novel is defined as a lengthy work of narrative fiction that has something wrong with it, a clinical candidate is always defective, too. Rarely does everyone on the team feel that the best compound was picked.

There's nothing necessarily wrong with that situation. Everyone feels that the compound with the best profile in their own specialty should have gone forward, and no one compound can do it all. Applied researchers and engineers the world over know that eventually you just have to get something out the door, rather than sending it around for another round of tweaking. There are always enough surprises waiting in the clinic. You'll never be able to plan for all of them, so you might as well get your compound out there and see what happens.

But sometimes there's a more justifiable reason for unhappiness, which can be summed up in the phrase "making your numbers." Many organizations have targets for how many projects they plan to launch each year, and how many they expect to take on to the clinic. (I wrote about this here in 2002.) What if you feel like your project is being pushed to the next phase just to meet an end-of-the-year target?

This kind of thing definitely happens, and I'm sure that my readers at the larger companies can confirm that. There are several possible outcomes. Sometimes things work out for the best, when it turns out the candidate compound was more ready for the clinic than anyone realized (or when it dies for reasons that no one could have foreseen.) In either of those cases, you're better off having found out.

But there really are times when a project needs a little longer in the oven. My advice in those situations is to fight the good fight, but know when to quit. Most projects are going to die in the clinic, anyway, sad to say, and you'll need to decide for yourself how much capital you want to spend advocating any particular one. Try to position the project as best you can if it has to go. Learn as much as you can from what happens to it in development, and see if that can be applied to a follow-up program. That one should have a better chance.

Of course, if your company is just tossing this over to the clinical side for the sake of doing it, not expecting them to actually develop the candidate, then you might not have a chance to learn much. But if that's what's happening, my advice is to take a look around. Is this a regular part of your company's culture? if it is, perhaps it's time to start looking elsewhere. We waste enough time, money, and effort in this industry without trying to. An outfit that's deliberately throwing stuff away has bigger problems than just your project.

Comments (1) + TrackBacks (0) | Category: Drug Development


1. jim p on August 16, 2005 1:46 PM writes...

Sad, but true, Derek. I don't think the use of metrics such as the number of clinical candidates per year will ever go away as long as pharma is run as a business. The thing is, the industry would best be served if the mindset were to change completely, and scientists were rewarded for killing bad drugs or bad programs/targets rather than simply for meeting arbitrary numbers. Everyone talks about reducing attrition rates, but I don't see it happening until there is a fundamental shift in overall corporate attitude.

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