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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: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

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April 7, 2011

What's Really Killing Pharma

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Posted by Derek

Update: link fixed!

Anthony Nicholls over at OpenEye really unburdens himself here, in a post that I recommend to anyone in the business (or anyone who wants to see what some of our problems are). Some highlights:

I have come to believe (and I admit that this is only a theory) that as more and more of pharma’s budget was funneled into advertising and direct marketing to both the general public and to doctors themselves, the path to the top in pharma ceased to be via the lab bench and instead was by way of Madison Avenue. . .

. . .I want to end with one of my favorite management insanities- the push within big pharma to remake themselves in the image of biotechs—the reasoning being that biotechs “get things done” and are more productive. Leaving aside the fact that over its history, biotech as a whole has mostly lost money (with only two years of profit in the last twenty-five), I wonder if it occurs to upper management that the principal difference between big pharma and biotech is simply much less upper management. If they are truly serious about making pharma like biotech, then upper management should simply resign. I’m confident that one step would do wonders for innovation.

There's a lot of good stuff in there, on management fads, dealing with the scientific staff, bean-counting, and more. Regular readers of this blog (and its comments section) will find a lot of their opinions reflected, for sure. . .

Comments (88) + TrackBacks (0) | Category: Business and Markets | Drug Industry History


COMMENTS

1. FormerWindPharmer on April 7, 2011 1:30 PM writes...

This is simply the best precis of the pharma industry as it stands today that I have ever read! He mentions the GSK CEO Witty a few times. The problem there is not that Witty is a bad CEO, I think he's quite good, rather it's the guys he inherited who run R&D, namely Vallance & Slaoui. As many have said on this forum, these guys are a catastrophic mix of arrogance and ignorance and when Witty wises up to them, it will be too late!

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2. -=GimP=- on April 7, 2011 1:37 PM writes...

This is one of the most honest pieces I have read in months and manages to include half a dozen REAL reasons why Pharma is failing. Required reading and I hope the author keeps his promise to follow up on Outsourcing.

DEREK: such pieces are your forte...?

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3. Agilist on April 7, 2011 1:41 PM writes...

Dear FormerWindPharmer, the usual clatrap cheer-leading those who like to blame pharma woes on "fads". Sorry you lost your job at GSK but don't blame Patrick & Moncef for your situation, perhaps you would have benefitted from some six sigma training yourself. As for Moncef's and Patrick's competence: each of them has probably forgotten more about drug discovery than you, or all the other contributors to this forum, will ever know!

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4. Nick K on April 7, 2011 2:10 PM writes...

Agilist: How many successful drugs have Slaoui and Vallance discovered? I'm genuinely curious to know.

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5. Brett on April 7, 2011 2:12 PM writes...

Good essay. That said, if the Pharma Business were more like Hollywood, you'd have about a million lawsuits a year, and your firms would be loaded with attorneys.

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6. Anonymous on April 7, 2011 2:13 PM writes...

With regards to the marketing aspect of pharma taking over, if you search on any job hunting website you will find that the pharma sales positions outnumber scientist positions by a huge number.

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7. HelicalZz on April 7, 2011 2:14 PM writes...

Really? He doesn't even understand the role of a CEO for a large public company, which is more about external relationships and capital allocation than operations, which is a COO or Presidents focus. Nice to have a 'theory', but whether big pharma changed its R&D vs. SG&A ratios isn't all that hard to come by.

Yeah, it is annoying when pharma wants to 'be more like biotech'. But circularly, since pharma has long been profitable, and biotech only recently so, isn't that an argument for the benefits of 'more' upper management. I don't quite get the 'don't be that way, but here's how' point. Pharma likes biotech because it does two things, 1) it allows them to capitalize (rather than expense) R&D via acquisition, and 2) it allows them to diversify R&D risk. Maybe one problem with pharma is too many scientists that don't appreciate business fundamentals.

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8. BixBoy on April 7, 2011 2:21 PM writes...

Derek, really fine piece you've highlighted to us all! The part about IT and how it's dealt with at Big Pharma has real resonance for me. The IT function at most big pharma is considered a consumable like electricity and has suffered particularly badly from outsourcing. It is also run by the very worst examples of empty suits who excel in the very "fads" (Agile, six and lean sigma, ad nauseum) that Anthony Nichols rightly decries. We now also have to suffer a lot of windbags talking about open innovation and the "Pistoia Alliance". This amounts to said Windbags trying to claim credit for work done at the NCBI, EBI, etc, etc. This scenario is true across big pharma.

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9. Gippy on April 7, 2011 2:22 PM writes...

Whats really killing Pharma?
Whats really killing Manufacturing?
Whats really killing Energy?
Whats really killing EVERYTHING PERTAINING TO A PHYSICAL ECONOMY?

Answer: The Financial Parasites as Usual

Go examine the owners of the Federal Reserve system and examine the last names of the individuals. Takes about an hour.

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10. CancerBio on April 7, 2011 2:22 PM writes...

"Define the vision, get and keep the right people..."
I could not agree more. I've heard on more occasion than one of research department heads/directors having to cut good talent because of bad management decisions. These companies are too top heavy (non-scientific MBAs). I've since divested my large-cap pharmaceutical investments; I don't see how these companies will stay at the top if they don't have good science pushing them up.

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11. Tt on April 7, 2011 2:24 PM writes...

Dearest "agilist",
You are, hands down, then funniest troll on this blog. Keep up the funny commentary.

As for the post, it is excellent. I'm an employee of big pharma and will definitely concur that all of the described maladies exist. For example, while six sigma works great in a factory, it stinks at discovery. Please let me know when someone discovers a drug because of some shiny new management wonder tool. The most productive teams I've observed are the ones where management is hands off due to disinterest. My philosophy is to just keep good results quiet until I have it developed to the point where it's more difficult for management to mess up. Personally, I'm fed up with the whole business as described by Nicholls and will jump ship the first chance I get. I know that I'm not the only big pharma grunt who feels this way, so expect the talent drain out of big pharma to continue.

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12. Agilist on April 7, 2011 2:27 PM writes...

Well said HelicalZz! As for how many drugs did X or Y discover? An absurd question: How many applications did Bill Gates write? Drug development, like software development, is a TEAM effort and Patrick and Moncef are team players! As for their scientific expertise, check out "Patrick Vallance" on PubMed!

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13. Hap on April 7, 2011 2:29 PM writes...

4: I don't know, but they seem to have found the secret to making 3/4 of a billion dollars disappear. If that isn't a drug, it certainly stimulates the desire for some, at least among their company's investors, and the laid-off.

8: Has biotech become recently profitable (other than through buyouts from big pharma)? Second, how does buying biotech allow you to diversify risk? You can do lots more research as a company than as many biotechs - you have the infrastructure and experience in particular areas that no small biotech is likely to have, and the so the money you spend on internal R+D goes to R+D, not building up the same (or rather, smaller and less effective versions) infrastructure lots of times. Biotech allows you to work your people harder, with less expectation of security, and thus enhances your productivity, but that gravy train probably won't last - at some point, people will see the writing on the wall and leave to find careers where they can actually do something besides work (if, of course, they ever do exist). The ability to put R+D in a different column helps the accountants, and maybe to con your investors, but if it doesn't help you get more drugs (which wouldn't be something small pharma is that good at doing), then it seems counterproductive.

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14. Gippy on April 7, 2011 2:32 PM writes...

Pharma likes Biotech because The Stupid Taxpayer subsidizes Biotech. Just another socialize losses, privatize profits scheme.

You scientists suffer from extreme myopia. According to you geniuses, every industry besides the fantastic Financial "Industry" in this so-called nation is filled with incompetents at the level of management. What a coincidence, huh?

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15. JeffC on April 7, 2011 2:40 PM writes...

Agilist. Man you are funny. Prior to joining GSK, Paddy had 6 months at Wellcome working on NOS inhibitors that didn't work. That's it. He came to GSK from an academic position at UCL with no expertise in drug discovery. Which is exactly why he's so far out of his depth. Oh and Bill Gates actually started Microsoft by writing code for BASIC which eventually led to MS-DOS. So even though I'm not a fan of his software, the guy did actually write it. Vallance has never ever discovered a preclinical candidate let alone a drug. GSK doesn't have too many people left who have discovered drugs. Even the entire team who invented Tykerb left long ago. Anthony Nicholls's piece is pretty much stop on sadly.

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16. zendudest on April 7, 2011 2:46 PM writes...

Agilist wrote: " As for their scientific expertise, check out "Patrick Vallance" on PubMed!"

I did--I find 231 papers and an H-number of 69...not bad but not exceptional--more of less what you would expect of a Full Professor at any first-rate Department of Pharmacology. Some nice papers in Lancet and Circulation but I don't see any from the 'big three' (Science, Nature, Cell).

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17. Nick K on April 7, 2011 2:52 PM writes...

Agilist: Just to repeat my question: in how many clinical candidates (successful or otherwise) have Vallance and Slaoui participated? All I want is a straight answer, which you've failed to give.

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18. BixBoy on April 7, 2011 3:03 PM writes...

Don't hold your breath, Nick K.

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19. Hap on April 7, 2011 3:05 PM writes...

I thought that lots of people in drug development hadn't come up with clinical candidates, though - is V/S's clinical candidate count a reasonable measure of their scientific expertise?

At what point does management in pharma actually become responsible for drug company outcomes? If the answer is "never", well, that might be part of the problem.

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20. DrSnowboard on April 7, 2011 3:22 PM writes...

Agilist: thanks for making me laugh out loud..really

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21. Nick K on April 7, 2011 3:25 PM writes...

Hap: All I want from Agilist is some evidence for his assertion that Vallance and Slaoui have "forgotten more about drug discovery than any of the contributors to this blog will ever know". And, to answer Bixboy, I'm not holding my breath.

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22. Hap on April 7, 2011 3:51 PM writes...

I'm not thinking that either the justification of the assertion or a straight answer is going to happen. I'd just prefer to nail them for the right reasons.

What's with the GSK puppets? Does GSK just inspire such loyalty from their employees or trolls, or does it have the most thin-skinned management or self-destructive PR department in recent memory? If they ever hire again, maybe they'll use the puppets in an ad campaign: "If we can inspire trolls such as these, just imagine how we inspire our employees."

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23. MolecularGeek on April 7, 2011 3:56 PM writes...

Agreed, the original post is spot on. The more problematic question is "Who in a position to fix things will read it?"

And Gippy (#14), actually most of us would say that financial industry is filled with incompetents as well (I suspect). A successful, well-run industry shouldn't need a government-funded bailout to avoid crashing the national economy from their liquidity crunch. When the financial gurus come up with a rational scheme for assigning present value to high risk ventures that doesn't reduce to "stop selling drugs and start selling hamburgers" maybe things will improve. I'm not holding my breath, though.

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24. MolecularGeek on April 7, 2011 3:58 PM writes...

Agreed, the original post is spot on. The more problematic question is "Who in a position to fix things will read it?"

And Gippy (#14), actually most of us would say that financial industry is filled with incompetents as well (I suspect). A successful, well-run industry shouldn't need a government-funded bailout to avoid crashing the national economy from their liquidity crunch. When the financial gurus come up with a rational scheme for assigning present value to high risk ventures that doesn't reduce to "stop selling drugs and start selling hamburgers" maybe things will improve. I'm not holding my breath, though.

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25. johnD on April 7, 2011 4:00 PM writes...

JeffC

Uh, sorry, but while Bill Gates and Paul Allen did write a BASIC OS for the Altair computer, they bought DOS from another Seattle Company. They didn't write it, but can claim to refine it and market it to IBM. But, they clearly did know what they were doing in relation to computer OS's.

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26. Beckenham on April 7, 2011 4:00 PM writes...

Senior management at GSK is certainly thin-skinned. Some years ago, one manager brave (or foolhardy) enough to argue in a reasonable and measured manner with Slaoui was told afterwards by her VP that her days were numbered. And, guess what, she was promptly given the package!

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27. MolecularGeek on April 7, 2011 4:01 PM writes...

Agreed, the original post is spot on. The more problematic question is "Who in a position to fix things will read it?"

And Gippy (#14), actually most of us would say that financial industry is filled with incompetents as well (I suspect). A successful, well-run industry shouldn't need a government-funded bailout to avoid crashing the national economy from their liquidity crunch. When the financial gurus come up with a rational scheme for assigning present value to high risk ventures that doesn't reduce to "stop selling drugs and start selling hamburgers" maybe things will improve. I'm not holding my breath, though.

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28. pete on April 7, 2011 5:04 PM writes...

Great read -- my heart beat a little faster in assent.

One remark regarding the article: While I'd agree that ridiculous oceans of cash were spent targeting protein kinases, I really can't be so quick to dismiss the enterprise. It's yielded compounds that are clinically valuable -- and others whose clinical value may grow as we figure out how to administer them more selectively.

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29. Doug on April 7, 2011 5:05 PM writes...

'f they are truly serious about making pharma like biotech, then upper management should simply resign. I’m confident that one step would do wonders for innovation.'

This dude is channeling Dilbert's last couple of days 'dead boss hand puppet' bit...

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30. pete on April 7, 2011 5:07 PM writes...

Great read -- my heart beat a little faster in assent.

One remark regarding the article: While I'd agree that ridiculous oceans of cash were spent targeting protein kinases, I really can't be so quick to dismiss the enterprise. It's yielded compounds that are clinically valuable -- and others whose clinical value may grow as we figure out how to administer them more selectively (i.e, avoid systemic dosing).

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31. Rick on April 7, 2011 5:33 PM writes...

There is so much to chew on in this article! No one has mentioned Nicholls' discussion of the negative impact of the Bayh Dole act on biomedical innovation. BD was intended to boost innovation by providing new financial incentives to academic researchers, but it ended up turning academic tech transfer offices into profit centers and creating new barriers to communication within and between the academic and inustry research communities. I'm not saying that BD is responsible for everything bad that happened, far from it, but it does provide many valuable lessons in how switching from a product focus (where profits follow) to a profit focus (where products follow) had the unintended consequence of damaging drug discovery productivity.

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32. Anonymous on April 7, 2011 8:53 PM writes...

It's pretty good article. But still, big pharma R&D (even in the glory days) didn't always crank out winners.

Still need a good sales team to polish some turds and maintain cash flow.

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33. luvyurnmr on April 7, 2011 9:34 PM writes...

Oh, Wow! I'm so glad someone finally said it. I'm not surprised it was Anthony Nicholls.
ROCS rocks!

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34. chris on April 8, 2011 1:37 AM writes...

Anthony Nicholls offers an insightful analysis which will make interesting reading for everyone in the Pharma industry.
I know a number of senior management regularly read "In the Pipeline" and I suspect this entry will be uncomfortable reading but unfortunately will be forgotten by tomorrow.

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35. Still Scared of Dinosaurs on April 8, 2011 6:56 AM writes...

As someone who spends a lot of time sloggng through Phase 3 trials thinking "Why the F are we doing this?" I have to wonder how much drug discovery one stupid decision in the design or management of a big trial costs.

Of course Phase 3 is when upper management takes ongoing interest in development so maybe there's a connection. In addition to too much upper management in bigger corporations I feel that there is a huge difference between development in companies that do vs. do not have products already on the market. Once a company starts marketing the amount of "we gotta do it this way because of the market" crap goes way up, often to the detriment of figuring out how to best use the drug.

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36. anonymous on April 8, 2011 7:04 AM writes...

A major problem is that Pharma puts way too much emphasis on team work. Individual rewards and competition between co-workers is seen as a bad thing and it actually what Pharma needs.

Team work "corporate values" are simply introduced to cover lazy and incompetent people.

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37. Pete on April 8, 2011 7:27 AM writes...

This is an exceptionally fine rant from Ant! I have heard coordinating Pharma R&D likened to steering an oil tanker.

R&D Management (originally trained as scientists) are not blameless in Pharma's death by a thousand cuts as they pursue measurability at the cost of relevance. The imposition of manufacturing models on the process of Drug Discovery in the complete absence of evidence of tangible benefits is another area of concern. I would tolerate some inefficiency in Discovery if it meant a better validated target and a relevant disease model.

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38. AR on April 8, 2011 8:58 AM writes...

Anonymous #36
I've first hand witnessed the use of competition metrics between employees. It didn't work out so well, at least not within a large biological assay group. What happened was the employee 'competitors' tended to keep troubleshooting methods secret, tended to hog instruments, focused on meeting management metrics instead of drug science which doesn't metric well, and, of course, the found the blame game useful.

Perhaps these issues could have been resolved, but, unfortunately, the program was initiated just before R&D downsizing. There was no apparent correlation of which 'competitors'were let go and which were retained, except the ratio of those let go tended to favor the over 50 year old PhD possessing years of experience. Natch.

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39. Cellbio on April 8, 2011 9:16 AM writes...

Agree with AR. I worked in a first rate company with incredible teamwork that all changed when it was claimed we did not weed out poor performers or reward excellence. This move coincided with McKinsey's war for talent non-sense and the "love-everything-about-Jack-Welch" era. The company has failed ever since, even with billions to spend. And as AR pointed to, it got real ugly around lay-off time. Came down to being a good political operator, not good scientist. The correlation that was obvious was those that agreed with the bosses above were retained.

The competition is unmet medical need, not the chemist or biologist down the hall. Go see if you can help them.

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40. chris on April 8, 2011 9:47 AM writes...

I agree with AR and Cellbio there is no need to try and build competition between colleagues, the challenges are so great that you need the best input from multiple scientists to hope to succeed. I've never met a chemist who didn't hope that the compound they made would be the next development candidate but they all recognise that they are building on the work of others.

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41. partial agonist on April 8, 2011 9:51 AM writes...

Back when I was in big pharma, I remember the first time I rolled my eyes (we all did) at overmanagement. They held a big videoconference, with most of us at our site in a large auditorium, without any advance discussion about what was the reason for the videoconference.

It turned out that they were rolling out our company's two or three sentence "mission statement" which apparently the big shots in suits had been having countless meetings for months, if not years, flying all ove the world from place to place and haggling over every single word and punctuation mark.

In the end it was just a bunch of classic management gobblydegook: "...we will use cutting edge technologies to address unmet medical needs..." blah blah blah.

To think that they had wasted so much time, effort, energy, and dollars on such a stupid little thing was maddening to all of the scientists. But I'm sure that the suits were happy with it and gave themseleves nice raises.

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42. RB Woodweird on April 8, 2011 10:43 AM writes...

1. Re the suggestion that a chemist would be better off if they paid more attention to six sigma instead of bellyaching: You have to understand that the principles of things like six sigma are part of a scientist's everyday thinking. It is painful and insulting to a scientist when some suit comes into their place of employment and says Good news, everyone! We're all going to learn how to measure stuff and do stuff based on those measurements! Group hug!

2. Don't bring Gates into this discussion. Here would be drug distribution and discovery under a Microsoft version of pharma: Microsoft comes out with a statin, lets CVS sell it at a nice low profitable cost, say $10 with the provision that Microsoft gets paid $10 every time CVS sells any statin. Pfizer comes along with a new statin of their own, but CVS won't sell it because they will have to pay Microsoft $10 per sale on top of whatever Pfizer charges. Plus, if CVS sells Pfizer statins, that might make Microsoft mad. Microsoft might increase the price to CVS and drop the price they charge Walgreens. So no new statins come onto the market.

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43. MoMo on April 8, 2011 12:18 PM writes...

Gates already has had his hands in Pharma funding the Medicines for Malaria Venture among others and recently with Nimbus and both have done substantial work, hiring only the best/experienced scientists with nary a policy wonk/MBA/lawyer/sales or clueless exec among them.

He may be cut-throat in the software business but he certainly keeps the best and brightest employed, unlike the Big Pharma model. I wish he could invest more of his time into this problem.

Bill Gates , If you are reading this, show us a sign, any sign, that you can help the World in the drug discovery sector. We will all be waiting anxiously..... to get back to work.

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44. GreedyCynicalSelfInterested on April 8, 2011 1:50 PM writes...

Go easy on Agilist, he's just trying to keep his job at BigPharma. Upper management reads these blogs and Agilist just needs to make his quota of b@ll licking this week. That's the secret to career success in this day and age. It's what they need to teach you in graduate school.

Management needs to hire productive workers so some of them can take credit for the success of the scientists. It's easier to take credit for someone else's acheivement if that person is not around to contradict your story, so they have to be shown the door sometime. Then, just hire a fresh 20-something overacheiver and repeat the process until you are VP or CEO. It's all politics and politics is theatre. Just recycle the script over and over, but change the actors and settings. It's like when Hollywood makes movies or sitcoms.

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45. Favin on April 8, 2011 4:29 PM writes...

@44 said "Bill Gates , If you are reading this, show us a sign, any sign, that you can help the World in the drug discovery sector. We will all be waiting anxiously..... to get back to work. "


Bill Gates is an incompetent that hinders the progress of his own field. He uses oligarch type business practices and good old "General Electric" style DC lobbying to hinder the development of any competitors in his business.

No competitors = lame products (easily verifiable for Microsoft).

Ever wonder why Apple is his only real competitor given the barrier to entry is relatively low in programming?

It's like there were only two automobile companies. There's at least one PC in almost every home for God's sake!

Bill Gates = plutocrat.

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46. Anon345 on April 8, 2011 5:10 PM writes...

Most "entrepreneurial" biotechs are run by R&D CEOs. I'd venture to say that biotechs have done an even worse job than pharma in doing what this industry is meant to do - get drugs to the market and to patients. What makes a successful CEO does not have anything to do with whether he is a business or R&D guy. It has to do with his / her own intrinsic abilities and the abilities of those in his organization.

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47. Drug_hunter on April 8, 2011 9:28 PM writes...

I guess I'm off the reservation again. There is nothing new in this rant. And, it misses the point that we are bad at discovering drugs because we are idiots about drug design. We don't know what we're doing. We don't understand disease biology. Or formulations. Or binding. Or PK. We are working on really hard targets without understanding one percent of what we need to know. And we use horrible processes. Of course management makes it worse with all their stupidity. But the fundamental problem is our scientific ignorance. It is easier for all of us to blame our bosses, and we have plenty to bitch about, but if we knew what we were doing we would be in a completely different place.

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48. Timer on April 8, 2011 11:18 PM writes...

The original captures a lot of what many today want to claim as the industry's ills. Unfortunately, it also gives opportunistic snapshots of pharma's "glory years". And what defined those successful times? New drugs which produced more income, more profits, more salaries, more bonuses, more jobs, larger companies, bigger R&D, all leading to even greater expectations all around that it would continue ad infinitum. And so, where does the fault really lie and what industry or technical apparatus has ever been able to maintain the great, glory times indefinitely? Steel? Railroads? Radio? Long playing records?

Unfortunately, those who do not properly look and learn from the past will ignore or selectively present history in coming up with any convenient conclusion; not unlike much of the country's current political climate via the Tea Party. Nothing new here either as thoughts and trend merge in time and space.

Yet, looking back, there have always been mergers, buy-outs in the drug industry. Companies with names like Burroughs-Welcome, Schering-Plough, Smith,Kline & French, and "new" represnetations such as Glaxo & later Novartis, amongst others. Mergers, buy-outs, aquisitions, combinations are not new; they have not originated only since the slow down of new-drug approvals; they are not the cause unto themselves for industry's woes.

Then there are the past leaders of major Pharma; history does not indicate that all were headed by Roy Vageles (as clever and talented as he indeed could be); in fact, only one was! Many came from marketing or business backgrounds, typically rising through the ranks of a company, not being hired from other industry or without some historical expertise within the industry. Another easy excuse for today's problems when being selective in the re-telling of history, but not proven to be a big exception to previous generational patterns. Good leadership is essential, but that has not changed over the decades. And let's put it out there: certainly some of these company's heads were not well considered then, either.

Together, these and other patterns, are symptoms of the times, not necessarily the ultimate cause of the industry's changing landscape. It's now time to recognize the issues for what they a really are: different diseases (not just another treatment for blood pressure), higher costs due to need for integration of the newest technologies, greater safety expectations (with good reason in many cases), actual need for demonstration of a true and valued positive clinical outcome (not simply to "physician, do no harm"), true accountability to the end-patient.

Yes, it is a difficult time for many, but the world changes, industry's evolve, problems move, scientific advancements for betterment of human health have become more challenging. Full-stop.

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49. Gambler on April 9, 2011 4:26 AM writes...

Agreed #48. If I hear one more time about how much better everything was in the good old days, I may retch. Times are different, drug discovery is more difficult, and big pharma significantly overextended itself, betting that the good times would last. Unfortunately, Anthony Nicholls is spot on when he diagnoses management's response to these issues. Rather than a steady hand at the tiller, we've had fundamental strategy rethinks every 6-12 months. The time has long passed to focus what remains of the R&D organizations on key areas of unmet need, and get out of the way as much as possible. Incentivize true innovation with longer term incentives tied to clinical outcome (i.e. like Hollywood residual payments), rather than micromanaging organizational design and bench time.

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50. Anonymous on April 9, 2011 5:10 AM writes...

Tittyfucking Christ

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51. TJM on April 9, 2011 8:39 AM writes...

#48 - Well said. There are many who lament their situation, few that recognize their share of the cause and act. Those that stop too often to complain have given up on their own creativity. The key is to keep striving, to keep challenging the problems Discovery, Development and bringing sorely needed relief to patients.

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52. Schmerk on April 9, 2011 9:34 AM writes...

I am surprise that Anthony Nicholls did not spend a paragraph analyzing the fall of Merck. It is a drug company which turned away from science and follows the Wall Street bozos. There is no way that pharma is a growth industry. It is not like putting the chips and camera together and you got an iPhone. We cannot even predict if the candidate would work in human. When the Merck bozos cannot satisfy the Wall Street bozos, the try to turn drug discovery into a sweat shop. Six Sigmas, metrics, cost cutting, process driven research, realignment, outsourcing, licensing, mega merger... whatever they think would make Wall Street happy so that they could pocket the gain in stock price.

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53. Rick on April 9, 2011 10:56 AM writes...

Gambler #49, I don't know if it was intentional, but saying "drug discovery is more difficult", offers us a "get out of jail free" card that I don't think we deserve and it is quite an insult to the hard work and brilliance of those who preceded today's titans of industry. We supposedly have all these wondrous tools that weren't available in yesteryear. And, we have been told, those tools will offset any incremental difficulty in the targets, mechanisms, PK, etc. Right?

I think Drug_Hunter (#47) raises an important point: IF the work seems to have gotten harder, perhaps it's partly because we got stupider. Our infatuation with "disruptive innovation" and shiny new (yet unproven) technologies and gadgets, coupled with an irrational headlong rush to abandon older approaches, despite no good evidence that they had lost their power, made us idiots. As one pointed example, I have actually heard people say "You can't discover a drug if you don't know the target." As my teenaged kids would say, "DUH!!!" We essentially thought that drug discovery problems would tremble and fall before the awesome (perceived)power of our cute new tools and mere thinking and hard work would be a thing of the past. Well, nature doesn't read Nature (or Science or Cell...) and didn't get the memo that she was supposed to drop new drugs on us like manna from heaven, as we seem to have expected.

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54. Anonymous on April 9, 2011 11:41 AM writes...

Reason for pharma's troubles??
Pfizer.

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55. Timer on April 9, 2011 12:58 PM writes...

Thanks Rick 53. Whenever hearing that "drug discovery has become harder", I have to bristle and object. All of today's fancy tool kits should make it more logical, more direct for the intellectual scientist, incluing databases, multiple modes of modeling, structural analyses, high throughput screening robotics, combinatorial synthetic methods & libraries, genomic analysis, mutational analyses, expression systems, knockout animals, preclinical ADME and PK screening methods....So why is it so much harder? Did the "scientist from the past" think it was a cake walk?

The one thing most missing, though, are good, predictable preclinical markers and models to human disease conditions that actually count clinically. There is no reason for an in depth analysis of what befell one company's (eg Merck's) R&D history.....as at the time they did a couple of things very well. One was picking therapeutic areas where there were good preclinical biomarkers (eg cholesterol, statins) and in vivo response (blood pressure, ACE inhibitors and receptor antagonists), even though details of the stories (eg HDL / LDL, concentration of statins in liver due to transporters) were still years in the making. The second was a commitment to the area and target, even after an initial development candidate was progressed, in contrast to other companies both then and now who stop work after a first dose to man milestone had been achieved with a single lead compound to move onto the next newest and greatest unproven concept (a company where I had been). Yes, problems today are encapsulated in both these details, most notably that diseases of high need, much focus (dementia of all various diagnoses, cancers, etc) have poor predictive biomarkers and animal models to real human endpoints, so the clinical risks become higher even as costs in testing for safety and efficacy also grow despite all the new, fancy, expensive, fun and sometimes distracting tools at our collective disposal, both in discovery and in development. X-ray structures of a compound bound to a target can make a great story and generate exciting hypotheses for new compounds to be synthesized. It has yet been shown to be useful in providing bioavailability, predicting brain penetration, decreasing genotox risk; in other words, ultimately making a hypothetical compound into a drug.

Yes, management can make things harder, presenting more reviews, insisting on extra paperwork and overhead. But someone must mind the financial store, as resources will always have a limit, as even here too, was done during the "great, old-time golden years of yore". Let's not pretend otherwise.


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56. Sili on April 9, 2011 4:49 PM writes...

and I admit that this is only a theory
Hypothesis! Permalink to Comment

57. Anon345 on April 9, 2011 9:35 PM writes...

So who runs Intel? An ex-sales guy. Who runs Cisco? An ex-sales guy. Who runs Oracle? An ex-sales guy. I could go on but you hopefully get the message.

Maybe the crux of the problem is that science has not made sufficient advances (despite all they hype created by "R&D" folks) to warrant getter better and more drugs to the market than in the "glory days"? The head of R&D at the likes of Pfizer, Merck, etc should be held more responsible for the mess that their companies have become than the CEOs.

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58. Past Retired on April 9, 2011 9:45 PM writes...

With ANY human endeavor, the biggest problems have always been, are always, and will forever be the fault of management.

Any organization, if it is to be optimally successful, must find a way to use the absolute minimum amount of management necessary to maintain order and productivity. Every tiny bit of excess management eats away at success.

Pile on enough management, and failure is a certainty.

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59. Cellbio on April 9, 2011 10:06 PM writes...

Timer, I think you make a coherent case for why drug discovery is harder today. The examples you cite, and others that come in the early days of biotech, simple replacement therapy for endogenous proteins, count as success in the glory days, and did serve markets, so what becomes left to attack is more difficult disease, that if we look closely, had been worked on prior to our wonder tools. I also agree that lack of persistence in an area erodes expertise and has people turn away from the challenges they see clearly to the promise of new fields or approaches where the challenges are not known and therefore may be even more difficult than the current direction.

I think the whole fail fast fad fueled a culture that ran away from known difficulties to run with the next big promise. Sometimes you have to cut your losses, but you also need a culture and leadership that is seasoned and knows the value of persistence.

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60. Timer on April 9, 2011 11:31 PM writes...

Anon 345: While the comparison of Pharma to the collective of computer, chip, and software "techs" is an easy jump to make, & one that on the surface seems to be a good fit, the R&D activities, the business models, the generational evolutions are quite different in many important ways. A bad chip design may simply not sell, or may lose money for the company. A bad drug can harm people. Also, in development of new software, computers, chips, cute toys (eg, like the i-pad--and it is cute) there is no level of scrutiny, review and need for legal marketing approval the equivalent of FDA or European Regulatory. Drug R&D carries this much greater burden of responsibility, need for expertise, and increasingly public set of "ethical" expectations to uphold. A number of years ago one of the big Pharma made a large effort to evolve its R&D to be in the image of computer tech; the fit was bad, with the results from this ill-founded experiment a huge set-back for the company long into later years. Unfortunately, companies (including this particular one) now are trying many of the same approaches again, with the outcome to be predictably the same. Further example of history's learnings that are lost as company's "desperation" sets in.

Cellbio: A trap, a falacy, in the availability of so much of today's new technology that "must" be applied to every R&D problem is that it can be a distraction, can provide "apparent data overload", but in real terms contributes little actual understanding and advancement. Does that make today's research problems harder? Perhaps, but it's then a human creation, not all based on the problems themselves.

One key, that seldom is discussed and applied is strong questioning on true vs perceived added-value of our fancy technical advances. If it isn't really going to help solve the problem, then what is the value of spending the time, energy and money with the new glitz. Generation of a pretty picture? Make a video that can be used for show & tell at a research meeting, or national conference? Yes, it can be fun and attention getting bling. But it can also be distracting for gaining insight and making real scientific progress, representing nothing more than limited "one trick ponies". The inclusion of our latest fancy tools and techincal gimics are increasingly applied, often upon insistence of upper managers who want to drive the R&D bus. And yet, there still is no proven substitute for clever, dedicated, committed insightful folks with ongoing enthusiasm who are willing to dig hard in the trenches.

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61. Nick K on April 10, 2011 6:25 AM writes...

To echo #60, perhaps all the flashy new tools and techniques have actually been deleterious to real drug discovery as they have lured people into thinking they knew more about diseases than they really did. We should go back to a more pragmatic, empirical approach based on animal models, and only worry about mechanisms and the like after the candidate has been nominated.

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62. Rick on April 10, 2011 8:41 AM writes...

Nick and Timer (#60 and 61), You hit on the crux of the matter, IMO.

In my discussions (formal and otherwise) with the new-ish breed of biotech leaders, who generally have no/weak scientific skills, but heavy finance/MBA training - be they senior executives, VCs or investment bank biotech/pharma stock analysis - there's one thing none of them get: what you mean when you say "the availability of so much of today's new technology... contributes little actual understanding and advancement." and "the flashy new tools and techniques have actually been deleterious to real drug discovery ". In the finance/MBA world, the utmost important thing is making money and these new tools generally made lots of money in licensing fees and M&A, ergo they were successful. To say these tools "contributed little to advancement" or were "deleterious to real drug discovery" is utter nonsense in this view. The usual reply, to me at least, has been something along the lines of, "Of course, we HAVE to put making money first, because you can't discover drugs without money, so just live with it for now." In the chicken-and-egg argument over whether profits or products should come first, today's biotech/pharma say it's profit before products.

By the way, this purely monetized view of the purpose of biotech/pharma, wherein profit is the product, is also why people use such large figures for the cost of capital part of the cost of drug development. Strictly in terms of monetary profit, cost of capital estimates that assume a pharmaceutical company could use its capital like a financial services company without losing its identity make perfect sense, because the nature of the product is unimportant as long as the company maximizes its profit.

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63. Cellbio on April 10, 2011 8:59 AM writes...

Timer, I agree with you. I have seen whole teams, hell most of R and preclinical, trapped in the belief that if attributes are measured, then this army of folks is doing drug discovery. Molecule made, IC50 measured, clogP determined, PK known, etc etc etc. Then whole teams prepare powerpoint slides in a predetermined format and sequence to present at a portal where review boards make their measurements of projects and determine what goes forward. I get that this is a trap and this is why I left big to work in smallcos.

However, I do think prior success in our industry makes continued success at previous rates more difficult. Psoriasis and RA are two diseases that are fairly well served at this point. Certainly in RA there is more to do, but the success of anti-TNF agents in RA, and anti-p40 agents in Pso create a higher demand for clinical performance of new entrants. In the case of Pso, I'd argue there is no path forward. These are the man made problems we want, but prior success does change our landscape. That is the point I thought you also described referring to old school efforts with predictive animal models and ready "biomarkers" like cholesterol and BP.

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64. Cellbio on April 10, 2011 9:24 AM writes...

Forgot to add my comment to Nick. I think the empirical approach is the way to go, but animal models do not serve the purpose. They fail in oncology, inflammation, and I guess, viewing from afar, they also fail in neuroscience and I have seen epic failures in metabolic disease. They may have utility somewhere, but I'd bet these include the areas well served by 1960s tissue bath drug discovery efforts like vascular tone.

For the ones I know better, oncology and inflammation, the models have a wholly different dynamic nature than human disease, often quite synchronized and driven in 'clonal' way when cells are a driving force. With the synchronization, most any manner of poisoning the system looks like efficacy. Seen many responses disappear when a simple thing like IP dosing by less experienced techs is replaced with oral gavage. These variables can be controlled to some extent, but indicate the sensitive nature of models that makes curing rodents much easier than effectively treating patients.

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65. timer on April 10, 2011 10:39 AM writes...

Thanks Rick and Cellbio.

Not trying to say the today's R&D problems are not challenging, but find it increasingly silly to excuse today's world's woes across the industry simply as being "harder". Researchers in the past worked within their own limited spheres of knowledge, making their work at the time also "hard". And with all of today's fancy, glitzy tools, shouldn't it actually be easier than in the past? False-god-idol substitutes for real insight or useful hypothesis that can be tested experimentally? Too often, folks continue to do what they can even if it does not, cannot, will not be be able to answer the key questions. But they continue on, because it's easier to stay on the same course and they can get away with it.

Agree with Rick comments on today's compulsive need for valuation to be derived on every step, idea, concept, process. But is the industry better at these than in the past? Is there true value added by playing this part of the business game? At the time of launch, Tagamet peak sales were predicted to be $50 million; it became the world's first billion dollar molecule (sorry Vertex), and resulted in total transformation of medical care at the time. Factual, historical, Nobel Prize stuff! Compare that to the recent HPV vaccines, both having been predicted to be multi-billion dollars cash-cow -- ultimate misjudgement. And, to those today who are in-charge, but have no experience in the scientific and experimental "doing" part...look no further than another recent posting by Derek on the upcoming departure at GSK. A guy who can easily be today's poster-child for selling concept and promise toward "creation of value" (show me the money!), lauded by many for showing a vision of transformational leadership to drive what is needed for different drug R&D efforts. OK, I'll bite, when actually seeing him stay with something long enough see the approval of actual transformational drugs, not simply moving from one gig to another to keep "one step ahead of the revenuers" in avoidance of true accountability.

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66. Nick K on April 10, 2011 11:00 AM writes...

#64 Cellbio: Fair comment, and I take your point about animal models. What I'm trying to say is that the current obsesion with new technologies and mechanistic approaches means that unpredictable, serendipitous drug discovery is becoming less and less likely.

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67. Anon345 on April 10, 2011 11:31 AM writes...

62. Rick:

You said...

"By the way, this purely monetized view of the purpose of biotech/pharma, wherein profit is the product, is also why people use such large figures for the cost of capital part of the cost of drug development. Strictly in terms of monetary profit, cost of capital estimates that assume a pharmaceutical company could use its capital like a financial services company without losing its identity make perfect sense, because the nature of the product is unimportant as long as the company maximizes its profit."

In response to the above...what is the genesis of a Biotech? In 99.999% of the cases a Biotech is financed by a VC Fund. Where does the VC Fund get capital from? From its Limited Partners. Why do the LPs give money to VC for? To generate returns. Where do returns come from? One sure shot way is to generate profits. So yes, if "INVESTORS" have bank-rolled your company then the #1 aim of that enterprise is to return the capital to the investors with a threshold return on capital. Otherwise, LPs won't participate in the Biotech industry in the future.

If you want to experience drug development without a singular focus on profits and / ore generating shareholder value (whether private or public) then you need to find organizations that do not rely on investors for their daily capital needs.

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68. Anon345 on April 10, 2011 11:37 AM writes...

#65. timer.

You said:

"And, to those today who are in-charge, but have no experience in the scientific and experimental "doing" part...look no further than another recent posting by Derek on the upcoming departure at GSK. A guy who can easily be today's poster-child for selling concept and promise toward "creation of value" (show me the money!), lauded by many for showing a vision of transformational leadership to drive what is needed for different drug R&D efforts. OK, I'll bite, when actually seeing him stay with something long enough see the approval of actual transformational drugs, not simply moving from one gig to another to keep "one step ahead of the revenuers" in avoidance of true accountability."


The guy's BIO reads...

"He earned his M.D. from Harvard Medical School and Ph.D. in genetics from Harvard University and he graduated with a B.A. summa cum laude and Phi Beta Kappa from Columbia University."

Certainly sounds like an R&D guy to me (a glorified one. maybe). Where is his finance / MBA type degree that is being dissed left right and center?

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69. Cellbio on April 10, 2011 11:45 AM writes...

Timer, love the image of today's transformative leaders staying one step ahead of the revenuers. Lived in a company where job rotation for predetermined "leaders" was the justification for rapid promotion. The cycles were 6 months. Just enough time to decry the current sad state of affairs, perform a magical transformation, and then run off before the train wreck became apparent.

Nick, I agree that the ability to measure more things more precisely coupled with simplistic mechanism models has supplanted the empirical approach, to the detriment of serendipity, without apparent gain in meaningful outcome. Try asking someone that is dutifully breaking down equilibrium binding constants to on rates and off rates, or a similar exercise driven by great new technology, how the team should use the data to improve the likelihood of success. The reply is either silence, they don't get it, or bluster, they get it and know they need to cover their ass.

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70. Rick on April 10, 2011 11:46 AM writes...

If we were in a room, I'd ask for a show of hands in response to the following 2 questions.

1. "How many of you have had a research program discontinued or not funded in the first place solely for one of the following reasons: 1, you don't know the molecular target; 2, your molecular target isn't genetically validated; 3, you don't have a high-throughput screen against a genetically validated target; 4, you don't have a combinatorial synthetic scheme for your hits; 5, modeling says your lead (pick one): is insoluble/too soluble, is not orally available, is a substrate/inhibitor for a major CYP, cannot be docked to the crystal structure of the target."

2. "How many of you have had a project proposal rejected because the risk adjusted NPV was not high enough?"

Close your eyes and imagine the result. Based on my experience, I expect that most, if not all, hands will be raised at some point. (I also envision octopusses in the audience to provide enough arms to raise, but that's my problem.)

As far as I know, these questions were rarely or never asked 25 years ago (in some cases, they couldn't have been) and drug discovery was far more productive and less costly than today. In the 25 years since, these questions have been routinely asked and, in my imaginary show of hands, resulted in many project discontinuations.

What does this suggest?

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71. Rick on April 10, 2011 11:59 AM writes...

Anon345 (#67),
I still believe that investors invest in some thing (i.e. a product) that they expect to produce a profit, whereas speculators put their money down on something because they expect money to come out the other end fast.

According to your logic, would a company that started out as a biotech, but abandoned research to become an online casket seller just to make money would count as a successful biotechnology investment? (Note: you can't make this up, it actually happened).

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72. Anon345 on April 10, 2011 12:13 PM writes...

Rick (#71)

Rick - No, I won't call it a successful biotech investment. A successful investment - possibly, depending on whether it generated requisite returns for the investor or not.

See, the crux of the problem here is a disconnect between what WE (people working in pharma / biotech) feel our mandate in life is and what THEY (the investors) want us to be doing. WE feel that the world around us should be altruistic. That we should given all the capital in the world necessary to discover and develop drugs. That it could take 10+ yrs for us to return money to our investors. That there should be no accountability cause after all discovery and development is inherently unpredictable. All well and good but here is the problem...let's say 2 entrepreneurs come and ask you 100 bucks each. One says 100 bucks is all he will ever need and in 3 years his company will be profitable and he will return 200 bucks to you. The other says every 2 years he will come back and ask you for 100 bucks more. In 10 years he will either return 800 bucks to you or 0. Who will you give your money to?

The above is a real issue. One that scares me when I think about the future of our industry. That's why at some point we do have think about or companies as businesses that need to play the part in corporate America. Else, do the alternative...join an academic lab and do unencumbered research.

And talking about business vs R&D leadership at biotechs...I have seen way too many of the latter where the VC backed biotechs have more members on their Scientific Advisory Board than full time employees. All the jazzy science that goes kapoot in a few years.

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73. Rick on April 10, 2011 12:54 PM writes...

Anon345 (#71),
Thanks for clarifying. Although I see your point, I think we have an important difference of opinion. I do NOT "feel that the world around us should be altruistic. That we should given all the capital in the world necessary to discover and develop drugs. That it could take 10+ yrs for us to return money to our investors. That there should be no accountability cause after all discovery and development is inherently unpredictable." I won't speak for anyone else here, but I suspect none of us hold that rigid, unrealistic point of view. But I'm willing to throw that question up to the group for responses: Do any of you share this premise?

Rather, I believe, as George Merck said in 1952, "We have always tried to remember that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been." In other words, we expect investors to invest in a product or product concept that will produce a reasonable profit. There is a potentially subtle, but crucially important, distinction between that view and expecting either total altruism or naked speculative profiteering. We want investors with expectations that are consistent with process' ability to deliver the product in a reasonable time frame, at a reasonable cost, with a reasonable probability of success FOR THAT PROCESS AS IT IS, not as they want it to be. There is a huge difference between expecting reasonableness and expecting altruism or philanthropy. The discussion here seems to indicate that the recipients of investors' largesse [WE] have a hard time seeing their reasonableness. And I don't think it's because WE haven't tried finding it or can't see it. Maybe investors and management need to work on that.

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74. Anon345 on April 10, 2011 1:31 PM writes...

Rick (#73).

Rick, I think we actually agree on more things than we disagree on. I just have an issue with the kind of blanket statements made in the OP - ALL ILLS OF PHARMA is because of business guys / management. That's just complete bullocks (technical term).

And regarding investors...It's an ever-shrinking universe who are willing to put up with our PROCESS. Can you blame them when they have alternative opportunities to invest in a Groupon that goes from ZERO to $6B valuation in 3 years?

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75. Ricardo Ros on April 10, 2011 4:02 PM writes...

Anon, the OP does not say that only. But it is indeed one of the main ills of not only Pharma, but of many of the big corporations. See car industry, some of the big electronics companies, aeronautics, and of course finance.

Regarding investors, any clever vc will put his money in a good concept/team.

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76. Rick on April 10, 2011 5:11 PM writes...

Anon345,
And if all the "Investors" expecting Groupon-like companies in biotech leave this minute, the average quality of investor and company would rise considerably and it wouldn't be a moment too soon. To the extent that there are such "investors" still skulking around biotech I ask, "What's taking you so long to get out???"

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77. drug_hunter on April 10, 2011 5:34 PM writes...

And in response to Rick #70, who asked us all to say whether we had ever had a project killed or not funded solely because of (fill in the blank reason):

The answer for me (>20 yrs in pharma & biotech) to each scenario is "never."

And I wonder why any of us would ever choose to work in an organization where the answer is anything other than "never."

Perhaps we are part of the problem.

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78. Anon345 on April 10, 2011 6:55 PM writes...

Rick (#76):

Agreed, the quality of new biotechs will indeed rise as fewer, but more carefully chosen projects / programs are funded by the remaining investors. BUT, this will be accompanied by a HUGE contraction in the # of people employed by the industry. Are we ready for that fallout?

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79. Rick on April 10, 2011 9:01 PM writes...

D_H (#77): you have been very fortunate or very good at avoiding R&D strategy meetings!

Anon345; As I'm sure you've noticed, with R&D layoffs in the double digit percentages the past couple years, we ARE already experiencing a huge contraction. Whether it's due to the slow senseless process currently inflicted by the short-sightedness of wannabe Groupon managers and investors or the rapid exodus of them makes little difference - the pain is inevitable. I don't say that lightly; I've lived with that pain myself. I've also learned that it's never as bad as the chronic anxiety of being held hostage by cynically or incompetently managed job insecurity.

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80. Confoundman on April 11, 2011 2:38 AM writes...

I think a big issue also isn't just that these companies are top heavy. Its their backgrounds. These finance/business MBA personnel are taught in terms of "widgets" and that is generally what their experience is in. Whether it is for a company that makes alternators, legos, cereal, etc. these are generally very simple products. Big-pharma should have management with either PhD/MBA, or PhD...They need people that understand the science and have experience in labs. I really feel that they just don't hire the right people to do the job and are doing nothing to train (long term planning) the right people to take over.
As for Groupon: that company is highly overrated and there is a general consensus that there is a "social media bubble".

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81. Petros on April 11, 2011 7:44 AM writes...

Surely another issue with the R&D managment is the propensity of company boards to bring in academic scientists, with no drug discovery background, to head up R&D

e.g
Merck Peter Kim -
Professor structural biology at MIT with a group of 20.

GSK Patrick Vallance
"clinical academic who led the Division of Medicine at UCL. 20 years of experience of clinical medicine"

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82. Beckenham on April 11, 2011 3:15 PM writes...

Hi Petros, the problem of appointing academics is then further compounded by their tendency to oust experienced guys and replacing them with yet more arrogant and clueless academics, Vallance certainly did that and the results are there for all to see.

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83. MIMD on April 11, 2011 6:26 PM writes...

Re: Another good one: empowering IT departments to make scientists use the same infrastructure as the guy at the front desk. Rather than see that scientists often have different computing needs than other parts of the business, IT demands obeisance to the corporate norm ... They create obstacles instead of removing them. Machine was made for Man, not Man for the Machine.

I wrote in some depth about that phenomenon ... in effect, de facto IT control of R&D ... at this link:

Conflation of IT with information science in the pharmaceutical industry

http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=pharma

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84. Gambler on April 13, 2011 7:01 AM writes...

Probably too late for anyone to see or care, but anyway...

No disrepect to the drug hunters of yesteryear was ever intended. I think persistence in the face of adversity is an absolute requirement and they had that for sure. I also agree that the fancy new data producing tools can be a distraction from some rather tedious grunt work that must be done (SAR, developing real measures of target engagement, etc.)

But surely we can agree that the landscape is different? We are the victim of our own success, as some have stated, and regulatory pressures mean it is actually far more difficult to even get into PhII as compared to decades ago when you could more easily test your hypothesis in the relevant human model. I see this as progress, but it does bring with it some problems.

There is a real need to make the process more efficient and just saying that more iterative testing in poorly predictive animal models is the best path forward is admitting defeat too early. There might be some value in these massive correlational datasets that are being generated for Tox prediction and new target ID. Phenotypic screens in more sophisticated 3D culture systems may generate less target-centric ways of treating disease. Attempting to deal with the tissue targeting problem with new delivery technologies may allow us to administer pleiotropic therapeutics more effectively in cancer and fibrotic diseases. Truly translational surrogate biomarkers (such as LDL, BP, BMD) for new diseases would be fantastic, but Pharma will not invest massively in this effort anymore.

Big pharma has a role to play in this - I think largely by educating government and academic partners about what works and what doesn't in the inefficient current state. We need to work together to somehow increase the odds that what we put into the clinic has a chance at providing real benefit.

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85. Anonymous on April 14, 2011 6:22 AM writes...

Gambler, good points that are well made.

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86. Been There on April 19, 2011 2:53 PM writes...

"We trained hard--- but it seemed that evey time we were beginning to form up into teams we would be reorganized. I was to learn later in life we tend to meet any new situation by reorganizing; and a wonderful method it can be for creating the illusion of progress while producing confusion, inefficiency and demoralization" Petronius, 210 B.C.

nope - we haven't changed in 2300 years!

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87. newbie on May 6, 2011 9:31 AM writes...

Coming late to the party here - but cellbio, if animal models are not the way to go, then what's the solution? (genuine question) Weren't animals successfully used in the golden years before the target-driven methods came along?

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88. ge dallas on June 30, 2011 3:04 PM writes...

Fantastic post and nice website.

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Conference in Basel
Messed-Up Clinical Studies: A First-Hand Report
Pharma and Ebola
Lilly Steps In for AstraZeneca's Secretase Inhibitor
Update on Alnylam (And the Direction of Things to Come)
There Must Have Been Multiple Chances to Catch This
Weirdly, Tramadol Is Not a Natural Product After All