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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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February 23, 2011

Gonna Focus on Re-Engineering the Tools for the Process

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Posted by Derek

I have tried several times to get my hands around what NIH head Francis Collins is talking about here (note: open-access article), but I now admit defeat. Allow me to quote a bit, and we'll see if anyone else out there has more luck:

We have seen a deluge of new discoveries in the last few years on the molecular basis of disease. . .(But despite) increasing investments by the private sector, there has been a downturn in the number of approved new molecular entities over the last few years. Also, drug development research remains very expensive and the failure rate is extremely high.

Perhaps in part responding to these factors, and to the downturn in the economy, pharmaceutical companies have cut back their investments in research and development. We can't count on the biotech community to step in and fill that void either, because they are hurting from an absence of long-term venture capital support. So, we have this paradox: we have a great opportunity to develop truly new therapeutic approaches, but are undergoing a real constriction of the pipeline. One solution is to come up with a non-traditional way of fostering drug development — through increased NIH involvement.

Hmm. I may have missed the deluge that he's talking about, but we'll set that concern aside. What might this "non-traditional way" look like? Collins again:

I like to think of this in a broad sense of “what kind of paradigm can we initiate and expand between academic researchers and the private sector to move the therapeutic agenda forward?” . . .By having the NIH more engaged in the pipeline, we can also ask whether we can improve the success rates of drug development. . .We need to re-engineer the process, with a lot more focus on the front end.

Right! Another thick block of wobbling gelatin. Let's see, we're going to get the NIH engaged, and, um, give them the tools, and re-engineer things, and oh yeah, focus. Definitely going to focus. Any more details to add?

There are a lot of moving parts to this set of resources that ultimately need to be synthesized into a smooth process. One of my goals over the next year is to try to identify ways to put these together into a more seamless enterprise.

Good to hear. Please, those of you with access to (see above) Nature Reviews Drug Discovery, where this interview appeared, take a look and see if you can condense anything more out of it than I did. I mean, King Lear had a more concrete plan of action than this one: "I will do such things - what they are, yet I know not, but they shall be the terrors of the earth."

Update: an NRDD editor has let me know that the interview is open access. He also points out that the piece was done before the official announcement of the NCATS idea. My take is while that might account for a bit of the fuzziness, everything I've seen since then has been similarly soft-focus. . .

Comments (41) + TrackBacks (0) | Category: Academia (vs. Industry) | Drug Development


COMMENTS

1. milkshake on February 23, 2011 2:29 PM writes...

The whole scheme looks increasingly like a power grab. The funding for the works and the people doing the research will roughly be the same but Collins will be their boss. Not much different from corporate reorganization (except for clueless shareholders its clueless government officials being pitched)

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2. Hap on February 23, 2011 2:31 PM writes...

But you can't remove the uncertainty of health care reform [something has to change, and if the SC nukes the Democratic plan, there will have to be something else which will affect drug companies (though maybe less)] and you can't tell the FDA how to choose what drugs to allow or even to do so consistently. Without removing those uncertainties, drug companies are going to have a tough time investing more money in R+D, because they don't have any idea how much money they can make or what levels of efficacy and safety they need to have a useful drug (and thus the probability of getting a drug through trials).

There are lot of research areas NIH could work on that would help pharma - biomarker validation and PK/PD studies, for example. This doesn't sound like the generation of general knowledge into drug development and action - it sounds like NIH trying to make drugs, which seems unhelpful. Particularly if you don't know or can't say what you're doing, or how it will be different from what drug companies have been spending hundreds of billions of dollars trying to do.

Between this and Collins' push for personalized medicine, there's an awful lot of money that is going away for no good end.

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3. OldLabRat on February 23, 2011 2:35 PM writes...

Sounds like Mr. Collins doesn't quite know about what happens after preclinical stages of discovery. Apparently, all we really need is a complete understanding of disease biology and then we can make the best compounds and that will solve the dearth of NCEs. What about GLP scale-up for preclinical tox? And characterizing the toxicity of impurities over 0.01% presence? I'm sure others will add to the long list of vital and often artful steps necessary to get to the clinic, let alone move beyond Phase I, that Collins glibly ignores.

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4. MoMo on February 23, 2011 2:37 PM writes...

Ye Gods! Haven't we had enough unpleasantness?

When will a real NIH leader emerge? The same old gene-jockey throwbacks making the rounds for a second and third time.

Get back to work Collins, everyone knows that 25% of the human genome work is flawed!

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5. Curious Wavefunction on February 23, 2011 2:45 PM writes...

Sorry, but for some reason some of the rambling reminds me of this.

I find it remarkable how Collins continues to think that if only there weren't layoffs and economics downturns, industry would have been able to churn out new drugs through translational genomics, and therefore now the NIH must take up this task.

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6. Sam Weller on February 23, 2011 2:45 PM writes...

I think he is pretty clear about it: "academic investigators need to have the tools to push discovery efforts forward themselves". His vision is that the NIH will be a pharmaceutical-company-like facility that will offer academics opportunities to push their ideas all through the preclinical stages and into Phase I and II trials.

For some reason he believes this NIH+academia consortium will be more successful than the private sector in drug development, and he also believes that this body will be able to take more risks, and to take on diseases with a lower commercial potential.

These are the guidelines and assumptions. The rest of the interview is the usual pile of empty words that we often see in press releases in the private sector. Words that convey that there is nothing concrete or guaranteed yet. Unfortunately, there is no reason to believe that academics or the NIH have a secret recipe for drug development. Otherwise, wouldn't they start their own companies? Also, taking more risks means in most cases spending more money on dead-end paths, which will sooner than later bring this endeavor to the same miserable place the industry is now in, only that in this case it will be public money that will go down the drain.

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7. Luigi on February 23, 2011 2:54 PM writes...

Once again Derek hits it on the head - Collins is a clueless technocrat promising and never delivering - the genome fell far below Collins' wishful thinking. And we can add to this Volkow at NIDA - why does she publish on cell phone effects on brain 2DG activation while her leadership has resulted in doodly squat in new directions or medications at NIDA. Under its current leadership the NIH is not much better than TARP

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8. Cellbio on February 23, 2011 3:11 PM writes...

Milkshake is right, this is a power grab, and typical for the types of Collins who excel at pushing big biology budgets. He first oversells the genome in order to get funds, now claims it was a success, but it is those guys over there failing to translate, so give me the money. And to be sure, this is a money grab. As I understand, this new effort would take money out of the current grant system which functions with at least some degree of independence from his control, and place it under his direct control (or so say my academic friends who despise Collins). Shameless.

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9. Anonymous on February 23, 2011 3:29 PM writes...

I think the deluge he refers to is in terms of molecular targeted therapies now in the clinic, as apposed to approved. I think his point is fair in this regard; we know orders of magnitude more about the molecular basis for disease and *potential* ways to inhibit it than we did even 10 years ago.

Regarding greater NIH involvement. I agree, it does sound a littly wooly. However, perhaps he means to make the point that the NIH, without shareholders (well, not the same types of shareholders!) might be well placed to explore loss-making innovations to the drug discovery process.

Whether that is sensible or possible is another matter, but i thought his points were fairly clearly stated.

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10. Nathan on February 23, 2011 3:30 PM writes...

At first I was also frustrated/annoyed at Collin's recent proposals. But then I began to think about it differently:

What is the biggest problem in the current pharma R&D model? I would argue that the biggest problem is that the current R&D price tag for a solid NDA/BLA far outweighs the payoff. The pharma R&D pricing model is broken: Try as they might, companies can't make their R&D pay off.

Enter the NIH. The Government is the only entity out there that doesn't HAVE to make its R&D efforts profitable. (think NASA, defense spending, environmental research, etc) Sure, I agree with everyone else: Government is inherently inefficient and will be no better (and probably worse) at discovering drugs than pharma. But so what? At least the R&D expenditures from government are likely to be sustained because our leaders (and our society) generally believe that healthcare R&D is a worthwhile investment.

Bottom line: Wall Street thinks that pharmaceutical R&D is a bad investment. Society thinks that pharmaceutical R&D is a good investment. How to reconcile that contradiction? Pump money into the government-based drug discovery. It won't be efficient, but it is better than the alternative.

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11. CMCguy on February 23, 2011 3:40 PM writes...

I actually do think Collins is on target with many statements. There is a lot more knowledge on certain diseases and biology that has not been translated true understanding and to effective treatments. And Pharma/Biotech seems less engaged in wider areas because funding/profit dynamics. Collaborations between academia and industry has already proved to be beneficial to both, with or without a direct new role of NIH. Where I have concerns are the effort seems divergent and potentially damaging to support of more basic research explorations that would be expected to be building blocks for future progress. Further although laudable intentions and even bright people involved I am not convinced a Government Bureaucracy will be able to better orchestrate greater and more rapid progress in drugs. Its nice to talk about re-engineering the front end but for the most part the back end in drug development is where expense and success/failure matter most so contributions could be minimal.

The interview mentions tighter interactions between NIH & FDA, again sounds like nice goal, yet when faced with requirements of FDA I have seen most academics/NIH types run back to their labs shaking their heads so they can focus on doing useful science.

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12. Hap on February 23, 2011 3:47 PM writes...

The government doesn't have generate a profit, but it does have to get money from somewhere - and those trillion-dollar deficits (God, I was hoping not to ever have to use those words together) aren't sustainable. At some point, either the research has to generate money, likely displacing drug companies, not something to help so much, or taxes have to be raised (which is highly unpopular - why we've been spending Social Security's money and lowering taxes, and why we haven't yet changed the tax structure to get rid of the alternative minimum tax). I don't know if the research is popular enough to sustain Congress when it has to discuss raising taxes or cutting NIH funding.

There are loss-making innovations for drug discovery to be found and which would be useful to spend money on, but the NIH making itself into a drug company seems like a poor way to find them.

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13. Industry Guy on February 23, 2011 3:53 PM writes...

With the line being 1.1 drugs developed successfully 15 years from now from Collins and his like.....I'll take the under. Any takers? $50

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14. In Vivo Veritas on February 23, 2011 4:34 PM writes...

Dang, Francis Collins is beginning to sound more like Billy Collins:

Another Reason Why I Don't Keep A Gun In The House

The neighbors' dog will not stop barking.
He is barking the same high, rhythmic bark
that he barks every time they leave the house.
They must switch him on on their way out.

The neighbors' dog will not stop barking.
I close all the windows in the house
and put on a Beethoven symphony full blast
but I can still hear him muffled under the music,
barking, barking, barking,

and now I can see him sitting in the orchestra,
his head raised confidently as if Beethoven
had included a part for barking dog.

When the record finally ends he is still barking,
sitting there in the oboe section barking,
his eyes fixed on the conductor who is
entreating him with his baton

while the other musicians listen in respectful
silence to the famous barking dog solo,
that endless coda that first established
Beethoven as an innovative genius.

______________

Perhaps a former poet laureate would do a better job running the NIH.

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15. Andrew on February 23, 2011 5:40 PM writes...

At first glance, I misread the start of this article as that you had tried several times to get your hands around the neck of Francis Collins....

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16. earth23 on February 23, 2011 6:19 PM writes...

Wow, lots of negativity here. It's easy to shoot down new ideas but industry R&D isn't working, who else can fund a solution other than the government? The interview is obviously a PR fluff piece, what did you expect? If you want details I'm sure they'll be in the federal register soon enough.

As a side note, there is the potential for job creation here. Last time I checked the pharmaceutical industry could use a few of those...

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17. Rick on February 23, 2011 6:27 PM writes...

Derek,
You need to play more buzzword bingo, a game that's helped many a middle manager stay sane and appear to be paying rapt attention during strategy or planning meetings with their "superiors". It's not about the content of what Collins is saying, which is non-existent, it's about saying the right code words to assure the other code-talkers in the audience that you're one of them.

Phrases like, “what kind of paradigm can we initiate”, “move the [insert objective here] agenda forward”, “[insert person or office here] more engaged in the [insert process here]”, “re-engineer the process”, “focus on the front end”, “There are a lot of moving parts”, “this set of resources”, “synthesized into a smooth process” and “seamless enterprise” - all of which appear in the short clip you shared and constitute enough hits for someone to text "BINGO!" during a meeting - make it sound like you're saying something profound and portentious even if (or especially if) you're still trying to find your ass with two hands and a flashlight. From that standpoint, Collins is actually remarkably (or frighteningly) good for a scientist.

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18. Sili on February 23, 2011 6:29 PM writes...

This is the man who took a frozen waterfall as a sign of the Truth™ of Christianity. You expect him to start making sense now?

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19. Hap on February 23, 2011 7:05 PM writes...

#16: With billions of dollars (of someone else's money) it's easy to create jobs. The question is, does it get you jobs you couldn't have gotten cheaper another way, or does it get drugs or knowledge that you need and weren't going to get otherwise? The former is highly unlikely (because NIH hasn't done it successfully ever - it's helped forward leads to pharma but not actually developed them). The lack of any actual idea of what NIH is actually looking for and what skills they have that can achieve their ends better than others is not hopeful for the latter.

Give someone a billion dollars with no clue and no previous experience to balloon around the world and my money's on them ending up drowned in the Atlantic or shot down over Somalia.

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20. Aspirin on February 23, 2011 7:23 PM writes...

You should also read Collins's book "The Language of Life" in which he lays out his utopian vision of translational genomics enabling a world without disease. The NIH center is simply a translation (pun intended) of this delusion into action.

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21. earth23 on February 23, 2011 7:41 PM writes...

@Hap

I don't think NCATS is looking to make things cheaper, I believe one of their stated objectives is to take compounds that industry has abandoned as not economically beneficial and develop them.

Furthermore,from the NCATS website: "We are working together to develop important details of these plans and are gathering information from a wide range of internal and external stakeholders. This information will be used to shape NIH’s final vision for NCATS. Until that information is systematically and objectively evaluated, the plan for NCATS remains a work in progress."

I guarantee there will be exhaustive input taken from the community. Other questions regarding the overall goals can be seen from the FAQ, which is all we have to go on at the current time. http://feedback.nih.gov/index.php/faq-ncats/


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22. anon on February 23, 2011 10:24 PM writes...

This is a "backdoor" nationalization of the pharmaceutical industry. It started with the NIH centers for drug discovery about a decade ago. Taking over health care in this way will not draw the ire of the anti-big government patriots, because the commoners don't understand drug discovery so well. First they (govt socialists) got the banks, then they got the autos then they got health care part I, this is health care takeover part II. Slow and steady, we march towards socialism.

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23. translator on February 23, 2011 11:26 PM writes...

We have seen a deluge of new discoveries in the last few years on the molecular basis of disease. . .(But despite) increasing investments by the private sector, there has been a downturn in the number of approved new molecular entities over the last few years

"Even though taxpayers give us $34B/yr, we haven't been able to substantially improve human health."

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24. PROVOCATEUR on February 24, 2011 12:50 AM writes...

For somebody who has read 'Happy Accidents: Serendipity in Modern Medical Breakthroughs', I am going to be a lot humble and say Big Pharma has still not delivered on its promises!
I welcome any money invested by the govt. in Research and admit it!Do we really know what it takes to get new medicines to market.All we end up with an over promised and under acheiving Avastin and no new anti bacterials in the last decade because there is no money in it!
We seem to give too much credit to ourselves for all our incremental acheivements and the only criticism I can come up with is to ask Mr. Collins how is he going to do it?
Govt. bashing has become a fad and I think the NIH has done a good jobI(polio vaccine, Lyrica etc.) .

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25. SP on February 24, 2011 8:11 AM writes...

I'm gobsmacked by commenters on a blog who think the head of the NIH is just some academic who doesn't know what's involved in drug discovery. Really? You think he's the head of the NIH and he doesn't know about preclinical and tox studies and the regulatory framework involved in bringing a compound to clinic/market?

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26. nakedemperor on February 24, 2011 8:50 AM writes...

@SP "Appeal to authority" is a classic logical fallacy.

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27. AR on February 24, 2011 8:55 AM writes...

#25 SP. Sorry, I do not agree. He may know all the parts that need to be bolted onto the NDA submission, but it is often like trying to describe battle to someone. Some things need to be experienced first hand.

On the plus side, there are plenty of ex-industrial scientists around to help. On the negative side, some of the scientists which Collins will take note may have been directly or indirectly responsible for the crisis the pharma industry has found itself.

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28. Anonymous on February 24, 2011 9:04 AM writes...

#26 SP.

Ummm - actually, while I haven't posted on this thread, count me into the ranks of those who thinks that the head of the NIH is unfamiliar with the processes of drug discovery. Nay, count me in the ranks of those who has great faith that he is unfamiliar, other than at the intellectual level, with the process. Unfortunately when people use the word "know", it can cover many levels of knowledge (discounting even that Adam "knew" his wife Eve). I would accept that Dr. Collins has an intellectual understanding of the process, and am certain that he could present wonderful Powerpoint slides on preclinical / tox / regulatory frameworks. My high school son did that as part of an assignment in 11th grade. I would, however, NOT accept that he has experienced the drug discovery process, contributed to it, had failures, learned from those failures, had successes, learned from those successes and then synthesized them into a framework to contribute. If he has, please present the evidence.

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29. Hap on February 24, 2011 9:44 AM writes...

If you want to get more drugs, making them cheaper to develop would probably be the best way. Since telling the FDA not to be so strict probably won't fly, validating biomarkers and PD/PK (for example) would probably be more effective at doing that. It would put drug development in the hands of people who have at least done it before and would provide a general service to both pharma and academics (and the rest of the world as well).

Instead, developing drugs that pharma won't make enough money for seems illogical - the gov't can afford to lose money, but only for so long. There will probably be people who know some of the factors into developing the drugs, but the infrastructure (intellectual, not physical, of which NIH should have lots) rests elsewhere, which means that the costs of developing the semi-orphan drugs will likely be even higher. The uncertainties involved in their development won't necessarily help other people make drugs more effectively.

Sorry, it still seems like a really bad idea.

Also, I'm sure Collins knows something about drug development and can go to others for pretty good knowledge. If there's a choice of who to lead troops to battle, though, usually one prefers retired generals (with battle experience) to military history professors without battle experience.

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30. LeeH on February 24, 2011 10:24 AM writes...

I'm pretty much on the left hand side of the political spectrum, but I think that trying to turn the NIH into another drug company is a really bad idea. Here are a few examples why.

1. The NIH is too slow. Activities are enabled by the granting process, which guarantees that processes that need to be put together in an assembly line process will fail.

2. Someone has to get into the trenches and bang away at the academic fundamentals that can be applied in drug discovery. Target discovery. Synthetic methods. Computational methods. Pharma cutbacks are reducing the ability of company scientists to do these kinds of fundamental activities, and that's where academia and government should be focusing. On tools that everyone can benefit by.

3. There are fewer fires under NIH asses to play nice with each other. Their survival depends more on getting funding at the individual or group level, not in cooperating for the common good of the organization.

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31. RB Woodweird on February 24, 2011 11:58 AM writes...

Collins went to a seminar run by the Underpants Gnomes, who subsequently charged him several million dollars and delivered to him this business plan:

1. Make small molecules
2. Find which ones have some affinity for receptors
3. ?
4. Profit!

Permalink to Comment

32. Dr. Demented on February 24, 2011 12:30 PM writes...

Right on RB! It reminds me of the old cartoon of the two mathematicians standing in front of a chalkboard. Step two in the complex equations was 'Then a miracle occurs.' Cracks me up.

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33. daen on February 24, 2011 1:43 PM writes...

One area where genomic research has made inroads is in molecular diagnostics (driven in part by affordable whole-genome microarrays from Affy and the like) which are beginning to have demonstrable value. What's interesting is that it seems that quite a few of these tests, as far as I can tell, are based on fairly broad gene expression profiles.

So here's a suggestion for a business model: develop a particular diagnostic test for an indication using gene expression profiling, apply systems biology to generate a regulation network described by said profile and rank candidate target intervention points. Then, more conventionally, feed the most promising targets into your drug discovery process.

This is not significantly different to existing target identification strategies, with the crucial difference being the early commercialization of a target or targets in the form of the diagnostic test.

Revenue can begin to be generated from the diagnostic test within a year or two. Money can be saved, too: the same network of clinicians that is built up to validate the test can be maintained and used later in Phase I/Ib, and beyond. I can imagine this early revenue generation and cost saving model being somewhat attractive to VCs.

There is a small wave of molecular tests from well-funded startups coming to market, and I think it's just a matter of time before someone figures out that molecular diagnostics could be used as a self-sustaining bootstrap mechanism for drug discovery.

So I'm a bit more optimistic than Collins about the role of private capital in future drug discovery ventures - it's just that the new model will start generating cash up front earlier.

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34. Anonymous on February 24, 2011 2:03 PM writes...

All Collins is saying is that historically NIH has not done very much drug development (instead focusing on more basic biology and molecular mechanisms of disease). Now he wants it to do more, in part because the genetic basis of so many diseases is now understood and in part because the lack of a profit motive enables NIH scientists to pursue drug development projects that are ignored by pharma. Is that so crazy? Why all the profound negativity? I mean of course its hard. No one is saying pharma is incompetent, just that the NIH will try, too. Is that so wrong?

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35. CMCguy on February 24, 2011 3:40 PM writes...

#25 SP I would challenge your astonishment which suggests just because Collin's is the head of NIH he automatically knows what's involved in drug discovery. Like #27 AR indicates there is a difference between intellectual knowledge and understanding/experiences. From what I know of his background there appears little that would point to much involvement outside theoretic platform in Genomes. Based on my own interactions there are many in academia (bio, chem), especially MDs, who are very unaware of how drug R&D occurs (its particularly irritating when they are paid consultants or on science advisory boards). But even if I do give Collin's the benefit of doubt so assume does know more about discovery/translation then his comments contain many buzz words and marks of nativity that makes me pause plus I still see underlying Politics as the motivator (telling Congress what they want to hear re NIH investment). Unfortunately much of his statements simply sounds like songs sung with many fads that have gone on before in Pharma(Genomics being one) that were supposed to escalate drug discovery to faster and cheaper drugs so I will be skeptical while keeping some hope for possible advances in undeserved disease areas regardless of time and price tag.

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36. Vince on February 24, 2011 4:49 PM writes...

Nathan,

I fully agree with you. Much of this criticism seems reflective given the little we know at this point. Although, sadly, it might be just a powergrab.

As you said, there is the potential for the NIH to be a catalyst for some very nice technological innovation which then trickles into to the private sector and boosts the overall productivity of the field. This has been occurring in the Defense and Space industries for sometime; a variation on the DARPA model might be interesting. As Sen. Nunn once remarked of SDI, the critics don't understand that the Soviets aren't so much afraid of the system in as much as the spill-over research. Which we've seen from improved solid-state lasers and fibre optics to distributed system command and control.

The problem becomes that eventually the organization becomes accountable for it's direct 'successes' and we'll see what happened with NASA reoccurring: falling back on safe, old, technology to accomplish a token result instead of pioneering new, bleeding-edge technologies that are high-risk/high-reward. Technologies that are potentially disruptive. We see less of the VentureStar's linear-aerospike type developments and more rehashing the '60s.

It's hard to keep a DARPA going...

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37. cliffintokyo on February 25, 2011 5:11 AM writes...

NCATS eems like another useful addition to the armamentarium for attacking the 'valley of death' gap to me; should contribute to POC.
I would feel more comfortable if a Medicinal Chemist who has won his spurs was in charge.

#31 & 32, Great stuff!
RB, you obviously read too much Dilbert!

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38. rhover on February 25, 2011 3:07 PM writes...

Unfortunately this "deluge of data" has minimal relevance to developing effective therapeutic drugs. For decades we've known the single genes that cause diseases like sickle cell anemia and cystic fibrosis. Yet for such "simple", "well-understood" diseases, there are still no cures or effective drugs. Chronic multifactorial diseases are not going to be solved just by having more -omics data. Cancer, heart disease, Alzheimer's, etc. are too complex to yield to pattern recognition in a huge database. We need more whole body physiologists and pharmacologists to crack open the dynamics of how these conditions develop and persist despite our best intentions.

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39. befuddled on February 26, 2011 4:55 AM writes...

A few points:

First, as I see it, what Collins is proposing isn't that new, and should be seen as an extension of the direction Zerhouni was moving in. See http://www.nejm.org/doi/full/10.1056/NEJMsb053723 for details.

Second, research by pharma has become fundamentally dysfunctional. Merger after merger, layoff after layoff, reorganization after reorganization, and years of blinkered short-term management are as at least as much to blame for the dearth of NCEs and NDAs as any FDA requirements.

Given that, why are so many sure that the NIH, which has a history of high quality research, has nothing to contribute? I think the molecular libraries and screening initiatives already underway at the NIH are good ideas.

That being said, I don't think that throwing money at the problem will help. It's not yet clear what NCATS will do. So far, it sounds like the emphasis will be on molecular targets. While that's the predominant direction of pharmaceutical research nowadays, I'd like to see the NIH put more resources behind better animal and cellular models of disease. That's the kind of research that I suspect *won't* be done in pharma going forward, and IMHO it would do a lot for translational research.

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40. Social Entrepreneur on February 28, 2011 5:23 AM writes...

Enough negativity!
The pharma model clearly doesn’t produce sufficient output to sustain itself. Likewise the VC-funded biotech model. The growing patient population of the future requires new medicines. We need to find a better balance between the financial benefit and the social benefit of our endeavours. Social enterprises of various kinds (not all under government control) can be part of the answer. Collins’ ideas may have their flaws, but at least he is proposing something different instead of pining for some perceived golden past.
I suppose that posting this entry immediately after the previous one (Want to Live Where Merck Used to Work?) was intended to be ironic! Any sensible opportunity to use talented people and great facilities to create new medicines should be welcomed.

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41. Wavefunction on February 28, 2011 11:36 AM writes...

SP, sorry, but Collins has always been a Polyanna when it comes to "translational genomics" enabled drug discovery. You should read his book "The Language of Life". It contains a lot of ambitious ideas and optimism but very little on the devil that's always in the details.

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