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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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January 25, 2012

Panel on Academic-Industrial Collaboration in Drug Discovery

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Posted by Derek

So, what questions should be asked? I've been asked to moderate a panel discussion ("Bridging the Valley of Death") at the upcoming Society for Laboratory Automation and Screening conference in San Diego. It's a session moderated by Bill Janzen from the University of North Carolina and Michelle Palmer from the Broad Institute, and the panelists are John Luk from the National University of Singapore, Rudy Juliano from UNC, Mao Mao from Pfizer (San Diego), Alan Palkowitz from Eli Lilly, and John Reed from Sanford-Burnham.

The discussion will be live-streamed (I'll put up the link that day), so if you're interested in that sort of thing, tune in. And as it says here, questions will be gathered "through social media sites, expert opinions and audience participation". And since this is one of those social media sites, more or less, I'd like to do some preparation by asking the question that I led off this post with. What would you like to see asked? What are the biggest issues and stumbling blocks? What should this audience get from all this?

Feel free to add suggestions in the comments, which are much appreciated. I'll run up some Twitter hashtags as the event gets closer, as well as keeping an eye on this post. Thanks!

Comments (35) + TrackBacks (0) | Category: Academia (vs. Industry)


COMMENTS

1. Chrispy on January 25, 2012 11:17 AM writes...


It would be interesting to find out how reproducible the industry folks find the results from academia. At the Big Biotech I was at most recently, the odds were about 50/50 of being able to reproduce animal models, etc.

I would also be curious what kind of research simply won't get done now that larger pharmaceutical companies are washing their hands of early research in the hopes of buying their leads.

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2. NoDrugsNoJobs on January 25, 2012 11:34 AM writes...

Every academic-company type collaboration I have been involved with resulted in about 3-6 months of wasted time while the lawyers haggled over the same old details - Are we any closer to moving to some sort of basic understanding that can expedite these things rather than haggling over the same old crap over and over again? Its like each side always starts off by asking for ridiculous things just to see if they can get it past the other side but knowing they never will, why waste everybody's time? I guess the lawyers have to feel like they are doing their jobs but its the research that suffers....IMHO

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3. RET on January 25, 2012 11:51 AM writes...

What mechanisms can be put in place to have experts for pharma help guide drug discovery programs in academia for optimal productivity?

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4. NoJobsNoDrugs on January 25, 2012 11:52 AM writes...

Do you know if your panel discussion will be livecast on the net? I've always wanted to see you speak (even if just moderating), but have never had the opportunity.

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5. Saamaanyan on January 25, 2012 12:12 PM writes...

Collaboration between academia and industry is restricted at some levels due to IP issues [who owns what out of the work?]. The same is not true when industry contracts the work out to CRO - it's a 'fee for service' arrangement. The CROs work on the explicit agreement that the return for their work is only monetary.

Can academia form such entities on the lines of CROs to gain some of the big bucks? This would be a win-win in that academia can get funded in a resource-crunched environment and the industry can benefit from the scientific eyes [better than CROs?] overseeing their work.

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6. Capek on January 25, 2012 12:28 PM writes...

How can the best interests of the students working in an "academic" environment be protected and promoted when contributing to such collaborative projects?

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7. marklar on January 25, 2012 1:03 PM writes...


Who provides project direction? Since companies are the ones sinking $$ into academia, I imagine that they (industry) will call most of the shots in the project and would not react well to prepared compounds that violate Lipinski guidelines.
How will this relationship affect the development of grad students' ability to think on their own if industry is calling most of the shots?
Is this a sustainable relationship? Are there enough grad students willing to enter drug discovery research given the state of the industry and where it appears to be headed?
Do the grad students have to wait until the patent application is published before they write up their thesis/dissertation? If no patent/application, then what?

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8. CR on January 25, 2012 1:04 PM writes...

@#3, RET:

"What mechanisms can be put in place to have experts for pharma help guide drug discovery programs in academia for optimal productivity?"

Because why? Pharma has been so productive over the past several years? Yes, let's have "experts" from Pharma come in and tell academic groups how to have redundant meetings, have business people tell them what not to work on...

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9. MJS on January 25, 2012 1:11 PM writes...

How might this relationship be similar or different depending on the field or disease-focus of the work? For example, I imagine academic/industry collaborations for cancer will/do look much different than for psychiatry due to the challenges of establishing preclincal models.

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10. patentgeek on January 25, 2012 1:15 PM writes...

What success stories can the attendees/panelists share: specific examples of drug candidates that entered Ph I as a direct result of industry academia collaboration? (Preferably where the early hit or lead was provided by the academics)? How did these successful collaborations work?

Re: IP issues: In most cases I've dealt with, this is difficult if not impossible to get around; joint ownership of the IP is necessary. This has never been a deal-breaker, though, in my experience, it requires negotiating terms which make economic sense to the industrial party.

Re: grad students: much of this type of collaboration these days is done through Translational Medicine centers, which often don't directly involve graduate students, or only at the periphery. For example, the Brain Science Institute at Johns Hopkins maintains its own coterie of chemists and biologists (non-students) for engaging in industrial collaboration.

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11. newnickname on January 25, 2012 1:31 PM writes...

Whatever Industry is doing of late isn't working very well (a few exceptions noted). Academia hasn't been trying at all until recently with the commitment of huge $ and the establishment of many Centers for Drug Discovery, e.g., Janzen at UNC and others (historical exceptions noted). Industry should just leave the Academics alone, let them make different mistakes and wait to steal the drugs they discover through one-sided licensing agreements.

Less cynically but still seriously, Academics can more easily focus on smaller markets and orphan diseases. Q: Is Industry interested in anything less than a 10-Billion Dollar Molecule?

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12. chris on January 25, 2012 3:23 PM writes...

I've been involved in a number of these sort of interactions and perhaps the best indicator of a likely successful collaboration is if both parties priority is to find a drug rather than fame and fortune.
The academic party can often bring highly specialised clinical expertise to the project together with biomarkers, assays etc.

At the early stage in projects access to HTS can be an issue and academic groups can start work on inappropriate starting points because that's all that is available. Perhaps a discussion as to whether countries should set up a National Screening Centre that could be accessed by academics?

Rigorous target validation and what this means/entails. (siRNA is not enough!).

Should public money given to academics be used to fund an overseas CRO/collaborator?

What happens if the industrial partner pulls out, what does the academic group need to do to ensure they have all the information/data needed to collaborate with another partner.

I've seen academic crystallographic groups who provide a "fee for service" to small biotech/pharma companies I'm sure there are other opportunities?

Should you agree a publication strategy up front?

Collaborations between academics are very common, when do you need to implement service contract? and how do you do it without the academic partner being offended.


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13. RET on January 25, 2012 3:29 PM writes...

@CR,

You clearly don't read this blog very often as Derek and many commenters have pointed out the lack of true medicinal chemistry and drug development expertise in academics. I don't disagree with you but if we are to improve productivity, scientists from academics and pharma need to work together.

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14. CR on January 25, 2012 4:15 PM writes...

@#13, RET:

I read this blog all the time and have seen the comments; and some are true. But it is also true that productivity and Big Pharma are an oxymoron these days. To have someone that you call an "expert" come in and mold an academic group into another pharma group is counterintuitive to me. Blind leading the blind. I've been on both sides of this and see the good and bad in both. Academics don't necessarily need Pharma to tell them how to be more productive - academics need resources.

And I will say most of the commenters on this blog are clearly Pharma people and adhere to the mantra that nobody can do drug discovery except Big Pharma. So many of these comments about academics (not all) are based on bias, ignorance, fear, etc. Drug discovery is hard, but there is enough people that know what they are doing and have been successful in academic drug discovery units to run them efficiently.

That being said, not sure how these "panelists" were chosen - seems to me none have been terribly successful.

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15. zorkbirder on January 25, 2012 4:25 PM writes...

How about a model where academics do Target Validation? Academics or Pharma can propose a target, Pharma runs a screen and releases tool compounds into the public domain (web page with in vitro data) so no IP issues and no restriction on publication. If the academic uses the tool to provide some pharmacological validation, then a exploratory chemistry program could start up to develop an in vivo tool compound. At this point Pharma would probably patent the lead series, but should then release the in vivo tool, fee-free as a non-exclusive license for basic research to all interested. The academic(s) continue to do a deep study into the target biology with the tools.
If the target is validated to Pharma's satisfaction, they take the project in house while the academic continues to explore and publish the details of the target biology using the best tool compounds.

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16. Cramer on January 25, 2012 5:16 PM writes...

Why restrict the discussion to academia-industry? Why not include big pharma - small company collaborations? The valley of death is not being adequately funded by risk averse VCs and preclinical licensing deals are virtually non-existent. Big Pharma $$ are needed to nurture small companies and provide access to development expertise. Pharma venture arms are helping but much more is needed!

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17. Student on January 25, 2012 5:27 PM writes...

Seems like a big costs saving attempt, IMO...You are basically getting all your reagents and labor at academic prices. It may seem like a small point, but multiply this across a multibillion dollar company and you are easily saving millions.
The question in my self interest: WILL PHARMA BE REQUIRED TO COMPENSATE THE RESEARCHERS FAIRLY?

If pharma brings their research model (with the drop of a hat they are willing to cut funding to GOOD projects) to the academics, what happens to the students and investigators when they invest all their time into a project and the company drops it on a whim? What happens when the investigator loses funding, because I'm assuming pharma is too self-interested to provide long term funding (as they are accustomed to with a R01)

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18. CMCguy on January 25, 2012 7:07 PM writes...

Could be of an obvious nature yet I would like to hear how they would blend the different Fundamental Objectives of Academia vs. Pharma. The former is focused generally on exploratory Research, with Education of studene hopefully as well, and push to Publications prime import. Pharma is more directed translation Research which migrates to Development and then ultimately Commercial Products/Business Operations (all in heavily Regulated context foreign to most Academics). While both can talk a Science as key to innovation the urgency and timelines do not often align. IMO "Biotech" has largely been this type of experiment and do not believe has a dramatically greater rate of success/ROI with a few notable exceptions.

It would be interesting to know specifically from John Reed how (if?) his work/discoveries in apoptosis have provided new marketed drugs (because seems now know much about that as basic biology function relative to many other areas however real world animals/Humans applications still lags)

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19. Anonymous on January 25, 2012 7:17 PM writes...

In agreement with what Student said, why does pharma need to collaborate with academia at all since they've already determined that they can do all the collaborating they need to across the Atlantic? You know how many ex-Pfizerites I've met who were specifically tasked with "managing outsourcing projects"? In other words, part of their job was to train people in other countries to take their job from them. And isn't Pfizer SD getting gutted? What's this crock of shit they're trying to peddle about being interested in collaboration?

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20. Jumbo on January 25, 2012 8:05 PM writes...

In my experience (big pharma BD/licensing), academic institutions think that, by finding a molecule that slows cell growth in a dish, they have a cure for breast cancer. In other words, using conventional pharma-speak, they have a lead or even an advanced hit (ignoring how often data are generated with off-the-shelf compounds that have no useful IP, even of the use kind). The gap isn't just getting IND-enabling data, but getting any in vivo pharmacology. This has been asked by some of the posters tangentially, but how prepared are academic institutions to make the necessary investments to generate a compound that merits the $millions that need to be spent even after in vivo pharmacological data are generated (i.e. once you can start to consider a molecule a potential candidate or at least optimized lead)? I am not talking of academics investing $millions, but how about a $50K xenograft study vs a positive control to prove in vivo pharmacology? It seems to me that the academic institutions want to have all pre-clinical work done by pharma without recognizing how little risk they have removed (a polite way of saying they expect too much money for the level of maturity of a project). And, as also pointed out before, do we really need to take six months to negotiate an MTA?

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21. bbooooooya on January 25, 2012 8:07 PM writes...

Be interesting to ask the guys from PFE and LLY how they feel about their companies taxes going to pay for the (NIH/NCI/NSF grant funded) research that is the seed of so many start ups. As a follow up, maybe ask how their companies feel about being the being the receipt of said subsidies from us, the lowly American taxpayer.

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22. SP on January 25, 2012 8:13 PM writes...

communities.washingtontimes.com/neighborhood/ad-lib/2011/apr/10/tax-evaders-wall-shame/

"7. Mega Pharmaceuticals Merck earned $9 billion in profits and paid no taxes in 2010, while Pfizer (largest drug maker) owed $10 billion in taxes but found the necessary loopholes to pay no taxes, thanks to its offshore subsidiaries in places like Luxembourg and the Isle of Jersey."

(Source is the Washington Times, so wash 3x with saturated NaCl)

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23. bbooooooya on January 25, 2012 9:52 PM writes...

http://www.sec.gov/cgi-bin/viewer?action=view&cik=310158&accession_number=0000950123-11-019286&xbrl_type=v#

Looks like MRK paid 670 mill on 1.7 bill in pre-tax income, at least as far as a quick look at latest 10-k.

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24. MoMo on January 25, 2012 10:06 PM writes...

No! Don't do it Dr. Lowe! These are the guys that brought you genomics, proteomics and combi chem and helped cause the collapse of the Pharma industry! Don't you see that? They will all be in one place! A hard working and creative guy in lab like you is toast!

Or have you joined them maybe? They probably need a organic chemistry ally, as the closest topics are automated chemical synthesis and they probably pick up fees and expenses.

But have a good time! And now for a serious industry-academia question:

When are both sides going to stop acting like A%%$#@%@ and focus on discovering drugs together? It has worked in the past and will always work in the future, if both cared to look.

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25. Anonymous Academic on January 25, 2012 10:21 PM writes...

@chris: "I've seen academic crystallographic groups who provide a "fee for service" to small biotech/pharma companies"

Really? That sounds like a huge waste of time - the crystallography required by drug companies usually isn't very interesting. Who really needs the money that badly?

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26. organicgradstudent on January 25, 2012 11:56 PM writes...

As a grad student who wasted 3 months on an academic-industrial collaboration that didn't work out (due to inevitable product instability), I can say that I've become disillusioned with the idea of this cooperative R&D. The positive aspect of this collaboration for academia is that my advisor gets money to support the lab. However, what do the grad students get? If my project worked out, I would have been listed on a patent, but it didn't work. It's still proprietary. A grad student needs material for a thesis as well as publications. If I can't talk about the failed project, can the connections I made in industry at least give me an advantage when applying for a job after I finish my Ph.D.? With the way industry is working today, I think the answer is sadly no. If academic-industrial collaborations are going forge synergistic relationships (which they should), what can the grad students gain from these collaborations when their industrial projects fail?

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27. Chemjobber on January 26, 2012 12:50 AM writes...

@25: Presumably, Professor Rheingold at UCSD does not need the money, but is happy to do such work for a fee. I've seen him offer it, more or less as a sales presentation.

One presumes that he charges a decent rate, gets his postdocs papers and doesn't have work the grant thing as hard.

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28. Anthony Bishop on January 26, 2012 1:11 AM writes...

Can universities actually 'go it alone' on drug discovery? What do they need from pharma apart from money? Could they get that money directly?

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29. Anonymous on January 26, 2012 4:09 AM writes...

@28 Can universities go it alone?

Certainly in the UK there are number of agencies and charities who are doing great work supporting the discovery stage. The problem comes when trying to fully profile and take a potential candidate forward.
Whilst there are translational awards, the funds available are so small that only a very, very limited number of cases can be supported. I suspect that none of the academics can undertake the development work so it is outsourced to a CRO.
The academics usually have no experience in the dealing with development issues, safety studies, regulatory work, GMP synthesis/formulation/stability etc.

Pharma involvement is often the easiest option.

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30. bbooooooya on January 26, 2012 8:32 AM writes...

"As a grad student who wasted 3 months on an academic-industrial collaboration that didn't work out"

Well, at least you got paid closer to an industrial wage for being a de facto pharma employee ($50k+) rather than an academic stipend, right.....

For me I think post docs who work in academic labs (at academic salaries) doing industrial work are the ones who really get hosed. At least industrial PDFs in industry get paid more (I think). Great system for pharma, though: pay less to "train" new workers who you won't hire because you can just funnel work through academic labs to train more future workers......

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31. CR on January 26, 2012 9:12 AM writes...

@ #28, AB and #29:

"Can universities actually 'go it alone' on drug disocvery?"

Depends on the end-point. Can universities go it alone up to the PCC stage? Yes. There are many multi-year, multi-million dollar funding opportunities out there from the NIH and other associations that one can get and be able to do Hit-to-Lead and even Lead Optimization. To be able to do this, however, the academic group needs people and infrastructure in place that know what they are doing (very few of these, actually). However, this is possible and is being done right now.

Can universities go through pre-IND/IND? Yes, but it's not as easy. There are some funds available for these as well; however, since these are competitive grants, there is a time-lag for the award (if you actually get the grant) so pre-planning is exceptionally important. Unlike Pharma who just advances compounds when ready, academics really need to line up the funding in advance - which is a Catch-22 because the compound may not be ready for the funding.

Can Universities actually go into clinical trials? Much less certainty here. The NIH does have funding available; however, they do not like having clinical trials performed where the molecule was discovered. So a particular university may be well-suited for the clinical work, but may not be able to do this for fear of conflicts. Again, due to funding timelines being a year behind (ie, submit a grant in Feb., if awarded you get the money next Feb. or so), planning is crucial and sometimes can hurt because grants need preliminary data that might not have been generated yet.

To me, the ideal situation is the academics stay with target validation and in some cases hit-to-lead and even lead optimization studies to in vivo POC and then partner. It's clear Pharma doesn't have the appetite to increase FTE's so having funding available for early stage research is much more attractive. The university's can take the early risk with association money and then Pharma can invest for the clinical development and, although they foot the bill for the more expensive work, they also reap the higher pay-outs while giving the university a small portion of the sales.

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32. johnnyboy on January 26, 2012 10:15 AM writes...

Seems like Derek's simple request for questions has devolved into the usual academia vs industry fisticuffs. Predictable I suppose...

In any case, the question that I would suggest would center on how, in such a collaboration, you could reconcile the basic divergence of the two partners' goals: the basic objective of academia still is (despite the patent fever that has gripped some academics) to get information out into the public domain, while that of industry is to protect its information with IP. How do reconcile that ? Or in more practical terms, how do explain to a grad student or post-doc that his work can't be published because the pharma partner decided it wasn't ? or how do you explain to the tax-payer that the grant money he provided to a university researcher is going straight into a private company's IP ?

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33. petros on January 26, 2012 11:36 AM writes...

Seems to be asimilar theme to this 2 day meeting recently organised by the Structural Genomics Consortium

http://www.thesgc.org/events/symposia/DrugDiscov2012

Translational medicine was one of the key issues.

One of the comments, by Andy Hamilton, Oxford's V-C, was how many US universities had established Drug Discovery Centres. (63). He did admit to having purchased Bayer's West Haven facility for Yale to do likewise.

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34. BioBritSD on January 26, 2012 12:30 PM writes...

IP seems to be a common theme. Given the location and the panel, perhaps ask what institutions can do to their IP policy to help? Contrast Sandford Burnham (relatively easy IP licensing) to TSRI(archaic and unweidly IP licensing)

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35. Cellbio on January 26, 2012 12:38 PM writes...

It is a false division to separate academia and industry and point to one or the other as failing drug discovery. It is one ecosystem that has failed. It has failed to support the scale of investment, to be accurate.

IMO, much of a company's pipeline is based upon the target and biology elucidated in academia, with tools and methods largely developed in academia. If you think otherwise, I'd then ask for a reflection on why pharma pipelines are (were) essentially identical? The answer is, at least partly, because the validation is the high science of academic research and shared in papers in Nature, Science, Cell, etc. A key question that follows is whether this productive phase of biological insight will yield a productive phase of drug discovery. Even if yes, did we resource operating against this insight too aggressively? A worthy debate here, but I am not so sure that the model systems (like mouse genetics) or current state of human genetics actually improve our odds of success over classic and empirically defined approaches like pharmacology (chemical biology these days?).

A related question is whether the nature of academic research and its reward systems fit into drug discovery well. The current reward is geared towards high profile publications that highlight novel insight and potential. This is fine, but quite distinct from providing evidence to support investment of 10s and 100s of millions into subsequent development. As discussed in this blog, and by Bruce Booth, the reliability of these aha findings is not great. In my thinking, this presents a real challenge to our success, as the failures cost real money and undermine confidence in those that put capital at risk, threatening our ecosystem further. So, I disagree with CR in the thinking that all academics need is resources. Incentives and rewards need to be aligned also, and I think that happens in industry better. Academia can point to the 'potentially huge potential' that remains remote and be well rewarded with grants. This is an ingrained mindset that will prove tough to change.

As the current shake out in industry rolls along, I also wonder about the scale of research at academia. If academia were held to productivity standards of industry, would it be fairing any better? Was research that generated the 3rd, 4th or 5th paper describing some biology worth the investment? In what manner and for what future employment are we "training" our grad students and post-docs? The last data I saw, from better times, only half of life science PHDs stay in science, of those that do, half end up in academia, half in industry. I suspect the numbers are worse for academic jobs today, and probably pretty bad for new PhDs landing an industry job. So are University research departments taking on new students today with the belief that the old style job market will get better, or with new ideas of how to prepare the student for today's reality, or really just because this low cost labor fuels a lucrative haul for research Universities, and fulfills the passion of tenured researchers (drives the fame and egos too)?

In this light, I am very skeptical that the new efforts around translational science are broadly sincere. I know many academics moving here because, to borrow the famous quote, "That's where the money is". I do believe some good things will come out of this, but the yield will be low unless the whole culture changes, people, attitudes, rewards, manner of training, all of it.

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