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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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September 17, 2009

The Drug Business: A Turbulent Future?

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Posted by Derek

One of this blog's regular correspondents has just been attending a chemistry outsourcing conference (program here), and heard a very interesting talk from Stefan Loren of a Baltimore investment advisory firm, Westwicke Partners. Loren's a product of the Sharpless lab, who went on to Abbott, then Wall Street (Legg Mason and into the hedge fund business), and had some very provocative things to say about our industry:

His talk, "The Pharma Titanic: It's Time to Root for the Iceberg" presented a sobering view of the challenges that big pharma will have to deal with if it wants to survive.

Loren opened with an overview of the US national health care debate. Regardless of the ultimate form that a national system takes, he believes we'll see mandatory insurance; this will be good for big pharma. He also believes that there will be strong pressure for mandatory comparative effectiveness testing...probably not good for big pharma. Who will pay for this and what resources this would require is another matter. Wearing his investment advisor glasses, he sees global pharma sales declining, led by North America, with future growth coming in Asia and Latin America. He also sees evidence of healthcare avoidance in the US: unfilled prescriptions, unfinished courses of prescriptions, and people just not visiting medical and dental practitioners - not a good trend.

The coming wave of patent expirations of the top 10 drugs will hit big pharma hard. Generics will grow: In 5 to 10 years, he predicts that 80 percent of ALL prescriptions will be generic. When coupled with the meager investments in bow wave research over the past 15+ years, as measured by IPOs, there's trouble ahead. Global biotech IPOs are in the toilet and the US is no longer viewed by the investment community as the global leader in biotech. There have been an unprecedented number of bankruptcies in biotech. There is going to be a huge oversupply of production capacity for small molecule manufacturing. ROIs for pharma and biotech are largely negative...it gets worse. He calls this the "death spiral."

Pharma pipelines are seen as very poorly run and wasteful. Poor projects linger far longer than they should. Too much emphasis is placed on me-too and line extensions. Too much emphasis is placed on acquisitions and licensing rather than innovation. Here it comes: he says "I have NEVER seen a merger that worked" We were then entertained by a chart showing Pfizer's stock market performance over the period of time from pre-WLA, through Pharmacia-Upjohn, and now Wyeth...you would not be a happy camper if you had put your retirement account in Pfizer management's hands and their merger mania. Wall Street has a saying "Two dogs don't make a kennel." Of course, what we hear is "this time it's different" along with the usual happy talk about synergies. Loren does believe that mergers can work and can be synergistic if the two companies merging are small...large mergers just don't work and large companies get paralyzed by bureaucratic inertia.

His solution? Break up large pharma into therapeutic areas and build shared networks between distinct entities. Small organizations can operate far more efficiently in decision making about research directions - use the network to maintain manufacturing efficiencies. Small focused companies will revitalize the industry and offer opportunities for scientists coming out of academia. In response to a question from the audience regarding Merck's ambitions to adopt this networked architecture, he doesn't believe they can make it work.

He does see light at the end of the tunnel with respect to supply chain assurance driving a return to sanity. The heparin, glycerin, and melamine disasters have awakened people and the cost of securing global supply chains is going to make US industry much more competitive. It also will focus serious scrutiny on big pharma. The "next heparin" case will have serious personal consequences for big pharma managers. . ."

Well, a good amount of this I agree with, but some of it I'm not sure about. Taking things in order, I don't know about a decline in US sales, but Asia is most definitely where a lot of companies are expecting growth. (And for "Asia", you could substitute "China" and be within margin of error). And his generic prescription figures may not be right on target, but the trend surely is. We've discovered a lot of useful drugs over the years, and anything new we find has to compete against them. The only way to break out of that situation is to find drugs in new categories entirely, and we all know how easy that is.

But as for the US not being the global leader in biotech - well, if we aren't, then who is? You could possibly make a case for "no clear leader at all, for now", but I think that's as far as I can go. And that coming oversupply of manufacturing for small molecule drugs, which may well be real, will be bad news for the companies that have already invested in that area, of course, but good news for up-and-comers, who will be able to pick up capacity more cheaply.

But Loren's comments about mergers I can endorse without reservation. I've been saying nasty things about big pharma mergers since this blog began, and nothing in the last seven years has changed my mind. And I certainly hope that his idea of smaller companies coming along to revitalize the industry is on target, because it's sure not going to be revitalized by (for example) Pfizer buying more people. I've made that Pfizer stock-chart point of his here, as well - like the rest of the industry, PFE stock had a wonderful time of it in the 1990s, but this entire decade it's been an awful place to have your money.

I expect these comments to bring in a lot of comments of their own - so, how much of this future are you buying?

Comments (23) + TrackBacks (0) | Category: Business and Markets | Drug Development | Drug Industry History | Regulatory Affairs


COMMENTS

1. processchemist on September 17, 2009 8:20 AM writes...

my 2 cents about the points I know something about.
Supply chain management: yes, the trend is slowly changing. But: none of you heard about the indian policy about clinical trials? Clinical trials running in indian facilities MUST be supplied with products made in India (this means that indian government is smarter than the free trade gurus of the western world, and they judge this sector strategical).
It's about 5 years that I hear about global GMP overcapacity. True. But not all capacities are of the same kind. And is unlikely that prices for a Phase I supply will be lower than the ones of the last three years. Also some chinese prices are rising. And this is a wonderful thing: our sector has been plagued by a destructive deflation on the industrial side, engeneered to fuel the financial side of the business. A reequilibration would be welcome.

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2. NYSpursFan on September 17, 2009 8:54 AM writes...

I think he's spot on. More and more generics + more folks insured means Rx growth and sales declining for branded Rx products. R&D innovation will come from a) foundations (which are inherently limited in scope), b) Chindia, as they migrate from being suppliers/service providors to innovators, anc c) Academia/Fed-funded programs.

Future drug development funding has to focus on developing the asset, not building a company around the asset. At a conference I'm attending this week, a prominent VC said up to 50% of a fund's investment dollars go towards building company infrastructure and lawyers, and not drug development. That model simply won't work anymore in the absence of a frothy IPO market.

I think the US will remain a global leader, but the gap will shrink. We'll see more innovation from Western Europe, China, and India.

Moving forward, the winners will be the CROs (especially those with "Western" operations in "Eastern" countries), generic companies, and anybody willing to work internationally in places like China, India, Russia, etc.

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3. NYSpursFan on September 17, 2009 8:56 AM writes...

I think he's spot on. More and more generics + more folks insured means Rx growth and sales declining for branded Rx products. R&D innovation will come from a) foundations (which are inherently limited in scope), b) Chindia, as they migrate from being suppliers/service providors to innovators, anc c) Academia/Fed-funded programs.

Future drug development funding has to focus on developing the asset, not building a company around the asset. At a conference I'm attending this week, a prominent VC said up to 50% of a fund's investment dollars go towards building company infrastructure and lawyers, and not drug development. That model simply won't work anymore in the absence of a frothy IPO market.

I think the US will remain a global leader, but the gap will shrink. We'll see more innovation from Western Europe, China, and India.

Moving forward, the winners will be the CROs (especially those with "Western" operations in "Eastern" countries), generic companies, and anybody willing to work internationally in places like China, India, Russia, etc.

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4. Palo on September 17, 2009 9:30 AM writes...

Big Pharma is bureaucratic, inefficient. It wastes too much in marketing, acquisitions and mergers. It develops me-toos and line extensions over real innovation. Solution: small biotechs rather than big pharmas. Good to hear all that from someone in your tribe.

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5. RB Woodweird on September 17, 2009 9:32 AM writes...

It looks like the most promising career in pharma is now as an investment advisor.

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6. The Pharmacoepidemiologist on September 17, 2009 10:12 AM writes...

Until such time as the MBAs get out of the R&D end of the pharmaceutical business (hopefully before they do to R&D what they did to marketing), there is little chance the pharmaceutical industry will thrive. It's no accident that when physicians ran R&D, the operations thrived. I wonder how long the airlines would be in business if you put a pig farmer in charge of each one. I doubt very long, since pig farmers know little about the airline business, much as MBAs know little about science and even less about medicine.

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7. barry on September 17, 2009 10:32 AM writes...

I haven't seen a plot of cost-of-bringing-a-drug-to-market vs. company size over the last twenty years, but I'm guessing it's a pretty good approximation of a straight line, with positive slope. No small company ever spent a billion dollars to bring a drug to market, because no small company ever had a billion dollars.

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8. Hap on September 17, 2009 10:42 AM writes...

But part of the goal of small biotechs is to become big drug companies, just like any other business. If there's no chance of doing that and succeeding, than people probably won't get into the business. Also, if the jobs for drug development are only at small companies (where much of the advantage is in being able to pay in stock or other promises of future cash than in actual cash), then unless chemists and biologists are less risk-averse than the ones I know, there won't be so many of them to staff companies. I don't think bio majors were looking to spend seven years in grad school so that they could spend the rest of their lives in grad school.

Highly competitive markets are great for consumers, but unstable, because they suck for business owners. Notice how chemical companies are trying to get out of commodity chemicals, trying to brand or formulate products directly to clients, and trying desperately to avoid "commoditization"? Nobody wants to play a ruthless game for low stakes. Either companies merge to form bigger ones to control the market, or people leave the busines and the few that are left control the market. Hoping that the pharma business will be a forever biotech is fruitless and illogical.

Oh, and if India wants drugs in its trials to made locally: Hello, China! I'd prefer to wait to get my drug ripped off until it at least actually reaches the market.

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9. Mutatis Mutandis on September 17, 2009 12:13 PM writes...

It is only too true that big pharma companies are too bureaucratic to succeed. Working at Big Pharma Company X myself, for the last four months or so I have received e-mail announcements of new organizational structures or management appointments virtually every day -- and not a single sign that our management might also be thinking about ways to substantially improve our capability to develop new drugs or our target selection.

If bureaucratic centralization was the answer to the problems of Big Pharma, we would KNOW, wouldn't we? It's hardly worth pretending that it has never been tried before.

I'm afraid that the problem with big companies is that they are almost always lead by people who are no research scientists, and even by people who subconsciously share the anti-scientific prejudices and the poor understanding of the scientific method that characterizes, sadly, most Americans. Because science is to them as hard to understand as magic (and indeed, virtually indistinguishable, per Clarke's Laws) managers instinctively try out every possible alternative option (several times, if their MBAs insist) before they will concede that to develop good drugs and get them approved, there is not alternative to doing good science.

This should be the time to overhaul -- and radically, too -- the way we choose targets, perform and analyse screens, select drug candidates, and perform clinical trials. Drug discovery is extremely old-fashioned, even compared to other sectors within biology, both in its working assumptions (which far too often go unchallenged) and in its procedures. The glut in expensive new technologies has produced very little return in investment because organizations have not changed their methodology accordingly. The fundamental reason is a lack of investment in critical thinking and fundamental understanding, which are perhaps not items you would put on the balance sheet or in the year-end goals, but which happen to be critically important.

I think it is correct to assume that the US is about to lose its leading position, and it won't be because health care reform is going to drain money out of the system. It's because a number of European companies, and I'm thinking primarily about the Swiss-based ones, are simply more innovative, and have more medical and scientific drive at the top. Their management is willing to take the risk of having a vision, instead of a mission statement filled with manago-babble, and acting on it. As Clarke stated, "The only way of discovering the limits of the possible is to venture a little way past them into the impossible."

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10. Anonymous on September 17, 2009 1:56 PM writes...

"I don't think bio majors were looking to spend seven years in grad school so that they could spend the rest of their lives in grad school."

AND..until the pharma companies stop pushing all the research science out of the business most bio researchers will find something else to do. I transitioned into Regulatory Affairs since 1.) It is hard to outsource; 2.) Uses all my skills developed doing research in industry the past 12+ years; 3.) pays better and 4.) it is the group that has a big impact on the bottom line of the company including their reputation. Oh and 5.) you can see the direct effect of your work on the patients which is why I went into this business in the first place.

Long live the king (pharma)! The king (pharma) is dead!

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11. Iridium on September 17, 2009 2:27 PM writes...

"Solution: small biotechs rather than big pharmas?"

That is a common theme. I am just curious.
What would be optimum size of a small biotech/small-big pharma?

I would say it is hard for a company with 10-30 employees to develop a new drug (unless the company has an "unlimited" budget for "unlimited" equipment and "unlimited" outsourcing).

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12. pharma process chemist on September 17, 2009 3:07 PM writes...

I think the model that the big pharma has being working towards is the develeopement, manufacturing, clinical, and commercializing of drugs. It is no longer a place where great innovative science happens. Therefore, you can see a model of many small pharma/biotech companies that do the research and once they have a compound they can be taken up by the big pharma for expensive clinical trials and eventual commercializing. This is already happening to a large extent. Pfizer has done it for years and survived on it and so have other big pharma's. Why waste the time and money to pretend to do research at big pharma anymore?

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13. Cialisize_Me on September 17, 2009 3:57 PM writes...

Big pharma mergers have *always* worked out---for those who planned, OK'd, and carried out the mergers. Lots of bonuses all around as rewards for successfully completing them. No offense to business development, but it seems like the incentives favor the immediate actions themselves (inlicenses, deals, mergers), rather than the long-term consequenses of those actions, like acquiring a dog compound/company or added bureaucracy (and no offense to dogs either).

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14. Hap on September 17, 2009 4:36 PM writes...

The Titanic analog is sort of curious, too - since the sinking of the Titanic didn't make ships better for the most part (apparently, with the exception that they included more life rafts), rooting for the iceberg seems like rooting for the death of an industry, with nothing else poised to replace it. Small companies might produce a lot, but are likely to cut corners because they don't have the money to run complete trials. (They also want to be big companies, as noted above - if the problem is with size and its consequences, then either there will be fewer small companies (because there is no point to success) or the same problems, later.) Academics can make drugs, but usually only in concert with pharma companies (and not all that many, yet). The government has the money and leverage to develop drugs, but it isn't clear that they can design and develop drugs better and more efficiently than pharma.

So, rooting for the industry to sink without something to replace it (and, oh, without any hint of change to the financial incentives and resultant behaviors that have played a big part in putting the Titanic (errr, pharma industry) and the iceberg together) seems like nihilism in action.

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15. milkshake on September 17, 2009 6:14 PM writes...

a better analogy than Titanic sinking would be the demise of colonial empires that followed the slaughter of WWII. You know, some of His Majesty colonial administrators had it pretty good, their native subjects a lot less so but at least they got sometimes decent roads, schools, clinics and functioning police that was not corrupt.

The life at the small lean companies post-breakdown could look rather like the post-colonial civil war in central Africa.

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16. AlchemX on September 17, 2009 9:55 PM writes...

Is the era of small molecule orally dosed drugs over? Will pharmaceutical companies have to use more than marketing to generate sales? I think the therapeutic torch is being handed to other areas. Stem cells seem to be making headway while new drug pipelines dwindle. A small molecule therapy may have to rely more on creative modes of delivery (materials/supramolecular?). I'm not saying synthetic chemists are becoming useless, but they are in surplus. The game seems to be over for simple small molecule therapy and the pro-BullShtrs (MBAs, consultants, ghostwriters, salesmen/women, etc.) are the only people making money while today's young scientists become so much cheap, narrowly trained labor.

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17. Mutatis Mutandis on September 18, 2009 5:55 AM writes...

There is no reason for assuming that the time of small molecule drugs is over: They retain very important advantages in production, storage and delivery. There is going to be more competition, and a need to make a decision about the right approach to treatment early on. But many of the new treatment modes still have to prove themselves. And small molecule drugs and stem cell based approaches are not necessarily in contradiction, as small molecules might be very useful to control the differentiation of (endogenous) stem cells.

The small molecule business may actually benefit from the growth in research on 'biological' drugs, because by its very nature this reminds us that effective drugs are primarily about biology and only secondarily about chemistry. The small molecule business has gambled too much on chemistry and paid far too little attention to biology, with a very high failure as a result. It was very bad in the first flurry of optimism about combinatorial chemistry, but even today many teams to too much chemistry work based on too superficial assumptions about the biology.

In this regard, we need to remind ourselves that X-ray crystallography is both a curse and a blessing. It's a blessing that we can see a structure of (some) proteins (often modified and always in a highly artificial environment), but we should learn to resist the seduction of confusing these marble statues with the real thing. Even Michelangelo's David cannot walk or breathe.

In the future, we will have to focus on properly understanding the biology first, and then choose whether we are going to interfere with the disease mechanism with a small molecule, an antibody, a peptide, gene therapy, or even stem cell treatment. There still will be a need for chemists, and perhaps not even fewer of them, but they are going to take a back seat and no longer can control projects the way they used to.

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18. Soon to be Pfizered on September 18, 2009 7:10 AM writes...

Can someone explain, clearly, why profit isn't good enough? All these doomsday scenarios are driven by the fact that 'there isn't enough growth'. So what?

I hope the future will be companies, small, medium, maybe even large, that are able to tell Wall Street to piss off. I'm so sick and tired of analysts going on and on about how the sky is falling. I'm sure you could find basically the same speech 5 years ago, 10 years ago, 20 years ago, ... It's always the same.

I just don't understand. Why do pharma managers get slammed all the time (deservedly) but Wall Street analysts get a pass? They are not our friends - they are only out to make money! They don't care about anything else. Plus, you can line up 10 analysts who say mergers don't work, I'll easily find 10 who insist its the only way forward. These are just opinions to convince clients that they know everything so please invest here and together we'll become multi-millionaires!

If everyone agrees with that, that nothing matters except the all-mighty dollar, then fine, lets drop research altogether and stop whining about it. Stick to all the wonderful generics, 75% of us can lose our jobs, flood every market, pull every penny out that we can, and then ... ? Uh-oh same problem, no more growth. Is this rational thinking?

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19. bbt on September 18, 2009 7:54 AM writes...

Only a matter of time.

Price controls (35-50%) on drugs in other countries amounts to a tariff. US consumers can only foot the bill for drug discovery for so long until it breaks the economy.

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20. CMCguy on September 18, 2009 10:09 AM writes...

#17. Mutatis Mutandis although I agree with what you state I would like to point out a couple of observations from slightly different tone. Combinatorial chemistry "craze" was driven by HTS evolutions from biology side which anticipated more "targets needs more compounds". The problem came as was both were hyped as new paradigms for discovery that would be faster and cheaper replacement route to drugs and so to Management it became a simpler "numbers game". These are great tools but should aid rather than replace more "traditional methods".

And in my view in terms of traditional drug development medchem has always taken a back seat to biology (whether chemists admit it or not). One makes compounds for SAR based on what the assay/model suggests "works". I am all for better understanding of biology but there is a point where one can never fully understand completely, particularly in living systems. There is a lot more understanding today there there ever was but it has not truly translated in to significantly more/better treatments (and that is the main problem converting knowledge into viable products. Frequently can not even study the biology without compounds (small molecules, biologics, gene fragments) that modulate the pathways. So there needs to be direct connections and collaborations between chemistry/biology to common project aim rather than arguments who is in control/more important.

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21. Evoluntary_Rich on September 18, 2009 11:21 AM writes...

On top of the misnomers you've already picked out of this rant/investor-pitch, he also used another couple of slights of statistics.

The number of IPOs this year is not an indication of anything specifically related to the pharma industry. IPOs were down across all industries in 2008 due to the state of financial sector, not the pharma sector.

The therapeutics areas idea was tried and failed. GSK have been doing this for 10 years in their "Centers of Excellence" set-up. All they acheived was more beauracracy and pointless competition for the same pot of money.

I agree with yours and another commentors points that the benefitors will be small companies and western CROs with eastern outfits.

Permalink to Comment

22. Evoluntary_Rich on September 18, 2009 11:25 AM writes...

On top of the misnomers you've already picked out of this rant/investor-pitch, he also used another couple of slights of statistics.

The number of IPOs this year is not an indication of anything specifically related to the pharma industry. IPOs were down across all industries in 2008 due to the state of financial sector, not the pharma sector.

The therapeutics areas idea was tried and failed. GSK have been doing this for 10 years in their "Centers of Excellence" set-up. All they acheived was more beauracracy and pointless competition for the same pot of money.

I agree with yours and another commentors points that the benefitors will be small companies and western CROs with eastern outfits.

Permalink to Comment

23. Rosalind on September 21, 2009 7:45 AM writes...

Regarding comparative effectiveness trials:

The pushback there is to have better molecular diagnostics to differentiate therapies, similar to what has been done w/ cancer diagnostics. It's not a huge leap, we already do a lot of this sort of thing in Phase II. So New Drug A might be good for severe depression with Marker B even though Old Drug C was used across the board for all depression but not so great for depression with Marker B. Unfortunately there, the more Affy chips we run, the more noise we generate.

Wyeth also did the "therapeutics areas" thing. Still had lots of projects hanging on too long, despite Bob Ruffolo's best efforts.

I don't see small companies as being the savior of pharma, though--hardly any have so much as a single person with the breadth of knowledge to bring a drug to clinical trials, much less to market. Most small biotechs I've seen (and I live in Beantown) have lots of people with very deep knowledge in an exceedingly narrow field, and the board of directors figures they can just sort of daisy-chain a bunch of these folks together and fill in the gaps with CROs. Then they are shocked, shocked! when things fall through the cracks, don't transfer properly, are suitable only for the Journal of Irreproducible Results...and that's the point at which they usually try to sell their molecule to Big Pharma.

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