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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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« CMPI Conference: CATIE and ALLHAT | Main | Back From DC »

February 21, 2007

CMPI Conference: Critical Path

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Posted by Derek

The last panel of the day (I missed a good part of one in between, unfortunately) is on the FDA's Critical Path initiative and personalized medicine in general. It's moderated by Greg Simon of FasterCures, and features Michelle Hoffman of Drug Discovery and Development, Robert McBurney of BG Medicine, Gualberto Ruaño of Genomas, John Swen of Pfizer, and Janet Woodcock of the FDA.

Hoffman makes the point that some of the hyper-sceptical reporting of drug and medical issues is a reaction to the genomics hype of a few years ago. (I know, some of you out there who've seen stories that were ripped right from an idiotic press release are wondering where this sceptical reporting is, but I think she's talking about, say, the New York Times.

McBurney spoke about his academic background, saying that he cares even more about data now than he did back then, since millions of dollars are riding on the results. He also mentions the genomic craze, using a good analogy - that a caterpillar and the corresponding butterfly have exactly the same genetic sequence. "I have the same genome I did when I was born," he said, "but some things have changed along the way". His company has recently signed a deal with the FDA to look at preclinical liver toxicity, wirh funding from several large drug companies.

Ruaño is speaking about reverse genomics, "bedside to bench" work for figuring out drug and tox mechanisms. He's summarizing a recent paper in Mol. Psych. on the metabolic effects of antipsychotic drugs - the weight gain and prediabetic symptoms seen in a subset of patients. He and his company did a large parallel search for DNA markers between the patient populations on the two ends of the weight-gain distribution. As it turned out, in olanzapine-treated patients, an ApoE marker was higher in the heavy group, and and ApoE4 one was higher in the lean. For risperidone-treated patients, the leptin receptor and the NPY5 receptor fit the same pattern. They're starting to use their markers prospectively to predict how new patients will respond.

That leads into John Swen's view from Pfizer. He makes the point right at first that he doesn't blame the media for the overhyping of new technologies, as opposed to the people promoting them. (He's got a point, although I'd share the blame out a bit more - compare Michelle Hoffman's view at the beginning of this post). His view of the Critical Path initiatives is that it's going to be long slog to get biomarkers and transitional medicine to work out - worth it, certainly, but not something that's going to start delivering in a short time frame. (No argument here!) He also thinks that we could be doing a lot better than we are in things like new clinical trial designs (which is interesting coming from a company that's run the first large published Bayesian clinical trial).

And finally, Woodcock of the FDA is being asked about how the whole Critical Path initiative is going to fare at its current level of funding. She also feels that the media are very cynical about the sorts of technologies that are being promoted, which corroborates the over-reaction theme. She also says that the parts of the scientific community that are "more vested in the reductionist model" are also pushing back a bit. (My take is that the minute something useful comes out of the whole personalized medicine field, most of the critics will shut up with great alacrity. Success has a thousand fathers, for sure, and nowhere more than in a drug company). She largely dodges the funding question, saying that's it not really the agency's job to lobby for funds, but says that the biggest obstacle she faces right now is getting enough reviewer time to evaluate proposals properly. She thinks that the single best use of the money, though, is personalized medicine (which I find a bit arguable at this point, but eventually she may well be right).

Comments (6) + TrackBacks (0) | Category: Current Events | Press Coverage | The Central Nervous System


COMMENTS

1. BOB on February 21, 2007 6:46 PM writes...

Any talk on the recent downsizing of Pfizer or other companies. Why dont you address the apparent fictional shortage of chemists that the media and others sensationalize to bring in more cheap labor? Or has your current situation not enlightened you as to the effects of globalization on your chosen profession?

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2. curiousGeorge on February 21, 2007 8:37 PM writes...

Derek,

From my perspective, iIt seems like the FDA is ambivalent about new technologies such as biomarkers and other diagnostics. On one hand they clearly see these technologies as the best hope in the short term for keeping up with the sheer volume of activity under their regulatory authority, and in the long run, inevidibly as in the best interest of the public; however, at the same time, they seem deeply skeptical of the novelty of such methods and the potential for both political and public health disasters.

Did you also sense this contradiction during your visit?

Permalink to Comment

3. Derek Lowe on February 22, 2007 7:54 AM writes...

cGeorge, all I can say is that the FDA official on this panel was quite enthusiastic about these things. But what the rest of the agency thinks, and what they're willing to act on, is an open question.

Permalink to Comment

4. Derek Lowe on February 22, 2007 7:57 AM writes...

Bob, my job didn't go to China or India. It just up and disappeared on me - my company now has hundreds fewer researchers than it did last year. And I'm not sure what you mean by "bring in" more cheap labor, because once the labor comes here, it's not so cheap any more.

Permalink to Comment

5. SNP on February 22, 2007 8:57 AM writes...

He's summarizing a recent paper in Mol. Psych. on the metabolic effects of antipsychotic drugs...

As long as we're pointing fingers about hyperbole, have you read that paper?

Permalink to Comment

6. Hap on February 22, 2007 9:47 AM writes...

Derek,

At least from what has been said by the ACS, we need more chemists, both from abroad (larger numbers of visas and/or easier accessibility) and in recruiting young people to become chemists. The relationship between this policy and the current (apparent, since I don't know) lack of chemistry employment is probably what is being remarked upon.

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