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Labor Pains and Gains


By John Russell
Sept 15, 2005 | Labor Day is the starting gun for industry's race through the next year. Few countries besides the United States galvanize so quickly and frenetically around a single yearly date. We've become homozygous for the September-get-back-to-work gene. (I wonder if there's a mouse model for this condition). Autumn is often when agendas are set.

Here are three watch items on my agenda:

1. Transparency
Scandal over Vioxx. Outcry over drug pricing. Criticism over lean pipelines. The $450-billion-plus pharmaceutical industry is feeling massively under-appreciated. It feels attacked by the press, misunderstood by the public, dogged by regulators, and swarmed over by an army of consultants claiming to have the secret sauce to make things right. There was a sort of generalized chest-thumping, press-pounding blast emitted by Big Pharma keynoters at DDT* this year.

Get over it. The pharmaceutical industry is under-appreciated. Drug finding and making is tough. The pharmaceutical industry does enormous good. Statins -- and a great many other drugs -- are saving and extending lives. Thank you. But pharma is a for-profit business. Its desire to do good occasionally collides with its imperative to maximize profits. Bad decisions are sometimes made. The real wonder is so little ill gets done.

Forget the press -- it's fickle and thrives on controversy (mea culpa). Instead, adopt real transparency in clinical trials, down to Phase II. Put the decision-making burden on doctors and patients. Pull the industry out of the bull's eye. Tone down rhetoric lambasting the media's failure to explain the risk-benefit nature of all drugs. It misses the point. Risk-benefit is a doctor-patient discussion that must be held in context. Worry less about revealing the competitive information (Phase II), accept a few lost sales, and avoid (mostly) the massive market withdrawals of the Vioxx variety.

2. Systems Biology
So, figuring out what systems biology is has become less important. Quietly, slowly, and against great bias, a few substantial biopharmaceutical companies have begun using pathway analysis tools, predictive computational models, and clever systems-level assays in real research programs. This contrasts with early-adopter flirtations of even a year ago. The tide hasn't turned, but it's turning.

Entelos, BioSeek, Pharsight, Optimata, GeneGo, Genstruct, Gene Network Sciences, and Genomatica are just a few systems biology companies that are succeeding to some degree. Some have been around for a decade while others are nearly new. On the user side Pfizer, Merck, AstraZeneca, and Novartis, again to name just a few, have active programs using systems biology tools. Pfizer even has a director of systems biology.

One healthy sign is the realism expressed by systems biology executives. Consider this from James Karis, CEO of model-maker Entelos, "We're at the very early stages still. I wish I could say something different. But we're going beyond early adopters. We used to see a lot of requests from people to look at something they already knew the answer to. They were just trying to find out how the models work. Now were seeing requests for help with problems they cannot solve."

Bio-IT World will cover this exciting space with one of several new e-newsletters, "Systems and In Silico Biology," to be launched later this fall and written by yours truly. If you play in this space, please drop me a line so that I can add you to my contact list.

3. Crawford and McClellan
Anyone heard from Mark McClellan lately? Didn't he work at FDA? Just kidding. I'm expecting to hear more from him and from his successor, FDA commissioner Lester Crawford, as their boss Secretary Mike Leavitt of Department of Health and Human Services pushes the drug and healthcare industries to work more closely together.

While McClellan is laboring away on pricing and efforts to connect clinical trial data and medical data, Crawford will be busy with his own four-point program outlined at DDT: 1) Technology Development and Innovation; 2) Patient and Consumer Protection; 3) Improving Manufacturing Practices; and 4) Modernize the FDA.

I'm hoping Crawford's tenure is long enough to actually do some of those agenda items.

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* Drug Discovery Technology and Development Conference, held in Boston in August.

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