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By Kevin Davies

Feb. 1, 2008 | You know the pharmaceutical industry is in trouble when the CEO of one of the top ten big pharmas decides to abandon his 44th-floor midtown view of Manhattan for cheaper digs on a lower floor. But that’s what Bristol-Myers Squibb (BMS) boss James Cornelius says he will be doing this year.

Some pharma CEOs may think that a bit drastic, but 2007 was another mediocre year for the industry. Just 19 new drugs were approved by the FDA, continuing a bleak run of productivity with few signs of an imminent upswing (See Can Academics Save Pharma? Bio•IT World, Nov. 2007; and Inside Andy Grove’s World of Bio-IT, Bio•IT World, Dec. 2007). But amid the gloom, there are — as there usually are — signs of genuine hope and innovation. From our standpoint, they exist in the fruits of basic research and in the output of dynamic new drug companies, as well as signs that big pharma is tackling its many problems head on.

So as we kick into 2008, here are a few silver linings that have caught our eye, trends that suggest there is more reason for hope in the bio-IT arena than ever before.

Complex Genetics: 2007 was a watershed year for the study of complex, multigenic diseases. To recap the list of gene mapping breakthroughs for common diseases that affect most Americans would fill this column. And 2008 was barely a week old before further exciting revelations of a genetic glitch associated with autism. As researchers continue to tease out mutations and copy number variants associated with common diseases, look for better insights into clinically relevant pathways and ultimately new therapeutics.

Biologics Bonanza: 2007 was “the year pharma fell in love with biologics,” according to The Motley Fool. And when AstraZeneca forks over a whopping $15 billion for a leading biologics company, MedImmune, one can only agree. It’s not just the favorable patent situation surrounding biotech drugs, however. As the recent successes of Genentech show, biologics can be very potent weapons against cancer and other diseases. BMS, Pfizer, Novartis and others are all expanding in this area.

Structure Prediction: One of Science magazine’s “Breakthroughs of the Year” was the long-awaited crystal structure of the beta-adrenergic receptor. For the family of G-protein-coupled
receptors, that makes two structures down, a mere 998 to go! Hence the sharp interest in protein folding predictions. 2007 saw a spectacular paper from David Baker’s group (See Improving Structure Prediction, Bio•IT World, November 2007), pointing to major progress in this field. (We will spotlight a stunning drug design application of similar methods in next month’s issue.)

Red, Red Wine: As someone who is partial to a spicy Shiraz every now and again, it’s good to know that the occasional indulgence might have health benefits. 60 Minutes said as much a few years ago with a report on the Mediterranean diet. Now Sirtris Pharmaceuticals, which went public last year, is demonstrating remarkable properties among derivatives of the active ingredient in red wine, a compound called resveratrol. It’s a reminder of the remarkable innovation at the heart of the biopharma industry.

Far Out FDA: As reported elsewhere in this issue (See p. 22), the FDA’s new mandate regarding electronic clinical documentation went into effect January 1st. While this might cause short-term pain for some biopharmas, it can only help the industry in the long term. This and other initiatives, including genetic testing information on drug labels (See Predicting Dose Response, Bio•IT World, September 2007), show some welcome far-sightedness at the FDA.

Stem Cells: In a science story that truly deserved to be front-page news, Japanese and American researchers reported success in reprogramming normal human cells to become stem cells, simply by introducing four genes. This does not obviate the need for continued embryonic stem cell research or excuse the White House’s smug reaction to the news, but it ensures that stem cell research has new, exciting avenues to explore.

Predictive Technologies: The FDA’s growing interest in predictive technologies is evidenced by R&D agreements with informatics and in silico powerhouses Ingenuity and Entelos. These items, together with a growing body of papers in the literature, suggest both growing interest in and near-term payoff from predictive approaches. 

Consumer Genomics: From 23andMe “spit parties” to the launch of the first full-genome sequencing services, 2007 was the year that personal/recreational/consumer genomics became a real entity. How will the public respond to these new services? Or physicians? How will the industry be regulated? And how much closer will we be to the $1000 genome by the end of 2008? Stay tuned…

Picking 44: And then there’s the small matter of this year’s U.S. presidential election. No endorsements here, but the prospect of a more tolerant and enlightened view of science and medical research cannot come soon enough.

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 This article appeared in Bio-IT World Magazine.
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