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Enabling Technologies

By Kevin Davies

May 15, 2007 |  A year or two ago, we privately polled a small group of scientists and advisors on a variety of issues about the scope and direction of this publication. A senior scientist at one big pharma suggested that Bio•IT World should consider changing its name.... to Bio•ET World. “ET,” he suggested, would stand for “Enabling Technologies.”

Although we clearly weren’t persuaded that changing a solitary vowel in our title would dramatically enhance this magazine’s reputation or prosperity, it was an intriguing thought. We certainly strive to report on the most critical enabling or disruptive technologies, and in this issue, we believe we’ve highlighted two that will transform the life sciences in the years to come.

Recently, I took a short road trip to Beverly, north of Boston, where in a small windowless laboratory, scientists from Applied Biosystems are tinkering with the instrumentation that could become the mainstay of the so-called next-generation sequencing field

Kevin McKernan, co-founder of Agencourt, part of which was acquired by Applied Biosytems last year for $120 million, generously acted as tour guide for a glimpse of the SOLiD platform. We saw the inner workings of half-a-dozen instruments, each named after a famous female scientist. You can too, both in Beverly and in Foster City, California, as Applied Biosystems is eagerly looking for early access partners to test the technology before it is commercially released early next year.

As described in this month’s cover story (see p. 22), the Applied Bio system stands out from the “sequence-by-synthesis” of Roche and Illumina because of an ingeniously different readout system that, in principle, provides greatly enhanced error detection. It also uses a very different kind of chemistry to most other approaches. But it does not (yet, at least) offer particularly long read lengths, and even senior executives acknowledge that its chief application will be in resequencing rather than de novo sequencing. At $600,000 per instrument, it’s not cheap!

The fate of SOLiD will be a fascinating story in the coming years, not least because Applied Biosystems has enjoyed a virtual monopoly in the DNA sequencing market since the company was founded two decades ago. At CHI’s inaugural next-generation sequencing conference in San Diego earlier this year, Applied’s Michael Rhodes confidently predicted that the SOLiD instrument would be the “Formula One” car of the next-generation sequencing field. When I suggested to him that perhaps a NASCAR analogy would be better suited for a predominantly U.S. audience, his English roots showed through: “Nah, Formula One’s faster!” he laughed.

While Applied Biosystems executives are understandably confident in SOLiD’s capabilities, it still lags Roche and Illumina, which continue to sell instruments, build market share, and garner prestigious publications. This month, Roche/454 will present further details on the first next-generation genome guinea pig — one James D. Watson.

Adopting Adaptive
Also this month, we take another look at the fascinating world of adaptive clinical trials. These trial designs, which we first covered in some detail last year (see “Real Time Trials,” Bio•IT World, June 2006), promise to dramatically improve the clinical trial process, offering the prospect of more sophisticated dosage and patient selection, and the potential to realize significant savings of time, patients, and money.

Our tour guides here are experts from software consultancy Tessella and Wyeth’s Michael Krams, one of the leading adaptive design architects within big pharma. Krams spent a decade at Pfizer, where he played a lead role in designing one of the first major adaptive trials, saving Pfizer a significant sum of money when the trial was halted early. Krams hopes to launch half-a-dozen adaptive trials this year at Wyeth. We heard a similar story from John Orloff at Novartis, who proclaims his company is, “among the few trail-blazers in applying novel statistical methods and trial designs to drug development. This includes adaptive/seamless designs.”

Tessella, based in the United Kingdom, has served as a consultant to big pharma on software issues for a quarter of a century, but has been quietly working on adaptive designs for almost a decade. With the field gaining momentum, there should be many more players and projects in this field soon. But as Krams, Orloff, and Tessella acknowledge, the true ROI on adaptive designs won’t emerge until the projects move into Phase III.

Sequencing and adaptive trials may work at opposite ends of the R&D/drug development pipeline, but both promise to have a profound impact on the future of medicine.

Email Kevin Davies.

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