The chief challenge for CIOs is piecing together all those diverse technologies into a fully integrated drug discovery process. Given that hundreds of vendors are jumping on the bioinformatics bandwagon and there are very few standards, that is no small feat. "R&D chiefs and CIOs are looking at all of these immature technologies in a quickly evolving marketplace and are being forced to spend quickly,"explains Craig Wheeler, vice president of Boston Consulting Group. "But it's necessary to put it all together - in silico [in the computer], in vitro [in test tubes] and in vivo [in life] - to get any real value out of it."
In order to do that, they've had to call in the IT troops, which have long been isolated from the lab scientists. Whether as a part of a new informatics department or working hand in hand with research, the role of IT is becoming increasingly important in the pharmaceutical industry. Peter Loupos, Aventis's vice president of drug innovation and approval information solutions, studied molecular biology and genetics as an undergraduate and IT as a graduate student. He now sits on the leadership team for drug discovery at Aventis and has watched the role of IT evolve.
Just five years ago, IS was a relatively isolated department responsible for providing infrastructure and operational support at Aventis. Today, the company's far-flung research teams depend on sophisticated software and hardware to do their jobs. The early phases of drug development are often done in silico, Loupos notes. "Similarly, it is impossible to perform global clinical trials and prepare [Food and Drug Administration] submissions unless the process is implemented with an e-business philosophy. This means that as an organisation we had to change our strategy, our focus and our skills,"he adds.
The role of IT is now central to successful research and development at Aventis. "This visibility has moved the organisation from the background to full partnership,"Loupos says. Aventis now employs "a cross-functional team approach, bringing together the skill sets of scientists, informaticians and IS professionals to create new solutions to drug discovery."
At Merck, the 30-person bioinformatics group is one-third computer scientists, one-third natural scientists and one-third that rare breed - the bioinformatician - with a dual background in science and IT. "To do [informatics] correctly you need to blend scientific skills and IT skills. Many on our staff are scientists with strong IT backgrounds,"Pfizer's Roberts says. "Otherwise you get technology without a purpose."
That partnership is particularly vital because most pharmaceutical companies are doing a combination of building some tools in-house, licensing software, and partnering with or buying up companies that already have a piece of the technology. The main reason for these acquisitions is that most can't find enough qualified individuals to keep up with their demand for new tools, and their core business remains drug, not software, development. "Our internal resources don't come close to matching our demand for tools,"says Ken Fasman, vice president and global head of research and development informatics at Massachusetts-based pharmaceutical company AstraZeneca. Fasman oversees a staff of 55 worldwide.
In 1998, Bristol-Myers Squibb built its own Laboratory Information Management System (LIMS), a database that allows the company to track DNA samples as they are sequenced, stored and analysed by scores of different scientists. The choice to build rather than buy at that time was out of necessity. "None of the vendors offered the kind of flexibility we needed,"Siemers explains. He needed a system that could be easily accessed by a scientist who was working at the bench with only three samples as well as by researchers examining 30,000 samples with a high-throughput screening device.
Although that LIMS is still in use at Bristol-Myers Squibb, the preference now is to buy informatics software and integrate it into the company's custom-built systems. "Our philosophy is if we can find a tool from a vendor that will do the task, it's in our interest to just go out and buy it,"Siemers says. "Our business is drug development, not software engineering."
But hundreds of vendors in the informatics space combined with varying standards and platforms makes the integration task tricky. Even Pfizer, known for doing more informatics in-house than most, works with about 15 major vendors in this area. "It's really become an integration job, and it's very difficult,"Roberts says. At Pfizer, Roberts uses simulation software from Missouri-based Tripos, chemical databases from California-based MDL Information Systems, and screening and visualisation tools from Massachusetts-based Spotfire, just to name a few. "We work very closely with all of our partners and try to sway them to build to our standards,"he says. "But frankly none of these systems are perfect, and we have to build a lot of bridges."
For example, Pfizer's scientists often use one database to examine the chemical structures of compounds in order to make assessments about their viability as drug targets. And then they have to transfer that information into a completely different piece of software from another vendor to assess that molecule's biological properties or safety. As a result, Roberts and his department are constantly faced with the challenge of building application programming interfaces (APIs) between different systems and databases.
Although vendors are beginning to offer more modular systems that can plug in to other systems or well-documented APIs in an effort to garner a bigger chunk of this billion-dollar business, many are still hawking closed, standalone systems. "We're able to push vendors more and more to work with open standards, but when someone has a monopoly position, you don't have a lot of leverage,"says AstraZeneca's Fasman, who works closely with his IS counterparts to deal with such problems.
The number of mergers and acquisitions in the drug industry further complicates the integration issue. Recent major drug marriages include Warner-Lambert with Pfizer, and SmithKline Beecham with Glaxo Wellcome to produce the Middlesex, England-based GlaxoSmithKline. "Everyone has different databases,"says Dinerstein of Aventis, which was formed by the merger of Hoechst Marion Roussel with Rhone-Poulenc Rorer in 1999. "We have immense amounts of data, but our first task is to figure out how to make that data accessible."
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