The marriage of IT and medical research may be just what traditional pharmaceutical companies need to survive in an increasingly competitive field.
Scientists at Aventis Pharma had just finished animal testing on a promising new drug to treat asthma, and they knew they had to move fast. Two of their biggest competitors, GlaxoSmithKline and Schering-Plough, had similar treatments further along in the drug testing pipelines. Both companies were already proceeding with human trials to test the effectiveness of the same approach Aventis was studying - an anti-interleukin-5 (anti-IL-5) therapy designed to inhibit a protein thought to foster asthma attacks. So rather than starting late down the same pro-tracted and pricey path, Aventis embarked on an unusual shortcut; it turned to California-based Entelos to run a new kind of software that could simulate a clinical trial on two virtual asthmatic patients named Alan and Bill. Results from the computer simulation program led Aventis to doubt that the anti-IL-5 therapy would be an effective agent against acute asthma attacks. The same conclusion was reached by its competitors after years of expensive clinical trials.
The biosimulation technology that Aventis used to achieve such cost-effective results is just one in a growing arsenal of new information technologies that offer tremendous potential to streamline and reduce the costs of drug development. Grouped under the umbrella of bioinformatics, these technologies all involve the use of computers to store, organise, generate, retrieve, analyse and share genomic, biological and chemical data for drug discovery. And their usage is spawning an entirely new branch of IT.
"It's a magical time in the history of science now that we have so much computing power and storage capacity,"says Robert Dinerstein, a senior research scientist in the New Jersey laboratories of Frankfurt, Germany-based Aventis Pharma.
It wasn't always so. The pharmaceutical industry, a conservative bastion of empirically minded scientists, has been slow to embrace new technologies. And, in fact, for much of the 20th century not much changed about the trial-and-error process of creating new medicines. Historically, the drug discovery process has invariably begun with a theory about the possible cause of a particular disease. "Some idea got us started - either from scientific literature, a particular researcher's expertise or just someone's crazy idea,"Dinerstein explains. The preclinical research continues with the synthesis and purification of a compound that appears to affect a certain protein or molecule thought to be involved in the disease process. Using test tubes and petri dishes, scientists then conduct efficacy and safety tests on that compound or drug candidate. If it passes that hurdle, they move to more extensive preclinical and clinical testing processes to determine how the body responds to the compound - how it's absorbed, distributed, metabolised and excreted (pharmacokinetics) - as well as the chemical effects of the drug on the body (pharmacodynamics). Then the testing begins on animals and proceeds to three phases of clinical trials in humans.
But the old-school approach to drug development is expensive, time-consuming and prone to failure. Nearly 75 per cent of the 5000 drug candidates currently tested in these different phases fall short of expectations and never reach the market. Factoring in the cost of all the drugs that fail, drug companies spend an average of $US880 million and 15 years to develop each new drug that does make it to market, according to a recent study by the Boston Consulting Group. And, of course, they pass those costs on to the consumer (employers, hospitals, insurance plans and patients) with prescription drug mark-ups that have become the target of increasing criticism.
Such high costs (and the ensuing negative publicity) have finally brought the pharmaceutical industry, kicking and screaming, into the IT age. In fact, bioinformatics may be just the shot in the arm drugmakers need to survive in an increasingly competitive and consolidating field. By fully integrating these new technologies, analysts say, pharmaceutical companies could cut the cost of creating a new drug in half and shave two to three years off the development. In addition, informatics holds the promise of uniting what have traditionally been separate research and development efforts within the same companies.
"We're an information-based industry, but we've been a bit behind in the extent to which we've been using computer-based tools,"Dinerstein says. "They've had better computer models for oil drilling than we've had for drug discovery."
While executives in this closely guarded industry won't say how much they're investing in research and development informatics, they are definitely hopping on board. New Jersey-based Merck & Company recently paid $US620 million to acquire Rosetta Inpharmatics, a Washington-based genomics and technology company. And New York City-based Pfizer says it recently spent more than $US100 million to create an "integrated system of high-speed discovery technologies". Pradip Banderjee, a senior partner with Accenture Consulting, conservatively estimates that drugmakers as a whole spend more than $US4 billion a year on that kind of technology, not including the cost of hardware. But compared with the cost of a clinical trial - particularly a failed one - it's not much. "We spend tens of millions of dollars on early clinical trials. If you could use this technology to tell someone early on whether or not to do a clinical trial, that would be significant,"Dinerstein notes.
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