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By Mark D. Uehling

September 9, 2002 | It's one of the medical world's most neglected disorders. Pharmaceutical Company Bashing Syndrome (PCBS) afflicts growing numbers of congressmen, journalists, and investment analysts. PCBS is not life threatening, but it is highly contagious. Victims are chronically dissatisfied with drug prices and product pipelines in the pharmaceutical industry.

But news from Boston after the Drug Discovery Technology World Congress in early August suggests that a cure for PCBS is on the horizon.

Unfortunately, the antidote is a pharmaceutical executive who stands more than 5 feet tall and will, as a result, be difficult to fit into a small plastic bottle. Patrice Milos manages pharmacogenomics and DNA sequencing at Pfizer Global Research and Development, a division of Pfizer Inc.

She doesn't have a specific drug to boast about, and she won't promise the moon. But Milos can articulate a sensible case for at least one scientific and IT challenge that large pharma companies, and only large pharma companies, can attempt. "We have unique opportunities as a large pharmaceutical company," Milos told the Boston audience. Milos explained that all of Pfizer's clinical trials are now assessed for pharmacogenomic relevance. To wit: matching the genetic makeup of patients to specific medicines.

That could mean a medicine that didn't quite pass muster in the past could be reintroduced and targeted only to those who will respond well to it, or who will not experience serious side effects.

"It wasn't standard practice to be doing standard genotyping and using it in clinical trials," Milos said. "That's what we set out to do." Milos said the project has been running for five years, which means it started well before the hoopla of the human genome project began inflating expectations for most shareholders of drug and biotech stocks.

Pfizer's program identifies selected patients in clinical trials and secures their consent to collect blood and genetic material, from which scientists extract DNA and RNA. The eventual goal of pharmacogenomics is to match a drug prescription not just to a patient of a certain age or sex but to a particular genetic and disease profile.

A first step down that path is cataloging the millions of subtle differences between individuals, or so-called single nucleotide polymorphisms (SNPs). Pfizer is also compiling its own SNP data because, as with drugs, there could be money to be made from diagnostic tests used in conjunction with medicines.

"What we see is potentially widespread medical screening with SNP chips," Milos said. SNP screening tests could lead to medicines customized to fit the patient, she explained.

The promise of pharmacogenomics is that good responses and immunity to side effects could be predicted from Pfizer's databases -- repositories of information built with clinical data from the thousands of patients in Pfizer-sponsored medical studies. With a drug like the cholesterol-fighting Lipitor, Milos said, there may be 100,000 patients in a variety of ongoing clinical studies; Pfizer has hundreds of drugs at various stages of development. That's a big pool of people to draw DNA from, though Milos won't say how many people Pfizer has sampled.

To compile its pharmacogenomic database, Pfizer spent a year and a half building a system that would take patient data and "anonymize" it, stripping it of identifying personal information that would make it possible for patients to be tracked down later. That may sound like a legalistic frill, but sensitivity to privacy will help the company enroll patients. It could also inoculate the company against the bad publicity that might result after the unintended release of information about the genetic condition of an ordinary family.

As Milos outlined the complex interdisciplinary scientific and IT aspects of what Pfizer is exploring, it was clear that a smaller company would never have had access to so many patients, much less the money to do the project right. Likewise, Pfizer was smart enough to partner with a smaller, nimbler expert in pharmacogenomics: Genaissance Pharmaceuticals of New Haven, Conn.

But part of what makes the Pfizer pitch appealing is that it is understated and devoid of the often grandiose promises of small biotech companies. (Some researchers believe those promises are a cause of PCBS.)

"We think we have a strategic approach," Milos said. "I don't think we've gotten it all right yet. But we've seen a lot of exciting developments over the past two years."





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