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Conference: Pharma R&D Spending Moving Downstream to Clinical Trials, ADME-Tox

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Watchers of the genomics tools trade have been whispering lately that pharma companies are tightening the purse strings on R&D spending this year—so much so that analysts have been quizzing execs at companies like Ciphergen about it during quarterly conference calls.

But the verdict delivered at the Thomas Weisel Partners Healthcare Tailwinds conference, held earlier this week in Boston, was that pharma spending on life sciences tools companies has not decreased: Rather it has just moved downstream.

“That industry will spend more money on R&D than I can imagine,” said Allen Lauer, CEO of instrument maker Varian and a 20-year veteran of the life sciences instrumentation industry. “I don’t think the issue is whether the spending is going to be enough to sustain a vital [tools] industry, but what to spend it on.”

“There is more spending in target validation, ADME-Tox, and new approaches to clinical trials,” said Alan Dance, senior vice president of corporate marketing at Affymetrix.

 

Pharmacogenomics: More Than Just a Fancy Word

 

In the arena of clinical trials, pharma companies are jumping full-tilt into pharmacogenomics, according to participants at the conference.

Pharmacogenomic studies of clinical trial populations have been happening “in spades,” said Daniel von Hoff, the director of the Arizona Cancer Institute and the founder of Ilex Oncology, during a panel on FDA registration strategies. Drug developers, von Hoff explained, are caught between investors who pressure them to produce positive results in short periods and the demands of the FDA for solid research. So they are using microarrays and other tools to “enrich” clinical trial populations before beginning trials. This enrichment process includes eliminating study subjects who would have an adverse response to a drug and choosing those whose disease is more likely to respond to a therapy.

“Until recently, I thought pharmacogenomics was a couple of years off,” noted Lauren Linton, vice president of applications marketing and R&D at Applied Biosystems. Then Linton saw a recent presentation by GlaxoSmithKline vice president of genetics research Allen Roses about how the company used pharmacogenomics to detect a subpopulation with an adverse reaction to a drug, she said.

Linton, who formerly co-directed the Whitehead Institute Center for Genome Research, added that she thought there would be “widespread adoption of genotyping” for pharmacogenomics. Not coincidentally, she noted that ABI and Illumina are soon planning to release their fiber optic-based genotyping assay system for this purpose.

Still, Linton said she believes FDA approval of genotyping as a clinical screening device is about a decade away.

Affy’s Dance added that he thought whole-genome SNP analysis is also going to be important in the long run, but said there is “a lot of genetics to be done before we get there.” In the meantime, he said, more limited tools like the p450 metabolism SNP array that Affymetrix is developing in partnership with Roche Diagnostics, as well as the company’s classic gene expression microarrays, are useful for pharmacogenomic studies. “We have found that gene expression profiles can correlate with clinical response,” he said.

 

ADME Adds Up

 

David Julien, president of Sigma Aldrich’s biotechnology division, said that his company is doing a brisk business in providing oligonucleotides for “home brew” targeted arrays and that he saw microarrays “shortening the bottleneck in ADMET testing.”

Affymetrix is also seeing its arrays increasingly used in predictive toxicology, according to Dance. While he said that demand for whole genome arrays for this purpose continued to “outstrip” demand for targeted arrays, he noted that the costs of ultra-high-throughput screening in toxicology or other areas would ultimately demand arrays with fewer genes each.

Along these lines, Dance said that Affymetrix may seek out a collaboration to develop targeted arrays for chemigenomics—possibly microplates with small numbers of gene probes in the bottom of the wells. Researchers would perform cell-based assays of lead compounds in these microplate wells, then look to see how particular compounds impacted expression of particular genes in the cell. But this is “early days,” said Dance. Just a handful of companies are interested in this application, and Affymetrix has not even decided how many probes would be needed per microplate well. Additionally, the company might need to further shrink feature size, which is now down to 18 microns, and would require a collaborator with expertise in liquid handling.

Would PerkinElmer be interested? According to Frank Whitney, head of life sciences at PerkinElmer and former president of Packard Biosciences, the company seems to have its hands full with the Packard acquisition. “We [just] put two companies together of roughly the same size,” said Whitney. “This is a big deal.”

— MMJ

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