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Genomic Technology Helped Drive 52-Percent Jump In R&D Success at Big Pharma; More Business Likely

Big pharma may have genomic tool vendors to thank in part for a recent surge in R&D productivity — and it could return the favor with greater technology investment.

After declining more than 20 percent from the mid-1990s to the early-2000s, the rate at which new candidates at the 10 biggest drug makers entered clinical testing has increased 52 percent in recent years, according to a report released last week from the Tufts Center for the Study of Drug Development.

According to CSDD Director Kenneth Kaitin, genomic technologies and methodologies, including mass spectrometry, genome sequencing, gene-expression, high-content screening, and SNP-genotyping, have played "an increasingly important role" in improving these numbers.

The report also showed that the overall percentage of drugs that reach the clinic and go on to win US Food and Drug Administration approval — 20 percent — hasn't changed much in 30 years, said Kaitin. But most of these candidates began life in the clinic before genomic tools were widely used, and big pharma, emboldened by the way these tools lifted their overall R&D productivity, may decide that investing more in new technologies might lead to better data and improved odds with regulators for the next crop of drug candidates.

"I don't think there is any question that's playing an increasingly important role in candidate selection for products that enter clinical testing. Every company that I speak to now is saying that a significant improvement in their ability to select compounds for clinical development is access to these tools."

"I don't think there is any question [genomic tools are] playing an increasingly important role in candidate selection for products that enter clinical testing," Kaitin told BioCommerce Week. "Every company that I speak to now is saying that a significant improvement in their ability to select compounds for clinical development is access to these tools."

The results of the study come at a time when big tool vendors, still smarting after weak pharma sales in 2005, remain anxious about the industry's spending plans for 2006. Some, like Waters and Thermo Electron, have expressed cautious optimism about big pharma's plans for big-ticket research instruments [see BioCommerce Week 4/26/2006]. Others, such as Beckman Coulter, expect "careful" pharma spending for the rest this year [see BioCommerce Week 2/26/2006], while Agilent said during its fiscal second-quarter financials this week that it sees "continued slowdown [in spending by] big pharma."

Tufts studies carry enormous weight within the pharmaceutical industry. Its high-profile study on the cost of developing new drugs, which it conducts about every 10 years, most recently found that it costs more than $800 million and takes up to 15 years to bring a drug to market. These results, released in 2001, have become at once a rallying cry for pharmas eager to lower the regulatory cost burden and a defense for skyrocketing prescription costs.

That study has also played into the hands of genomic tool vendors that claim their technologies can lower the cost of drug discovery early in the game, at once saving millions in early-stage R&D funds while stacking the enrollment deck with patients genetically more likely to respond favorably.

The productivity study, therefore, might offer a hint of encouragement to entrenched tool vendors, especially instrument shops that have been buffeted by pharma's cyclical spending patterns. Though the study did not seek to learn why R&D productivity increased or to address technological tools that might have helped enable it, Kaitin said big pharma officials whom he interviews tell him genomic tools are becoming increasingly important to them.

R&D heads at big pharma "are all talking about their increasing reliance on these platforms to make better determinations about which products to move forward," he said.

Schprechen Sie Pharma?

Tool vendors wishing to compete more aggressively for pharma's R&D dollars should know that "customer relationships are important," and companies able to "speak the language of pharma" will have better relationships, said Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development.

"One of the things that pharma has been very suspicious of is vendors that don't speak pharmaceutical-ese," he said. "They want people who can talk about drug development and understand drug development."

Big pharma is notoriously insular and distrustful of outsiders, so "if you want to sell to [them] and have them embrace your technology in a way other than just buying it and trying to bring it into their drug-development process, I would say speak their language."

But even that stereotype is evolving. The vision of big pharma as insular is "slowly changing," Kaitin said, and the changeover could play into vendors' favor. "There's been a sort of a turnover within the industry where the old guard is being replaced by people who have more of a global view of the process, and the need to incorporate different aspects," Kaitin said. "Because we live in a different type of world [than] drug developers of the past lived."

— KL

According to the study, the rate at which new drugs entered the clinic increased 52 percent between 1998-2002 and 2003-2005 after sliding 21 percent between 1993-1997 and 1998-2002.

Though most genomic technologies in common use today were introduced in the late-1980s and early-1990s to attack what Kaitin calls pharma's "productivity problems," there was a paucity of "good validation techniques" available to help researchers winnow good leads from bad, he said.

"So the industry continued randomly selecting candidates, which resulted in low success rates and high costs," said Kaitin. "What's changed over the last few years is that many big pharma companies explored, and many smaller [technology] companies are providing more tools for making better determinations for which candidates are more likely to succeed."

The Tufts study also found that the percentage of drug candidates that win US regulatory approval has not changed much in the past 30 years: Around 20 percent of drugs that entered the clinic at Phase I went on to win FDA approval, as did around 60 percent of Phase I-II drugs, approximately half of drugs in Phase II-III, roughly 70 percent of drugs in Phase III-NDA Sub, and around 95 percent of drugs in the NDA Sub/NDA App stage.

"The fact is, if you increase the number of products that enter clinical testing and you are keeping the success rates the same, the [drug] companies will very quickly run into a wall where they can't afford to bring all of these products into development," said Kaitin. "And that's not a good place to be."

Kaitin said genomic technologies were not used very often when these drugs entered the clinic, however, and said he believes these tools could help the current generation of candidates increase their odds of attaining regulatory approval.

"I think that's what these technologies are offering that didn't exist in the past," he said. "My hope is that as this newest crop of products starts moving through … the development process, we're going to start to see a slow creeping up of clinical success rates, which will enable better leveraging the technologies."

— Kirell Lakhman ([email protected])

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