NEW YORK, May 18 (GenomeWeb News) - Genomic technologies have helped to significantly increase the number of drug candidates that enter clinical trials at the world's biggest pharmas, according to a report released last week from the
After declining more than 20 percent from the mid-1990s to the early-2000s, the rate at which new drugs entered the clinic increased 52 percent between 1998-2002 and 2003-2005, the report found.
Though the study did not seek to learn why R&D productivity increased or to address technological tools that might have helped enable it, TCSDD Director Kenneth Kaitin said discussions he has with officials from big pharma indicate that genomic technologies and methodologies have played "an increasingly important role" in driving the improvement. These tools and methods include mass spectrometry, genome sequencing, gene-expression, high-content screening, and SNP-genotyping.
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. 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 [genomic tools are] playing an increasingly important role in candidate selection for products that enter clinical testing," Kaitin told GenomeWeb News sister publication 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."
TCSDD reports 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 new 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.
Kaitin said drug company 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.
The complete version of this article, which includes tips for building better relationships with big pharma, appears in the current BioCommerce Week.