A recent stufy by the Tufts Center for the Study of Drug Development (home of Red Sox fan Joe DiMasi who is also the lead author of the study) found that “genomic technologies have helped to significantly increase the number of drug candidates that enter clinical trials.” According to the Center, “During 2003-05, the rate at which the 10 top selling U.S. drug companies initiated clinical trials for new drug candidates rose by 52 percent, following a 21 percent decline from 1993-97 to 1998-02.”
In an interview with GenomeWeb News sister publication BioCommerce Week, Tufts Center director Ken Kaitin noted though the study did not seek to learn why R&D productivity increased or to address technological tools that might have helped enable it.” 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.
“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 . “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.”
Now the question is: can we apply the same science being used to improve drug discovery — characterized by the emergence of more validated drugs hitting more precise targets — to the process of drug development. The opportunity is enormous. Which is why supporting the Critical Path Initaitve is so critical.