Upturn predicted in pharmaceutical R&D

Following years during which fewer new drugs received marketing approval in the United States, drug developers are poised to reverse the trend, according to the Tufts Center for the Study of Drug Development.

The key to improving R&D productivity is the willingness of drug developers to use new tools, such as pharmacogenomics, to accelerate the pace of translating basic research into viable drug candidates and the aggressive management of clinical trials, Kenneth I Kaitin, director of the Tufts center, told Pharma Industry News.

The Center for the Study of Drug Development (CSDD) released its “Outlook 2006” report on drug and biotech development trends in January.

“As drug development has become more complex and expensive, developers have concentrated their resources on fewer projects,” Kaitin told Pharma Industry News. “This, in turn, has led to fewer new drug approvals in the last few years.

“Turning this around will require the industry, working with regulators, to embrace strategies and technologies that will enhance development of more complex drugs of high therapeutic value while improving assessments of product safety and effectiveness,” he said. “It’s a tall order, but it can be done.”

Between 2002 and 2004, according to the CSDD, only 58 new drugs received marketing approval from the U.S. Food and Drug Administration—a 47 percent drop from the peak of 110 new drugs approved between 1996 and 1998.