Tufts Study Offers Optimism for Drug Developers

Despite development challenges such as rising R&D costs, increasingly strict regulatory requirements, and safety concerns, drug developers have cause for optimism, according to the Tufts Center for the Study of Drug Development.

According to the center’s most recent study, the contributing factors for this optimism include the use of new technologies to reduce late-stage development failures and control costs, reliance on global outsourcing to speed development and reduce costs, and more coordination between U.S. and European regulators.

“While drug developers have understood that their long-term viability depends on improving R&D productivity—and have taken steps to address the issue—they’re about to see their efforts pay off in terms of improved success rates and greater numbers of new medicinal products reaching the marketplace,” said Tufts CSDD Director Kenneth I. Kaitin.

Mr. Kaitin cited that the number of new drugs entering clinical testing by the top 10 firms increased by 52% in the first part of this decade. He also said that new product development at small/mid-tier pharma and biopharma companies is making up for the product gap that large pharma firms have been experiencing. “Most notably, drug companies are improving their management of risk, especially by actively lowering late-stage attrition rates through greater use of information technology and other development practices,” he said.

The Tufts CSDD’s Outlook 2007 report included other positive trends such as improving drug discovery by examining pre-competitive data to identify and validate new targets, small/mid-tier pharma adopting outsourcing and other clinical practices used by big pharma to control costs and manage risk, and for biotech firms, increasing biodefense and pandemic disease related R&D.

Regulatory trends include the FDA modifying its regulation of off-label prescription uses by evaluating current studies or by requesting new ones before deciding whether to further regulate off-label uses. The report also cited that within two to three years, approximately 65% of FDA-regulated clinical trials for top pharma companies will be conducted abroad. Additionally, the EMEA will focus on new legislation for integrating drug regulatory agencies of new EU members into a comprehensive European system.