Tufts publishes Outlook document for 2005

Drug companies can significantly increase the flow of new prescription drugs, while maintaining patient safety, if they adopt more innovative R&D strategies aimed at improving clinical success rates and lowering clinical study costs, according to the Tufts Center for the Study of Drug Development.

"Product pipelines are the bottleneck in bringing new medicines to market," said Tufts Center Director Kenneth Kaitin, in connection with the release today of the Tufts Center's Outlook 2005 report on drug and biotech development trends.

The report will shortly be available for download from Tufts' website.

"Despite rapidly rising R&D spending by the research-based industry, the number of new drugs and biologics submitted to the FDA for review has steadily decreased in recent years," he noted.

Drug developers must bolster R&D efficiency to remain competitive, continued Kaitin, adding that one of the most effective ways to improve R&D productivity is by terminating unpromising R&D projects as soon as possible.

The earlier that unpromising projects are stopped, the sooner funds and other resources can be re-allocated to, presumably, more productive lines of research.

According to Tufts, a new prescription medicine, on average, costs $802 million and takes up to 15 years to develop and win approval.

Investing in state-of-the-art information technology, to better understand the data generated in discovery, and developing strategic alliances with specialised drug developers remain two of the most promising routes available to drug companies to improve R&D productivity, according to Kaitin.

Other near-term trends cited in the Outlook 2005 report include: Steps to encourage industry to apply innovation to its manufacturing processes, including the "critical path" initiative to improve productivity, will play a major role in developing new, prevention-oriented drugs and biologicals.

Implementation of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 will spur public and private efforts to quantify the costs and benefits of specific drugs.

Rapidly rising prescription drug spending will increase pressure on drug developers to prove the cost-effectiveness of their products to ensure reimbursement in private and public markets.

Biotechnology firms are poised to prosper in the near-to-medium term due to their ability to field products with higher approval success rates.