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Pharma Community Looks to Improve

Annual DDT conference addresses inefficiencies in launching new drugs

by Rick Mullin
August 15, 2005 | A version of this story appeared in Volume 83, Issue 33


FDA and industry need to share.
FDA and industry need to share.

The pharmaceutical and biotech research community converged on Boston last week for the 10th annual Drug Discovery Technology conference, sponsored by IBC Life Sciences. Much of the discussion at conference sessions and in the exhibit area centered on how little the industry has accomplished over the past 10 years in improving the efficiency of bringing drugs to market.

"Why is there still only a 10% chance of a preclinical candidate making it to the market?" asked Christine T. Fischette, executive director of global business development and licensing for Novartis Pharmaceuticals and chair of the business sessions at the conference. Research managers at major drug companies, investment bankers, systems and services vendors on the exhibit floor, and the newly appointed commissioner of FDA took a stab at the question during the four-day event.

Most of them pointed to insufficient data management, inefficient business processes, and the need for management to tolerate higher levels of risk. Many cited the need to better understand disease mechanisms.

"There is no need to change the basic business model," said Mathew Bell, director of discovery research strategy at Wyeth Research. But there is a huge amount of efficiency to be gained.

Drug company executives need to be more flexible and patient as researchers take on new challenges, Bell added. Getting early data on how drug candidates work in humans is a key to success, "but it takes courage from management because it takes longer," he said.

Jeremy Levin, head of strategic alliances at Novartis Institutes, pointed to a disconnect between research departments and upper management, especially in companies that have worked in partnerships. "The bulk of [the industry's] alliances have failed," he said, "often because research didn't address expectations of the management of the alliance."

In a keynote panel with R&D managers from Pfizer, Wyeth, and Abbott Laboratories, FDA Commissioner Lester M. Crawford addressed the need for industry and his agency to share information without creating a conflict of interest. He also pointed to the need to improve harmonization of international regulatory authorities, an effort that has been under way for 15 years.

Robert R. Ruffolo Jr., president of Wyeth Research, said he is discouraged by the inability of U.S., European, and Japanese regulators to adopt a more unified regulatory framework that would alleviate the burdens of dealing with multiple drug approval processes. "Quite frankly, it's a big disappointment to me," he said.



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