Where are the new drugs?

The push to improve the pipeline

Editor’s Note:  This story, originally published in 2005, has been updated.

Bill Snyder
Published: July, 2005

Tomorrow's medicine chest?  Three-dimensional model of a heterotrimeric G protein, pursued as a possible target for drug therapy.
Photo illustration by Dean Dixon
In 2004, only 23 truly new drugs, called “new molecular entities,” were approved in the United States.

That’s less than half of the number approved in 1996, even though annual research-and-development spending by the pharmaceutical industry more than doubled—to nearly $40 billion—during the same eight-year period.

With the sequencing of the human genome has come a plethora of new technologies to mine it. Yet this new wealth of biological understanding, coupled with the growing demand for drugs that can treat and prevent chronic disease, has raised the bar for proving safety and efficacy to unprecedented heights. Consequently the search for new drugs has become more complicated—and much more expensive.

Depending on the calculations, the journey of a single pill through the convoluted development pipeline can take 15 years and cost more than $1 billion. That’s before any money is spent on marketing.

Much has been written lately about the perceived excesses of drug marketing and inadequate efforts to ensure drug safety. This issue of Lens magazine begins with a look at the top of the pipeline, and how academic medical centers are partnering with industry and the federal government to replenish the shelves of society’s medicine cabinet.

“Drug companies realize the need to cover a broader range of biology. They just can’t do it all and never have,” says Lawrence J. Marnett, Ph.D., director of the Vanderbilt Institute of Chemical Biology. “And so partnerships with universities, with academic health centers make a lot of sense.”

The institute exemplifies the growth of translational research programs at universities around the country. Aided and encouraged by the federal government, these efforts are designed to develop the tools and the knowledge base needed to meet today’s drug-development challenges.

“Our goal is to take those very early stage discoveries around drug targets and lead compounds, and go another step toward handing that information off to biotechnology and pharmaceutical companies and other organizations that can hopefully translate our discoveries into new drugs for patients,” says Jeffrey Balser, M.D., Ph.D., dean of the Vanderbilt University School of Medicine and associate vice chancellor for Research.

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