Some of the stories Lynn Rose told me the other week made me laugh out loud, and want to cry in mercy. One story was about the academic researcher who ran a single experiment in an animal species that panned out. This scientist, who shall remain nameless, figured it was time to call up the FDA to set up a meeting—maybe next Tuesday?—about starting a clinical trial.
Without sounding like too much of a smarty-pants, Rose, an associate professor at the University of Washington School of Medicine, had to explain to the clueless person that the FDA requires studies in multiple animal species, including rigorous safety tests known as “Good Lab Practice-Toxicology” studies before you even think about getting permission to try it on humans. It requires loads of documentation. Plus, there’s no way in the world to get a meeting by next Tuesday, because the FDA staff are under crushing workloads to keep up with all the existing applications.
“People in academics don’t get training on how to deal with the FDA,” Rose says, ruefully. “There’s a lot of naivete out there. Our job is to tell the person what they’re doing is fantastic, and show them, here’s what you need to do to get it where you want it.”
Rose and her colleague, Kim Folger Bruce, are front-line soldiers in Seattle’s bid to iron out the many kinks in the way drugs advance from basic discovery through development. The vision for this “translational research” program, which comes from National Institutes of Health director Elias Zerhouni himself, is that too much of the NIH’s $27 billion annual research budget goes into basic science that never leads to a new drug or device. More emphasis needs to be put ontaking this work, as the cliché goes, “from bench to bedside.” Three of Seattle’s star biomedical researchers—Nora Disis of the University of Washington, Mac Cheever of the Fred Hutchinson Cancer Research Center, and Bonnie Ramsey of Seattle Children’s Hospital—aim to pull off this mean feat through a five-year, $62 million grant from NIH.
The first part of the grant arrived a year ago, and the grunt work of turning part of this lofty vision into a reality is falling to Rose and Bruce. They work next door to each other at offices of Seattle Children’s Hospital in the Metropolitan Park West office in the Denny Triangle.
Their program has been given the truly bureaucratic name of the “Institute of Translational Health Sciences” or ITHS. Rose and Bruce are focused on one key component of this effort, helping make animal experiments that lead researchers down the translational path.
It would be hard to pick two people better suited to serve as diplomats between the worlds of academic science and the biotechnology industry. Rose spent 16 years in the early part of her career as an immunologist, including a stint as a postdoc at the Hutch, and a decade as an assistant professor at the UW. She learned about the next step in the continuum of drug development—and why nine out of 10 drug candidates fail in clinical trials—during stints at ZymoGenetics, Icos, and PathoGenesis.
Bruce has a similar career arc. She did 18 years as a biochemist, with expertise in mammalian genetics, before cutting her teeth in industry at Bristol-Myers Squibb and PathoGenesis, among other places.
Besides the technical skills required, this project obviously requires a person with a temperament that includes patience, and a sense of humor. … Next Page »
By posting a comment, you agree to our terms and conditions.