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.
Much of the work revolves around trying to bridge the cultural gap between academics—who are often clueless about what it takes to develop a drug—and industry types who don’t know where to look to take advantage of some of the resources in the community.
For example, few people in town realize that the Fred Hutchinson Cancer Research Center can produce antibody drugs in a clean facility that meets FDA manufacturing standards, Rose says. Even many people in the research community would be hard-pressed to tell you which lab in town has some down time available on a mass spectrometer, an expensive tool used to precisely identify certain proteins in a sample, which might be useful for identifying signs of cancer in blood.
“We have to create an ability to share resources better with a common goal of developing new drugs,” Rose says.
Some of this work is fairly mundane, like creating a database of all these available tools for drug development, loaded with names, e-mails and phone numbers, Rose says. Some of the work focuses on listening to people in industry about what can be done to make their jobs easier. One suggestion that’s already being incorporated: the UW is being asked to produce more graduates with an expertise in regulatory affairs, so industry can hire people who aren’t as naive about the FDA as the researcher I mentioned at the beginning of this story.
Another part of this job is political and cultural. Rose still runs into academic researchers who think that drug development is a plodding, dirty business for overpaid hacks, and something academics should avoid (my words, not hers). As someone who has worked in both worlds, she says this is wrong, and, frankly, counterproductive. Based on a story related by John Slattery, the UW medical school’s vice dean for research, this anti-industry ethic stems back more than two decades, when one of the leaders in the UW School of Medicine once remarked, “We don’t do drug development. We do research.” Rose didn’t want to elaborate more about this culture problem, other than to say, “It colored people’s views of industry for a long time.”
If this is still the prevailing attitude—and we heard some evidence this summer in a report from biotech CEOs that it still is—then this means the drug development process is in trouble. Because of the recession, biotech and pharmaceutical companies are even less inclined than usual to harvest raw, promising ideas from academia, like embryonic stem cells, and start putting investment capital to work behind them.
“You’ve got to give it to industry on the 50-yard line now,” Rose says. “In a different era, a pharmaceutical company could take it on the 10-yard line and run it downfield.” She adds, “The university is not a pharmaceutical company, but we have to get our IP licensed, and that is what it takes.”
Getting all the players moving in the same direction behind this idea is obviously not easy. The UW is a $1 billion-a-year research colossus, with several thousand employees, and the Fred Hutchinson Cancer Research Center alone has a more than $308 million annual budget. The Washington Biotechnology and Biomedical Association counts more than 450 members in this fragmented industry filling various roles in drug development. The UW TechTransfer office, much maligned in the past, is just getting used to new leadership under Linden Rhoads, with a mandate of forming more startup companies.
By the time I left the interview, I got the sense that Rose and Bruce certainly have their moments when they just shake their heads (like when a researcher didn’t know what a Phase III clinical trial was). Other times, they think of how cool it would be to help make drug development into a better-oiled machine.
“We want this to be a humming research enterprise,” Rose says. “We want to help the scientists interact with people in industry, and with each other. There’s too much redundancy, of people who see a need and try to fill it on their own, without thinking about how they can work together.” She adds, “This is really about herding cats.”
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