By Meredith Wadman
One of the better-kept secrets about the massive clinical research hospital at the National Institutes of Health (NIH) in Bethesda, Md., has been tucked away for half a century in Wing D of a building that dates to 1953. That is about to change.
The Pharmaceutical Development Section (PDS) is a corps of 20 chemists, pharmacists, pharmacokineticists and technicians who make investigational agents for many of the 1,500 clinical research studies running at any given moment at the NIH's Clinical Center. It is not a drug-discovery group, but rather a team of experts who churn out custom-made pills, vaccines, intravenous drugs and capsules, and even ointments and creams, for NIH investigators when the investigational agents they need aren't available.
Twenty-first century technology and government-mandated manufacturing standards have outpaced the equipment and capacities of the group's old, 743-square-metre workspace. But, if all goes according to schedule, in early June it will move seamlessly into a new, $12-million, 1,115-square-meter drug-making facility--a warren of rooms seven years in the planning that is tailor-made for the group's purposes.
From bench to clinic
The new shop "is going to help the people who work here move ideas from the laboratory bench to the patient faster and better," says John Gallin, director of the Clinical Center. Robert DeChristoforo, chief of the centre's Department of Pharmacy, adds that the facility "will expand the capacity for clinical trials at the NIH Clinical Center--and has the potential to assist outside investigators as well."
The PDS's new digs are a reservoir of state-of-the-art machinery and minus 80 ºC freezers; high-efficiency particulate-absorbing filters populate the ceiling; and highly purified water circulates through stainless-steel pipes that cost over $1,000 per meter. There are meticulous controls on air temperature, humidity and pressure. The facility's layout and structural materials are geared to maximum cleanliness--right down to the easily-scoured, porous epoxy floors.
Most of the building's cost was paid through the NIH's buildings and facilities budget, with a small amount contributed from funding from the American Recovery and Investment Act.
The PDS makes roughly one-third of the 1,000 or so drugs--including placebos--that the Clinical Center uses in its research protocols at any given time. Its analytical unit is responsible for quality-control studies that ensure the products' integrity and purity. Its staff help principal investigators to work out the tiniest details of doses and delivery methods, whether they are preparing a parotid-gland injection or putting a film coating on a placebo pill to make it indistinguishable from the active drug in the trial. Crucially, they also help investigators through the paperwork required to win approval from the Food and Drug Adminstration (FDA) to use an investigational drug in a human study.
"I don't know of any other hospital in the country that has a facility like this," boasts Gallin. He envisions a day when the PDS--which currently runs an eight-hour shift--is open 24/7 and its NIH-based clientele is expanded to include substantial numbers of extramural clinical investigators; currently it serves only scientists based on the NIH campus. "My dream," he says, "is that this will be a resource that will benefit many investigators."
The current facility, launched in 1956, will keep functioning until the new one is up and running. Its storied history includes its packaging for human trials of a failed cancer drug, azidothymidine (AZT), in the 1980s, after a young NIH investigator named Sam Broder--later director of the National Cancer Institute--decided to investigate whether it would work to treat AIDS. In 1987, AZT became the first AIDS-fighting drug approved by the FDA.
The old facility has been "terrific," Gallin says. "This just brings it into the modern era."