NIH boosts its clinical core

The National Institutes of Health is upgrading its drug development and manufacturing facility -- new location, new equipment, same mission -- to "help move ideas from the laboratory bench to the patient faster and better," said John Gallin, director of the NIH Clinical Center. Mark O. Hatfield Clinical Research CenterImage: National Institutes of HealthAs I toured the new $12 million, over 1,000 square meter facility today (March 25), I meandered through room after room of new, top of the lin

Written byJef Akst

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Mark O. Hatfield Clinical Research Center
Image: National Institutes of Health

As I toured the new $12 million, over 1,000 square meter facility today (March 25), I meandered through room after room of new, top of the line equipment, high quality air filters, and easily cleanable epoxy flooring -- all aimed to better meet the US Food and Drug Administration's standards of good manufacturing practice (GMP). My tour comes just a few weeks after the NIH and FDA linkurl:announced a collaboration;https://www.the-scientist.com/blog/display/57174/ to increase efforts in translational and regulatory science. While the timing of the new partnership is purely "coincidental," Gallin said, the NIH did consult with the FDA during the designing of the new facility and plans to invite the agency to inspect it. "If it's not up to snuff," Gallin said, "we'll fix it." The Clinical Center (CC) currently hosts about 1,500 clinical research studies, about half of which are clinical trials in phase I or phase II. A lot of the CC's work focuses on rare diseases that industry tends to shy away from because they don't have a big market. The center also investigates the possibility that existing drugs, often donated by the pharmaceutical companies that own them, could be used to treat other diseases. In both cases, "our hope would always be that we pass the baton on to industry after we get over that so-called valley of death," Gallin said -- the gap between when the basic research is finished and when industry sees enough potential in a drug candidate to warrant starting a development program. The transition to the new facility is currently scheduled for early June.
**__Related stories:__***linkurl:Regulatory science gets boost;https://www.the-scientist.com/blog/display/57174/
[24th February 2010]*linkurl:Paying for Patients;https://www.the-scientist.com/article/display/54196/
[February 2008]*linkurl:Bringing Cancer Science to the Bedside;https://www.the-scientist.com/article/display/52976/
[April 2007]

Meet the Author

Jef Akst

Jef (an unusual nickname for Jennifer) got her master’s degree from Indiana University in April 2009 studying the mating behavior of seahorses. After four years of diving off the Gulf Coast of Tampa and performing behavioral experiments at the Tennessee Aquarium in Chattanooga, she left research to pursue a career in science writing. As The Scientist's managing editor, Jef edited features and oversaw the production of the TS Digest and quarterly print magazine. In 2022, her feature on uterus transplantation earned first place in the trade category of the Awards for Excellence in Health Care Journalism. She is a member of the National Association of Science Writers.

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