It’s definitely a 21st-century ambition: a chip inlaid with human cells representing physiological systems from heart to brain to gut. A chip that would separate the wheat from the chaff among myriad potential new drugs, dispensing with those toxic to humans before they ever enter a human body. And doing so quickly and cheaply.
Today, the US military and the National Institutes of Health (NIH) proposed developing just such a chip in a US$140 million effort over the next five years. The Pentagon’s storied Defense Advanced Research Projects Agency (DARPA) is teaming with NIH — a first — to execute the project, with each agency committing $70 million. The NIH contribution would come from its director’s discretionary ‘Common Fund’, but be administered through a proposed new translational medicine centre at the biomedical agency. The Food and Drug Administration will also play a part, advising the agencies on how to meet its requirements for safety and effectiveness.
NIH director Francis Collins, reached by phone today after attending the ceremony where President Barack Obama signed a new patent law, waxed enthusiastic about the shared research project. “I will admit this is pretty ambitious but the time is right,” he said.
According to Collins, the aim is to get ten different physiological systems represented on the chip. If everything works as hoped, this would allow scientists to assess the effects — both in terms of safety and efficacy — of a candidate drug on gene expression, on epigenetics on metabolites and on proteins in the cardiovascular system, the neurological system, and more.
“The idea is you’re looking for signatures that would tell you whether this is a safe compound to try in a human patient,” Collins said. “And you could tune that system by starting with compounds where you know they’re safe because they have been given to lots of people.”
There is even a hope that induced pluripotent stem cell technology will make it possible to develop chips with multiple different cell types from individuals of different genotypes, making it possible to discern that a drug safe for one subgroup is not safe for another.
Why, one might ask, would the military be interested in such an enterprise? In a 16 September media release, the Pentagon minces no words on that question: “The Department of Defense needs to rapidly develop and field safe and effective medical countermeasures against biological threats to U.S. warfighters.”
As for the division of labor, “DARPA researchers will concentrate their efforts on engineering platforms and the biology required for scientific proof of concept. The NIH’s National Center for Advancing Translational Sciences (NCATS) will focus on developing complementary microphysiological systems to mimic human physiology and pathology,” the press release says.
The announcement that NIH’s embryonic NCATS will house the programme comes just as that centre is awaiting Congressional approval, with a proposed 1 October launch date looking elusive.
So it perhaps didn’t hurt when Obama, speaking to high school students at the ceremony today, did a little cheerleading for the centre. In remarks detailing his administration’s efforts to boost technology and scientific innovation, he noted, “Today, for example, my administration is announcing a new centre that will help companies reduce the time and cost of developing lifesaving drugs.”
The NIH also recently posted this advertisement for a director for NCATS. It says that the agency will begin reviewing applications on December 2. Asked if this move ignores the wishes of Congressman Denny Rehberg, the Montana Republican who heads the House subcommittee that funds NIH, and who in June expressed his displeasure with the director search, Collins said: “I hope it would not be in any way seen as that.” He noted that Health and Human Services Secretary Kathleen Sebelius has assured Rehberg that no hire will be made unless and until Congress signs off on the new, $723 million centre by appropriating funds for it.