[Updated 4/11/17, 9:44 a.m. See below.] Experimental drugs encounter their earliest tests in petri dishes and animals, but these tests can fall short of predicting what happens in humans. The life sciences industry has been pursuing what many hope is a better way: packing human cells into tiny chips developed as stand-ins for organs.
This chip technology has come far enough along that the FDA now wants to see if it is ready for the market. Today, Boston startup Emulate is announcing a research partnership with the agency aimed at finding out if the company’s organ-on-a-chip technology can stand up to what’s necessary for evaluating new products. Foods, dietary supplements, and cosmetics will be the first products tested. But Geraldine Hamilton, president and chief scientific officer of Emulate, says the goal of the partnership is to eventually bring these testing capabilities to drugs.
“Everyone wants the same thing— to put this technology in the hands of the end user to enable better prediction of human response,” Hamilton says.
The partnership with FDA is what’s called a Collaborative Research and Development Agreement. These arrangements bring private companies together with FDA laboratories to develop and test new technologies that have the potential for reaching the market. The FDA declined comment on Emulate’s announcement. In a blog post, Suzanne Fitzpatrick, senior advisor for toxicology in FDA’s Center for Food Safety and Applied Nutrition, says that the chips can help scientists see how the body processes a dietary supplement ingredient or a chemical in a cosmetic, which in turn can be used to help assess the risks to human health. Hamilton says the agency has committed five scientists to the three-year partnership. Likewise, Emulate will also bring five of its scientists to the project, which will take place in FDA laboratories. [Sentence added with detail from FDA blog post.]
The FDA has been looking at alternative testing methods for some time. In 2012, the agency teamed up with the National Institutes of Health and the Defense Advanced Research Projects Agency (DARPA) in an initiative called “Human on a Chip.” The goal was to create a 3D representation of 10 different organ systems.
In a 2012 blog post, Jesse Goodman, then FDA’s chief scientist and deputy commissioner for science and public health, said that animal testing is expensive and doesn’t always detect toxic effects that would be found in humans. Conducting these tests on a small chip that has human cells could offer a different way to test compounds.
Hamilton says that the Emulate technology was part of the Human on a Chip initiative, ultimately receiving $37 million in grant funding from DARPA while the research was still at Harvard’s Wyss Institute. She says the new collaboration marks the progress that Emulate has made with its technology. The company spun out of the Wyss Institute in 2014 backed by a $12 million Series A round of financing. Two years later, Emulate raised $28 million in a Series B round.
Emulate calls its organ-on-a-chip technology the Human Emulation System. Translucent chips, about the size of a USB drive, are packed with cells in order to replicate a human organ. The company has also developed instruments and software that accompany the chips. Emulate has developed organ chip models for the lung, liver, intestine, and skin. Hamilton says the partnership with FDA will focus on Emulate’s liver chips from various species (dog, rat, and human) to assess toxicology results it produces in both animals and humans.
The Emulate technology is already in testing with several pharmaceutical companies. Emulate’s publicly disclosed partners include Merck (NYSE: MRK), Johnson & Johnson (NYSE: JNJ), and Covance, now a division of Burlington, NC-based laboratory testing giant LabCorp (NYSE: LH). Hamilton says the testing that will occur under the FDA collaboration is similar to what the company has been doing with its pharma industry partners.
Emulate is not the only company that has developed organ-on-a-chip technology. Huntsville, AL-based SynVivo also makes tiny chips that simulate a biological environment that can be used for researching the interactions between drugs and cells. And late last year, the Draper Laboratory, a non-profit research and development organization headquartered in Cambridge, MA inked a three-year partnership with Pfizer (NYSE: PFE) to build organ-on-a-chip models for the liver, vascular, and gastrointestinal organs that could potentially test drug candidates.
Photo by Emulate.