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FDA, Emulate to Test Organs-on-Chips for Drug Toxins

Lung-on-chip

Lung-on-chip device (Emulate Inc.)

11 April 2017. A joint venture between Food and Drug Administration and a developer of chip devices simulating human organs, is evaluating the chips as a way to test new drugs for toxic effects. FDA and Emulate Inc. in Boston, Massachusetts, a spin-off enterprise from the Wyss Institute for Biologically Inspired Engineering at Harvard University, will assess the ability of organs-on-chips to fulfill regulatory needs for testing drugs, as well as food, dietary supplements, and cosmetics.

The agreement, called a Cooperative Research and Development Agreement or Crada, will review Emulate’s systems that simulate functions of the liver, a key organ that metabolizes and removes chemicals, such as drugs, from the blood stream. Emulate’s organs-on-chips are polymer plastic devices with fine channels etched in the surface or drilled through, lined with live cells, and designed with supporting instruments and software to perform and measure functions similar to humans or animals. The company says its devices can provide more precise and reliable testing of drugs, food, and cosmetics than many preclinical tests now performed with lab animals.

The Crada with FDA will evaluate simulated liver-on-chip systems as devices to provide accurate and reliable data for the agency’s regulatory decision-making processes. The review will look specifically at chips simulating livers from humans, dogs, and rats to identify and measure chemical or biological hazards, comparing performance of the chips against findings from tests on humans and live animals. Emulate Inc. will also use the results as feedback to refine their products.

Emulate Inc.’s individual organ chips are designed to connect into integrated multi-organ networks, what the company calls its Human Emulation System. The agreement allows for expansion into other types of organ chips, including intestine, lung, and cardiac systems. The company says both parties plan to publish the results of studies conducted under the Crada.

In an FDA blog post, Suzanne Fitzpatrick, an adviser on toxicology at the agency, expects the Crada to apply scientific processes with organs-on-chips technology. “In some ways,” says Fitzpatrick, “science is like a recipe in that both can go through a number of incarnations before they work. There’s a lot of experimenting and tweaking, collaborating and comparing. And that’s what we’ll be doing at FDA with the organs-on-chips research.” She also notes that FDA, with National Institutes of Health and Defense Advanced Research Projects Agency, are supporters of the technology since 2012.

A Crada is a collaborative project where agencies or national labs make their staff, facilities, and equipment available for research with a private company that also provides funding for the project, as well as its own staff, facilities, and equipment. Crada agreements often include provisions for licensing the results of the joint research, but no intellectual property aspects of the agreement with Emulate were disclosed.

Emulate Inc. licenses its current technologies from the Wyss Institute, with Donald Ingber, the institute’s director, also a founder of Emulate and chair of the company’s scientific advisory board. Science & Enterprise reported on Emulate Inc.’s founding in July 2014 and its second funding round in March 2016. From both instances, the company raised a total of $40 million in venture funds.

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