Boston-based Emulate and the U.S. Food & Drug Administration’s Office of Foods and Veterinary Medicine have inked a Cooperative Research and Development Agreement (CRADA) to advance the company’s organ-on-a-chip technology and create a better model to study toxicology.
The agreement seeks to tackle a problem that has plagued both commercial product development and biomedical research: finding a model that closely replicates how human tissues respond to certain agents.
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“The goal is to put the technology in the hands of the FDA, and give FDA experts first-hand experience studying the predictability of the system to create a standard of testing,” said Emulate’s President and Chief Scientific Officer Geraldine Hamilton in a phone interview.
Emulate’s chips seek to duplicate many of the factors that contribute to the cellular microenvironment: target tissue, extracellular matrix, immune cells and blood components, as well as the physical motions that can influence how cells behave.
“The chips are designed to apply the mechanical forces that replicate the cell’s natural environment but also act like blood, providing nutrients and taking away waste products,” said Hamilton. “We’re not trying to build an entire organ on the chip, but rather emulate the factors that drive cell function and the complexity of that cell function.”
The collaboration between FDA and Emulate will focus on toxicology testing to better evaluate the safety of cosmetics, dietary supplements and food. The hope is that the company’s liver chip will predict toxicity in humans better than current cell-based and animal models. Eventually, the agreement may expand to include lung, intestine and cardiovascular chips.
In addition to investigating the system’s predictive ability and refining Emulate’s technology, this collaboration will also study why human and animal tissues react differently in toxicology studies. Emulate will create liver chips for rats, dogs and humans to better understand the differences between species that can make animal models less predictive.
“Transporters and enzymes in the liver show marked differences between mice and humans,” said Hamilton. “We need to bridge the gap between the animal data and the human results.”
Founded in 2014 by researchers from the Wyss Institute at Harvard, Emulate believes their plug-and-play system could have a profound impact on drug discovery, reducing the number of toxicology and other surprises that shut down clinical trials. The company has built collaborations with J&J and other pharma companies, as well as academic researchers, to explore the technology’s potential.
“These chips can provide a range of applications throughout the drug discovery and development process,” said Hamilton. “You can use them for new target identification and validation all the way to safety and efficacy testing.”
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