April 11, 2017
By Alex Keown, BioSpace.com Breaking News Staff
BOSTON – Emulate Inc. and the U.S. Food and Drug Administration’s Office of Foods and Veterinary Medicine entered into a Cooperative Research and Development Agreement to “evaluate and qualify” Emulate’s organ-on-a-chip technology.
The company and the regulatory agency will determine if the technology is a strong enough platform for toxicology testing to meet regulatory evaluation criteria for new products. The products first on the block will include foods, dietary supplements and cosmetics, the company announced this morning. The studies will use Emulate’s Human Emulation System, which includes Organ-Chips, instrumentation and software apps.
Using the system will help the companies and FDA examine more closely the way human tissues respond to various agents. Emulate’s Human Emulation System recreates the natural physiology of specific human tissues and organs that is designed to provide a predictive model for a human response.
“We are looking forward to combining our expertise with leading researchers at FDA to explore how our Organs-on-Chips technology integrates with existing product testing frameworks – opening the potential for a new paradigm for establishing improved standards, creating more predictive models, and helping to better evaluate safe products for human use,” Geraldine Hamilton, president and chief scientific officer of Emulate, said in a statement.
Emulate’s organ chips are about the size of a AA battery and contain hollow channels “lined with tens of thousands of living human cells and tissues.” An organ-chip is a living, micro-engineered environment that recreates the natural physiology and mechanical forces that cells experience within the human body, according to Emulate.
In an interview with MedCity News, Hamilton said the chips the FDA will be evaluating 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.” She said it’s intended to emulate factors that drive cell function and the complexity of a cell’s function.
When the collaborative research begins, the near-term goal will look at Liver-Chips developed by Emulate to assess the system’s capabilities to predict the effects on human biology of chemical and microbiological hazards found in foods, cosmetics and dietary supplements. This should provide feedback for the FDA the efficacy of Emulate’s technology for research. The research will look at Liver-Chips from multiple species–humans, dogs and rats. The choices will allow researchers to see how the toxicology data differently affects the three species. In her interview with MedCity News, Hamilton said it is necessary to “bridge the gap” between animal data and human data.
If effective, the belief is that the organ-on-a-chip technology will have a significant effect on the drug development and allow companies to avoid toxicology issues that could hamper clinical trials.
If the data from these first trials are positive, the deal between Emulate and FDA will allow for the expansion of the project to include additional organ chips, including the Intestine-Chip, Lung-Chip, and Cardiac system.
