By Diagnostics World Staff
April 11, 2017 | Emulate announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Food and Drug Administration’s (FDA) Office of Foods and Veterinary Medicine. Under this multi-year CRADA, Emulate and FDA will collaborate to evaluate and qualify the use of Emulate’s Organs-on-Chips technology as a platform for toxicology testing to meet regulatory evaluation criteria for products – including foods, dietary supplements, and cosmetics. The CRADA studies will use Emulate’s Human Emulation System, comprised of Organ-Chips, instrumentation, and software apps. The system recreates the natural physiology of specific human tissues and organs, and is designed to provide a predictive model of human response to diseases, medicines, chemicals, and foods with greater precision and detail than other preclinical testing methods, such as cell culture or animal-based experimental testing.
“This CRADA has evolved from FDA’s familiarity with our technology – even before Emulate’s spinout in July 2014 – as part of FDA and NIH collaborations at the Wyss Institute at Harvard University,” Geraldine A. Hamilton, President and Chief Scientific Officer of Emulate told Diagnostics World via email. “One of the toxicology leaders at FDA, Suzanne Fitzpatrick, has been involved in the collaborative research when Emulate’s technology was at the Wyss, dating back to 2010. Over the years of being connected with our technology, Fitzpatrick and her colleagues recognized the progress that has been made at Emulate to commercialize the technology, and they determined that now is an opportune time to establish this CRADA because the Organs-on-Chips technology has reached a point to fit within the regulatory process.”
Suzanne Fitzpatrick also discussed the CRADA between FDA and Emulate in an FDA blog post.
According to Hamilton, the collaborative research under the CRADA will be led by FDA’s Division of Toxicology, within the Office of Applied Research and Safety Assessment, which will have an onsite installation of the Human Emulation System for experimental testing at FDA.
The collaborative studies under the CRADA will utilize the Human Emulation System, specifically various Liver-Chips developed by Emulate, in an applied toxicology setting 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. These activities will enable FDA to review and provide feedback on the performance and application of the Emulate system for FDA research. It will also enable Emulate to use the information obtained from FDA during this study for further development and improvement of its Human Emulation System. In the collaboration, FDA and Emulate researchers will initially use Emulate’s Liver-Chip from multiple species (Human Liver-Chip, Dog Liver-Chip, and Rat Liver-Chip), to conduct studies to assess the cross-species differences in toxicology data between humans and animal species. The collaborators plan to publish the data and findings from the CRADA studies.
“The focus of the multi-year CRADA is on toxicology testing which is well-known to be a linchpin in the regulatory process for product safety,” said Hamilton. “There are challenges associated with today’s toxicology testing which relies heavily on animal models, and yet there are gaps in the translation of toxicology results from animal models to humans. For example, transporters in and out of the liver and detoxifying enzymes vary significantly between animal species. Such physiologic differences between mice and dogs, compared to humans, can create inaccuracies when drawing conclusions based on animal models to predict human safety.”
As part of the CRADA research, Emulate will be using the Human Emulation System to evaluate the Liver-Chip across different animal species, along with the Human Liver-Chip. This will enable:
- Comparison of the Human Liver-Chip to existing animal data, for product testing.
- Demonstration of robustness and the ability to better predict human response to use Emulate’s Organs-on-Chips technology as an industry standard.
- In addition, Emulate will be able to use the information to refine our system to be tuned to how the regulators would like to use the data in a regulatory setting.
- Emulate and FDA plan to publish the data and findings from the CRADA studies.
The CRADA collaboration agreement allows for future expansion to additional Organ-Chips, including the Intestine-Chip, Lung-Chip and Cardiac systems. Depending on the evolution of the research and additional areas of interest, Emulate may conduct further training of FDA researchers on the Human Emulation System.