The partnership gives Swiss Pharma giant Roche access to "organ-on-chip" firm Emulate’s Human Emulation System for the discovery and development of new classes of therapeutic antibodies and drug combinations.
“The collaboration with Roche is a significant opportunity for Emulate’s Human Emulation System to continue to be adopted by pharmaceutical leaders,” Emulate’s chief scientific officer Geraldine Hamilton told this publication.
But “this collaboration is unique because Roche plans to use the Human Emulation System across the entire drug process,” said Hamilton, “from discovering novel drug targets, to understanding disease mechanisms, to evaluating the efficacy and safety of new drugs.”
Roche will use Emulate’s Organ-Chips to model the effects of therapeutic antibodies in humans, overcoming the limitations of current preclinical experimental methods, and gaining further insight into disease mechanisms to increase predictability and early detection of biomarkers, and to reduce the use of animals in scientific testing.
Emulate’s proprietary Organ-Chips are tiny hollow channels lined with tens of thousands of living human cells and tissues, Hamilton explained. The size of an AA battery, they model human organs – including the lung, liver, brain, intestine and kidney – and are “living, micro-engineered environments that recreate the natural physiology and mechanical forces that cells experience within the human body.”
She added: “Organ-Chips work within the Human Emulation System that provides a real-time window into the inner workings of human biology and disease – offering researchers a new technology designed to predict human response with greater precision and detail than today’s cell culture or animal-based experimental testing.”
Emulate is translating the technology into a commercially available lab-ready system, Hamilton said, which is designed to provide a new R&D platform that predicts human response to diseases, medicines, chemicals, and foods with greater precision and detail than cell culture or animal testing experimental methods.
As such, we asked how the US Food and Drug Administration (FDA) and other regulatory agencies were supporting such a shift from traditional animal models.
In April 2017, Emulate entered a three-year collaborative research program with the FDA to use Emulate’s Liver-Chips in a toxicology setting to predict the effects of chemical and microbiological hazards on the human liver, she told us.
“The focus of the multi-year CRADA is on toxicology testing to demonstrate the capability of the Human Emulation System to predict product safety," she said.
“The goal is to improve on the ‘gaps’ that currently exist in the translation of toxicology data from animal models to human impact and advance the regulatory sciences field of toxicology which is a linchpin for approving the safety of many products.”