There is an ecosystem of many stakeholders who play a role in the discovery of new drugs, and each of them have a vested interest in making the drug discovery system work successfully and efficiently. Yet, the realities of a flawed system are evident in the facts and figures. A Phase 1 clinical trial for one compound can cost close to $15 million and take years to complete. Data published on www.fdareview.org also shows that only about 10 percent of drugs entering Phase 1 trials actually make it to market, which translates to considerable financial losses for those in the other 90 percent.
Recently, a wide range of these stakeholders – from pharmaceutical companies and academic researchers, to disease foundations and CROs – have signed on to work with Emulate, Inc., a privately held company at the forefront of a new technology, called ‘Organs-on-Chips.’ James Coon, CEO of Emulate, and his team of scientific researchers, designers and engineers are aiming to change the way drug candidates are evaluated in the laboratory by using Organs-on-Chips technology an alternative to today’s cell culture and animal testing techniques. In the past week, two new collaborators have joined forces with Emulate: a CRO, Covance Drug Development, and a major cancer research center, the Ellison Institute for Transformative Medicine at USC. This adds to the growing list of partners – including Johnson & Johnson, Merck, the Michael J. Fox Foundation for Parkinson’s Disease, and the government defense agency DARPA – who are putting their hopes and expertise on the line to advance Organs-on-Chips technology into the mainstream of the drug-development process.
Coon says one of the reasons so few drugs make it to market is due to the conventional in vitro models and animal models currently being used by the pharmaceutical industry. To identify viable drug candidates, these models rely on data points from static human cell cultures in plastic dishes that do not represent the broader living biology of human tissues and organ systems, or on studies in animals that do not always directly translate to human biology. Organs-on-Chips technology offers a new approach. By placing living human cells in an engineered microenvironment that recreates what’s happening within tissue systems, Coon says the technology offers the ability to create the smallest functional unit of a human organ, which gives a biological context that is much more effective at predicting human response than today’s cell cultures or animal testing.
Organs-on-Chip is a technology originally designed by Donald E. Ingber M.D. Ph.D., founding director of The Wyss Institute for Biologically Inspired Engineering at Harvard University, and Dan Dongeun Huh, Ph.D., assistant professor in the department of engineering at the University of Pennsylvania, that combines microfabrication techniques and engineering principals to create living, functioning human organs inside engineered microenvironments. Measuring in a size similar to a AA battery, each chip is made of a clear flexible polymer that contains tiny hollow channels lined by living human cells. Just as if cells from a patient’s body were biopsied and then studied, these translucent devices can be created by scientists to use as a window into the inner workings of human organs.
Since spinning out of The Wyss Institute for Biologically Inspired Engineering in July 2014, Emulate has evolved its Organs-on-Chips technology to become a commercially-viable product platform for use in industry. By housing the Organs-on-Chips within an automated system Emulate offers a way for researchers and product developers to not only conduct experiments that are predictive of normal human physiology, but they also can create different disease states within the Organs-on-Chips to help determine appropriate therapeutic intervention. This lab-ready automated system includes three components: the Organs-on-Chips, the instrumentation that automates the use of those chips, and the software apps that allows scientists to collect and analyze data. Because Emulate is integrating their Organs-on-Chips technology into a ‘plug-and-play’ system, end users can easily conduct experiments to meet customized needs within their own labs.
“In collaborations announced over the last year, industry leaders, such as Merck, the Michael J. Fox Foundation and Johnson & Johnson, are recognizing that the Organs-on-Chips technology can be valuable in predicting human response in applications throughout the drug development process and are now engaged in using the technology for a wider range of applications,” says Coon. “This includes early-stage processes, such as discovering new drug targets and understanding disease mechanisms, as well as late-stage testing of the efficacy and safety of new drug compounds.”