Emulate Offers an Innovative New Model for Non-Animal Testing
In December 2022, President Biden signed the FDA Modernization Act 2.0, as approved by the House, and passed unanimously in the Senate. That’s a big deal, because among the landmark legislation’s provisions is one eliminating the requirement for testing on animals for drug safety. While companies can continue animal testing if they choose to, they now have the opportunity of verifying product safety through alternative means.
Since passage of the original 1938 Federal Food, Drug, and Cosmetics Act, animal testing had been required as part of every application for a novel drug or medical device intended for use in humans. The revamped legislation responded to numerous advances in alternative testing methods made possible by emerging technologies. By doing so, it offers humans a way to put our ethical values into practice by limiting animal testing going forward. Here’s what you need to know:
Simulating Human Organs on a Chip
Emulate CEO Jim Corbett stopped by the Business for Good podcast to tell me more about how his company, Emulate, can help displace the use of animals in labs. Jim provided expert corporate testimony to Congress in the run-up to passage of the FDA Modernization Act, discussing how Emulate’s organ-on-a-chip is one of the latest developments in the alternative medical testing field. According to Jim, their product is not only more humane, but is also more accurate than animal-based test methods.
If you think about it, this makes sense. Human anatomy and physiology are vastly different than those of commonly used animals in labs. While we enjoy chocolate, it’s harmful to our pet dogs. Cats and dogs can develop anemia if they consume onions, garlic, and chives. And avocados can cause cardiovascular damage to pet rabbits. Animals just aren’t exactly like us.
Enter Emulate, which has placed actual human cells on chips whose operations mimic the processes at work in the human body. Venture capitalists are on board with this, too. In fact, to date, Emulate has raised a quarter billion (yes, billion) dollars in funding.
Supporting Medical Ethics
Jim Corbett has worked for a number of companies, from start-ups to Fortune 100 firms. Throughout his career, he’s focused on biotech and innovation in analytic instrumentation, medical imaging, and in vitro diagnostics. Immediately prior to his work leading Emulate, he served as president of discovery and analytical solutions with PerkinElmer Health Sciences, Inc. when speaking with our audience, Jim noted that his company is working in the same ethical spaces as organizations like the Center for Humane Economy and the Center for Contemporary Sciences. Both are players in the fight to decrease the number of animals used in research.
Jim does think it will be “a slow process” of encouraging companies to forgo animal testing in an industry where it’s been mandatory in clinical trials for almost a century. He sees Emulate as being at the forefront of that process, offering innovative clinical investigation methods not predicated on animal models. He anticipates, for example, that Phase One clinical trials — the level concerned with basic safety — could eventually adopt Emulate’s organ-chips to replace one of the two previously required animal species models.
According to Jim’s Congressional testimony, animal clinical models lack both sensitivity and specificity when it comes to predicting drug toxicity in people. He told us that nine out of every 10 drugs that begin clinical trials will eventually fail for one of two very important reasons: They either can’t demonstrate their “efficacy endpoint” — meaning that they aren’t successful in treating the condition they attempt to treat — or it’s determined that they’re toxic to humans. And all the while, these trials cost into the billions of dollars and take on average nine to 14 years to be completed successfully.
Building a Better Human Model
Because animal models don’t accurately predict toxicity in humans, we need alternatives that work outside the bodies of animals. We need models that will better replicate the biological processes of humans specifically. Emulate is trying to solve this long-standing practical problem alongside the ethical one.
The technology Emulate uses grew from research conducted by Harvard University and DARPA, the research arm of the United States Department of Defense. Emulate’s organ-chip is the size of a computer thumb drive. They put human cells into an environment that simulates a specified human organ — the lungs, kidneys, colon, intestinal system, and even the brain. The company can then simulate a range of normal biochemical processes on its organ-chips, including the flow of blood and nutrients.
Then Emulate can check a variety of scenarios involving new drugs or chemicals in this organ-simulation, replicating what happens in the human body. This research environment is far more advanced than traditional in vivo models, in which scientists test how substances react within the body of living animals.
Although Emulate’s model technically uses in vitro technology — methods that work in a laboratory environment — Jim says its technology can more effectively model the processes of an actual human body than in vivo processes. Most of the cells used in Emulate’s organ chips are taken from human donors, all of whom have given informed consent. The company’s biologists then build the model with these cells, sometimes in combination with simulated human organ cells.
Race against the Status Quo
Some of today’s top pharmaceutical companies are already using organ-chip models from Emulate. At this point, the company’s products haven’t replaced other in vitro or in vivo models. However, the Big Pharma firms are integrating Emulate into their work processes to complement and compare to the efficacy of more traditional models.
It’s encouraging that recent research out of Emulate shows promising results from a large trial study of the company’s liver organ-chip. The chip detected 87 percent of the compounds judged by the FDA to be toxic to the human liver. All the compounds had already been tested in two different animal models and in clinical trials, and all these models failed to detect their toxicity.
Jim noted for our audience that the FDA Modernization Act represents “a milestone,” and “a triggering point” for his company and the alternative biotech industry. The new legislation is poised to create new opportunities and should bring in potential players who previously had been watching and waiting to see what would happen.
In fact, after our conversation, Jim was planning to return to Washington to give more testimony on the subject, hoping to secure more dollars to support government agency research and validation data. There just haven’t been enough studies done to date to provide conclusive proof to skeptics that a non-animal model will really work.
As Jim told me, “The status quo is my biggest competitor right now.”
