Emulate is the leading provider of next generation in vitro biological models. Researchers use their organ-on-a-chip technology to understand and predict drug response with greater precision and detail than possible with conventional cell culture or animal-based methods. CEO Jim Corbett talked about Emulate’s business, in response to emailed questions.
Why did you join Emulate?
With Emulate, I saw one of those rare opportunities to bring truly game-changing technology to healthcare. Organ-Chips are poised to redefine how we evaluate the safety, efficacy and overall success rate of drug development. For the first time, this technology can provide researchers a superior alternative to using experimental animals during the drug development process, bringing better therapeutics to patients sooner.
What specific need/problem are you seeking to address in healthcare?
Today, the pace of drug discovery is accelerating with the availability of tools like genomic sequencing and significant advances using induced pluripotent stem cells (iPSCs) to fuel our ever-expanding knowledge of human biology. However, pharmaceutical companies still need to bring potential therapies in their pipelines to market, and that terribly inefficient process has not changed in decades.
In 2021, it still takes far too long and costs too much money to successfully bring a drug to market — usually 10 or more years at costs that can rise to $2 billion. Once in the clinic, the failure rate of new drugs is also ridiculously high, with some estimates at 90 percent. This is because animal models are fundamentally poor predictors of human response due to species differences, yet they are still heavily relied upon for predicting drug safety and efficacy before human trials.
To overcome the challenges of using tools that don’t have high predictive capabilities, biopharmaceutical companies around the world are looking to reduce, refine and eventually replace animal models for preclinical drug development, toxicology studies and disease modeling to save time, reduce costs and be more predictive for clinical trials.
At Emulate, we develop engineered microphysiological systems called Organ-Chips with defined composition at the cell, tissue and organ level. The predictive capability of Emulate’s Organ-Chip technology enables the discovery of contributors to human physiology and pathophysiology and helps researchers make the best decisions for their experiments.
What does your product do? How does it work?
The Human Emulation System includes Organ-Chips where cells are grown in culture, and hardware and software that support the experimental chip modules and control the growth conditions. Each Organ-Chip is a transparent, flexible microenvironment that contains two parallel chambers that can be configured to grow human cells from an organ of interest, such as the liver, kidney proximal tubule, intestine, lung and brain. The Organ-Chip recreates the natural physiology and mechanical forces that cells experience within the human body, including blood and air flow. To recapitulate what happens during breathing or peristalsis, dynamic forces like stretch and pressure can be applied to the culture system.
The system is a self-contained, lab-ready and open platform for studying human biology and disease with greater precision and control than current cell culture or animal-based testing methods. Academic researchers have used Emulate’s technology to model organ components such as the glomerulus, bone marrow and lymphoid follicles while pharma organizations primarily turn to validated models such as the Emulate Brain-Chip or to explore conditions like liver toxicity, neuroinflammation, and colon inflammation.
Is this your first healthcare startup? What is your background in healthcare?
I would consider Emulate my third healthcare startup. I founded a software startup called CADx Systems in the oncology imaging space for breast cancer detection, which was acquired by iCad. I then took on the role of president at ViaCell, a cord blood banking business which also invested in technology for stem cell expansion from umbilical cord blood. After ViaCell was acquired by PerkinElmer, I spent 11 years leading different global divisions including the $1.8B discovery and analytical solutions business, and the diagnostics and human health sectors. In March of 2020, I joined Emulate as Chief Executive Officer.
Who is your customer? How do you generate revenue?
We have three primary customer segments: academic scientists who are addressing many basic research questions; biopharma companies who develop drugs and bring therapeutics to market; and government accounts like the FDA, NASA, and the U.S. Army that are interested in applying Organ-Chip technology to a variety of projects including Covid-19, bio terrorism, and how humans respond while in space. Our customers purchase validated organ-specific models we refer to as Bio-Kits that contain qualified cells and protocols, or they can purchase a Basic-Kit to create models of their own design along with the consumables and culture support and monitoring systems necessary to conduct their experiments.
Do you have clinical validation for your product?
Organ-Chips are considered research tools and thus are not regulated by the FDA. The FDA has recently created a program called ISTAND to help life sciences companies like Emulate submit for a context-of-use planning. We’re currently researching the ISTAND program to determine our best path forward.
In addition to the ISTAND program, I’m also very encouraged by proposed changes in federal policy. There are two bills before congress, the FDA Modernization Act which specifically calls for the FDA to allow data developed from organ-chip technology to be submitted as part of an investigational new drug (IND) application. The other is the recently introduced Humane Research and Testing Act (HR 1744) that will, among other actions, establish a National Center for Alternatives to Research and Testing under the National Institutes of Health (NIH). The new center would be dedicated to increasing transparency and understanding regarding the use of research animals and would require the NIH to develop, fund and execute a plan to enumerate the number of animals used in biomedical research, and incentivize companies to use non-animal methods by educating and training scientists on human-relevant research methods. As we head towards the future together, Emulate will continue to support researchers as they adopt next-generation in vitro Organ-Chip models, and we look forward to the progress that will come about when Organ-Chips are considered routine use for drug discovery and development.