There is an emerging biotech movement that promises to transform medical science and radically overhaul the arduous process of bringing new drugs, foods and cosmetics to market.
Teams of academic and government researchers and a handful of start-ups have created human organs-on-chips — miniaturized versions of livers, lungs, kidneys, intestines and other vital innards. The nascent science, now being evaluated by the FDA, offers a less time-consuming and costly way to test drugs, foods, cosmetics and dietary supplements for efficacy and toxicity, with the goal of vastly improving upon traditional cell culture and animal-based methods.
It sounds futuristic, but it's not sci-fi. Each organ-on-a-chip, roughly the size of a AA battery, is made from a flexible, translucent polymer. Inside are tiny tubes, each less than a millimeter in diameter, lined with living human cells extracted from a particular organ. When nutrients, air, blood and test compounds, such as experimental drugs or cosmetic ingredients, are pumped through the tubes, the cells replicate some of the key functions of that organ, just as they do in the body.
Data published by FDAReview.org, a project of the nonpartisan Independent Institute, indicates that only about 1 in 10 drugs that enter clinical trials ultimately win Food and Drug Administration approval. According to the California Biomedical Research Association, it takes an average of 12 years for a drug to travel from preclinical research to the patient, at an average cost of $359 million. Do the math on the 90 percent of those drugs that don't make it and you can see the need for a revolutionary new approach.
"The current tools don't always give us the complete picture," said Geraldine Hamilton, president and chief scientific officer at Boston-based Emulate, a three-year-old private spin-off of the Wyss Institute for Biologically Inspired Engineering at Harvard University, a pioneer of organs-on-chips that has a multiyear R&D agreement with the FDA.
"When you put cells in a [petri] dish, they're in a static environment and don't interact with each other in the same way as they do in the body," she said, referring to a common preclinical first step. Tests on animal systems, Hamilton added, often do not accurately translate to those in humans, because of dissimilarities in our respective biologies.
Emulate has combined design, engineering and biology to recreate a dynamic microenvironment housed within its organ chips. "Think of the chip like a home away from home for an organ," Hamilton explained. "We can control the way cells interact with each other by applying relevant mechanical forces." For example, Emulate's lung chip can simulate breathing in and out. Blood and airflow are reproduced in the chip's tiny channels.
Besides increasing the speed and accuracy of drug testing, organs-on-chips present a range of game-changing potentials. They can be embedded with a particular disease, such as cancer or asthma, and provide researchers with a cost-effective mini laboratory for introducing immune cells or drugs and observing reactions in real time. It's also possible to grow separate chips of a human gut, a cow gut and an insect gut and then compare how each species' intestines react to a pesticide, an implausible experiment using those actual animals. Further down the road are you-on-a-chip models containing stem cells, a key component in so-called personalized medicine, and an entire human-on-a-chip, linking every organ together to study holistic interactions between cells and tissues.