Before approving a drug, the FDA requires that it is first tested in animals. But what happens when these animalsbecome scarce? An emerging technology called organs-on-chips (OOCs) may provide an answer that could revolutionize the way drugs are tested worldwide.
OOCs are small devices, about the size of a USB, that mimic human organs and their functions. These chips can be used to test how different drugs will interact with an organ, and how that organ’s functions will change as a result.
The chips are filled with different cells and solutions to replicate a variety of organs in different conditions. For example, we can create a “mimic” of a normal pancreas and change different aspects of the chip to mimic a pancreas with cancer.
FDA regulations currently require that companies first prove that their drug is safe to use in non-human primates, such as monkeys, before beginning human testing for drug approval. These primates are mainly sourced from China.
Due to the COVID-19 pandemic, China has banned their export, leaving the U.S. scrambling to get primates for drug testing. This high demand and limited supply have also led to skyrocketing prices for these primates, making analready long and expensive drug-approval process almost impossible to fund.
Even though the U.S. government has boosted funding for American non-human primate facilities, the problem can’tbe solved overnight. It will take years before newly bred monkeys are ready to be used in drug testing.
Because of the scarcity of primates, the focus has shifted to finding substitutes that are cheap and easy tomanufacture. That’s where OOCs come in. They can be used to replicate complex conditions and find the best way to treat them.
For example, pancreatic cancer is often referred to as a “death sentence” because the tumors often developresistance to chemotherapy. This resistance occurs because a group of cells stick to the tumor, forming a sort of shield around it, protecting the tumor from treatment.
We are currently working on a chip that will mimic these pancreatic cancer shields. Our goal is to better understand how these pancreatic cancer shields form, and the best way to penetrate them to destroy tumor cells.
If a drug for this were to be tested today, a company would need to request a set of non-human primates, getapproval to induce cancer in these primates, wait for the cancer to fully develop, test the drug, wait for the drug to take effect, and, finally, analyze the results. This extensive analysis will determine if the company has wasted lots of money and time, or if they should spend even more money and time to move on to human trials.
OOCs can dramatically expedite this process. Samples for the chips can be extracted from patients that already have pancreatic cancer, thus eliminating the wait time for the cancer to develop in the testing animals. Becausethey use human samples that are easy to extract from a patient, they pose little to no risk to humans, thusdecreasing the need for extensive paperwork for drug testing approval.
Additionally, even though non-human primates are currently the standard for drug approval, as they are the animals that most closely resemble the physiology of humans, they are not perfect testing subjects. In someinstances, drugs that were deemed safe in primates ended up harming humans, like the disastrous TGN1412.
Because OOCs use human cells, they may offer a more accurate representation of how these drugs will interact with the human body and filter out more potentially harmful drugs. This, along with the fact that they are easy andcheap to manufacture, opens the possibility for OOCs to act as an excellent substitute for animal testing.
Future applications include connecting multiple OOCs, each representing a different organ, to create a “body-on-chip.” This will give us a better understanding and a more detailed analysis on how a drug might interact with other organs in the body.
OOCs are the technology of the future and have the possibility to replace a prolonged and expensive drug approval process, saving many primates and human lives. By making the process shorter and cheaper, they havethe possibility of launching live-saving drugs faster into the market, providing a better guarantee of their safety in humans, and making drugs less expensive for those who desperately need them.
Mariana Viso is a graduate student in the College of Engineering at the University of Miami. Read more about the inaugural “Op-ed Challenge.”
