As some countries and companies roll out new rules to limit animal testing in pharmaceutical products designed for people, scientists are stepping in with a new way to test therapeutic drug candidates and determine drug safety and drug interactions – without using animals. The development of “chemosynthetic livers,” which could dramatically alter how drugs are made, was presented at the 247th National Meeting & Exposition of the American Chemical Society (ACS), the world’s largest scientific society.
… “Researchers in drug discovery make small quantities of new potential drug compounds and then test them in animals,” said Chorghade, who is chief scientific officer of Empiriko Corporation and president of THINQ Pharma. “It is a very painstaking, laborious and costly process. Frequently, scientists have to sacrifice many animals, and even after all that, the results are not optimal.”
Typically, when researchers are onto a new compound that could address an unmet human health need, they test it on animals to see if it’s toxic before taking it into clinical trials with human subjects. They figure this out by doing something called metabolic profiling. That is, after giving an animal a test drug, the experimental compound does its designated job in the body until the liver breaks it down. Then researchers try to detect the resulting, minute amounts of molecular byproducts, or metabolites. It’s these metabolites that are often responsible for causing nasty side effects that can derail an otherwise promising therapeutic candidate.
This is where Empiriko’s patented chemosynthetic liver technology (Biomimiks™) comes in. Chorghade has developed these stand-ins, which are catalysts that act similarly to a group of enzymes known as cytochrome P450. Catalysts are substances that speed up processes that otherwise wouldn’t happen or would occur slowly. Many of these cytochrome P450 enzymes break down drugs in the liver.
So rather than using lab animals, researchers could figure out metabolic profiles of drugs by mixing them in test tubes with chemosynthetic livers. Chorghade’s team at Empiriko has already demonstrated how Biomimiks™ works with several pharmaceutical compounds.
This is in no way a threat to my actual job. Well technically it has zero effect on me as I no longer work on the animal side to drug discovery. Still back when I did, I see a LOT of benefits to this. Getting drug compounds is a slow process and volumes are slow. Think about it as prototyping in other industries. Prototypes are expensive and slower to make than something that has been tooled up for mass production. Same as drugs.
There are other processes that have been recently innovated like using computer models, and of course the old mainstay of cell culture. This is just another step to help out that early development.
Of course you still NEED animals as no model is perfect. For that same reason we still need human test subjects as well, as no animal has 100% identical biology to humans. Still the low organisms get the earliest tests, then onto the larger animals (general dogs and pigs, but occasionally drugs are tested on primates) and the last steps before a drug is approved for sale is human subjects, first healthy humans, then sick people who haven’t responded to other treatments.
Any process like this speeds up the time and money needed to get a new drug from concept to market. If you’re one of those people who don’t understand why pharmaceuticals are so damn expensive, re-read this article to see what needs to be done, and remember that it takes many people to run each test cohort and cook up each batch of drug.
Its not a cheap game, and anything that makes it cheaper helps EVERYBODY.
H/T Mrs. Weer’d