Can In Vitro Methods Replace Animal Testing?

Can in vitro methods replace animal testing?

I rephrase in a more relatable format: would you agree to become a healthy volunteer to test a new drug candidate that was not studied in animals but was thoroughly characterized using computational models, studies in human cell cultures, and organ-on-a-chip systems??

Regardless of what your answer might be, this month, US Congress passed the FDA Modernization Act 2.0, giving drug companies the option to use alternative safety-testing models instead of animal testing when submitting new drug applications. This marks a significant change from the Federal Food, Drug and Cosmetics Act of 1938, which requires animal testing for all new drug development protocols. Proponents of this initiative claim that this shift allows for more modern and potentially more effective ways of evaluating the safety of new drugs.?

And the most important reason is, of course, saving animals and ceasing the suffering of our little brothers. I totally support this quite a noble goal. But over several years of running BiopharmaTrend.com as an independent consulting boutique, I had numerous discussions with different drug discovery and biotech experts, conducted many interviews with KOLs, etc. And sometimes, I heard an opinion that invitro strategies of today were not quite ready to substitute animal testing, at least not for all therapeutic areas, and that the area of translational research was plagued with failures when it came to the practical implementation of such modern tools as human cell cultures, organ-on-a-chip systems, functional systems, and computational models (no doubt, artificial intelligence-based) to predict clinical outcomes. This is not a formal study of mine, by any account, and not even my opinion (which is still evolving on this subject). But the fact that some really experienced folks think that way makes me wonder if this is the case.?

On the other hand, there is a wave of companies advancing cutting-edge in vitro technologies. For instance, in previous issues of this newsletter, I mentioned some of the companies in, say, organ-on-a-chip space here and here: 7 Companies Advancing Organ-on-a-Chip Technology.?

Besides, recently Emulate, Inc., a provider of in vitro models, has announced the publication of a study in Nature Communications Medicine that compares the performance of their human Liver-Chip model to animal in vivo models and human 3D hepatic spheroids in predicting drug-induced liver injury (DILI). The study, the largest of its kind to date, found that the human Liver-Chip model could improve patient safety and reduce small-molecule clinical trial failures due to liver toxicity by up to 87%. These results meet the guidelines set by IQ MPS, a member of the International Consortium for Innovation and Quality in Pharmaceutical Development.

In a blinded study, researchers evaluated 870 Emulate human Liver-Chips using 27 known hepatotoxic and non-toxic drugs, including seven pairs of toxic and less toxic structural analogs, as required by IQ MPS guidelines. The results showed that the Emulate human Liver-Chip correctly identified 87% of drugs that caused drug-induced liver injury in patients, even though they passed animal testing. Additionally, the Emulate human Liver-Chip did not incorrectly identify any drugs as toxic, resulting in 100% specificity and supporting its use in toxicology screening processes.

Importantly, their computational economic value analysis estimated that routine use of Organ-Chips to assess cardiovascular, neurological, immunological, and gastrointestinal small molecule toxicities could similarly generate approximately $24 billion dollars per year due to increased research and development productivity. With 40% of current drugs in the pipeline being biologics, this value is expected to increase even more as Organ-Chips are further incorporated into the biopharmaceutical drug development pipeline.

And what do you think? Can in vitro technologies replace animal testing? Write in the comments, and let’s discuss (or debate, if needed).?

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Welcome to Biotech Oracle's newsletter "Where Technology Meets Biology." I am sharing noteworthy news, trends, biotech startup picks, industry analyses, and interviews with pharma KOLs. Contact [email protected] for consulting or sponsorship opportunities at www.BiopharmaTrend.com. Shop world-class chemistry for drug discovery at www.enaminestore.com.

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-- Andrii