Congress and the FDA are advocating for pharmaceutical companies to transition from animal testing to technology for drug research. While this shift is still in progress, both startups and established industry players are actively working towards this goal.
At Children’s Mercy Hospital in Kansas City, researchers have developed a groundbreaking innovation: miniature lab-grown “hearts” known as organoids. These tiny, beating structures, only visible under a microscope, can be cultivated from a patient’s own stem cells within days. Doctors at the hospital utilize these organoids to screen for the most effective medication for a patient’s condition, significantly reducing the time spent on trial and error.
Organoids hold immense promise in the realm of drug testing and could potentially lead to the eventual elimination of animal testing.
Since the enactment of the 1937 law mandating animal testing for drug safety, there have been instances where drugs approved through animal trials have caused harm to humans. In a recent experiment, researchers tested 27 drug compounds that had previously been deemed safe through animal studies. Using a new technology called “organ-on-a-chip,” which involves clusters of cells within a miniature electronic device that mimic organ behavior, the researchers discovered that these liver organs-on-a-chip accurately predicted which compounds were harmful. This advancement could revolutionize drug development by saving billions of dollars annually and enhancing safety measures.
Aside from safety concerns, the financial aspect of drug development also drives the need to shift away from animal testing. With pharmaceutical companies spending over $2 billion on average to bring a single drug to market, and a majority of drug candidates failing in clinical trials, there is a pressing need for more accurate testing methods.
London-based Mytos, founded in 2016, is at the forefront of developing an automated system for growing cell cultures. By replicating human cells in a petri dish, researchers can conduct drug tests more efficiently and reliably. Mytos’ technology is already being adopted by pharmaceutical companies to test treatments for diseases where animal models fall short.
The FDA has proposed transitioning away from animal testing, starting with monoclonal antibodies, which are used to treat various conditions. The agency’s guidance advises drug developers to utilize alternative testing methods to ensure safety and efficacy, ultimately relying on human data for drug evaluation.
President Joe Biden’s signing of the FDA Modernization 2.0 Act, eliminating the animal testing requirement for FDA approval when alternative safety data is available, marks a significant step towards reducing reliance on animal testing. This bipartisan effort has gained momentum, with the National Institutes of Health also prioritizing human-based research technologies.
While organoids and cell cultures show promise in replacing animal testing, they have limitations. Organoids provide insights into specific areas of the body but fail to capture systemic effects. To address this challenge, companies like Gordian Biotechnology are pioneering innovative techniques such as mosaic screening, enabling evaluation of multiple gene therapies in one animal. This approach reduces costs and allows for more accurate predictions of a drug’s long-term effects.
San Francisco-based Vivodyne is developing more complex organoids that closely mimic human organs, enhancing scientists’ ability to predict drug efficacy early in the development process. Additionally, companies like Parallel Bio are leveraging artificial intelligence to model human immune responses to potential medicines, with the goal of reducing reliance on animal models.
While technology may not entirely replace animal testing, the collective effort towards this goal is gaining traction. The bipartisan support for reducing animal testing highlights the potential to enhance drug development processes and make medicine more accessible and affordable for all.
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