A recent article in Nature magazine highlights exciting developments in the field of drug toxicity testing, which could revolutionize the way new medications are brought to market. As we’ve discussed earlier, the FDA Modernization Act, which was unanimously passed by the Senate in September 2022, seeks to diversify the methods by which drug companies can test their products for safety and efficacy before they are marketed to the public. The passing of this bill represents the culmination of years of research and collaboration between scientists, drug company representatives and various members of the government.
Harnessing New Technologies
The Nature article discusses another crucial element of this wide-reaching initiative: the FDA-led Alternative Methods Group, a program dedicated to further exploring the use of cutting-edge alternatives to animal testing in drug toxicity screening. The Alternative Methods Group, in turn, operates as part of the FDA’s Predictive Toxicology Roadmap, with the goal of achieving “animal 3Rs” (Replacement, Reduction and Refinement).
Addressing Limitations
Animal testing has been the primary method of determining drug toxicity for many decades, but advances in science and technology have placed the limits of this technique into sharper focus.
Many people consider the use of animals in drug testing to be inhumane, regardless of efficacy. But moral considerations are not the only reason for a push toward alternative techniques. First and foremost, animal testing is also not always the most accurate predictor of a drug’s potential effect on humans, given the physiological differences between species. In addition, animal testing is comparatively expensive and time consuming, necessitating delays and potentially raising the cost of the end product.
Lower Expense and Better Results
Cell-based methods, including microphysiological systems and organs-on-a-chip, are a particularly promising alternative to animal testing, since they mimic an in vivo environment and are thus more likely to provide an accurate indication of human toxicity. Computer modeling techniques (in silico) offer great potential as well, and have the added bonus of being much speedier than traditional animal testing processes.
The Need for Buy-In
As noted in the Nature article, however, the lack of funding for these alternatives presents a roadblock. While the FDA has allocated several million dollars from its 2023 budget to further develop the Alternative Methods/animal 3Rs strategy, money is also needed for drug companies and other manufacturers to put the results of this strategy into practice. As of now, the National Institutes of Health (NIH) does not have a program dedicated to animal testing alternatives.
Members of the Alternative Methods Group and other advocates of the animal 3Rs are hoping to shift perspectives with their findings, while acknowledging that more research and testing must be done in order to ensure that alternative techniques are a safe and valid replacement. And there is certainly a groundswell of support for the initiative around the world; the European Parliament recently voted overwhelmingly in favor of phasing out animal testing, for example.
In all likelihood, animal testing will one day be a thing of the past. In order for that to happen sooner rather than later, scientists, drug companies and government agencies must continue to work together to facilitate the development of safe, modern and effective alternatives.
Located in San Antonio, TX, StemBioSys develops cell culture technologies licensed from The University of Texas Health Science Center, San Antonio. Our work represents the next evolution in stem cell research. For more information about StemBioSys and our patented technology, please contact us.