The FDA Modernization ACT 2.0 was signed into law by President Biden on December 29, 2022. The bill stands as an update to some of the language from the 1938 Federal Food, Drug, and Cosmetics Act of 1938, which required animal testing in all new drug development protocols. This change modernizes the near century old original law that mandated animal testing for new drugs. Specifically, language was modified from the 1938 Act where the term ‘preclinical tests (including animal tests)’ was replaced with ‘nonclinical’ to mean a test “conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.”
The new law does not eliminate animal testing, but allows for alternatives for purposes of drug and biological product applications and opens doors for methods beyond animal studies before proceeding with human clinical trials. Although, it is important to note that the legislation allows the FDA to clear a drug from human trials without first testing in animals, it does not require that it do so. Regardless, this is a step in the right direction and will bring further light to alternative testing methods to advance drug development such as cell-based assays, organ chip/microphysiological systems, and computer modeling/AI.
Cell based assays
Cell based assays are laboratory techniques used in drug discovery and biological research to assess and measure biological or biochemical activity in living cells. These assays are crucial for understanding the cellular mechanisms of a drug and for evaluating its efficacy and toxicity. In these experiments, living cells are used as a testing platform, allowing for the introduction of a drug or compound, to observe changes in cell health, function, signaling pathways, or gene expression. These assays can assist in understanding how a drug interacts with its target in a cellular context, validating whether a specific target is relevant for a particular disease. Additionally, cell-based assays are essential in early-stage testing for assessing toxicity of new drugs and help to predict how a drug may affect human tissues or organs.
Cell based assays are a cornerstone of modern drug discovery that offer biological relevance, efficiency, and predictive power that is crucial for identifying and developing new therapeutic agents. Here at SBH we are a world leader in cell-based assays to measure the biological activity of cytokines and growth factors, offering a comprehensive list of 330 different bioassays. We offer nearly 400 unique human cancer cell lines and multiple cell-based disease models for your needs, with 11 different platforms for biomarker analysis.
Organ chips / Microphysiological Systems / Organoids
Organ chips, also known as microphysiological systems, are microfluidic cell culture devices that mimic the physiological function of specific organs or tissues. The goal of these devices is to replicate the complex biological responses of organs in vitro, which can be useful for drug development and disease modeling. In these systems, microfluidic channels are lined with living cells, and allow flow of liquids to mimic blood or other fluid flow experienced in vivo. Living cells are seeded in the channels, allowing capabilities such as multiple layers of several cell types or co cultures of multiple tissue types. Advanced systems can link multiple organ chips together, which replicates the interaction between different organs. For example, a drug could be processed by a liver chip before its metabolites are introduced to another organ system such as a kidney chip. The possible applications include drug development, disease modeling, and personalized medicine. In the pharmaceutical industry, chips can be used for testing the response of human cells to drugs. Chips can be used for disease modeling to study disease progression and response to treatments in a controlled environment. In the future, organ chips could be used to test how specific patient’s cells might respond to a particular treatment, paving the way for more personalized medicine approaches.
In collaboration with Bonds Biosystems, SBH offers organoid work as well. Organoids are miniature, simplified versions of organs, produced in vitro. Derived from stem cells, organoids are 3D cellular structures that resemble an organ by structure and function through self organization. Organoids develop functional properties of the organs they mimic, such as neuronal activity in brain organoids, or insulin production in pancreatic organoids. Similar to microphysioloigcal systems, organoids provide another non animal model for testing and research in disease modeling, drug development, and personalized medicine approaches.
Computer modeling / AI
Computer modeling and artificial intelligence are increasingly becoming integral tools in biological research. In drug discovery and development, AI algorithms can rapidly screen chemical compounds to predict their efficacy as potential drugs. Additionally, AI models are capable of analyze vast datasets to predict how drugs might interact with various targets in the body, and foresee potential side effects. AI tools are also capable of predicting protein structures based on their amino acid sequences and can help predict how small molecules such as drugs can fit into a proteins active site, assisting in rational drug design. Algorithms such as deep learning are also increasingly used to analyze medical images to detect and diagnose diseases such as cancer. Of course there are challenges with these methods, such as data quality and availability. The efficacy of these methods is highly dependent on the quality and quantity of data available. Despite these challenges, as the technologies progress and become more reliable, these systems will significantly reduce time and cost as compared to more traditional methods.
Some areas of research stand to benefit from the FDA Modernization Act 2.0, such as drug discovery and development, disease modeling, toxicology, and basic biological research. Generally, in the areas that can benefit from this change, there are clear advantages in terms of time and financial investments. Animal studies are expensive and lengthy. Other benefits include ethical considerations, relevance to human physiology, and the ability to offer more controlled environments in vitro to study specific variables.
At SBH we are here to assist you via our cell-based assay and biomarker services, offered for a very competitive price. Take a look at our list of currently available cytokine bioassays, and please reach out to discuss your specific needs!
Sources:
https://www.congress.gov/bill/117th-congress/house-bill/2617/text https://www.npr.org/2023/01/12/1148529799/fda-animal-testing-pharmaceuticals-drug-development
Adashi, E. Y., O'Mahony, D. P., & Cohen, I. G. (2023). The FDA Modernization Act 2.0: Drug Testing in Animals is Rendered Optional. The American journal of medicine, 136(9), 853–854. https://doi.org/10.1016/j.amjmed.2023.03.033 https://www.science.org/content/resource/new-path-new-drugs-finding-alternatives-to-animal-testing
Wikswo J. P. (2014). The relevance and potential roles of microphysiological systems in biology and medicine. Experimental biology and medicine (Maywood, N.J.), 239(9), 1061–1072. https://doi.org/10.1177/1535370214542068
Ingber, D. E. (2022). Human organs-on-chips for disease modelling, drug development and Personalized Medicine. Nature Reviews Genetics, 23(8), 467–491. https://doi.org/10.1038/s41576-022-00466-9
Zhu, J., Ji, L., Chen, Y., Li, H., Huang, M., Dai, Z., Wang, J., Xiang, D., Fu, G., Lei, Z., & Chu, X. (2023). Organoids and organs-on-chips: Insights into predicting the efficacy of systemic treatment in colorectal cancer. Cell Death Discovery, 9(1). https://doi.org/10.1038/s41420-023-01354-9
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