Dec 16, 2022

News provided by Share this article Share this article WASHINGTON, Dec. 16, 2022 /PRNewswire/ -- In an opinion article published today in Frontiers Medical Technology, section on Pharmaceutical Innovation link here , Center for Contemporary Sciences (CCS) lists a dozen reasons why Organ-Chips are better than animal experimentation at modeling human disease and for drug development. In this article, CCS Chief Science Officer Dr. Zaher Nahle conducts an analysis of a landmark study published on December 6, 2022, in Nature Communications Medicine by Emulate, Inc. The existing drug development paradigm, established by statute in 1938 under the Federal Food, Drug, and Cosmetics Act (FFDCA), requires animal tests to be conducted to assess safety and efficacy in all new drug applications submitted for regulatory approvals, even though 90—95% of drugs that pass animal testing fail when tried in humans. As such, a growing number of stakeholders worldwide are demanding human relevancy across scientific research, including preclinical studies and drug development. The CCS opinion piece, titled "A Proof-of-Concept Study Poised to Remodel the Drug Development Process Liver-Chip Solutions for Lead Optimization and Predictive Toxicology" articulates some of the current concepts associated with the topic of human relevancy in preclinical research. Importantly, it sheds the light on the solutions offered by Organ-Chips, especially in predicting liver toxicity. Liver toxicity is the leading cause of termination of clinical trials due to toxicity. In turn, unmanaged toxicity is a major impediment in drug development, accounting for around 30% of clinical trial failures. The opinion article also comprehensively evaluates a study by Emulate, showing the superiority of Liver-Chips in predicting drug liver toxicity in humans, as compared to existing standard methods like animal testing. Specifically, the Emulate human Liver-Chips correctly identified 87% of drugs that caused serious liver toxicity and deaths in patients despite passing through animal testing. Moreover, the opinion article assesses the economic argument presented therein showing that $billions in productivity gains can be acquired by incorporating the technology into the drug development process at the preclinical stages. This is an important development in pharmaceutical medicine. Some of the areas specifically addressed in the CCS article include the important focus on liver toxicity, the marked sensitivity demonstrated in predicting the toxicity of drugs by the Liver-Chips, the superior capability of the Liver-Chips to not falsely label safe drug candidates as toxic, the convincing economic argument for using Liver-Chips, the rigorous quality control performed in the Emulate study, as well as the existing limitations of the technology at this point. "The Emulate study is one of the most critical developments in the field of Organ-on-a-Chip technology," said Zaher Nahle, PhD, MPA, Chief Science Officer at the Center for Contemporary Sciences. "It shows the primacy and utility of the technology in predictive toxicology. It also demonstrates the immediate readiness of such technology to transform critical phases of the drug development process, in particular lead optimization and preclinical assessment, making the entire process safer, cheaper, faster, and more effective. "    "We will soon be embarking into a new era in medicine and medical research," says CCS CEO and Co-Founder Aysha Akhtar, MD, MPH. "Experimenting on animals, whose biology are vastly different from humans, will one day be a thing of the past and that is a good thing for human health and animal protection. Advanced testing methods based on human biology will revolutionize the way we approach medicine and health and lead to individualized medicine." For additional background and testimonials on the Emulate study, including Dr. Nahle's, see here. CCS continues to support work that enact policies and improved science to promote healthcare innovation and human-relevant testing. About Center for Contemporary Sciences Center for Contemporary Sciences  (CCS) is pioneering a paradigm shift towards innovative, evidence-based research methods that are based on human biology. We champion technologies that are better for humans and that replace animal testing. SOURCE Center for Contemporary Sciences ×