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Human-Relevant Test Methods Can Improve Drug Development. It’s Time to Use Them.
There’s been a long-simmering debate about alternatives to animal testing one day replacing the use of dogs, primates, rodents, and other animals conscripted into testing and experimentation.
The Center for a Humane Economy is now working with biotech and pharma companies to promote this transition to more humane and human-based science.
The history of animal testing, especially when it comes to drug development, reveals that animal testing is not predictive of the human response to drugs.
That’s why it’s so important for Congress to hit the reset button when it comes to our drug approval paradigm. The FDA Modernization Act, H.R. 2565 and S. 2952, will eliminate an animal-testing made for new drugs built into statute. If Congress enacts the measure, it will broaden the scope of tools that drug developers can employ to test drugs for safety and efficacy.
But what are those tools and are they available now? Here’s a short survey of the 21st technology that can revolutionize science and promote life-saving medicines across species lines.
- Organ-on-a-chip disease model used to determine efficacy. A scientific team supported by the National Institutes of Health has created a bioengineered 3-D model that mimics the biology a pair of rare, devastating neuromuscular diseases. Using the organ-on-a-chip model, researchers showed how a drug could treat the diseases. They provided key preclinical data for a drug company to submit to the U.S. Food and Drug Administration to get authorization for testing in a clinical trial.
- Liver Chip outperforms animal tests. In a recent study, researchers assessed the performance of 780 human Liver-Chips across a blinded set of 27 known hepatotoxic and non-toxic drugs. The study demonstrated that the Emulate Liver-Chip was able to correctly identify 87 percent of the tested drugs that caused drug-induced liver injury in patients, despite passing through animal testing. At the same time, the Liver-Chip did not falsely flag any drugs as toxic, supporting its use in toxicology screening workflows. The study also concluded that routine use of the Emulate Liver-Chip to identify liver toxicity risk in small-molecule drug development could generate approximately $3 billion per year by driving an increase in research and development productivity.
- Immune System on-a-chip to develop vaccines. “The flurry of vaccine development efforts sparked by the COVID-19 pandemic were impressive for their speed, but the increased demand suddenly made traditional animal models scarce resources. The LF Chip offers a cheaper, faster, and more predictive model for studying human immune responses to both infections and vaccines, and we hope it will streamline and improve vaccine development against many diseases in the future,” said corresponding author Donald Ingber, M.D., Ph.D., who is the founding director of the Wyss Institute.
- Repurposing existing drugs to treat COVID-19: The Wyss Institute team moved quickly to address the COVID-19 crisis, and conducted mechanistic studies of viral infection-associated inflammation enabled by the novel capabilities of human Organ Chips. This led to the repurposing of Azeliragon for COVID-19 and is being commercialized by Cantex. This potentially lifesaving therapy will enter clinical trials, and eventually be placed in the hands of patients for treating COVID-19 and address other inflammatory diseases as well.
The Center is excited to work with pharmaceutical companies to usher in these methods and this new legal and regulatory framework. But as with everything, change requires human agency. We need you to be involved to demand that business and government do better when it comes to developing lifesaving and life-enhancing drugs and also to reduce the numbers of animals conscripted into painful and lethal service. Contact your legislators today to make your voice heard.
Tamara Drake is the director of research and regulatory affairs for the Center for a Humane Economy.
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