After decades of reliance on animal testing methods, everything is set to change due to regulatory shifts around the globe (such as the European Union animal testing ban) and the U.S. Food and Drug Administration’s Modernization Act. The U.S. has additionally seen activity at the state level with California’s latest ban as a prime example.
The FDA legislation The bill does not end animal testing, but it now permits drug developers to use alternative methods to test for toxicity when feasible.
From lab mice to beagles, animals are being used in fewer numbers and subjected less to unnecessary testing. At the same time, pharmaceutical firms are turning to faster, cheaper, more accurate drug development options.
This includes technologies like BioAI and the work of Dr. Isaac Bentwich of Quris. Dr. Bentwich outlines to Digital Journal the main advantages with the new legislation and accompanying technology.
Dr. Bentwich sees the shift away from animal testing and towards the use of more accurate models as a good thing, and he notes the governmental driver: “The FDA Modernization Act’s unanimous approval by the Senate is a historic watershed event for the industry. If signed by the President as expected before yearend, it will eliminate the 84-year mandate for the FDA to do safety testing based on animal testing.”
The advantages of this move are clear to Bentwich: “Removing the reliance on antiquated and inaccurate animal testing models in drug development is not only a win for animals, it is a win for entire industry and will ensure improved drug safety, better patient outcomes and more efficient drug innovation.”
This includes more accurate decision making. Here Bentwich explains: “For over a hundred years, animal testing has been used as a means of ‘clinical prediction’ to identify what drugs are clinically safe and efficacious, and hence merit the entry to clinical trials. However, animal testing is an extremely poor predictor of clinical safety and efficacy – almost 90 percent of drug candidates that successfully pass animal testing failing in clinical trials.”
Such measures are also spurring on innovation. Bentwich’s assessment of this emerging market is: “Spurred by new regulations like the FDA Modernization Act, drug developers will likely race to embrace breakthrough innovations. But while AI-driven drug discovery has become the leading frontier for pharma innovation and AI pharma companies have shown significant success in various stages of the drug discovery and development funnel, they still can’t predict clinical safety of a drug candidate.”
Calling out his own innovation, Bentwich states: “Quris is the only one that completely changes the clinical prediction paradigm.”
Providing example, he clarifies: “Integrating several disruptive technologies – machine learning, patient-on-chip, nano-sensing, and stem-cells – the Quris BioAI platform takes a radically different approach to accurately predict clinical safety, which has the potential to revolutionize the entire pharmaceutical industry.”
As to applications, Bentwich notes: “The potential applications for our technology platform span across all disease areas – including rare disease drug discovery, finding new ways for patients to benefit from existing drugs (or drug combinations), all while better predicting clinical safety to accelerate their path to market.”
Dr. Bentwich continues, looking at animal welfare: “Regulatory reforms altering animal testing mandates, both in the United States and around the globe, are a step in the right direction for our furry friends.”
There are also businesses advantages, says Bentwich: “Beyond this, replacing animal testing with advanced technology platforms will drive dramatic, and revolutionary, acceleration and cost reduction for drug development that creates new opportunities. Embracing BioAI platforms will reinvigorate rare diseases drug development, which has been too often overlooked because drug development has been so slow and expensive.”
