Source: Financial Alliance.
The news that the USA Food and Drug Administration (FDA) claims to gradually replace animal testing requirements has driven stock prices of AI pharmaceutical development Concept companies in the USA today.
Among them, $Recursion Pharmaceuticals (RXRX.US)$ During the trading session, it once surged over 30%, now with an increase of nearly 20%; in addition, $Simulations Plus (SLP.US)$ rising nearly 20%,$Certara (CERT.US)$ Increased by over 14%.
However, the industry has mixed opinions on this news. From the perspective of AI pharmaceutical companies, the cancellation of animal testing requirements for monoclonal antibodies and other drugs, in favor of pursuing AI-based toxicity computational models, cell lines, and organoid toxicity testing in laboratory settings, represents a trend in Industry development. Yet, there is also an opinion that this is a good Concept but is still far from being implementable.
The FDA plans to eliminate animal testing.
On April 10th, local time, the USA FDA announced a significant decision to gradually eliminate the requirement for animal testing for monoclonal antibodies and other drugs, opting for more effective, human-relevant methods for drug safety and efficacy evaluation.
FDA Director Martin A. Makary stated, "By utilizing AI-based computational models, human organ-based laboratory testing, and real-world human data, we can provide patients with safer treatments more quickly and reliably while reducing R&D costs and drug prices. This is a win-win for public health and ethics."
In the announcement, the FDA indicated that utilizing Computer modeling and AI to predict drug behavior would significantly reduce the need for animal testing. Additionally, using lab-cultured human 'organoids' and chip organ systems (which simulate human organs such as the liver, heart, and immune organs) to test drug safety yields a more direct understanding of human responses.
It is worth mentioning that the FDA also introduced incentive policies, such as companies submitting robust safety data from non-animal tests may receive streamlined reviews.
There is still time before large-scale application.
In response to this, Liu Xiao, Vice President of Business at Xingcheng Biotechnology and Deputy Director of the MAH Special Committee of the China Pharmaceutical Enterprise Management Association, pointed out in an interview with the Financial Associated Press, "Using organoids and AI in toxicological experiments to replace animals is a good attempt, but it may be a bit too ambitious."
Liu Xiao believes that this is a very good concept, but it is far from being implementable. Because under the current technological conditions, without sufficient animal toxicology tests, the safety of recklessly advancing human trials cannot be guaranteed due to the lack of good data support.
Firstly, even if researchers fully understand the entire gene sequence, they still cannot find effective treatments for many types of diseases. Secondly, the human body is a more complex system than the genome. For example, in the tumor microenvironment of human tumor cells, there are many possibilities for tumor escape, and AI and organoids cannot simulate the fragile immune system of leukemia patients. Therefore, it is impossible to simulate with the current technology.
When asked when AI and organoids could completely replace animal experiments, Liu Xiao stated that his original expectation was within ten years, but the recent restrictions on access to the US NIH database and the increasing geopolitical risks may delay this. This is not something that can be accomplished by the scientific team of any single country; it requires global cooperation.
Editor/jayden
