Drug developers are raising the adoption of AI technologies when it comes to discovery and safety testing in order to get rapid as well as cheaper results, which, by the way, happen to be in line with an FDA push so as to decrease animal testing in the years to come.
It is well to be noted that in the coming three to five years, making use of AI and cutting back on animal testing can as well reduce the timelines and expenditures by at least 50%, say 11 different experts from certain contract research firms, biotech companies as well as brokerages.
Certara, the drug development software maker, along with biotech’s like Schrodinger and also Recursion Pharmaceuticals, are at present using AI already so as to forecast how experimental drugs might as well get absorbed, distributed, and in a way trigger the toxic side effects.
According to the president of drug development solutions at Certara, Patrick Smith, they are getting to the point where they do not actually have to do the animal testing anymore, and this, by the way, works with companies that are into infectious disease drugs like the monoclonal antibodies for hepatitis B.
Recursion remarks that its AI-based drug discovery platform took only 18 months to move a molecule within clinical testing as a cancer drug candidate, which was way faster vis-Ã -vis the industry average of 42 months.
TD Cowen analysts, as well as Jefferies, happen to anticipate that such AI-driven approaches will slash the costs and timelines by around 50% from the present estimates of almost 15 years and $2 billion that’s needed so as to get the drug to market.
The shift also syncs well with the vision of the FDA towards approaches like AI-driven technologies and human cell models, as well as computational models that have gone on to become the new benchmark since the agency looks forward to making animal studies an exception for preclinical safety as well as toxicity testing in the coming three to five years.
It is well to be noted that the new approaches are anticipated to, at the end of the day, lead to lower drug prices. The U.S. Food and Drug Administration had remarked on this in its April statement, which went on to outline the road map for companies so as to decrease their dependence when it comes to animal testing, specifically in the case of monoclonal antibody drugs.
However, the industry experts have still opined that the new methods are unlikely to completely replace animal testing.
Under the present FDA requirements when it comes to monoclonal antibodies, companies go ahead and perform clinical studies within animals to test if there are any harmful effects of a drug. These studies most often than not take anywhere between one to six months and also need around 144 non-human primates on average, which come at an expense of $50,000 each, as per the FDA.
The Novel Approach
One of the largest research contractors in the world, Charles River is among the industry mainstays that invest in AI and the often referred to as the new approach methodologies—NAM.
These NAMs make use of AI and computer-based modelling as well as machine learning in addition to the human-based models like organs-on-chips so as to anticipate how a drug might go ahead and work in the body. An organ-on-a-chip happens to be a small device that is lined with living human cells that go ahead and replicate major functions of an organ.
It is worth noting that the NAM portfolio of Charles River already generates almost $200 million in yearly revenue.
There are smaller players who are cropping-up
Apparently, InSphero is already going ahead and testing safety along with efficacy in 3D liver models – in which the lab-grown liver microtissues enable the replication of the functions of the organ.
Schrodinger, which is New York-based, goes on to mix physics-based simulations along with AI so as to predict drug toxicology.
However, there are industry experts who say that in the near future, companies will make use of a hybrid approach, thereby decrease animal testing and at the same time supplementing with data that happens to come from these novel methods.
According to life sciences and biotech analyst with TD Cowen, Brendan Smith, he does not think that one can get to the point immediately in the near future where all of a sudden, animal testing vanishes completely.
