Congress last week passed the FDA Modernization Act 2.0 removing the requirement to use animal testing in drug development. This will allow pharmaceutical companies to use other safety trial models when presenting new drugs.
This is important because the Federal Food, Drug, and Cosmetic Act of 1938, which is still in effect, mandates animal testing for every new drug development protocol. Proponents of non-animal testing have argued that the cost of animal research is high – in dollars, time and delays in approvals of beneficial drugs for human use. They also argue that certain drugs that were deemed safe by animal studies have subsequently caused harm to human subjects in clinical testsalthough the latter position is poorly quantified.
Once the FDA Modernization Act 2.0 is enacted, a moment of transition will follow. The section of the House bill that allows for the incorporation of alternatives to animal use in preclinical testing outlines the approaches most likely to predict human response based on scientific evidence. These include cell-based questions; organ chips and microphysiological systems; and sophisticated computer modeling. Several of these approaches allow drug developers to incorporate safety assessment alternatives that are strong enough to convince regulators that a program has been scaled down enough.
The bill comes at a pivotal time; modern toxicity testing has moved away from reliance on animal studies. An alternative has been mechanism-based testing strategies, such as cell assays. These are already used as research tools to support the interpretation of in vitro toxicity data, as well as the design of in vitro Considerable experimentation and progress has been made in making the tests available and deployable in a user-friendly form.
so called Organ chips and microphysiological systems began to be used more frequently when testing Covid-19 drugs and vaccines, which would have helped researchers better understand how Covid-19 interacted with human organs and triggered an immune response. Using human cells and artificial structures, these approaches create an environment that mimics or models organ function, and they may have application in genetic testing of drug testing efficacy in various human populations using human genetic material. .
The average cost to bring a drug to market is around $2 billion, more than half of which is spent on clinical trials. But before the trials are conducted, researchers are increasingly using computer modelling, a technology that has been around for several decades and which offers several advantages.
Sophisticated modeling that uses in silico, computer-based tests with virtual patients, biosimulation is quick and relatively inexpensive and reveals rich information about how a drug would work and how best to design a trial before the drug is tested on patients. Biosimulation also offers the flexibility of computer-based testing, allowing developers to optimize trial design and dosing for different patient populations.
By relaxing regulatory requirements for animal testing, the law allows scientists to more fully utilize cutting-edge innovative technologies in future drug development strategies. These alternatives are not yet the complete answer, but increasingly adopting a “totality of evidence” approach where the combination of multiple data points can be used to assess whether a threshold of confidence is met with respect to safety of a drug at a particular dose, regulators allow developers to speed up the process.
Now that Congress has passed the FDA Modernization Act, pharmaceutical companies need to consider how to take advantage of the translation tools described above, which can be an important part of a drug developer’s arsenal. Depending on how they are used, they can allow researchers to more quickly and cost-effectively develop life-saving drugs and vaccines that patients need.
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