FDA Modernization Act & What It Means for VeriSIM Life

“Insanity is doing the same thing over and over and expecting different results” is a quote often attributed to Albert Einstein, and a sentiment that should resonate with any veteran of the pharmaceutical or biotech industries. The drug discovery and development process has been fundamentally flawed and dysfunctional for decades, with many years and much money wasted on expensive and often non-translational animal testing. 

With the recent passing of the FDA Modernization Act, however, we have now reached the pivotal turning point at which the FDA can accept the use of new drug research methods without animal tests being a necessary part of the equation. The recent act has updated the regulatory rules and guidance set by the 1938 Food, Drug and Cosmetics Act -  that relied on animal-based data in applications submitted for regulatory approvals, even with a 90-95 percent failure rate in clinical trials. This outdated legislation was put into motion long before the technological wave in the later part of the millennium, long before big data, and failed to take into account the capacity of artificial intelligence’s ability to improve the translatability of drug discovery programs. 

The FDA Modernization Act strikes out the language referencing animal testing and introduces, in its place, “non-clinical tests” such as those made possible by AI and data modeling. This change has seen a level of bipartisan support rarely witnessed in legislation today, and it is a critical milestone in the history of R&D in that it supports use of simulation and predictive technologies to increase efficiency and candidate success.

VeriSIM Life has been ahead of the curve in recognizing these advantages for five years and counting, pioneering the way towards this inevitable industry change by using technology to help clients increase the efficacy of preclinical testing while taking measures towards “de-risking” the process. For this reason, we at VeriSIM Life are incredibly excited to see that Congress has recognized the value of using new approaches to solve the problems, and decreasing the risks, inherent in the old methods of preclinical testing. 

Indeed, this change marks the end of an era and the beginning of a new one in which new technology-based solutions for predicting drug candidate efficacy are not only accepted, but encouraged. This act, combined with the EU’s recent implementation of new measures to minimize animal testing, paves the way for a greater investment in AI and machine-learning technologies by all stakeholders - technologies that VeriSIM Life has been using for years to deliver meaningful results to clients. 

While some pharmaceutical experts have hesitated to consider relying on simulation and predictions over traditional methods, it is clear that the industry professionals who were sitting on the sidelines will now jump into discussions around the topic with a fresh new interest and an open mind.  

The team at VeriSIM Life have been trailblazers from the start in using modeling and AI to transform translation for the better. The BIOiSIM™ platform along with our Translational Index™, improves return on drug development investment and reduces risk, while speeding up the discovery and development process making life-saving, better medications more affordable. We are thrilled that this new legislation will put technology companies like VeriSIM Life front and center in discussions around R&D and accelerate our already impressive trajectory to revolutionizing the industry with AI and modeling. The passing of this act is a win for animals, for patients, and ultimately, for science, a field that technological advances can only drastically enhance.