Leveraging Opportunities to Change the Landscape of Drug Safety

Did you take Ibuprofen today? Have you ever been on antibiotics? Do you have a loved one with cancer or that has passed from cancer?

99% of people reading this will answer yes to one of those questions, which means that 99% of people are stakeholders in the pharmaceutical industry and by default, in drug development. However, the majority of these stakeholders don’t understand what goes into drug development and how it can impact them.

On average, a new drug takes 10-15 years to develop with 90% of those that make it to clinic failing due to insufficient efficacy and safety. This means that potentially life saving drugs that could save your mom or your dad or your daughter today, won’t be available for another 5-7 years, if ever. Why? The clear and simple answer is animal testing.

Before new drugs get to the clinic, they spend 8-10 years in preclinical development where the brunt of testing is done on animals. Assessing if the drug works, or is efficacious, is done in animal disease models and assessing if the drug is safe is done in healthy animals. The translation of these evaluations to the clinic is the driving force behind the long development timelines and high fail rates, and the inadequacies of this translation is majorly due to the limitations of animal testing.

Every year, millions of animals are used in research to bring new drugs to market but are largely untranslatable to humans. Biological differences, heavily siloed data, and noise saturated studies are a few of the reasons why animals do not, and cannot, translate. For example, rats can develop drug-related kidney tumors by inducing α2u-globulin nephropathy, however, this pathway is generally irrelevant in humans. In the landscape of assessing drug safety, it’s obvious how impactful this “untranslation” can be.

As a new drug moves through the development pipeline, the last stage prior to entering the clinic is nonclinical toxicology. This stage is the pivotal phase of development that determines if the drug is actually safe enough to be administered to humans. It is a highly regulated stage that uses the most animals in drug development and the readouts from these studies are the highest weighted decision-makers when it comes to FDA approval. Currently, the only option in the industry for conducting these studies is to do so in animals and as we just learned, the untranslation of animals is a huge problem, meaning that even after the 8-10 years the drug just spent in safety testing the industry is still moving potentially unsafe or inadequately characterized medicines to people. This greatly undermines the animal lives sacrificed and puts patients lives at risk.

What a massive problem, but what’s the solution? For one, we are in a day and age where a vast amount of historical data exists. Drug development has been an ever-changing and ever-optimizing industry, and with technology all of these data are now computerized. Technology has also brough us artificial intelligence and machine learning, tools that have demonstrated massive improvements in many industries including the pharmaceutical industry. Finally, the FDA recently made legal changes that no longer require new drugs to go through animal testing before approval. The door is open, now is the time to walk through it.

There have been several advances in the space around nonclinical toxicology, for instance, in drug discovery and clinical trials. However, there is still no significant traction within nonclinical toxicology in developing improved alternatives to animal testing. This pain point is so antiquated and solutions are long overdue. Mimicry Solutions is a startup working to alleviate arguably the most critical problem in drug development with ARTEMIS™, a computational platform that turns animal predictions of drug safety into human predictions by un-siloing study data.

Alternatives to animal testing in the nonclinical toxicology space will drastically cut down on development time while generating better safety profiles, enabling more drugs to reach the clinic and remain there. Imagine a world where a loved one has access to life saving treatments today, not 5-7 years from now. Imagine patients being able to benefit from lifesaving experimental medicines without fear of death. This is a realistic opportunity that did not exist just a few years ago, but only if we grab it by the horns.

Dessi McEntee, MS, DABT is a board-certified toxicologist with an MS in Pharmacology and Toxicology and a BS in Animal Science. Dessi has over a decade of extensive experience in nonclinical toxicology in the pharmaceutical industry and has overseen drug development strategies across startup, small and big pharmaceutical and biotech companies. Dessi is currently the Founder & CEO of Mimicry Solutions, working to reinvent drug safety through ARTEMIS™ by turning animal predictions into human predictions. More information can be found at www.mimicrysolutions.com.