Uniting Cellular Toxicogenomics, Gene Therapy, and AI for Personalized Toxicology in the AI-Tailored Era

In the ever-evolving field of toxicology and pharmaceutics, the fusion of state-of-the-art technologies is imperative. This abstract explores the symbiosis between toxicogenomics, cell and gene therapy, artificial intelligence (AI), and regulatory tools, heralding a new epoch of personalized medicine within toxicological research. Embracing the "Tired Population" paradigm, which emphasizes individual susceptibilities and responses to toxicants, our approach utilizes AI to tailor interventions and mitigate risks at a personalized level. To achieve this, we advocate for the incorporation of New Approach Methodologies (NAMs), which revolutionize conventional toxicological paradigms. By leveraging toxicogenomic insights, we unravel the intricate interplay between genetic factors and toxicant exposure, laying the groundwork for precision toxicology. Furthermore, the integration of cell and gene therapy presents innovative avenues for targeted interventions, minimizing adverse effects and maximizing efficacy. The addition of regulatory tools such as EPA ICE's Curve Surfer, In Vitro-In Vivo Extrapolation (IVIVE), and Physiologically-Based Pharmacokinetic (PBPK) modeling enhances the capabilities of NAMs. Curve Surfer enables dynamic visualization of chemical data, facilitating informed decision-making. IVIVE bridges the gap between in vitro experiments and in vivo outcomes, enhancing predictive accuracy. PBPK modeling offers a mechanistic understanding of chemical kinetics within biological systems, enabling refined toxicity assessments. Our comprehensive approach transcends traditional one-size-fits-all strategies, embracing the inherent diversity of human populations. Through AI-driven analyses of vast datasets and the integration of regulatory tools, we decode complex toxicity profiles, facilitating tailored interventions based on individual genetic makeup and environmental exposures. By uniting diverse disciplines and leveraging technological advancements, we empower toxicologists to usher in a new era of personalized medicine, where toxicity assessments are not only predictive but also preventive and personalised.