Toxicologic Pathology Forum*: Opinion on New Technologies and Trends Disrupting Drug Discovery and Development: How...

The pace of technological innovation in the pharmaceutical industry, like in many other sectors, is accelerating rapidly. This is not only reshaping how pharmaceutical Research and Development (R&D) is conducted (e.g., introduction of novel models, endpoints, and instrumentation) but also influencing the types of therapeutic modalities being developed. In addition, societal and regulatory expectations have evolved to emphasize approaches that align with the 4Rs principles (Replacement, Reduction, Refinement, and Responsibility) and to encourage the replacement of animal testing with new approach methods (NAMs) through the FDA Modernization Act 2.0. While innovation, societal changes, and regulatory evolution are not new, what stands out is the unprecedented speed and scale at which these transformations are occurring. This acceleration is fueled predominantly by groundbreaking technological advancements (e.g., artificial intelligence, deep learning, communication tools, and digital pathology) in the context of rapidly changing societal dynamics such as globalization, social networking, and the increase in remote working. Given these potentially disruptive changes, it is essential to consider how toxicologic pathologists need to adapt. More importantly, how can they leverage these advancements to contribute even more significantly to the discovery and development of novel, safe, and effective medicines? In essence, what types of toxicologic pathologists will the pharmaceutical industry require in the future?