Translational Virology in the Era of New Approach Methodologies: Bridging Human-Relevant Models, Artificial Intelligence, and Clinical Innovation.

The COVID-19 pandemic highlighted both the strengths and limitations of conventional translational virology pipelines. While unprecedented scientific advances accelerated vaccine and antiviral development, substantial challenges remain in predicting human responses, evaluating emerging threats, and rapidly translating mechanistic discoveries into effective interventions. Simultaneously, advances in New Approach Methodologies (NAMs), including human organoids, organ-on-chip platforms, computational modeling, and AI-enabled analytics, are creating new opportunities to transform virology research toward more predictive, human-relevant, and scalable frameworks.Despite the progress individual NAM technologies have demonstrated, their full translational value can only be realized through integrated workflows that connect mechanistic virology, predictive modeling, clinical evaluation, and regulatory decision-making. However, integration between these innovative tools and translational pipelines remains fragmented inspite of these exciting advancements. A comprehensive approach is needed to harmonize these methodologies, ensuring that scientific breakthroughs at the bench can be efficiently and ethically translated to clinical benefit.This Research Topic aims to accelerate bench-to-bedside discovery in virology by spotlighting New Approach Methodologies (NAMs) that improve the predictive power, speed, and human relevance of translational research. Specifically, it will explore how adaptive designs, ex vivo systems, and computational screening approaches can enhance integrated systems and framework. Contributors are encouraged to address questions such as how NAMs can refine preclinical modelling, what frameworks are needed to validate predictive performance, and how data-driven strategies can optimize the repurposing and deployment of antiviral candidates. The overarching goal is to foster a multidisciplinary dialogue that bridges experimental virology, computational biology, regulatory science, and clinical innovation.To gather further insights in translational frameworks that connect preclinical innovation with real-world clinical deployment, we welcome articles addressing, but not limited to, the following themes:Development, qualification, validation, and regulatory acceptance of NAMs in virologyHuman-relevant organoid, tissue explant, organ-on-chip, and microphysiological systems for studying viral infection, immunity, and pathogenesisAI, machine learning, and systems biology approaches for antiviral, vaccine, and host-directed therapeutic discoveryComputational virology, digital twins, and in silico prediction of virus–host interactionsMulti-omics integration for translational biomarker identification and patient stratificationAdaptive, platform, and decentralized clinical trial methodologies for antiviral and vaccine evaluationTranslational frameworks linking preclinical evidence, clinical outcomes, and real-world dataPandemic preparedness and rapid-response platforms for emerging viral threatsReproducibility, standardization, data sharing, and FAIR principles in translational virologyEthical, regulatory, and policy considerations for implementation of NAMAccepted article types include Original Research, Review, Mini Review, Methods, Perspective, and Policy and Practice reviews. Topic editors: Sayandip Mukherjee, Giuseppe Andrea Sautto Source: https://www.frontiersin.org/research-topics/83229/translational-virology-in-the-era-of-new-approach-methodologies-bridging-human-relevant-models-artificial-intelligence-and-clinical-innovation