Aug 2026· Life· Vol 16, pp. 1346· 0 citations· 55 references
Medicine
TL;DR
The study highlights that the diagnostic algorithm has ceased to be merely a laboratory support tool and has become a strategic asset and an integral adjunct to therapeutic decision-making, making continuous skills development (digital upskilling) an essential requirement for professionals in the biopharmaceutical sector.
Abstract
The progressive integration of Whole Slide Imaging (WSI) technology and Artificial Intelligence (AI) architectures is driving a structural transformation in pathology and precision oncology. This structured critical review analyzes and systematizes the impact of this technological transition along two fundamental operational dimensions of the modern biopharmaceutical industry: pre-registration Clinical Research and post-launch strategies governed by Medical Affairs. The first section explores how computational pathology is improving efficiency and reducing risk in drug development. Replacing analog visual assessment—intrinsically subject to inter-observer and intra-observer variability—with quantitative algorithms for cellular classification and segmentation enables optimization of patient recruitment in clinical trials, reducing screening failure rates. This review also examines the emerging role of Spatial Biology in extracting complex topological metrics from the Tumor Microenvironment (TME) and the use of AI for the objective and auditable quantification of critical surrogate endpoints, such as Pathological Complete Response (pCR), while acknowledging that algorithmic precision remains sensitive to pre-analytical variables and dataset biases. In the second section, the study investigates the strategic evolution of Medical Affairs, acting as a vital scientific communication and translational bridge between the complexity of Data Science and clinical hospital practice. Challenges related to AI adoption by clinicians are examined, emphasizing the importance of educational programs based on Explainable AI (XAI) to overcome the cognitive limitations of the black-box paradigm and the complex regulatory validation pathway for Software as a Medical Device (SaMD) under the stringent European IVDR framework—supported by an analysis of historical regulatory benchmarks such as the Paige Prostate case. The paper also explores the potential of AI in the large-scale generation of Real-World Evidence (RWE), applied to the creation of synthetic control arms in pharmacoeconomic settings. In conclusion, the study highlights that the diagnostic algorithm has ceased to be merely a laboratory support tool and has become a strategic asset and an integral adjunct to therapeutic decision-making. Overcoming current challenges related to data privacy through Federated Learning architectures, together with the imminent transition toward Foundation Models, foreshadows a fully data-driven healthcare ecosystem, making continuous skills development (digital upskilling) an essential requirement for professionals in the biopharmaceutical sector.
The present review analyzes the existing context of AI pathology systems, particularly diagnostic precision, clinical validation, and technical systems such as convolutional neural networks and transformers and discusses the integration challenge in clinical workflows for these systems.
Abdul-Mohsen G. Alhejaily, D. Alghamdi· Biomedical Reports· 0 citations
This narrative review examines the evolution of artificial intelligence (AI) in healthcare, with a focus on the transition from early rule-based systems to modern deep learning architectures and their integration into clinical practice. We examine foundational technologies, including convolutional neural networks for image interpretation, vision transformers for modeling long-range dependencies, and generative adversarial networks for image reconstruction and synthesis. The review further discusses the emergence of multimodal foundation models that integrate imaging with textual and genomic data to enhance diagnostic robustness. The application of these technologies is analyzed across three primary domains: Radiology (image enhancement and automated interpretation), cardiology (electrocardiographic and echocardiography analysis), and oncology (tumor classification and treatment planning). Specific attention is given to the national context in Türkiye, highlighting local initiatives such as TEKNOFEST and TÜBİTAK-supported projects that foster domestic AI development. While AI offers significant benefits in terms of diagnostic accuracy and treatment workflow optimization, challenges regarding data privacy, algorithmic bias, and interpretability (“black box” issues) persist. Future progress depends on the development of explainable AI, rigorous prospective validation, and the establishment of ethical regulatory frameworks.
Abdulkadir Yıldırım, Ö. Özdemi̇r· Artificial Intelligence in M...· 0 citations
A dual-perspective framework to systematically bridge the gap between algorithmic advances and practical demands of pathological diagnosis and prognosis is proposed, which offers practical guidance for selecting and designing AI solutions tailored to specific clinical goals.
Yun-Qiu Gao, Teng Ma, Lisha Li et al.· Chinese Medical Journal· 0 citations
AI has the capacity to strengthen diagnostic pathology by improving consistency, measurement and efficiency and moving from experimental use to routine reporting will require broad validation across centres, enhanced model transparency, strong quality‐assurance systems and close cooperation between developers and pathologists.
J. H. Shazia Fathima, Mugundan Raghavelu Narendran, Mohammed Sharique Ahmed Quadri et al.· Analytical Cellular Patholog...· 0 citations
Radiation oncology is a highly digital and data-intensive discipline in which artificial intelligence (AI) is increasingly being incorporated into the clinical workflow. From image analysis and automatic segmentation to treatment planning, adaptive radiotherapy, radiomics, and outcome prediction, AI has the potential to improve efficiency, reproducibility, and treatment personalization. This narrative review summarizes the principal concepts underlying machine learning and deep learning and examines their current applications across the radiation therapy pathway. Particular attention is given to automated contouring, knowledge-based and automated planning, cone-beam computed tomography (CBCT)- and magnetic resonance imaging (MRI)-guided adaptive radiotherapy, toxicity and tumor-control prediction, and the integration of radiomic, clinical, dosimetric, and molecular data. The available literature suggests that AI can reduce repetitive workload and inter-observer variability and may facilitate more consistent treatment planning. However, technical performance alone does not establish clinical benefit. Major challenges include data quality, dataset bias, limited external generalizability, interpretability, cybersecurity and data governance, and the need to define responsibility when AI-generated outputs are used in patient care. Prospective, multicenter validation and continuous quality assurance are therefore essential. The future of AI in radiation oncology is unlikely to be the replacement of the radiation oncologist, but rather a human–AI partnership in which automation supports clinical expertise. If AI successfully releases clinical time, this resource should be reinvested in patient communication, shared decision-making, research, innovation, and education.
S. Ichou, K. Nouni, A. Lachgar et al.· MedPeer publisher· 0 citations
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