Digital & Computational Pathology - Global Medical Affairs, Top 10 Pharma

A Biopharma Stakeholder in global medical affairs discusses their extensive use and experience with digital pathology. They use scanners and image analysis tools for preclinical safety studies, clinical trials, and pharma services. They mention the advantages of digital pathology in consultation, specialty care, tumor boards, education, and research, which include efficiency and collaboration benefits as well as global accessibility. The stakeholder explains that while whole site imaging systems have been FDA cleared mostly in surgical pathology, there are special needs and use cases in fields like neuropathology, dermatopathology, and hematopathology. They also discuss the use of AI algorithms in digital pathology, which can provide insights and quantitation that pathologists may miss, such as identifying important characteristics for prognosis and treatment response. However, there are challenges to overcome, such as interoperability issues and inconsistency in image annotations and file formats among different scanners. The interview concludes by discussing the challenges of standardizing digital pathology scans across different devices and the need for vendors to differentiate themselves and facilitate adoption. The stakeholder suggests that FDA clearance, cost, and format interconvertibility are important considerations. They also mention the importance of enhancing current pathology practices, maintaining biological plausibility in diagnostics, and ensuring a clear link between tests and drug mechanisms. Overall, the stakeholder emphasizes that a complete digital pathology offering should balance compliance with device specifications and customer needs, and regulatory reform or relaxation may be necessary to support this.