Georgia Creswell began her presentation by drawing on her background as an IHC scientist at MedImmune and AstraZeneca and her subsequent experience at Leica Biosystems, before joining Diagnexia Analytix. She set the scene with an analogy, likening the field of pathology – particularly within translational research and clinical trials – to a storm. This analogy recurred throughout her talk, illustrating the complexity and turbulence faced by organisations in this space.
Creswell highlighted the multifaceted challenges currently affecting pathology in clinical trials. These include the proliferation of study and research sites, the involvement of multiple vendors and internal stakeholders, and the burden of oversight on contract research organisations (CROs). She noted that inconsistent quality control (QC) and regional regulatory variability further complicate matters, especially when studies span multiple geographies. The increasing demand for extracting more data from fewer tissue samples, coupled with a shortage of specialist pathologists, exacerbates these issues.
She shared direct feedback from clients, revealing common pain points such as insufficient in-house pathology expertise, reluctance to micromanage CROs, lack of disease-specific experience among large CROs, inconsistent endpoint scoring, and quality management issues across geographies. Many clients also reported suboptimal pathology protocols, often only seeking expert intervention when problems had already arisen.
Creswell argued that expert pathology can bring clarity to this storm. She emphasised the importance of defining endpoints and feasibility early, developing robust pathology manuals, and embedding expert pathologists with relevant disease experience into study teams. Consensus review models, such as dual reads with adjudication, and strong oversight of CROs and labs are presented as best practice.
She described Diagnexia Analytix’s mission as acting as a “lighthouse in the storm”, offering bespoke, flexible pathology services that integrate seamlessly with client workflows. Their global network of 250 pathologists and digital infrastructure enables rapid turnaround and standardised, audit-ready outputs. Creswell concluded by reiterating that while pathology cannot eliminate all challenges, it can serve as a guiding force, helping sponsors navigate complexity and achieve reliable, regulator-ready results.
