In her presentation, Bethany Montgomery, a technology lead from ARC Regulatory, discussed strategies for designing successful early phase translational medicine studies. Montgomery began by introducing ARC Regulatory as a Belfast-based consultancy specialising in precision medicine, particularly in vitro and companion diagnostics. The company supports developers in designing and validating assays, navigating regulatory pathways, and generating clinical evidence.
Montgomery highlighted the challenges sponsors face when selecting laboratories for early phase studies. Through primary market research, ARC Regulatory identified common pitfalls, such as laboratories lacking regulated design control, limited experience with IVDR, inconsistent project management, and poor communication. Many central testing labs, she noted, show little interest in early phase studies due to small patient populations and slow enrolment, preferring to engage at the commercialisation stage. Additionally, technology gaps persist, with some labs unable to offer essential assays like immunohistochemistry, ELISA, or NGS.
The presentation outlined two main routes for lab selection: local testing at the point of care, which offers faster data generation but risks variability, and central testing, which ensures regulatory consistency but at a higher cost. Montgomery emphasised the importance of visiting potential labs to verify their compliance with quality management systems, technical expertise, capacity, and regulatory standards.
A key focus was the health institution exemption under IVDR Article 5(5), which allows certain institutions to bypass CE marking, accelerating project timelines and reducing costs. ARC Regulatory ensures that documentation is robust, enabling a smooth transition to performance study applications if regulations change.
Montgomery described the rigorous process of assay validation, advocating for the use of CLSI guidelines to ensure comprehensive and customisable validation packages. She illustrated this with a recent Claudin18 validation study, detailing the experimental design, instrumentation, and results, which demonstrated high accuracy, precision, and reproducibility.
Looking ahead, ARC Regulatory continues to expand its capabilities, introducing new assays such as C-Met and HER2, and preparing for the launch of NGS platforms. The company remains committed to maintaining high quality and regulatory standards, offering innovative solutions and flexibility to clients while operating as a designated health institution.
