Companion Diagnostics in an Evolving Global Regulatory Landscape: Alignment of Co-Development Strategies for Diagnostics and Targeted Therapies

How to align and harmonize global companion diagnostic development requirements within a changing regulatory landscape emphasizing clinical development.

The realization of precision medicine and application to disease and treatment is dependent upon the concomitant availability of IVD CDx tests that guide the safe and effective use of targeted therapeutics. Coordinated drug-diagnostic co-development models are the most effective paths to regulatory approval. Contemporaneous test development from a validated biomarker assay during early phase clinical development to the availability of the final version of the CDx test intended for commercialization for use in the pivotal studies is essential to ensure marketing authorization for both drug and CDx.

The regulatory landscape for IVD development is rapidly evolving to support new technologies and testing formats while delivering safe and effective products that meet patient needs while also maintaining compliance to statutory requirements. The new EU IVD Regulation (IVDR) is bringing about landmark changes in the development and marketing of IVDs including new requirements related to technical documentation, clinical data, risk management, and postmarket surveillance. For CDx assays the IVDR changes classification requiring NB evaluation of the technical dossier and EMA review. To achieve requirements for performance evaluation, alignment of test development and validation strategies to comply with global regulatory obligations is essential to support jurisdictional requirements for clinical performance and utility.

This presentation will discuss a global regulatory roadmap for the CDx product life cycle with innovative strategies to coordinate development, expedite timelines and mitigate risk. Key considerations and challenges will be outlined for CDx development and clinical performance evaluation to comply with new regulatory requirements. The presentation will propose alignment of key stakeholders including therapeutic developers, diagnostic companies, laboratories, and clinical research organizations with regulatory requirements resulting in a more efficient approach to facilitate the advancement and aligned introduction of therapies and CDx.