Speaker Details 

Amber McNair

Senior Clinical Trials Regulatory Manager, IQVIA

Clinical trials are facing unprecedented challenges from increasing costs, regulatory and policy changes to patient expectations. New concepts for personalised medicine is a business trend worthy of investment, but with known regulatory roadblocks for clinical trials that use biomarkers in drug development, it can be challenging for pharma. The introduction of CTR and IVDR in Europe saw the use of diagnostics in clinical trials thrown into the spotlight, but the regulation of in vitro-diagnostic devices (IVD) was a new challenge for pharma Sponsors. The submission of two trials, the performance study under IVDR for an investigational IVD, and the clinical trial for the investigational drug even for a Phase I proof of mechanism / concept clinical trial is seen as a huge regulatory burden, particularly when the pharma Sponsor has no intention of partnering with the manufacturer to bring the IVD to market. This regulatory burden and operational load can increase with each phase of the drugs development, often ballooning in Phase 3. The European Commission listened to industry and in a push to make the EU more appealing to innovative patient care, is piloting a revolutionary concept of a joint submission of the IVD and clinical trial via the Clinical Trial Information System via the EC COMBINE project. If successful, the pilot will thrust the alignment of two different regulations and help pharma offer personalised medicine to patients faster. As a chair in EC COMBINE, we will discuss how IQVIA’s considerable experience as a CRO in the combined clinical trial space can help overcome challenges by using real world successful case studies from both IVD submissions and clinical trials and demonstrate that the EU can be at the forefront of adaptable and patient centric care.