Global CRO Perspectives on ICH M10, NGS and Immunogenicity Harmonization
In June 2023, leaders from across the global bioanalytical community gathered in Orlando, FL, for the 16th Closed Forum of the Global CRO Council for Bioanalysis (GCC). The outcome, now published in Bioanalysis, captures candid discussions, survey data, and consensus recommendations on some of the most pressing scientific and regulatory challenges facing our industry today.
Smithers is proud to have participated in this important forum, contributing to conversations that are actively shaping the future of bioanalysis.
What’s Inside the White Paper?
This comprehensive meeting report goes far beyond high-level commentary. It delivers real-world insights from CRO leaders on:
• ICH M10 implementation – One year later, how are laboratories adapting? What challenges remain?
• NGS assay validation – Is the industry ready for harmonized guidance?
• qPCR vs. dPCR validation – Do digital platforms require independent recommendations?
• Flow cytometry validation – Practical solutions to regulatory and technical hurdles.
• Tissue biomarker assays – Matrix considerations, long-term stability and fit-for-purpose validation.
• Internal standard response – Evaluating variability and aligning with regulatory expectations.
• Immunogenicity harmonization – Where do disagreements still exist?
• Industry shifts post-pandemic – Staffing, supply chain pressures, capacity and cost impacts.
Backed by survey responses from nearly 30 international CROs, this white paper provides a transparent look at how the industry is interpreting guidance, where practices diverge, and where harmonization is still needed.
Why This Matters Now
With regulatory expectations evolving and modalities such as gene and cell therapies driving increasingly complex assay strategies, alignment across laboratories has never been more critical. From ICH M10 compliance to advanced molecular platforms and immunogenicity best practices, the discussions summarized in this report highlight both progress and persistent gaps.
For bioanalytical scientists, regulatory professionals, and sponsors alike, the insights shared by the GCC offer a valuable perspective on current industry standards and where they may be heading next.
If you’re navigating validation strategy, preparing for inspections, or evaluating assay platforms in today’s shifting bioanalytical landscape, this report is essential reading.
Download the full white paper to explore the detailed survey findings, consensus recommendations, and forward-looking perspectives from global CRO leaders.