Reflecting on the 19th Workshop on Recent Issues in Bioanalysis (WRIB 2025), held in New Orleans, I can conclude that our bioanalytical community has returned to pre-pandemic conference attendance levels. Congratulations to the entire WRIB organizing team for assembling a robust agenda, attracting excellent speakers, and providing valuable content. There was a lot to absorb scientifically, but it was also wonderful to see familiar faces and meet new people. The week flew by, and New Orleans itself offered something for everyone, including fantastic food.
As I mentioned in my previous WRIB 2025 blog, I focused on the main 3-day workshop and the Global Bioanalytical CRO Council (GCC) forum, but I also heard great things about the specialized workshops. There was a strong emphasis on owning the science and advancing our bioanalytical discipline through innovation and adaptability. Clearly, we are living and working in a rapidly changing world and evolving markets, but bioanalysis remains crucial to drug development and understanding human disease. Efficiency improvements through AI technologies and thoughtful risk-taking were consistently highlighted throughout the week.
Day 1 of the main workshop began with immunogenicity assays and regulatory expectations. There were excellent presentations challenging the status quo of immunogenicity assessments, including the role of LC-MS, singlicate analysis in LBAs, and single-tier anti-drug antibody (ADA) strategies. Immunogenicity strategies for biosimilars and oligonucleotide therapies preceded the intriguing concept of assessing innate immune responses of host cell proteins in recombinant peptides. I had not considered the manufacturing process impurities on the immunogenicity profile of the final biotherapeutic product thus adding to my education of cell-based assays and the critical characterization required. Next was a session dedicated to biomarker bioanalysis, where two speakers addressed the challenges of reliable and appropriate calibrator material. This content was very relatable and a reminder that understanding your calibrator material is essential for accurate biomarker data interpretation. I frequently see this is underappreciated when designing biomarker bioanalysis assays and these talks will be something I’ll reference going forward. The FDA's LDT ruling was also featured in this session, providing a good overview of its scope and regulatory intent, but noting that the ruling has been blocked in Federal court. This recent news leaves the FDA's response still to be determined. The afternoon sessions covered cell and gene therapy topics and relevant bioanalytical approaches, including next-generation sequencing (NGS), digital droplet PCR, flow cytometry, and TruCulture-based assay techniques. Much of this was valuable education for me, and I'm still reviewing the presentation materials (in hard copy still!) provided to all WRIB attendees.
Day 2 saw a reorganization of the agenda due to FDA speakers not attending WRIB in person. However, with remote presentations and podium presentations from other regulators, a lot of material was still covered in 28 different talks. While the 10-minute formats kept many talks at a high level, the breadth of topics spanned the spectrum of bioanalysis, from immunogenicity and AI/ML to the latest regulatory guidance, biomarkers, and perspectives on new drug modalities. These presentations often reminded me of unexpected challenges faced by regulators. In the global drug development industry, guidelines and laws are integral, alongside the science, to ensure safe and effective drugs reach patients.
Day 3 focused on mass spectrometry, chromatography, and sample preparation. It's always exciting to see advances in the discovery field of bioanalysis, as these innovations can translate to the regulated space in the future. The first session of the third day featured great presentations on robotics, AI, and even a "blast from the past" with accelerator mass spectrometry for microdosing applications. Native LC-MS for biologic drug biotransformation and using LC-MS for ADA isotyping caught my attention to conclude the morning session. I see this as a key aspect of the future of LC-HRMS and a logical extension of intact protein mass analysis. The potential of direct analysis without dependance on critical reagents and avoiding analytical bias could simplify workflows and improve bioanalytical data interpretation. The afternoon continued the theme of new and challenging applications of mass spectrometry approaches to biomarker determinations in tissues—a keen area of interest for me. Additionally, both Day 1 and Day 3, along with the interspersed Q&A panel discussions, concluded with a summation of what from the sessions would be included in the 2025 White Paper in Bioanalysis. These White Papers serve as scientific conference reports with recommendations from the WRIB meeting and become useful reference articles so watch out for the publication in near future.
My week in New Orleans concluded with the GCC closed forum. This session provided a look at regulated bioanalysis through the lens of a CRO, often with valuable nuance. High-profile topics on the agenda included CRO compliance with the 2025 US FDA BMV Guidance for Biomarkers, continuation of the hotly debated Sample Reconciliation recommendations, Cross-Validation Harmonization, and the use of Electronic Lab Notebooks (ELNs) in CROs. As expected, there were robust discussions, and I hope we can reflect the key debate angles in a white paper from this GCC forum. The FDA biomarker BMV guidance showed split opinions, with some appreciating the clarity that reference to ICH M10 brings. Others, including myself, shared concerns about the lack of reference to context of use (CoU) in ICH M10, which is pivotal for biomarker bioanalysis. The ICH M10 language around cross validations was another thoroughly debated topic, focusing on whether acceptance criteria should apply. We were reminded that the expert working group (EWG) for M10 explicitly positioned the guidance language to avoid acceptance criteria for cross-validation statistical assessments. Bioanalysts often seek acceptance criteria, but this is one area where variables may easily preclude a priori criteria. Concluding GCC with a discussion on the trials and tribulations of implementing ELN systems in regulated bioanalytical CROs seemed particularly apt. The potential benefits are obvious, but the challenges are significant. I’ve been involved in a long journey on adoption of ELN systems in our own labs (a topic of a future blog). It’s more challenging than anyone first considers adapting human-based notebook documentation into a fully electronic system. However, I feel as an industry we are getting there now and such community discussions, as fostered by GCC, help the debate, further our discipline and keep us aligned in supporting optimized drug development.
Next year, the 20th WRIB will be held April 13-17 in Dallas, TX. It's hard to believe I've been attending this meeting for 20 years, but it's as relevant as ever. Congratulations again to the WRIB organizing team.
