Next week, I will be attending the 19th Workshop on Recent Issues in Bioanalysis (WRIB 2025) in New Orleans, LA. WRIB is the largest bioanalytical-specific conference in North America. I've been attending since it was known as the Calibration and Validation Group (CVG) Workshop on Regulated Bioanalysis. This workshop brings together bioanalytical subject matter experts and regulators from around the world, influencing many aspects of today's bioanalysis practices. The format has evolved from a single-track meeting in Montreal, Canada, back in 2007, to an intense full week of the main workshop agenda supplemented with seven specialized workshops. There's something for everyone passionate about bioanalysis.
Alongside WRIB is the Global (Bioanalysis) CRO Council (GCC) closed-door meeting. This GCC meeting has been ongoing since 2010 and involves CRO representatives discussing the science of bioanalysis, particularly pertinent to the outsourcing of regulated bioanalysis. Managing regulatory guidance compliance with different sponsor interpretations presents unique challenges for bioanalytical CROs, making this meeting valuable and engaging. Both WRIB and GCC are held annually, emphasizing reporting discussions and conclusions in white papers. They involve a cross-section of our bioanalytical community and enable a deep dive into current topics. Accompanying the presentations are scientific poster sessions each day of the main workshop and an active exhibitor hall to promote networking and meeting representatives in the bioanalytical industry.
Looking through the agenda for WRIB 2025, it's a bit daunting to figure out what to focus on. I've registered for the main workshop to broaden my knowledge across the bioanalysis spectrum. Colleagues are attending some specialized workshop presentations, so I'll be chasing them for summaries on those parallel sessions, particularly on advanced LC-MS topics. I see some tantalizing topics on emerging drug modalities (e.g., antibody oligonucleotide conjugates [AOCs]), multiplexing LC-HRMS for novel biomarkers, and the latest advances in tackling familiar challenges (non-specific binding, recovery, and analyte stability).
Day 1, which falls on Tuesday, April 7th, will have me focused on the latest perspectives on bioanalytical techniques for immunogenicity assays, biomarkers and gene/cell therapies. I expect there will be updates on thoughts around the FDA’s lab developed test (LDT) final ruling and how it will impact clinical development– noting that this week the US District Court nullified the regulation. Biomarker bioanalysis method validation (BMV) of course is in vogue with the FDA’s finalized guidance on the topic issued earlier this year. I’m sure this will induce lively discussion throughout the week. This will likely roll into Day 2 which is traditionally WRIB’s “Ask the Regulators” day. It’s unclear now of the FDA’s participation in WRIB 2025 with some travel restrictions the agency is operating under, but FDA speakers are on the finalized agenda. In any case we’ll have other regulators on the podium to hear latest updates, case studies and perspectives. Day 3 of the main workshop is where I’ll get my updates on LC-MS regulated bioanalysis. I expect significant content on AI and robotic automation of course but also intriguing topics catch my eye on the agenda include ADA isotyping by LC-MS, post-translation modification (PTM) characterization by hybrid IA-LC-MS and tissue biomarker bioanalysis.
The concluding day for me will be the GCC meeting, where we have another packed day of regulated bioanalysis topics. The FDA biomarker BMV guidance is again a "hot topic." I sense this will be the theme of the week. Additionally, I'll help address three pertinent discussion topics: Sample Reconciliation, Post-Extraction Sample Stability, and Cross-Validation Harmonization.
As expected, WRIB 2025 will be a busy week of engaging discussions on bioanalysis science and an opportunity to catch up with familiar clients, friends, and new connections in our integrated bioanalytical community. If you're there and want to connect, please stop by the IQVIA Laboratories booth number 42 during one of the breaks and ask for me. Hope to see you there and if so, I wish you safe travels.
