Nanh Nguyen
Translational Medicine Biomarker Lead UCB
Nanh is an experienced translational medicine and biomarker expert with over 25 years of experience across academic research and the pharmaceutical industry. Holding a PhD in science with expertise in immunology and virology, Nanh has led biomarker strategy, assay development, and translational research across vaccines, immuno-oncology, and neuroscience. With additional experience in vaccine regulatory affairs, Nanh is passionate about accelerating the translation of scientific discoveries into innovative therapies that improve patient outcomes
Seminars
Eliminate the variability and comparability issues that undermine biomarker confidence across studies. This hands-on workshop equips you with frameworks for selecting validated assays, establishing harmonisation protocols across multiple vendors and platforms, and building regulatory-grade validation packages. Walk away with actionable strategies to reduce interlab variability, leverage IVD-approved assays, and create biomarker data sets that withstand regulatory scrutiny and enable meaningful historical data comparisons.
Workshop Highlights Include:
- Dissection of a failed biomarker programmes, examining the root causes, financial impact, and specific corrective actions that could have prevented the failure, providing cautionary lessons you can apply immediately
- Interactive group discussion on navigating the regulatory landscape in Europe versus US, understanding when validated assays are mandatory versus when research-use-only assays are acceptable, and strategies for transitioning from exploratory to regulatory-grade biomarkers
- Approaches to managing the competitive multi-vendor assay landscape, where differing platforms complicate standardisation, including the use of round-robin studies, shared reference materials, and harmonisation consortia
- Quality control strategies to ensure reproducibility across batches, sites, and time when deploying ultrasensitive biomarkers in multi-site global trials, including the establishment of internal standards and calibration procedures to maintain assay performance throughout a clinical programme
