The increasing importance of biomarkers in the drug discovery process calls for a comprehensive biomarker strategy that must include assay development and validation. CHI's Inaugural Biomarker Assay Development meeting addresses "fit-for-purpose鈥 method development, spanning pre-clinical and clinical drug development, as well as diagnostics. The meeting will provide an overview of novel assay platforms for genomic and proteomic analysis, as well as multiplexed assays, flow cytometry, and more. It will also discuss the pros and cons of developing the assay in-house vs. adopting off-the-shelf solutions/kits vs. outsourcing. And finally, since the meeting is co-located with the Translational Cancer Medicine meeting, it will also focus on biomarker assays in oncology.