Online Program

Return to main conference page
Thursday, October 19
Thu, Oct 19, 2:45 PM - 4:15 PM
Aventine Ballroom C
Perspectives on Team Science and Collaboration in Biomedical Research

Finding DLMO: Collaboration in Moving a Biomarker from the Literature to the Clinic (303866)

*Eve Pickering, Pfizer, Inc 

Keywords: biomarker, collaboration, DLMO, clinical trials

Biomarkers that appear to be common practice in the literature can nevertheless be challenging to use in a clinical trial. This presentation describes building a scientific community to bring a marker of circadian rhythm into the clinic. There are many biomarkers in the literature that might be useful for assessing a circadian pattern. For example, salivary melatonin can be sampled over time in a dim light condition. The point at which the melatonin begins to increase is an important landmark in the pattern, and is referred to as Dim Light Melatonin Onset, or DLMO. A multi-disciplinary team collaborated to implement the salivary melatonin assay and assess DLMO in a clinical trial. The plan started with the design of a Human Biology study to confirm our ability to conduct a dim light study, collect salivary samples, measure melatonin, and compute DLMO. Complications included assay formulation details, complementary assessments of circadian activity that may or may not agree with the DLMO, and competition between automated and hand scoring. Statistics, biology, pharmacology, data science and clinical talents were needed to successfully transfer the assay to the clinic.