Single Molecule Counting (SMC™) Technology Enables Acceleration of Drug Development Programs

Advances in bioanalytical tools has enabled the evaluation of appropriate biomarkers as well as assess drug efficacy and drug safety facilitating both translational and clinical research.  The accurate detection and monitoring of clinically relevant low-level biomarkers, such as, cTnI, IL-17a, IL-17F, and IL-23 can provide valuable insights into early disease progression or indication of disease and thus have become attractive candidates for targeted therapies of pharmacokinetic and pharmacodynamic (PK/PD) studies. However, due to the low-abundance of these biomarkers, obtaining robust measurements in clinical samples has been difficult. Furthermore, as therapeutics become more complex the modality induced immune responses observed during clinical trials, particularly the early incidence of anti-drug antibodies (ADA) induction and the implications of these responses’ in product safety and efficacy, is crucial for any drug development program. The recent FDA guidance (Jan 2019) recommends 100 ng/mL sensitivity for clinical screening and confirmatory assays events as well as the necessity of these assays to be target and drug tolerant, the latter of which can often be a challenge.  This presentation will discuss how research studies, including PK/PD and ADA, using Single Molecule Counting (SMC™) Technology, have enabled researchers to gain unprecedented insights into complex disease processes , drug safety and efficacy as well as potentially overcome some of the challenges to facilitate the drug development program.