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.
Anitaben Tailor, Ph.D.
Biology Technical Marketing
Anitaben Tailor brings over 10 years' of immunoassay platform experience in the biopharmaceutical industry. Anita earned her Master's in Pharmacology at Kings College, London and then went on to do her Ph.D. in Biochemical Immunopharmacology at the University of London, UK. She was a Post-Doctoral Fellow in physiology and pharmacology at LSU Health Sciences, followed by faculty positions at Johns Hopkins and NIH. In 2009, Anita moved into industry as a Field Application Scientist for Meso Scale Diagnostics and Singulex (Merck). In 2016, Anita was appointed the global role of SMC® Technology and Application lead within the Life Science Division at Merck, where she lead multiple teams globally on the utility of SMC® technology as a bioanalytical tools for multiple research applications within industry and academia. More recently Anita joined the global Biology Technical Marketing group, focusing on the Immunoassay portfolio within Pharma and CROs.
Duration: 51 min
Presented: Tue , March 30, 2021