Upcoming Global Web Symposia
May 30, 2012
11:00 am – 12:30 pm EDT
Symposium Course Description:
Biomarker assays in the development of therapeutics is often challenged with limited sample volumes, slow assay development and need for high quality data to support bioanalysis from discovery to clinical trials. Please join scientists from Pfizer, Radix Biosolutions, and Ablynx nv as we explore the latest developments in fit-for-purpose determinations of biomarkers using the Gyrolab™ nanoliter-scale immunoassay platform and its' impact on maximizing performance and productivity of ligand binding biomarker assays in the clinical development of therapeutics.
Robert A. Durham, Ph.D., Manager Field Application Specialists, North America
Biomarker Assay Co-Development and Validation: an Industry and CRO Process
Kerry Oliver, Ph.D., General Partner, Radix Biosolutions, Austin, TX, USA
Chad A. Ray, Pfizer, Inc., La Jolla, CA, USA
Fit-For-Purpose Development and Validation of a Challenging Biomarker Assay on Gyrolab for a Novel Nanobody® Drug Candidate
Ariëlla Van de Sompel, Senior Research Associate, Pharmacology, Ablynx nv, Belgium
Blocking IL-6R results has shown clinical benefits with tocilizumab, a marketed anti-IL-6R monoclonal antibody. ALX-0061 is a highly specific anti-IL-6R Nanobody engineered to obtain half-life extension (HLE) in vivo, and high target affinity and potency. A Gyrolab™ based biomarker assay was developed for ALX-0061 in order to support preclinical toxicology studies in cynomolgus monkey. In plasma, free soluble IL-6R (sIL-6R) concentrations were quantified using the Gyrolab platform as this platform was considered optimal for not disturbing ALX-0061/IL-6R complexes during the analysis procedure. The method was successfully validated for its use to determine the proximal pharmacodynamic effect of ALX-0061.
Results from the herein described assay were compared to an additional biomarker assay (ELISA) quantifying total sIL-6R. Both target biomarker assays were used to support the single dose dose-range finder study in cynomolgus monkey, in which ALX-0061 dose-dependently affected total and free sIL-6R levels. The Gyrolab-based method was shown to be fit-for-purpose for the determination of free sIL-6R concentrations in cynomolgus monkey plasma samples. The assay was employed to confirm the proximal pharmacodynamic effect of ALX-0061 in cynomolgus monkey in which a good inverse correlation between total sIL-6R, free sIL-6R and ALX-0061 was demonstrated.
Glucagon-like Peptide (GLP-1): Gyros vs. Other Quantitation Platforms
Mark Dysinger , Senior Scientist, Pharmacokinetics, Dynamics, and Metabolism, Pfizer Global Research and Development, Groton, CT, USA
Glucagon-like peptide (GLP-1) is an important biomarker for both obesity and diabetes. GLP-1 has been historically quantified by colorimetric ELISA and more recently ECL. This presentation provides background of the biomarker in terms of structure, function, and biological importance, and how the historical quantification platforms compare to Gyros performance. Particular emphasis is given to assay dynamic range and sensitivity.
250 First Avenue Suite 300Needham, MA 02494P: 781.972.5400F: 781.972.5425E: email@example.com
biological therapeutic productsbiomarkers & diagnosticsbiopharma strategybioprocess & manufacturingchemistryclinical trials & translational medicinedrug & device safety
drug discovery & developmentdrug targetsgenomicshealthcareit & informaticstechnology & tools for life sciencetherapeutic indications
conferencesreportsbarnett educational servicesconsultingpublications & eNewslettersprofessional services
executive teamtestimonialschi timelinemailing listcareers