Understanding biomarkers for use as exploratory, primary, and secondary clinical endpoints is essential in drug development.
Overview
Reliable diagnostic, prognostic, predictive, pharmacodynamic, and pharmacokinetic biomarkers are critical to assure correct patient selection, drug dosing, and monitoring to get a patient a drug that is going to work for them. How a biomarker assay is being applied to a drug's development will determine when an assay should evolve from research quality to a clinical diagnostic test. The requirements for a laboratory developed test with regard to assay performance, validation requirements, and when the assay is used for patient selection and risk determination within a clinical study will be presented.
Join us for insights on:
- FDA view on biomarkers
- Regulatory requirements for a biomarker assay when used as a primary, secondary or exploratory clinical endpoint
- Developing a biomarker assay for exploratory use, for determining clinical efficacy and safety endpoints, and as a companion diagnostic
- Application of biomarker methods
- Bioanalytical and CLIA case studies
Audience
This webinar is intended for clinical pharmacologists, bioanalytical scientists, medical technologists, and diagnostic kit vendors.
Presenters
Roger Hayes, PhD
Dr. Hayes has held numerous leadership positions in the global life sciences industry and academia, leading teams in the development of state-of-the-art bioanalytical and analytical techniques to bring medical and chemical products to market. For nearly two decades, he led strategic and research initiatives for large pharmaceutical companies that included both GLP and non-GLP preclinical studies as well as clinical trials.
Andrew Roche, PhD
Dr. Roche has 20 years of experience within the clinical trials industry with particular focus on the intricacies of biomarkers, associated laboratory methods, and their ability to facilitate an efficient and accurate assessment of the clinical safety and efficacy of therapeutics moving through clinical trials.