We shall see what happens on 24 July.
<<11:00 Filling the Gap between Discovery and Clinically Validated Biomarkers
Philip Hemken, Abbott Laboratories
Abstract:
This talk will focus on the development of robust assays for biomarkers, which is an important step in filling the gap between the discovery and clinically validated biomarkers. First, the decision process to generate a biomarker assay for clinical use will be described. What are the characteristics of a biomarker that would make it clinically useful, especially in cancer diagnostics? Second, the steps in the R&D process of developing a marker assay and evaluating clinical performance will be given in detail. The development of an ARCHITECT TIMP-1 (tissue inhibitor of metalloproteinases-1) immunoassay for colorectal cancer detection will be used as an example to demonstrate the types of analytical performance testing that is necessary to validate a biomarker immunoassay. Preanalytical considerations will be reviewed. Reagent selection and characterization, definition of assay requirements, initial assay concept, reagent optimization and the final analytical validation of the biomarker’s assay performance will be described. Examples of some critical performance requirements, such as, lack of cross-reactivity with similar molecules, resistance to human anti-mouse antibodies and heterophilic antibodies, lack of high dose hook effects, and others will be presented. The overall emphasis will be to provide information for developing a robust immunoassay with as little analytical error as possible in order to confidently address the clinical utility of a biomarker.
Speaker Bio:
In 1997 Dr. Hemken joined Abbott Laboratories and is a project manager in the Cancer Core R&D team. He is currently managing the Cancer New Leads Team, of which he has been a member for 10 years, and he is managing the development of a new cancer biomarker. Dr. Hemken received his M.A. in Biotechnology from Washington University in St. Louis (1991) and his Ph.D. in Molecular, Cellular and Developmental Biology at Iowa State University (1996). He then held a postdoctoral position at Argonne National Laboratory. At Abbott, he first worked in Technical Support then moved on to Molecular Diagnostics R&D. Then he worked at Vysis, an Abbott Laboratories Company, in FISH Probe R&D. In the Cancer Core R&D group, Dr. Hemken has worked on the team that developed tissue inhibitor of metalloproteinase-1 (TIMP-1) for the ARCHITECT immunoassay system and on the RECAF project.>>
