Discovery & Development of Circulating Biomarkers for Drug DevelopmentTuesday, 28 October 2014 at 09:15 Add to Calendar ▼SELECTBIOenquiries@selectbiosciences.com Biomarkers play important roles for drug development, because (1) biomarkers can show target engagement (proof of mechanism) of drug candidates, (2) biomarkers can determine right dosage and dosing schedule (pharmacodynamic biomarkers), (3) biomarkers can identify responders/poor responders for drug candidates (patient stratification), and (4) biomarkers can monitor drug responses (drug monitoring). Disease target tissue analysis is common in oncology area, but we cannot always get archival tissue samples when we need. Especially it may be hard to obtain tissues samples when our drug is used as 3rd line therapy. In addition, we sometimes need clinical samples from both pre- and post-dosing. Body fluid samples such as plasma, serum, urine would be ideal for biomarker analysis, because it is relatively easy to obtain samples during clinical studies, even multiple time points. Proteins, endogenous metabolites and miRNAs are interesting as circulating biomarkers among different disease areas. During the conference, I would like to show some examples from our data, and discuss current challenges such as: How to obtain clinical relevant samples for preclinical studies? How to show scientific rationale about drug efficacy/patient stratification biomarkers? How to determine the cut-off values? When is a good time to start the development of companion diagnostics? |