Biomarker Dev Strategies for Therapeutics| Preclinical to Phase 2 | Bioinformatics | ex Revolution Medicines| ex Clinical Cytogeneticist | Bridging Bench to Bedside: Precision in Every Step
An oldie but a goodie. Tracking of the BCR-ABL fusion during the development of imatinib was a fabulous example of a successful pharmacodynamic biomarker. Imatinib, a tyrosine kinase inhibitor, was developed for treating CML, driven by the BCR-ABL fusion protein. PD biomarkers were crucial in its clinical trials to demonstrate the drug's efficacy and guide treatment strategies. The Philadelphia chromosome was tracked using two methods: 1. BCR-ABL Transcript Levels: A decrease in BCR-ABL mRNA levels by qPCR indicated effective inhibition of the BCR-ABL kinase, correlating with reduced leukemic cell proliferation. 2. Cytogenetic Response: Cytogenetic analysis of Philadelphia chromosome-positive cells. Reduction in these cells demonstrated the drug's impact on the leukemic cell population. The latter was one of the first tests I did when I started my Cytogenetics career in 2005. For those of you who have never seen what a Philadelphia chromosome looks like down the microscope- see the karyotype above! As we continue to develop more oncology therapies, remembering these milestones reinforces the power of biomarkers and their uses in our quest to conquer cancer. Don't forget to include pharmacodynamic biomarkers in your early development folks! #biomarkers #drugdevelopment #precisiononcology #biopharma ---- Hi! I'm Josie. I help Biopharma develop successful biomarker strategies. If you'd like to hear more send me a message or book a free discovery call!
Diagnostics Executive/Consultant
9 个月t(9;22)(q34;q11)