Laboratory Considerations for Clinical Trials
Science:Life Sciences
Genomics has come a long way from the days of being primarily a discovery tool.
It used be that essentially all of the genomic data that was being produced as part of clinical trials was purely exploratory in nature. We're doing a great deal of that now, there's no doubt about that. However, now we're actually translating those into real uses. So for example, we might have specific markers that we're using for patient selection. We might have specific markers that are candidates for eventual development companion diagnostic and so we are taking them into clinical trials, characterizing them further.
Dr. Hurban discusses the use of broad genomic features such as microsatellite instability and tumor mutational burden as biomarkers in addition to specific point mutations that have been in use for some time.
He envisions a future where a multidisciplinary approach leads to a companion therapeutic strategy as opposed to a companion diagnostic strategy. In this approach, a single test could direct a patient into any of a number of therapies rather than testing the possibility of one therapy at a time.
What is the Role of Digital Pathology in Clinical Trials
AI in Pathology: Advancements, Challenges, and the Road Ahead
Flow Cytometry as an IVD technology for Companion Diagnostics
Flexible Approaches for Biotech Companies in Clinical Trials
Risk Management for Biotech Companies in Clinical Trials
3 Things to Consider in Preparation for Your Biotech Testing or Trial
Hybrid assays: an interview with Barry Jones and Adriane Spytko
Managing Sample Data from Vendors
Automation within an ADME Laboratory
Bioanalytical Automation of Samples
Consent Tracking for Clinical Samples
Tracking Clinical Trial Samples
Avoiding Canceled Tests in Pediatric Samples
Covid Vaccine Testing
Hybrid Assays for Protein Bioanalysis
High Throughput ADME Testing
Liquid Biopsy Collection in Clinical Development Programs
An Next Generation Sequencing Approach to Influenza Vaccine Development
Standardization of Tumor Mutational Burden by Alignment to Reference Standards
Monitoring the Tumor Micro-environment with Flow Cytometry - Mark Edinger
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