Laboratory Considerations for Clinical Trials
Science:Life Sciences
Mike Brown is the Senior Director of Immuno-analytical and the Bioanalytical Site Lead at Q2 Solutions. In this episode, he describes the considerations for pharmacokinetic and immunogenicity assays in the development of biologics.
He lays out the types of analysis that are needed along with the associated challenges, such as detecting the concentration of a specific antibody therapeutic present at 100 picograms/ml in an antibody background of up to 20 billion picograms/ml. He suggests that sponsors think about the reagents that will be essential for the assays that need to be performed. An analyst will ask:
"Are you going to help put some tools in our toolbox to be able to see that needle in a haystack?" And what the sponsors need to be able to do is to really have good lines of communication within their company, to make sure during the drug development program, that they actually are beginning to invest in those specific materials.
And having disease state matrix during method development, also, in my opinion, it's critical to ensuring that once we get into that patient population, we reduce the risk those are going to be big surprises for working in that biological matrix that's going to interfere with that assay selectivity. The lead times can be significant as can the price, but it really does mitigate risk.
Dr Brown also recommends engaging the FDA early to reduce any risk to your timelines. No one wants to get to the point of submission to find out that the approach was unacceptable and lose precious 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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