From The Stage

In Review: Evaluating the New ICH M10 Guideline Draft

Dr. Corinna Fiorotti
Posted by Dr. Corinna Fiorotti / / BioAgilytix Insight, Industry Update

As a member of Bioanalysis Zone’s recent panel discussion, Dr. Corinna Fiorotti evaluated the new ICH M10 guideline draft in terms of its practicality, language, and projected influence. Read her expert insights with accompanying video clips.

BioAgilytix Team Q&A: Meet Jelle Hempenius, Business Development Director, Europe

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, CRO Selection

Did you know that BioAgilytix’s ‘deep bench’ extends beyond those we have working in the lab? Many individuals in our operational departments, from business development to QC, are also formally trained scientists with extensive in-lab experience. One such team member is Jelle Hempenius, who recently joined BioAgilytix as Business Development Director, Europe.

Webinar Sneak Peek: Exploratory Biomarker Testing—to Qualify or Validate the Assay?

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

Biomarkers are endogenous molecules with much individual variability, and there is still not yet one clear and concise guidance for biomarker validation – so there are still questions around what it takes to sufficiently validate the performance characteristics of a biomarker assay to ensure it can properly establish the value of the target biomarker as a qualified DDT.

510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

The answer to the question is “it depends”. Commonly a combination of 510K approved kits (in Europe known as assays that need to follow IVD-directive 2017/746) and research use only (RUO) kits are used to support the biomarker analysis needed in clinical trials because both types of assays have different strengths and limitations. To select the appropriate kit requires an understanding of these pros and cons in the context of the intended study the assay must support.

BioAgilytix Team Q&A: Meet Mike Losauro, Senior Business Development Director at BioAgilytix

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, CRO Selection

Did you know that many of our team members have cross-functional background experience both in the lab and in customer-facing roles, making them uniquely equipped to help us deliver both high quality science and service? In this Q&A session, we talk with Mike Losauro, Senior Business Development Director at BioAgilytix, about how he applies his scientific background to his role today.

Key Takeaways from the 13th Annual WRIB, 2019

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Industry Update

Last month at WRIB, our scientific team had the opportunity to participate in a number of discussions surrounding the latest topics of interest in biomarkers, immunogenicity, and regulatory standards. We wanted to share some of the event takeaways we found most interesting and valuable.

What Drives BioAgilytix’s #TeamBehindtheScience?

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, CRO Selection

What drives BioAgilytix’s #TeamBehindtheScience? Our own Thomas Corey Custer, Nora Freudenberger & Nathan Rudemiller discuss what led them to a scientific career & what propels them on a personal level.