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.

Gene Therapy Trends: Conditional Approval of Zynteglo Brings Ex Vivo Gene Therapy Into Focus

Dr. Lydia Michaut
Posted by Dr. Lydia Michaut / / Gene Therapy, Industry Update

The recent approval of Zynteglo further builds credibility to the specific and emerging class of cell therapies engineered via “ex vivo” gene therapy. We explain how these cell-based gene therapies work, and how they lend themselves to a host of translatable techniques for future therapeutic candidates.

C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Biomarkers, Industry Update

A contributing author to the Critical Path Institute (C-Path)’s “Points to Consider Document,” Dr. Afshin Safavi summarizes considerations outlined in the paper designed to establish consensus on the expectations for the validation of assays used in the regulatory qualification of fluid biomarkers.

Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / Bioanalytical Platforms, Immunogenicity

The observation of drug-specific IgE antibodies which may cause anaphylaxis prompts the need to test for these antibodies - but because IgE are 2000-fold less prevalent than IgG antibodies, a very sensitive detection method is required. We discuss why the ImmunoCAP platform provides an ideal system to analyze IgE-mediated drug hypersensitivities.

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.