The Future Science Group (FSG) published journal, Bioanalysis, which is a leading MEDLINE indexed journal for bioanalysts, today announced the release of its Special Focus Issue on 'Biomarker Assay Validation (BAV) '.
This Special Focus Issue hopes to offer readers of the journal an insight into the various issues that exist surrounding the BAV, how these issues have evolved over the years, as well as the recent regulatory activities around these.
This issue was guest edited by Steven Piccoli (Neoteric) and Fabio Garofolo (Angelini Pharma).
Dr. Piccoli stated: "The issues of biomarker assay validation have evolved over the years, reflecting significant changes in thought-provoking chemotypes, steady advances in analytical technologies and a much more granular interrogatory proposed in support of precision medicine."
He continued: "In order to explore these concerns, this themed issue of Bioanalysis has been dedicated to Biomarker Assay Validation and shares with the reader scientific insight, regulatory opinion and pertinent examples of the current processes."
In this issue, parallelism assessments in LBA biomarker assay development and validation, clinical biomarker validation, the evolution of fit-for-purpose biomarker validations as well as many other important topics are discussed by experts and key opinion leaders in the biomarker field.
Another highlight of this issue is the progress update for the C-Path White Paper on the joint FDA &C-Path Initiative collaboration on analytical validation of biomarker assays used in the FDA biomarker qualification process.
Hannah Makin, one of the co-editors for Bioanalysis commented: "We are delighted to publish this Special Focus Issue, which aims to provide a glimpse into the critical questions that are raised by the issues of biomarker assay validation, as well as the recent regulatory activities surrounding these. We hope that this Special Focus Issues highlights the importance of communication between scientists, regulators, and stakeholders in order to tackle difficult medical challenges and ultimately achieve significant healthcare improvements for patients."