June 27, 2018

Bioanalysis publishes special focus issue on ‘Biomarker Assay Validation’

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.”

The full issue is available online here:


The guest editors’ free-access foreword article is available online here:


About Bioanalysis


Bioanalysis is a MEDLINE-indexed journal covering the latest scientific, technical and regulatory developments relevant to those working on the analysis of xenobiotics and biotics in biological matrices. This is, primarily, bioanalysts working in pharmaceutical research and development, clinical laboratories, clinical toxicologists, forensic toxicologists and sports doping analysts.


About Bioanalysis Zone


Since launching in 2011, Bioanalysis Zone has attracted over 7,500 active members from the global bioanalytical community, representing the pharmaceutical, biotech and CRO industries, along with academia and healthcare. Each month, thousands of members visit the site to read industry news, original research exclusive interviews and commentaries. Membership is completely free of charge. Sign up online at:


About Future Science Group


Founded in 2001, Future Science Group (FSG) is a progressive publisher focused on breakthrough medical, biotechnological and scientific research. FSG’s portfolio includes two imprints, Future Science and Future Medicine. In addition to this core publishing business, FSG develops specialist eCommunities. Key titles and sites include Bioanalysis Zone, Epigenomics, Nanomedicine and the award-winning Regenerative Medicine.


The aim of FSG is to service the advancement of clinical practice and drug research by enhancing the efficiency of communications among clinicians, researchers and decision-makers, and by providing innovative solutions to their information needs. This is achieved through a customer-centric approach, use of new technologies, products that deliver value-for-money and uncompromisingly high standards.


© 2019 Future Science Group

Unitec House, 2 Albert Place,

London, N3 1QB, UK

Tel: +44 (0)20 8371 6090

  • LinkedIn - White Circle
  • Facebook - White Circle
  • Twitter - White Circle
  • YouTube - White Circle