C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification
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…
Key Takeaways from the 13th Annual WRIB, 2019
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 Assessment of Gene Therapy Compounds
By Dr. Arno Kromminga and Dr. Lydia Michaut
Gene therapy has experienced an exciting resurgence in the post-genomic era, but unwanted immunogenicity is still a…
New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications
The FDA’s recently released new guidance, designed to facilitate development and validation of assays for the detection of anti-drug antibodies for immunogenicity testing, includes several…
Key Takeaways from Oxford Global’s 14th Annual Biomarkers Congress
Couldn’t make the Oxford Global’s 14th Annual Biomarkers Congress? Read our recap of the key opportunities and challenges in biomarker development that scientists discussed.
The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors
...material, gene therapy uses DNA to manipulate a patient’s cells to compensate for abnormal genes or to make a beneficial protein, and cell therapy…
Biomarkers and Immunogenicity in the Spotlight at the 2016 10th Workshop on Recent Issues in Bioanalysis
The whitepaper based on discussions at the 10th Workshop on Recent Issues in Bioanalysis (WRIB) has been published! Everyone who participated, are very excited to…