From The Stage

A Dose of Pharma and Biotech News: December 12, 2019

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, Industry Update

With innovative research driving pharmaceutical and biotech breakthroughs, industry progress is accelerating at a rapid pace. We've compiled some recent industry articles on the latest topics to share with you.

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.

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.

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.

Podcast Feature: Enabling the Breakthroughs of Tomorrow, Today

Jim Datin
Posted by Jim Datin / / CRO Selection, Industry Update

BioAgilytix’s President and CEO, Jim Datin, sat down to discuss the exciting growth trends in large molecule development, and how BioAgilytix is growing in kind to support the increased need for specialized bioanalysis to accelerate these innovative therapies to market.

Immunogenicity Assessment of Gene Therapy Compounds

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / Gene Therapy, Industry Update

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 concern. Our latest blog gives insight into the current concepts for designing an immunogenicity assessment strategy fitting the specific needs of a given gene therapy compound.

New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / Immunogenicity, Industry Update

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 needed revisions and clarifications. Our own immunogenicity expert, Dr. Arno Kromminga, outlines the significant updates made.