From The Stage

Vector Innovation to Improve Gene Therapy Safety: A Credit to Scientific Tenacity

Dr. Lydia Michaut
Posted by Dr. Lydia Michaut / / BioAgilytix Insight, Gene Therapy

A new clinical trial by St. Jude Children’s Research Hospital for the treatment of SCID-X1 highlights a major advancement in gene therapy safety over recent years, in this case spurred by scientists who were courageous enough to push forward the development of safer vectors to overcome serious adverse events (SAEs) that were resulting from the previous generation of gene therapies developed for SCID-X1.

Webinar Sneak Peek: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars

Todd Lester
Posted by Todd Lester / / BioAgilytix Insight, Biosimilars, Immunogenicity

On January 23rd I’ll be hosting a webinar with Dr. Dominque Gouty that will summarize key insights from the recently published paper by the American Association of Pharmaceutical Scientists (AAPS) entitled “Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs”. I had the privilege to contribute as an author on this pivotal paper, which lays out a consensus recommendation for use of a one-assay approach to develop and validate ADA assays supporting biosimilar drug development programs. It has taken years of industry discussion and collaboration…